Placebo ( DrugBank: - )
28 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 3 | 脊髄性筋萎縮症 | 50 |
| 5 | 進行性核上性麻痺 | 47 |
| 6 | パーキンソン病 | 1050 |
| 11 | 重症筋無力症 | 160 |
| 13 | 多発性硬化症／視神経脊髄炎 | 1263 |
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 53 |
| 37 | 膿疱性乾癬（汎発型） | 42 |
| 40 | 高安動脈炎 | 6 |
| 46 | 悪性関節リウマチ | 1772 |
| 49 | 全身性エリテマトーデス | 607 |
| 50 | 皮膚筋炎／多発性筋炎 | 93 |
| 51 | 全身性強皮症 | 275 |
| 53 | シェーグレン症候群 | 180 |
| 63 | 特発性血小板減少性紫斑病 | 132 |
| 66 | IgA腎症 | 133 |
| 67 | 多発性嚢胞腎 | 102 |
| 79 | 家族性高コレステロール血症（ホモ接合体） | 53 |
| 85 | 特発性間質性肺炎 | 372 |
| 86 | 肺動脈性肺高血圧症 | 458 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 70 |
| 96 | クローン病 | 1195 |
| 97 | 潰瘍性大腸炎 | 1383 |
| 140 | ドラベ症候群 | 49 |
| 144 | レノックス・ガストー症候群 | 51 |
| 149 | 片側痙攣・片麻痺・てんかん症候群 | 6 |
| 226 | 間質性膀胱炎（ハンナ型） | 89 |
| 271 | 強直性脊椎炎 | 264 |
| 276 | 軟骨無形成症 | 18 |
3. 脊髄性筋萎縮症
臨床試験数 : 237 / 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05337553 (ClinicalTrials.gov) | July 6, 2022 | 14/4/2022 | A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy | A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Ambulatory and Non-Ambulatory Participants With Spinal Muscular Atrophy With Open-Label Extension | Spinal Muscular Atrophy;Neuromuscular Diseases;SMA | Drug: taldefgrobep alfa;Drug: Placebo | Biohaven Pharmaceuticals, Inc. | NULL | Recruiting | 4 Years | 21 Years | All | 225 | Phase 3 | United States;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 2 | NCT05115110 (ClinicalTrials.gov) | June 2, 2022 | 1/11/2021 | A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy | A Two-Part, Seamless, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Patients With Spinal Muscular Atrophy | Spinal Muscular Atrophy (SMA) | Drug: RO7204239;Drug: Placebo;Drug: Risdiplam | Hoffmann-La Roche | NULL | Recruiting | 2 Years | 25 Years | All | 259 | Phase 2/Phase 3 | United States;Belgium;Italy;Netherlands;Poland;United Kingdom;Germany |
| 3 | EUCTR2021-003417-19-NL (EUCTR) | 25/05/2022 | 11/01/2022 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7204239 in Combination with Risdiplam (RO7034067) in Ambulant Patients with Spinal Muscular Atrophy | A TWO-PART, SEAMLESS, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7204239 IN COMBINATION WITH RISDIPLAM (RO7034067) IN AMBULANT PATIENTS WITH SPINAL MUSCULAR ATROPHY | Spinal Muscular Atrophy (SMA);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: N/A Product Code: RO7204239/F01-01 INN or Proposed INN: N/A Other descriptive name: GYM329 Trade Name: Evrysdi INN or Proposed INN: Risdiplam | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;Poland;Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 4 | EUCTR2021-005314-34-ES (EUCTR) | 11/05/2022 | 09/03/2022 | Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with Later-Onset Spinal Muscular Atrophy Who Are Being Treated with Nusinersen or Risdiplam | Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy - SAPPHIRE | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Apitegromab Product Code: SRK-015 INN or Proposed INN: Apitegromab | Scholar Rock, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 204 | Phase 3 | France;United States;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 5 | NCT05156320 (ClinicalTrials.gov) | February 24, 2022 | 1/12/2021 | Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam | Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients With Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy | Spinal Muscular Atrophy;Spinal Muscular Atrophy Type 3;Spinal Muscular Atrophy Type 2;SMA;Neuromuscular Diseases;Muscular Atrophy;Atrophy;Muscular Atrophy, Spinal;Neuromuscular Manifestations;Anti-myostatin | Drug: Apitegromab;Drug: Placebo | Scholar Rock, Inc. | NULL | Recruiting | 2 Years | 21 Years | All | 204 | Phase 3 | Germany;Italy;Netherlands;Poland;Spain;United Kingdom;Belgium;France;United States |
| 6 | EUCTR2021-003417-19-PL (EUCTR) | 18/01/2022 | 25/10/2021 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7204239 in Combination with Risdiplam (RO7034067) in Ambulant Patients with Spinal Muscular Atrophy | A TWO-PART, SEAMLESS, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7204239 IN COMBINATION WITH RISDIPLAM (RO7034067) IN AMBULANT PATIENTS WITH SPINAL MUSCULAR ATROPHY | Spinal Muscular Atrophy (SMA);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: N/A Product Code: RO7204239/F01-01 INN or Proposed INN: N/A Other descriptive name: GYM329 Trade Name: Evrysdi INN or Proposed INN: Risdiplam | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;Belgium;Poland;Netherlands;United Kingdom;Italy | ||
| 7 | EUCTR2021-003417-19-IT (EUCTR) | 03/01/2022 | 18/10/2021 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7204239 in Combination with Risdiplam (RO7034067) in Ambulant Patients with Spinal Muscular Atrophy | A TWO-PART, SEAMLESS, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7204239 IN COMBINATION WITH RISDIPLAM (RO7034067) IN AMBULANT PATIENTS WITH SPINAL MUSCULAR ATROPHY - NA | Spinal Muscular Atrophy (SMA) MedDRA version: 20.0;Level: LLT;Classification code 10079415;Term: Spinal muscular atrophy type III;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10051203;Term: Spinal muscular atrophy congenital;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10079413;Term: Spinal muscular atrophy type I;Classification code 10079416;Term: Spinal muscular atrophy type II;Classification code 10079417;Term: Spinal muscular atrophy infantile onset;Classification code 10079419;Term: Spinal muscular atrophy pre-symptomatic;Classification code 10079418;Term: Spinal muscular atrophy later onset;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: N/A Product Code: [RO7204239/F01-01] Trade Name: Evrysdi Product Name: Risdiplam Product Code: [RO7034067] INN or Proposed INN: Risdiplam | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;Poland;Belgium;Netherlands;United Kingdom;Italy | ||
| 8 | ChiCTR2000041208 | 2020-12-30 | 2020-12-22 | A randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of salbutamol sulfate tablets in the treatment of children with spinal muscular atrophy | A randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of salbutamol sulfate tablets in the treatment of children with spinal muscular atrophy | spinal muscular atrophy | experimental group: salbutamol sulfate tablets ;control group:placebo; | The Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 2 | 17 | Both | experimental group:60;control group:30; | Phase 4 | China |
| 9 | EUCTR2016-000750-35-GB (EUCTR) | 25/11/2020 | 23/06/2016 | A study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of Risdiplam (RO7034067) in type 2 and 3 spinal muscular atrophy patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RISDIPLAM (RO7034067) IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) Type 2 and 3 MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F12 INN or Proposed INN: risdiplam Product Name: RO7034067 Product Code: RO7034067/F13 INN or Proposed INN: risdiplam | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 2 | United States;Serbia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Croatia;Bulgaria;Germany;China;Japan | ||
| 10 | NCT03781479 (ClinicalTrials.gov) | January 21, 2019 | 18/12/2018 | Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients | A Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3 | Muscular Atrophy, Spinal | Drug: Amifampridine Phosphate;Drug: Placebo Oral Tablet | Catalyst Pharmaceuticals, Inc. | NULL | Completed | 6 Years | 50 Years | All | 13 | Phase 2 | Italy |
| 11 | EUCTR2016-000750-35-BG (EUCTR) | 20/06/2018 | 04/06/2018 | A study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO7034067 in type 2 and 3 spinal muscular atrophy patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7034067 IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F12 INN or Proposed INN: n.a Product Name: RO7034067 Product Code: RO7034067/F13 INN or Proposed INN: n.a | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 2 | Serbia;United States;Spain;Ukraine;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;China | ||
| 12 | EUCTR2017-004600-22-IT (EUCTR) | 04/04/2018 | 07/04/2021 | Clinical study evaluating the effect of Amifampridine Phosphate in Ambulatory Patients with Spinal Muscular Atrophy (SMA) Type 3. | A Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients with Spinal Muscular Atrophy (SMA) Type 3 - SMA-001 | Spinal Muscular Atrophy (SMA) Type 3 MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE Product Name: Amifampridina fosfato Product Code: [Amifampridina fosfato] INN or Proposed INN: AMIFAMPRIDINA Other descriptive name: 3,4-Diaminopyridine Phosphate | CATALYST PHARMACEUTICALS INC. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Italy | ||
| 13 | JPRN-JapicCTI-173722 | 03/4/2018 | 04/10/2017 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7034067 in Type 2 and 3 Spinal Muscular Atrophy Participants (Sunfish) | A Two-Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7034067 in Type 2 and 3 Spinal Muscular Atrophy Patients | Spinal Muscular Atrophy | Intervention name : RO7034067 INN of the intervention : risdiplam Dosage And administration of the intervention : po Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : po | CHUGAI PHARMACEUTICAL CO., LTD. | NULL | complete | 2 | 25 | BOTH | 168 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe |
| 14 | EUCTR2016-000750-35-HR (EUCTR) | 27/03/2018 | 12/04/2018 | A study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of Risdiplam (RO7034067) in type 2 and 3 spinal muscular atrophy patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7034067 IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) Type 2 and 3 MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F12 INN or Proposed INN: risdiplam Product Name: RO7034067 Product Code: RO7034067/F13 INN or Proposed INN: risdiplam | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 219 | Phase 2 | United States;Serbia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;China;Japan | ||
| 15 | EUCTR2016-000750-35-DE (EUCTR) | 09/11/2016 | 13/07/2016 | A Study to investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7034067 IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) Type 2 and 3 MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F12 INN or Proposed INN: Risdiplam Product Name: RO7034067 Product Code: RO7034067/F13 INN or Proposed INN: Risdiplam | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 219 | Phase 2 | Serbia;United States;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;China;Japan | ||
| 16 | NCT02908685 (ClinicalTrials.gov) | October 20, 2016 | 19/9/2016 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants | A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients | Muscular Atrophy, Spinal | Drug: Placebo;Drug: Risdiplam | Hoffmann-La Roche | NULL | Active, not recruiting | 2 Years | 25 Years | All | 231 | Phase 2/Phase 3 | United States;Belgium;Brazil;Canada;China;Croatia;France;Germany;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Turkey;United Kingdom;Argentina;Australia;Sweden;Switzerland;Taiwan |
| 17 | EUCTR2016-000750-35-BE (EUCTR) | 06/09/2016 | 12/07/2016 | A study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of Risdiplam (RO7034067) in type 2 and 3 spinal muscular atrophy patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7034067 IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) Type 2 and 3 MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F12 INN or Proposed INN: risdiplam Product Name: RO7034067 Product Code: RO7034067/F13 INN or Proposed INN: risdiplam | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 219 | Phase 2 | United States;Serbia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;China;Japan | ||
| 18 | EUCTR2016-000750-35-IT (EUCTR) | 29/08/2016 | 28/06/2016 | A Study to investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Efficacy of RO7034067 in Type 2 and 3 Spinal Muscular Atrophy Patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7034067 IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) MedDRA version: 19.0;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F06 with solvent (RO7034067/F08) INN or Proposed INN: n.a Product Name: RO7034067 Product Code: RO7034067/F07 with solvent (RO7034067/F09) INN or Proposed INN: n.a | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 2 | United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 19 | EUCTR2014-003626-40-BE (EUCTR) | 09/06/2016 | 30/03/2016 | Nivolumab versus placebo after surgery in subjects with urinary tract cancer | A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma - CheckMate 274 | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: LMI070 Other descriptive name: LMI070 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 1;Phase 2 | Netherlands;Germany;Italy;United States;Czech Republic;Hungary;Poland;Belgium;Denmark;Russian Federation;Bulgaria | ||
| 20 | JPRN-JMA-IIA00231 | 29/01/2016 | 01/12/2015 | Multicenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophy : Confirmatory Trial | Multicenter cooperative and investigator initiated clinical trial using valproic acid in childhood onset spinal muscular atrophy : Confirmatory Trial | spinal muscular atrophy | Intervention type:DRUG. Intervention1:SMART, Dose form:GRANULES, Route of administration:ORAL, intended dose regimen:VPA 12.5mg/kg or 25mg/kg is to be taken once a day after supper.. Control intervention1:Placebo, Dose form:GRANULES, Route of administration:ORAL, Intended dose regimen:Placebo is to be taken once a day after supper.. | Institute of Medical Genetics, Tokyo Women's Medical University | NULL | Completed | >=1 YEARS | <7 YEARS | BOTH | 28 | Phase 2B | Japan |
| 21 | NCT02644668 (ClinicalTrials.gov) | January 14, 2016 | 23/12/2015 | A Study of CK-2127107 in Patients With Spinal Muscular Atrophy | A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study of CK-2127107 in Two Ascending Dose Cohorts of Patients With Spinal Muscular Atrophy | Spinal Muscular Atrophy | Drug: Placebo;Drug: Reldesemtiv 150 mg;Drug: Reldesemtiv 450 mg | Cytokinetics | Astellas Pharma Global Development, Inc. | Completed | 12 Years | N/A | All | 70 | Phase 2 | United States;Canada |
| 22 | NCT02633709 (ClinicalTrials.gov) | January 7, 2016 | 15/12/2015 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers | A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending-Dose(SAD), Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food and the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of RO7034067), and Pharmacodynamics of RO7034067 Following Oral Administration in Healthy Subjects | Spinal Muscular Atrophy | Drug: Itraconazole;Other: Placebo;Drug: Risdiplam | Hoffmann-La Roche | NULL | Completed | 18 Years | 45 Years | Male | 33 | Phase 1 | Netherlands |
| 23 | NCT02941328 (ClinicalTrials.gov) | December 2015 | 30/9/2016 | SPACE Trial: Pyridostigmine vs Placebo in SMA Types 2, 3 and 4 | A Phase II, Mono-center, Placebo-controlled, Double-blind, Crossover Trial to Investigate Effect and Efficacy of Pyridostigmine in Dutch Patients With Spinal Muscular Atrophy Types 2, 3 and 4 | Spinal Muscular Atrophy;SMA;Kugelberg-Welander Disease | Drug: Pyridostigmine;Drug: Placebo | UMC Utrecht | NULL | Completed | 12 Years | N/A | All | 39 | Phase 2 | Netherlands |
| 24 | EUCTR2011-004369-34-NL (EUCTR) | 22/04/2015 | 03/11/2014 | SPACE trial SMA and Pyridostigmine in Adults and Children; Experimental trial to assess effect of pyridostigmine compared to placebo in patients with spinal muscular atrophy types 2, 3 and 4 | SPACE trial SMA and Pyridostigmine in Adults and Children; Efficacy trial Phase II, mono-center, doubleblind, placebo-controlled, crossover trial to assess efficacy of pyridostigmine in patients with spinal muscular atrophy types 2, 3 and 4 - SPACE trial | Proximal spinal muscular atrophy (SMA) is characterized by weakness of predominantly axial and proximal muscle groups and is caused by homozygous deletion of the survival motor neuron 1 (SMN1)-gene. There are 4 SMA types (type 1-4), with a descending order of severity. Age at onset and achieved motor milestones are the characteristics to define severity. Treatment of SMA is exclusively supportive. MedDRA version: 17.1;Level: LLT;Classification code 10068209;Term: Spinal muscular atrophy adult onset;System Organ Class: 100000004850 MedDRA version: 17.1;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: pyridostigmine bromide Product Name: Mestinon Product Code: RVG 03820 | Universtiy Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands | ||
| 25 | EUCTR2014-002246-41-ES (EUCTR) | 15/04/2015 | 03/03/2015 | A Study of RO6885247 in Adult and Pediatric Patients with Spinal Muscular Atrophy (MOONFISH) | A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO6885247 FOLLOWING 12 WEEKS OF TREATMENT IN ADULT AND PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY (MOONFISH) - MOONFISH | Spinal Muscular Atrophy MedDRA version: 18.0;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: RO6885247/F03 INN or Proposed INN: n.a. Other descriptive name: n.a. Product Code: RO6885247/F02 INN or Proposed INN: n.a. Other descriptive name: n.a. | Roche Farma S.A., en nombre de F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1 | France;United States;Spain;Turkey;Netherlands;Italy;United Kingdom;Switzerland;Sweden | ||
| 26 | NCT02240355 (ClinicalTrials.gov) | November 2014 | 11/9/2014 | A Study of RO6885247 in Adult and Pediatric Patients With Spinal Muscular Atrophy (MOONFISH) | A Multicenter, Randomized, Double Blind, Placebo Controlled, Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6885247 Following 12 Weeks of Treatment in Adult and Pediatric Patients With Spinal Muscular Atrophy (MOONFISH). | Muscular Atrophy, Spinal | Drug: RO6885247;Drug: placebo | Hoffmann-La Roche | NULL | Terminated | N/A | 55 Years | Both | 9 | Phase 1 | United States;Canada;France;Italy;Netherlands;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic |
| 27 | EUCTR2014-002246-41-IT (EUCTR) | 23/10/2014 | 09/09/2014 | A Study of RO6885247 in Adult and Pediatric Patients with Spinal Muscular Atrophy (MOONFISH) | A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO6885247 FOLLOWING 12 WEEKS OF TREATMENT IN ADULT AND PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY (MOONFISH) - MOONFISH | Spinal Muscular Atrophy MedDRA version: 17.0;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: RO6885247/F03 INN or Proposed INN: n.a. Other descriptive name: n.a. | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | United States;Spain;Netherlands;United Kingdom;Switzerland;Italy | ||
| 28 | NCT01671384 (ClinicalTrials.gov) | August 2013 | 13/8/2012 | Valproate and Levocarnitine in Children With Spinal Muscular Atrophy | Randomized Placebo Controlled Trial of Valproate and Levocarnitine in Children With Spinal Muscular Atrophy Aged 2-15 Years | Spinal Muscular Atrophy | Drug: Valproate, Levocarnitine;Drug: Placebo | All India Institute of Medical Sciences, New Delhi | NULL | Recruiting | 2 Years | 15 Years | Both | 60 | Phase 3 | India |
| 29 | NCT01645787 (ClinicalTrials.gov) | June 2012 | 5/7/2012 | Short and Long Term Treatment With 4-AP in Ambulatory SMA Patients | Columbia SMA Project: 4-AP as a Potential SMA Therapeutic Agent and Biological Mechanisms of Action | Spinal Muscular Atrophy | Drug: 4-aminopyridine;Drug: Placebo | Columbia University | NULL | Completed | 18 Years | 50 Years | Both | 11 | Phase 2/Phase 3 | United States |
| 30 | EUCTR2010-020386-24-GB (EUCTR) | 31/01/2011 | 08/10/2010 | Safety and Efficacy of Olesoxime (TRO19622) in 3-25 yrs SMA patients | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years). MedDRA version: 14.0;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: OLESOXIME Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Germany;Netherlands;Italy;United Kingdom | ||
| 31 | EUCTR2010-020386-24-DE (EUCTR) | 29/12/2010 | 28/07/2010 | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years). MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy | Product Name: OLESOXIME Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 32 | EUCTR2010-020386-24-NL (EUCTR) | 18/11/2010 | 28/06/2010 | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years). MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy | Product Name: OLESOXIME Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 33 | NCT01302600 (ClinicalTrials.gov) | November 2010 | 18/2/2011 | Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients. | Phase II, Multicenter, Randomized, Adaptive, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Year Old Spinal Muscular Atrophy (SMA) Patients. | Spinal Muscular Atrophy Type II;Spinal Muscular Atrophy Type III Non Ambulant | Drug: Olesoxime;Drug: Placebo | Hoffmann-La Roche | Association Française contre les Myopathies (AFM), Paris | Completed | 3 Years | 25 Years | Both | 165 | Phase 2 | Belgium;France;Germany;Italy;Netherlands;Poland;United Kingdom |
| 34 | EUCTR2010-020386-24-BE (EUCTR) | 29/10/2010 | 27/07/2010 | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years). MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy | Product Name: OLESOXIME Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 35 | EUCTR2010-020386-24-IT (EUCTR) | 14/09/2010 | 01/09/2010 | Phase II,multicenter,randomized,adaptive,double-blind,placebo controlled study to assess safety and efficacy of olexosime (TRO19622)in 3-25 year old Spinal Muscular Atrophy (SMA) patients | Phase II,multicenter,randomized,adaptive,double-blind,placebo controlled study to assess safety and efficacy of olexosime (TRO19622)in 3-25 year old Spinal Muscular Atrophy (SMA) patients | Spinal Muscular Atrophy - type II or III in non ambulant patients aged 3-25 years MedDRA version: 9.1;Level: LLT;Classification code 10032950 | Product Name: olesoxime Product Code: TRO19622 INN or Proposed INN: olesoxime | TROPHOS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 36 | EUCTR2007-001088-32-IT (EUCTR) | 29/07/2008 | 18/07/2008 | A PHASE II RANDOMIZED, DOUBLE-BLIND STUDY VS. PLACEBO FOR THE EVALUATION OF EFFICACY AND TOLERABILITY OF SALBUTAMOL ADMINISTERED BY ORAL ROUTE IN PATIENTS AFFECTED BY SPINAL MUSCULAR ATHROPHY. - ND | A PHASE II RANDOMIZED, DOUBLE-BLIND STUDY VS. PLACEBO FOR THE EVALUATION OF EFFICACY AND TOLERABILITY OF SALBUTAMOL ADMINISTERED BY ORAL ROUTE IN PATIENTS AFFECTED BY SPINAL MUSCULAR ATHROPHY. - ND | Patients affected by SMA MedDRA version: 9.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy | Trade Name: VOLMAX*30CPR 4MG R.P. INN or Proposed INN: Salbutamol | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | |||
| 37 | NCT00533221 (ClinicalTrials.gov) | October 2007 | 12/9/2007 | Pilot Study of Growth Hormon to Treat SMA Typ II and III | Can Treatment With Human Growth Hormone Increase Strength in Spinal Muscular Atrophy Type II and III? | Muscular Atrophy, Spinal | Drug: somatotropin;Drug: Placebo | University Hospital Freiburg | Novo Nordisk A/S | Completed | 6 Years | 35 Years | Both | 20 | Phase 2 | Germany |
| 38 | NCT00481013 (ClinicalTrials.gov) | July 2007 | 30/5/2007 | Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy | Prospective Controlled Trial of Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy (VALIANTSMA) Study | Spinal Muscular Atrophy | Drug: Valproic Acid (VPA);Drug: Placebo | University of Utah | Families of Spinal Muscular Atrophy;Abbott | Completed | 18 Years | 60 Years | Both | 33 | Phase 2 | United States |
| 39 | NCT00485511 (ClinicalTrials.gov) | June 2007 | 11/6/2007 | A Trial of Hydroxyurea in Spinal Muscular Atrophy | A Randomized, Double-Blind, Placebo-Controlled Trial of Hydroxyurea in Spinal Muscular Atrophy | Spinal Muscular Atrophy | Drug: Hydroxyurea | Kaohsiung Medical University Chung-Ho Memorial Hospital | NULL | Completed | 4 Years | N/A | Both | Phase 2/Phase 3 | Taiwan | |
| 40 | NCT00774423 (ClinicalTrials.gov) | January 2006 | 16/10/2008 | Study to Evaluate the Efficacy of Riluzole in Children and Young Adults With Spinal Muscular Atrophy (SMA) | Multicentric, Randomized, Double-blind Study Versus Placebo, With Two Parallel Groups Treated to Evaluate the Efficacy and the Tolerance of Riluzole in Children and Young Adults (6 to 20 Years of Age) With SMA. (Type II and Type III) | SMA | Drug: Riluzole | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 6 Years | 20 Years | Both | 141 | Phase 2/Phase 3 | France |
| 41 | NCT00227266 (ClinicalTrials.gov) | September 2005 | 23/9/2005 | Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy | Multi-center Phase II Trial of Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy (SMA CARNI-VAL Trial) | Spinal Muscular Atrophy | Drug: Valproic Acid and Levocarnitine;Drug: Placebo | University of Utah | Families of Spinal Muscular Atrophy;Leadiant Biosciences, Inc.;Abbott | Completed | 2 Years | 17 Years | All | 94 | Phase 2 | United States;Canada |
| 42 | NCT00568698 (ClinicalTrials.gov) | January 2004 | 4/12/2007 | A Pilot Therapeutic Trial Using Hydroxyurea in Type I Spinal Muscular Atrophy Patients | A Pilot Therapeutic Trial Using Hydroxyurea in Type I Spinal Muscular Atrophy Patients | Muscular Atrophy, Spinal | Drug: Hydroxyurea;Drug: Placebo to match hydroxyurea | Stanford University | NULL | Completed | N/A | 2 Years | All | 29 | Phase 1/Phase 2 | United States |
| 43 | NCT00568802 (ClinicalTrials.gov) | January 2004 | 4/12/2007 | A Pilot Therapeutic Trial Using Hydroxyurea in Type II and Type III Spinal Muscular Atrophy Patients | A Pilot Therapeutic Trial Using Hydroxyurea in Type II and Type III Spinal Muscular Atrophy Patients | Muscular Atrophy, Spinal | Drug: Hydroxyurea;Drug: Placebo to match hydroxyurea | Stanford University | NULL | Completed | 1 Year | 10 Years | All | 27 | Phase 1/Phase 2 | United States |
| 44 | EUCTR2021-005314-34-NL (EUCTR) | 10/03/2022 | Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with Later-Onset Spinal Muscular Atrophy Who Are Being Treated with Nusinersen or Risdiplam | Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy - SAPPHIRE | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Apitegromab Product Code: SRK-015 INN or Proposed INN: Apitegromab | Scholar Rock, Inc. | NULL | NA | Female: yes Male: yes | 204 | Phase 3 | France;United States;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom;Italy | |||
| 45 | EUCTR2021-003417-19-DE (EUCTR) | 18/11/2021 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7204239 in Combination with Risdiplam (RO7034067) in Ambulant Patients with Spinal Muscular Atrophy | A TWO-PART, SEAMLESS, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7204239 IN COMBINATION WITH RISDIPLAM (RO7034067) IN AMBULANT PATIENTS WITH SPINAL MUSCULAR ATROPHY | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10079413;Term: Spinal muscular atrophy type I;Classification code 10079415;Term: Spinal muscular atrophy type III;Classification code 10079416;Term: Spinal muscular atrophy type II;Classification code 10079417;Term: Spinal muscular atrophy infantile onset;Classification code 10079418;Term: Spinal muscular atrophy later onset;Classification code 10079419;Term: Spinal muscular atrophy pre-symptomatic;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: N/A Product Code: RO7204239/F01-01 INN or Proposed INN: N/A Other descriptive name: GYM329 Trade Name: Evrysdi INN or Proposed INN: Risdiplam | F.Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | |||
| 46 | EUCTR2021-003417-19-BE (EUCTR) | 15/12/2021 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7204239 in Combination with Risdiplam (RO7034067) in Ambulant Patients with Spinal Muscular Atrophy | A TWO-PART, SEAMLESS, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7204239 IN COMBINATION WITH RISDIPLAM (RO7034067) IN AMBULANT PATIENTS WITH SPINAL MUSCULAR ATROPHY | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10079413;Term: Spinal muscular atrophy type I;Classification code 10079415;Term: Spinal muscular atrophy type III;Classification code 10079416;Term: Spinal muscular atrophy type II;Classification code 10079417;Term: Spinal muscular atrophy infantile onset;Classification code 10079418;Term: Spinal muscular atrophy later onset;Classification code 10079419;Term: Spinal muscular atrophy pre-symptomatic;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: N/A Product Code: RO7204239/F01-01 INN or Proposed INN: N/A Other descriptive name: GYM329 Trade Name: Evrysdi INN or Proposed INN: Risdiplam | F.Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;Poland;Belgium;Germany;Netherlands;Italy;United Kingdom | |||
| 47 | EUCTR2016-000750-35-PL (EUCTR) | 20/02/2018 | A study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO7034067 in type 2 and 3 spinal muscular atrophy patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7034067 IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F12 INN or Proposed INN: risdiplam Product Name: RO7034067 Product Code: RO7034067/F13 INN or Proposed INN: risdiplam | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 219 | Phase 2 | United States;Serbia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;China;Japan | |||
| 48 | EUCTR2016-000750-35-FR (EUCTR) | 26/01/2018 | A Study to investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Efficacy of RO7034067 in Type 2 and 3 Spinal Muscular Atrophy Patients | A TWO-PART SEAMLESS, MULTI-CENTER RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND EFFICACY OF RO7034067 IN TYPE 2 AND 3 SPINAL MUSCULAR ATROPHY PATIENTS. | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RO7034067 Product Code: RO7034067/F06 with solvent (RO7034067/F08) INN or Proposed INN: n.a Product Name: RO7034067 Product Code: RO7034067/F07 with solvent (RO7034067/F09) INN or Proposed INN: n.a | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 186 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 49 | EUCTR2010-020386-24-FR (EUCTR) | 01/06/2010 | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. | Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years) MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy | Product Name: OLESOXIME Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | NA | Female: yes Male: yes | Phase 2 | France;Belgium;Germany;Netherlands;United Kingdom;Italy | ||||
| 50 | EUCTR2021-005314-34-BE (EUCTR) | 11/02/2022 | Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with Later-Onset Spinal Muscular Atrophy Who Are Being Treated with Nusinersen or Risdiplam | Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy - SAPPHIRE | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Apitegromab Product Code: SRK-015 INN or Proposed INN: Apitegromab | Scholar Rock, Inc. | NULL | NA | Female: yes Male: yes | 204 | Phase 3 | United States;France;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy |
5. 進行性核上性麻痺
臨床試験数 : 89 / 薬物数 : 107 - (DrugBank : 40) / 標的遺伝子数 : 65 - 標的パスウェイ数 : 108
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03446807 (ClinicalTrials.gov) | December 2021 | 20/2/2018 | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Parkinson Disease;Multiple System Atrophy;Progressive Supranuclear Palsy | Drug: Droxidopa;Drug: Placebo Oral Tablet | Loma Linda University | H. Lundbeck A/S | Not yet recruiting | 50 Years | N/A | All | 32 | Phase 2 | United States |
| 2 | NCT04937530 (ClinicalTrials.gov) | June 23, 2021 | 16/6/2021 | RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY | A Randomized, Double-blind, Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: RT001;Drug: Placebo | Retrotope, Inc. | NULL | Recruiting | 40 Years | 80 Years | All | 40 | Phase 2 | Germany |
| 3 | NCT04539041 (ClinicalTrials.gov) | February 16, 2021 | 25/8/2020 | Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear Palsy | A Randomized, Participant, Investigator and Sponsor Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intrathecally Administered NIO752 in Participants With Progressive Supranuclear Palsy | Progressive Supranuclear Palsy (PSP) | Drug: antisense oligonucleotide;Drug: placebo | Novartis Pharmaceuticals | NULL | Recruiting | 40 Years | 75 Years | All | 66 | Phase 1 | United States;Canada;Germany;United Kingdom |
| 4 | NCT04253132 (ClinicalTrials.gov) | January 1, 2021 | 17/12/2019 | Evaluation of Tolfenamic Acid in Individuals With PSP at 12-Weeks | A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Tolfenamic Acid for the Treatment of Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: Tolfenamic Acid;Drug: Placebos | NeuroTau, Inc. | The Cleveland Clinic | Not yet recruiting | 40 Years | 85 Years | All | 24 | Phase 1/Phase 2 | United States |
| 5 | NCT04008355 (ClinicalTrials.gov) | June 22, 2020 | 18/6/2019 | A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 on Cerebrospinal Fluid Biomarkers in 36 Patients With Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: AZP2006 oral solution;Drug: Placebo oral solution | AlzProtect SAS | NULL | Completed | 40 Years | 80 Years | All | 36 | Phase 2 | France |
| 6 | NCT04185415 (ClinicalTrials.gov) | December 3, 2019 | 2/12/2019 | A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP) | A Participant-Blind, Investigator-Blind, Placebo-Controlled, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP) | Progressive Supranuclear Palsy | Drug: bepranemab;Drug: Placebo | UCB Biopharma SRL | NULL | Completed | 40 Years | N/A | All | 25 | Phase 1 | Belgium;Germany;Spain;United Kingdom |
| 7 | NCT03924414 (ClinicalTrials.gov) | November 15, 2019 | 2/4/2019 | Trial of Parkinson's And Zoledronic Acid | TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease | Parkinson Disease;Osteoporosis;Parkinsonism;Parkinson's Disease and Parkinsonism;Atypical Parkinsonism;Progressive Supranuclear Palsy;Multiple System Atrophy;Vascular Parkinsonism;Dementia With Lewy Bodies | Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: Placebo | California Pacific Medical Center Research Institute | National Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's Foundation | Recruiting | 60 Years | N/A | All | 3500 | Phase 4 | United States |
| 8 | NCT04184063 (ClinicalTrials.gov) | September 16, 2019 | 29/7/2019 | Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) | A Pilot Exploratory, Randomised, Placebo-controlled, Double Blinded, Cross-over , Phase 2a Study to Explore Efficacy and Safety of NBMI Treatment in Patients With Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA) | Progressive Supranuclear Palsy;Multiple System Atrophy | Drug: NBMI;Other: Placebo | EmeraMed | NULL | Completed | 40 Years | 85 Years | All | 20 | Phase 2 | Slovenia |
| 9 | NCT04014387 (ClinicalTrials.gov) | June 2, 2019 | 11/4/2019 | Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP) | Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP) | Treatment | Drug: Suvorexant;Drug: Zolpidem;Drug: Placebo oral capsule | University of California, San Francisco | US Department of Veterans Affairs | Recruiting | 18 Years | N/A | All | 60 | Phase 4 | United States |
| 10 | JPRN-UMIN000036522 | 2019/04/15 | 16/04/2019 | Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug | Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug - Clinical trial for PSP using anticholinergic drug | Progressive supranuclear palsy | Trihexyphenidyl hydrochloride max.3mg for 3 months Placebo max. 3mg for 3 months | 1) Department of Neurology, Gifu University Graduate School of Medicine, 2) National Hospital Organization, Higashi Nagoya Hospital | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 32 | Not selected | Japan |
| 11 | EUCTR2018-000506-34-SI (EUCTR) | 04/02/2019 | 09/03/2018 | EMERA006- A pilot, exploratory, randomised, placebo-controlled, double blinded, cross-over, Phase 2a study to explore efficacy and safety of NBMI treatment in patients with Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA). - EMERA006 | EMERA006- A pilot, exploratory, randomised, placebo-controlled, double blinded, cross-over, Phase 2a study to explore efficacy and safety of NBMI treatment in patients with Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA). - EMERA006 | PSP or MSA;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NBMI Product Code: NBMI INN or Proposed INN: emeramide Other descriptive name: N1,N3-BIS(2-MERCAPTOETHYL) ISOPHTHALAMIDE | NBMI Science Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Slovenia | ||
| 12 | EUCTR2016-001635-12-ES (EUCTR) | 04/07/2018 | 10/05/2018 | A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy. | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy | Progressive Supranuclear Palsy MedDRA version: 20.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-8E12 INN or Proposed INN: ABBV-8E12 Other descriptive name: ABBV-8E12 Product Code: ABBV-8E12 INN or Proposed INN: ABBV-8E12 Other descriptive name: ABBV-8E12 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | United States;Canada;Spain;Australia;Germany;Italy | ||
| 13 | EUCTR2016-002554-21-GR (EUCTR) | 09/03/2018 | 02/01/2018 | Study of BIIB092 in Participants With Progressive Supranuclear Palsy | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy | Progressive supranuclear palsy MedDRA version: 20.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB092 INN or Proposed INN: BIIB092 Other descriptive name: BIIB092 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Japan;Korea, Republic of | ||
| 14 | NCT03391765 (ClinicalTrials.gov) | January 24, 2018 | 2/1/2018 | An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) | An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) | Progressive Supranuclear Palsy (PSP) | Drug: ABBV-8E12;Drug: Placebo solution for IV infusion on Day 15 | AbbVie | NULL | Terminated | 40 Years | N/A | All | 142 | Phase 2 | United States;Australia;Canada;Italy;Japan;France |
| 15 | EUCTR2016-002554-21-IT (EUCTR) | 24/01/2018 | 25/05/2021 | A study to test the effectiveness and safety of test product BIIB092 compared to placebo in participants with progressive supranuclear palsy, arare and progressive condition that can cause problems with balance, movement, vision, speech and swallowing | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy - A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and s | Progressive supranuclear palsy MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB092 Product Code: [BIIB092] INN or Proposed INN: BIIB092 | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 459 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 16 | EUCTR2016-001635-12-DE (EUCTR) | 23/11/2017 | 20/02/2017 | A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy. | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy | Progressive Supranuclear Palsy MedDRA version: 20.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-8E12 Product Code: ABBV-8E12 Other descriptive name: ABBV-8E12 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | United States;Canada;Spain;Australia;Germany;Italy | ||
| 17 | EUCTR2016-001635-12-FR (EUCTR) | 26/10/2017 | 17/07/2017 | A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy. | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy | Progressive Supranuclear Palsy MedDRA version: 20.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-8E12 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Canada;United States;Italy;France;Australia;Germany;Spain | ||
| 18 | EUCTR2016-002554-21-DE (EUCTR) | 18/08/2017 | 19/04/2017 | A study of BIIB092 in participants with Progressive Supranuclear Palsy | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB0092 in Participants with Progressive Supranuclear Palsy | Progressive supranuclear palsy MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB092 INN or Proposed INN: BIIB092 Other descriptive name: BIIB092 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 459 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Canada;Australia;Germany;Japan;Korea, Republic of | ||
| 19 | JPRN-JapicCTI-173627 | 01/8/2017 | 26/06/2017 | Study of BMS-986168 in Patients With Progressive Supranuclear Palsy (PASSPORT) | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BMS-986168 in Participants with Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Intervention name : BMS-986168 Dosage And administration of the intervention : BMS-986168 intravenous infusion on specified days Control intervention name : Placebo Dosage And administration of the control intervention : Placebo intravenous infusion on specified days | Bristol-Myers Squibb K.K. | NULL | 41 | 86 | BOTH | 396 | Phase 2 | NULL | |
| 20 | EUCTR2016-002554-21-GB (EUCTR) | 21/07/2017 | 10/04/2017 | Study of BIIB092 in Participants With Progressive Supranuclear Palsy | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy | Progressive supranuclear palsy MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB092 INN or Proposed INN: BIIB092 Other descriptive name: BIIB092 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 459 | Phase 2 | Canada;Australia;Germany;Japan;Korea, Republic of;United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France | ||
| 21 | EUCTR2016-002554-21-AT (EUCTR) | 30/06/2017 | 20/04/2017 | Study of BIIB092 in Participants With Progressive Supranuclear Palsy | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy | Progressive supranuclear palsy MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB092 INN or Proposed INN: BIIB092 Other descriptive name: BIIB092 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 459 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Japan;Korea, Republic of | ||
| 22 | EUCTR2016-002554-21-ES (EUCTR) | 08/06/2017 | 24/04/2017 | A study to test the effectiveness and safety of test product BMS-986168 compared to placebo in participants with progressive supranuclear palsy, a rare and progressive condition that can cause problems with balance, movement, vision, speech and swallowing | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BMS-986168 in Participants with Progressive Supranuclear Palsy | Progressive supranuclear palsy MedDRA version: 19.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BMS-986168 INN or Proposed INN: BMS986168 Other descriptive name: BMS986168 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Canada;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 23 | NCT03068468 (ClinicalTrials.gov) | June 1, 2017 | 27/2/2017 | Study of BIIB092 in Participants With Progressive Supranuclear Palsy | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy | Supranuclear Palsy, Progressive | Drug: BIIB092;Drug: Placebo | Biogen | NULL | Terminated | 41 Years | 86 Years | All | 490 | Phase 2 | United States;Australia;Austria;Canada;France;Germany;Greece;Italy;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom |
| 24 | EUCTR2016-001635-12-IT (EUCTR) | 31/05/2017 | 05/02/2018 | A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy. | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy - NA | Progressive Supranuclear Palsy MedDRA version: 20.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ABBV-8E12 Product Code: ABBV-8E12 INN or Proposed INN: ABBV-8E12 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Canada;Australia;Italy | ||
| 25 | NCT02985879 (ClinicalTrials.gov) | December 12, 2016 | 1/12/2016 | A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP) | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: Placebo;Drug: ABBV-8E12 | AbbVie | NULL | Terminated | 40 Years | N/A | All | 378 | Phase 2 | United States;Australia;Canada;France;Germany;Italy;Japan;Spain |
| 26 | NCT02460094 (ClinicalTrials.gov) | October 2, 2015 | 20/5/2015 | Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy | A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: BIIB092;Drug: Placebo | Biogen | NULL | Completed | 41 Years | 86 Years | All | 48 | Phase 1 | United States |
| 27 | NCT02494024 (ClinicalTrials.gov) | July 2015 | 30/6/2015 | Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy | A Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: Single dose C2N-8E12;Drug: Single dose placebo | C2N Diagnostics | NULL | Completed | 50 Years | 85 Years | All | 32 | Phase 1 | United States |
| 28 | EUCTR2013-003740-23-ES (EUCTR) | 04/02/2015 | 05/12/2013 | Evaluation of masitinib in the treatment of Progressive Supranuclear Palsy | A prospective, multicentre, randomised, double-blind, placebo-controlled, parallel groups, phase 2b/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Progressive Supranuclear Palsy (PSP) | Progressive Supranuclear Palsy MedDRA version: 14.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib 100mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: MASITINIB MESYLATE Product Name: masitinib 200mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: MASITINIB MESYLATE | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain | ||
| 29 | NCT02133846 (ClinicalTrials.gov) | May 2014 | 6/5/2014 | Safety Study of TPI-287 to Treat CBS and PSP | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TPI 287 in Patients With Primary Four Repeat Tauopathies: Corticobasal Syndrome or Progressive Supranuclear Palsy | Primary Four Repeat Tauopathies (4RT);Corticobasal Syndrome (CBS);Progressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD) | Drug: TPI 287 2 mg/m2;Drug: TPI-287 20 mg/m2;Drug: Placebo;Drug: TPI-287 6.3 mg/m2 | University of California, San Francisco | CBD Solutions;Tau Consortium | Completed | 50 Years | 85 Years | All | 44 | Phase 1 | United States |
| 30 | EUCTR2012-005539-10-DE (EUCTR) | 29/04/2014 | 18/12/2013 | Clinical study to investigate the efficacy and safety of two dose levels of NT 201 versus placebo in treating chronic troublesome sialorrhea in various neurological conditions. | Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation | Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury. MedDRA version: 18.1;Level: PT;Classification code 10039424;Term: Salivary hypersecretion;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A | Merz Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Poland;Germany | ||
| 31 | JPRN-UMIN000008959 | 2012/11/01 | 16/10/2012 | Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy | Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in MSA and PSP | Multiple system atrophy(MSA)Progressive supranuclear palsy (PSP) | hydrogen water pseudo-water (nitrogen filling water) | Juntendo University School of Medicine, Department of Neurology | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 40 | Phase 1 | Japan |
| 32 | EUCTR2010-019159-23-GB (EUCTR) | 22/12/2010 | 08/10/2010 | A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy. | A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy. | Progressive Supranuclear Palsy MedDRA version: 14.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Davunetide Product Code: AL-108 INN or Proposed INN: Davunetide | Allon Therapeutics Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Australia;Germany;United Kingdom | ||
| 33 | EUCTR2010-019159-23-DE (EUCTR) | 08/11/2010 | 27/08/2010 | A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy. | A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy. | Progressive Supranuclear Palsy MedDRA version: 14.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Davunetide Product Code: AL-108 INN or Proposed INN: Davunetide | Allon Therapeutics Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2/3 | France;United States;Canada;Australia;Germany;United Kingdom | ||
| 34 | NCT01110720 (ClinicalTrials.gov) | October 2010 | 23/4/2010 | Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy | A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: Davunetide;Drug: Placebo | Allon Therapeutics | NULL | Completed | 41 Years | 85 Years | Both | 313 | Phase 2/Phase 3 | United States;Australia;Canada;France;Germany;United Kingdom |
| 35 | EUCTR2008-007520-26-DE (EUCTR) | 24/06/2010 | 13/11/2009 | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to assess the Efficacy, Tolerability and Safety of Rasagiline in Subjects with Progressive Supranuclear Palsy (Phase III) | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to assess the Efficacy, Tolerability and Safety of Rasagiline in Subjects with Progressive Supranuclear Palsy (Phase III) | Progressive Supranuclear Palsy MedDRA version: 12.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy | Trade Name: Azilect INN or Proposed INN: Rasagilin Other descriptive name: RASAGILINE MESILATE | Klinikum der Universität München | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 36 | NCT01056965 (ClinicalTrials.gov) | January 2010 | 21/1/2010 | Davunetide (AL-108) in Predicted Tauopathies - Pilot Study | A 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted Tauopathies | Predicted Tauopathies, Including;Progressive Supranuclear Palsy;Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17;Corticobasal Degeneration Syndrome;Progressive Nonfluent Aphasia | Drug: davunetide (AL-108, NAP);Drug: Placebo nasal spray | University of California, San Francisco | NULL | Completed | 40 Years | 85 Years | All | 12 | Phase 1 | United States |
| 37 | NCT01187888 (ClinicalTrials.gov) | January 2010 | 20/8/2010 | Efficacy, Tolerability and Safety of Azilect in Subjects With Progressive Supranuclear Palsy | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Rasagiline in Subjects With Progressive Supranuclear Palsy (Phase III) | Progressive Supranuclear Palsy | Drug: Rasagiline;Drug: Sugar pill | Prof. Dr. Stefan Lorenzl | Teva Pharmaceutical Industries;Ludwig-Maximilians - University of Munich | Terminated | 50 Years | 80 Years | Both | 44 | Phase 3 | Germany |
| 38 | NCT01049399 (ClinicalTrials.gov) | December 2009 | 13/1/2010 | Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112 Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy | A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112, a GSK-3 Inhibitor, Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: tideglusib;Drug: placebo | Noscira SA | i3 Research | Completed | 40 Years | 85 Years | Both | 146 | N/A | United States;Germany;Spain;United Kingdom |
| 39 | EUCTR2009-013097-40-ES (EUCTR) | 17/11/2009 | 29/07/2009 | Estudio doble-ciego, controlado con placebo, aleatorizado, de grupos paralelos, para evaluar la seguridad, tolerancia y eficacia de dos dosis orales diferentes de NP031112, un inhibidor de GSK3, versus placebo, como tratamiento de pacientes con Parálisis Supranuclear Progresiva leve o moderada | Estudio doble-ciego, controlado con placebo, aleatorizado, de grupos paralelos, para evaluar la seguridad, tolerancia y eficacia de dos dosis orales diferentes de NP031112, un inhibidor de GSK3, versus placebo, como tratamiento de pacientes con Parálisis Supranuclear Progresiva leve o moderada | Parálisis Supranuclear Progresiva leve o moderada MedDRA version: 9;Level: LLT;Classification code 10036813;Term: Progressive supranuclear palsy MedDRA version: 9;Level: PT;Term: Progressive supranuclear palsy | Product Name: NP031112 Product Code: NP031112 600mg Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione Product Name: NP031112 Product Code: NP031112 800mg Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione | Noscira S.A. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Spain;Germany;United Kingdom | |||
| 40 | EUCTR2009-013097-40-DE (EUCTR) | 06/11/2009 | 30/07/2009 | A double-blind, placebo-controlled, randomized, parallel-group study evaluating thesafety, tolerability and efficacy of two different oral doses of NP031112, a GSK-3inhibitor, versus placebo in the treatment of patients with mild to moderateProgressive Supranuclear Palsy. - TAUROS | A double-blind, placebo-controlled, randomized, parallel-group study evaluating thesafety, tolerability and efficacy of two different oral doses of NP031112, a GSK-3inhibitor, versus placebo in the treatment of patients with mild to moderateProgressive Supranuclear Palsy. - TAUROS | Mild to Moderate Progressive Supranuclear Palsy MedDRA version: 12.0;Level: LLT;Classification code 10036813;Term: Progressive supranuclear palsy MedDRA version: 12.0;Level: PT;Term: Progressive supranuclear palsy | Product Name: NP031112 Product Code: NP031112 600mg Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione Product Name: NP031112 Product Code: NP031112 800mg Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione | Noscira S.A. | NULL | Not Recruiting | Female: yes Male: yes | 125 | United Kingdom;Spain;Germany | |||
| 41 | EUCTR2009-013097-40-GB (EUCTR) | 30/10/2009 | 23/07/2009 | A double-blind, placebo-controlled, randomized, parallel-group study evaluating the safety, tolerability and efficacy of two different oral doses of NP031112, a GSK-3 inhibitor, versus placebo in the treatment of patients with mild to moderate Progressive Supranuclear Palsy. - TAUROS | A double-blind, placebo-controlled, randomized, parallel-group study evaluating the safety, tolerability and efficacy of two different oral doses of NP031112, a GSK-3 inhibitor, versus placebo in the treatment of patients with mild to moderate Progressive Supranuclear Palsy. - TAUROS | Mild to Moderate Progressive Supranuclear Palsy MedDRA version: 12.0;Level: LLT;Classification code 10036813;Term: Progressive supranuclear palsy MedDRA version: 12.0;Level: PT;Term: Progressive supranuclear palsy | Product Name: NP031112 Product Code: NP031112 600mg Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione Product Name: NP031112 Product Code: NP031112 800mg Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione | Noscira S.A. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom | ||
| 42 | NCT00385710 (ClinicalTrials.gov) | November 2006 | 10/10/2006 | Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine) | Randomized Placebo-controlled Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: valproic acid;Drug: Placebo | Nantes University Hospital | NULL | Completed | 45 Years | 75 Years | Both | 28 | Phase 2 | France |
| 43 | NCT00382824 (ClinicalTrials.gov) | September 2006 | 28/9/2006 | Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP) | Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind Study | Progressive Supranuclear Palsy | Dietary Supplement: Coenzyme Q10;Other: Placebo | Lahey Clinic | NULL | Completed | 30 Years | N/A | All | 61 | N/A | United States |
| 44 | NCT00328874 (ClinicalTrials.gov) | May 2006 | 21/5/2006 | Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy | Mono-center, Prospective, Double-blind, Placebo-controlled, Randomized Clinical Phase IIa Trial to Assess the Safety, Tolerability, and Immediate Biological Effects of Coenzyme Q10 - nanoQuinon® in Progressive Supranuclear Palsy | Progressive Supranuclear Palsy | Drug: Coenzyme Q10 | German Parkinson Study Group (GPS) | MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany;Pitzer Stiftung;Philipps University Marburg Medical Center | Completed | 40 Years | 85 Years | All | 20 | Phase 2 | Germany |
| 45 | NCT00605930 (ClinicalTrials.gov) | April 2004 | 14/1/2008 | A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy. | Energy Metabolism in Neurodegenerative Diseases: A Randomized, Double Blind, Placebo-Controlled Clinical Pilot Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy. | Progressive Supranuclear Palsy | Dietary Supplement: Pyruvate, creatine, niacinamide;Dietary Supplement: Placebo | University of Louisville | NULL | Completed | N/A | N/A | All | 20 | N/A | United States |
| 46 | NCT00532571 (ClinicalTrials.gov) | January 2004 | 18/9/2007 | Effects of Coenzyme Q10 in PSP and CBD | Effects of Coenzyme Q10 in PSP and CBD, A Randomized, Placebo-Controlled, Double Blind Cross Over Pilot Study | Progressive Supranuclear Palsy;Neurological Disorders | Drug: CoQ10 | Lahey Clinic | NULL | Completed | 40 Years | N/A | All | Phase 2/Phase 3 | United States | |
| 47 | EUCTR2016-002554-21-FR (EUCTR) | 15/06/2018 | A study to test the effectiveness and safety of test product BMS-986168 compared to placebo in participants with progressive supranuclear palsy, a rare and progressive condition that can cause problems with balance, movement, vision, speech and swallowing | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BMS-986168 in Participants with Progressive Supranuclear Palsy | Progressive supranuclear palsy MedDRA version: 20.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BMS-986168 INN or Proposed INN: BMS986168 Other descriptive name: BMS986168 | Bristol-Myers Squibb International Corporation | NULL | NA | Female: yes Male: yes | 396 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Netherlands;Japan;Korea, Republic of |
6. パーキンソン病
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05709301 (ClinicalTrials.gov) | April 1, 2023 | 11/1/2023 | Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease | Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease | Parkinson Disease;Mild Cognitive Impairment | Drug: Donepezil Hydrochloride;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Not yet recruiting | 50 Years | 80 Years | All | 120 | Phase 2 | NULL |
| 2 | NCT05634876 (ClinicalTrials.gov) | April 2023 | 23/11/2022 | UB-312 in Patients With Synucleinopathies | A Phase 1b Clinical Trial of UB-312 in Patients With Synucleinopathies | Multiple System Atrophy;Parkinson Disease | Biological: UB-312 Injection;Biological: Placebo Injection | NYU Langone Health | NULL | Not yet recruiting | 40 Years | 75 Years | All | 8 | Phase 1/Phase 2 | United States |
| 3 | NCT05766813 (ClinicalTrials.gov) | March 2023 | 24/2/2023 | Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease | Parkinson Disease | Drug: Lenrispodun;Drug: Placebo | Intra-Cellular Therapies, Inc. | NULL | Recruiting | 40 Years | 80 Years | All | 132 | Phase 2 | United States |
| 4 | EUCTR2021-004849-20-AT (EUCTR) | 13/12/2022 | 05/08/2022 | A Study to Assess the Safety of BIIB122 Tablets and if it can Slow the Worsening of Early-Stage Parkinson’s Disease in Participants Between the Ages of 30 and 80 | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB122 Product Code: DNL151, DN0001575, DN1575 INN or Proposed INN: NA Other descriptive name: DNL151, DN0001575, DN1575 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 640 | Phase 2 | United States;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Poland;Netherlands;Germany;China;Japan | ||
| 5 | NCT05435755 (ClinicalTrials.gov) | December 2, 2022 | 15/3/2022 | Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease. | The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease. | Parkinson's Disease | Biological: hAESCs treatment;Biological: placebo (saline) | Shanghai East Hospital | Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | Not yet recruiting | 30 Years | 70 Years | All | 12 | Early Phase 1 | China |
| 6 | NCT05642442 (ClinicalTrials.gov) | December 1, 2022 | 30/11/2022 | A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease | A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants With Parkinson's Disease | Parkinson Disease;Tremor | Drug: Placebo;Drug: Suvecaltamide | Jazz Pharmaceuticals | NULL | Recruiting | 40 Years | 80 Years | All | 160 | Phase 2 | United States |
| 7 | NCT05589766 (ClinicalTrials.gov) | November 28, 2022 | 13/10/2022 | N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease | N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease | Parkinson Disease | Dietary Supplement: Nicotinamide Riboside;Other: Placebo | Haukeland University Hospital | NULL | Recruiting | 40 Months | 100 Years | All | 80 | N/A | Norway |
| 8 | NCT05568498 (ClinicalTrials.gov) | October 30, 2022 | 15/6/2022 | Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease | Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease | Parkinson Disease;Depression | Dietary Supplement: Probiotic;Dietary Supplement: Placebo | University of British Columbia | NULL | Not yet recruiting | 40 Years | 80 Years | All | 60 | Phase 2 | NULL |
| 9 | NCT04810104 (ClinicalTrials.gov) | October 2022 | 15/3/2021 | Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug | Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug | Parkinson Disease;Mild Cognitive Impairment | Drug: AZD0328;Drug: Placebo | King's College London | Helse Stavanger HF;Michael J. Fox Foundation for Parkinson's Research;Parkinsons Org UK;AstraZeneca;Masaryk University;Norges Parkinsonforbund, Norway;University of Exeter;Stichting Lygature;Innovative Medicines Initiative | Withdrawn | 50 Years | 80 Years | All | 0 | Phase 2 | Norway |
| 10 | NCT05418673 (ClinicalTrials.gov) | August 26, 2022 | 10/6/2022 | A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants With Parkinson's Disease and Pathogenic LRRK2 Variants | Parkinson Disease | Drug: BIIB122;Drug: BIIB122-Matching Placebo | Biogen | Denali Therapeutics Inc. | Recruiting | 30 Years | 80 Years | All | 400 | Phase 3 | United States;France;Spain |
| 11 | NCT05357989 (ClinicalTrials.gov) | August 3, 2022 | 19/4/2022 | A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD | A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease | Parkinson's Disease, Idiopathic | Drug: Buntanetap;Drug: Placebo | Annovis Bio Inc. | TFS Trial Form Support | Recruiting | 40 Years | 85 Years | All | 450 | Phase 3 | United States;Germany;Hungary;Italy;Poland;Spain |
| 12 | NCT04147949 (ClinicalTrials.gov) | August 2022 | 27/10/2019 | AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia | Randomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia | Parkinson Disease;Dyskinesia, Medication-Induced;L-Dopa Causing Adverse Effects in Therapeutic Use | Drug: AV-101;Drug: Placebo | VistaGen Therapeutics, Inc. | NULL | Not yet recruiting | 30 Years | 80 Years | All | 20 | Phase 2 | NULL |
| 13 | NCT05670782 (ClinicalTrials.gov) | July 19, 2022 | 21/12/2022 | A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease | A Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KM-819 in Healthy Older Adults and Participants With Parkinson's Disease | Parkinson Disease | Drug: KM-819;Drug: Placebo | FAScinate Therapeutics Inc. | Parexel | Recruiting | 40 Years | N/A | All | 330 | Phase 2 | United States |
| 14 | NCT05318937 (ClinicalTrials.gov) | July 6, 2022 | 1/4/2022 | A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment | Parkinson Disease;Cognitive Dysfunction | Drug: SAGE-718;Drug: SAGE-718-matching placebo | Sage Therapeutics | NULL | Recruiting | 50 Years | 75 Years | All | 76 | Phase 2 | United States |
| 15 | NCT05258071 (ClinicalTrials.gov) | June 15, 2022 | 10/2/2022 | A Clinical Study Evaluating Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's Disease (PD) | A Randomised, Placebo-controlled, Multicentre Phase IIb Study Evaluating the Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's Disease | Parkinson Disease | Drug: Pirepemat;Drug: Placebo | Integrative Research Laboratories AB | NULL | Recruiting | 55 Years | 85 Years | All | 165 | Phase 2 | France;Germany;Poland;Spain;Sweden |
| 16 | NCT05424276 (ClinicalTrials.gov) | May 23, 2022 | 10/6/2022 | A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease | A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease | Parkinson Disease | Drug: IkT-148009;Drug: Placebo | Inhibikase Therapeutics, Inc. | NULL | Recruiting | 30 Years | 75 Years | All | 120 | Phase 2 | United States |
| 17 | NCT05348785 (ClinicalTrials.gov) | April 19, 2022 | 4/4/2022 | A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80 | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease | Parkinson Disease | Drug: BIIB122;Drug: BIIB122-Matching Placebo | Biogen | Denali Therapeutics Inc. | Recruiting | 30 Years | 80 Years | All | 640 | Phase 2 | United States;France;Germany;Netherlands;Poland;Spain |
| 18 | EUCTR2019-002627-16-ES (EUCTR) | 31/03/2022 | 31/03/2022 | A study for evaluation of the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | A randomised, placebo-controlled, multicentre phase IIb study evaluating the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pirepemat, 50 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate Product Name: Pirepemat, 100 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate | Integrative Research Laboratories Sweden AB (IRLAB) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | France;Poland;Spain;Germany;Sweden | ||
| 19 | NCT04879134 (ClinicalTrials.gov) | February 28, 2022 | 4/5/2021 | Apomorphine Effects on Pain in Parkinson's Disease | Apomorphine Effect on Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Cross-over Study | Parkinson Disease | Drug: Apomorphine Injectable Solution;Drug: Placebo | University of Calgary | Paladin Labs Inc. | Recruiting | 18 Years | 70 Years | All | 40 | Phase 2/Phase 3 | Canada |
| 20 | EUCTR2019-002627-16-PL (EUCTR) | 21/02/2022 | 11/01/2022 | A study for evaluation of the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | A randomised, placebo-controlled, multicentre phase IIb study evaluating the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pirepemat, 50 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate Product Name: Pirepemat, 100 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate | Integrative Research Laboratories Sweden AB (IRLAB) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | France;Spain;Poland;Germany;Netherlands;Sweden | ||
| 21 | NCT05287503 (ClinicalTrials.gov) | February 15, 2022 | 28/1/2022 | Ambroxol as a Disease-modifying Treatment in GBA-PD | Ambroxol as a Disease-modifying Treatment to Reduce the Risk of Cognitive Impairment in GBA-associated Parkinson's Disease. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial | Parkinson Disease;GBA Gene Mutation | Drug: Ambroxol Hydrochloride;Drug: Placebo | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | University of Campania Luigi Vanvitelli;IRCCS National Neurological Institute C. Mondino Foundation | Recruiting | 21 Years | 80 Years | All | 60 | Phase 2 | Italy |
| 22 | NCT05266417 (ClinicalTrials.gov) | February 7, 2022 | 23/2/2022 | Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD) | Parkinson Disease | Drug: INS-GSH;Drug: Matched Placebos | Gateway Institute for Brain Research | NULL | Recruiting | 30 Years | 85 Years | All | 56 | Phase 2 | United States |
| 23 | NCT04831281 (ClinicalTrials.gov) | January 20, 2022 | 1/4/2021 | ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial) | A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Parkinson Disease Dementia;Dementia With Lewy Bodies | Drug: ATH-1017;Drug: Placebo | Athira Pharma | NULL | Active, not recruiting | 40 Years | 85 Years | All | 28 | Phase 2 | United States |
| 24 | NCT05083260 (ClinicalTrials.gov) | January 4, 2022 | 23/9/2021 | NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa | A Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study in Parkinson's Disease (PD) Participants Treated With Carbidopa/Levodopa and NE3107 | Parkinson Disease | Drug: NE3107;Drug: placebo | BioVie Inc. | NULL | Completed | 30 Years | 80 Years | All | 46 | Phase 1/Phase 2 | United States |
| 25 | NCT03446807 (ClinicalTrials.gov) | December 2021 | 20/2/2018 | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Parkinson Disease;Multiple System Atrophy;Progressive Supranuclear Palsy | Drug: Droxidopa;Drug: Placebo Oral Tablet | Loma Linda University | H. Lundbeck A/S | Not yet recruiting | 50 Years | N/A | All | 32 | Phase 2 | United States |
| 26 | NCT04944017 (ClinicalTrials.gov) | November 23, 2021 | 22/6/2021 | Ketamine for the Treatment of Depression in Parkinson's Disease | Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) | Parkinson's Disease;Depression | Drug: Ketamine Infusion;Other: Placebo - Saline Infusion | Yale University | Fox (Michael J.) Foundation for Parkinson's Research | Recruiting | 40 Years | 80 Years | All | 56 | Phase 2 | United States |
| 27 | NCT05173701 (ClinicalTrials.gov) | November 22, 2021 | 8/11/2021 | Effects of Probiotics on Peripheral Immunity in Parkinson's Disease | Effects of Probiotics on Peripheral Immunity in Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Probiotics;Dietary Supplement: Placebo | Franca Marino | Università degli Studi del Piemonte Orientale Amedeo Avogadro;Università degli Studi dell'Insubria | Enrolling by invitation | N/A | N/A | All | 88 | N/A | Italy |
| 28 | NCT04871464 (ClinicalTrials.gov) | November 11, 2021 | 29/4/2021 | Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease | Role and Mechanism of Bifidobacterium Triple Viable Capsules in Improving Motor Symptoms in Patients With Mild to Moderate Parkinson's Disease: a Multicenter Randomized Clinical Study | Parkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Movement Disorders;Neurodegenerative Diseases;Central Nervous System Diseases;Nervous System Diseases | Drug: Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules;Other: Placebo | Beijing Friendship Hospital | NULL | Recruiting | 40 Years | 85 Years | All | 240 | Phase 4 | China |
| 29 | NCT05297201 (ClinicalTrials.gov) | November 2, 2021 | 17/2/2022 | Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients With Levodopa Induced Dyskinesia | Phase II, Double Blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 (PDE10A Inhibitor) in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesia | Parkinson Disease;Dyskinesia, Medication-Induced | Drug: CPL500036 - low dose;Drug: CPL500036 - high dose;Drug: Placebo | Celon Pharma SA | National Center for Research and Development, Poland | Recruiting | 50 Years | 80 Years | All | 108 | Phase 2 | Poland |
| 30 | NCT05056194 (ClinicalTrials.gov) | November 1, 2021 | 17/9/2021 | Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study | A Double-blind, Randomized, Placebo-controlled, Parallel, Study to Assess the Efficacy and Safety of XW10172 MR for the Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease | Parkinson Disease;Excessive Daytime Somnolence | Drug: Valiloxybate;Other: Placebo | XWPharma | NULL | Not yet recruiting | 40 Years | 75 Years | All | 70 | Phase 2 | NULL |
| 31 | NCT05036473 (ClinicalTrials.gov) | October 12, 2021 | 10/8/2021 | A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease | A Phase II Randomized, Parallel, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Efficacy and Safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease | Parkinson Disease | Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets;Drug: Placebo | Shanghai WD Pharmaceutical Co., Ltd. | NULL | Recruiting | 30 Years | 75 Years | All | 40 | Phase 2 | China |
| 32 | NCT05084365 (ClinicalTrials.gov) | October 10, 2021 | 7/10/2021 | A 6-month Study to Evaluate Sulforaphane Effects in PD Patients | A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients | Parkinson Disease | Drug: Sulforaphane;Drug: Placebo | Central South University | NULL | Not yet recruiting | 40 Years | 75 Years | All | 100 | Phase 2 | NULL |
| 33 | NCT04912115 (ClinicalTrials.gov) | October 5, 2021 | 25/5/2021 | Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia | A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo- Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa- Induced Dyskinesia in Subjects With Parkinson's Disease | Dyskinesias;Movement Disorders;Central Nervous System Diseases;Nervous System Diseases;Neurologic Manifestations | Drug: Ketamine;Drug: Midazolam | PharmaTher Inc. | NULL | Suspended | 30 Years | 85 Years | All | 30 | Phase 2 | United States |
| 34 | EUCTR2020-006053-22-SE (EUCTR) | 22/09/2021 | 26/07/2021 | A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 versus Placebo in Levodopa-induced Dyskinesia in Parkinson’s Disease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 versus Placebo in Levodopa-induced Dyskinesia in Parkinson’s Disease | Parkinson´s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NLX-112 INN or Proposed INN: BEFIRADOL | Neurolixis SAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Sweden | ||
| 35 | NCT04691661 (ClinicalTrials.gov) | September 9, 2021 | 16/12/2020 | Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease | A Randomized Double-blind Placebo-controlled Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Radotinib in Parkinson's Disease | Parkinson Disease | Drug: Radotinib HCl 50 mg;Drug: Placebo | Il-Yang Pharm. Co., Ltd. | NULL | Recruiting | 40 Years | 80 Years | All | 40 | Phase 2 | France |
| 36 | EUCTR2020-005011-52-PT (EUCTR) | 03/09/2021 | 29/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Portugal;Serbia;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 37 | NCT04857359 (ClinicalTrials.gov) | August 6, 2021 | 21/4/2021 | Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy | Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy | Parkinson Disease;Dyskinesia, Drug-Induced;Dyskinesias | Drug: Dipraglurant;Drug: Placebo | Addex Pharma S.A. | NULL | Recruiting | 30 Years | 85 Years | All | 140 | Phase 2/Phase 3 | United States |
| 38 | EUCTR2020-005011-52-BE (EUCTR) | 19/07/2021 | 07/04/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 39 | NCT04995081 (ClinicalTrials.gov) | July 16, 2021 | 16/7/2021 | Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD) | A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease | Parkinson Disease | Biological: Biological/Vaccine: Allogeneic HB-adMSCs;Other: Placebo | Hope Biosciences Stem Cell Research Foundation | Hope Biosciences | Recruiting | 45 Years | 80 Years | All | 60 | Phase 2 | United States |
| 40 | EUCTR2020-006004-16-PL (EUCTR) | 16/07/2021 | 23/04/2021 | Phase II clinical trial to assess anti-dyskinetic efficacy of CPL500036, in patients with levodopa-induced dyskinesia in Parkinson's disease | Phase II, Double blind, Randomized, Placebo controlled, Parallel group, Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 (PDE10A inhibitor) in Patients with Parkinson's Disease Suffering from Levodopa Induced Dyskinesia | Levodopa-induced dyskinesia in Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PG203 INN or Proposed INN: CPL500036 Other descriptive name: CPL500036 | Celon Pharma S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 2 | Poland | ||
| 41 | EUCTR2020-003265-19-IT (EUCTR) | 15/07/2021 | 07/06/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson's Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease - - | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: [UCB0599] Trade Name: DaTSCAN Product Name: DaTSCAN Product Code: [DaTSCAN] INN or Proposed INN: IODIO IOFLUPANO-123I | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Canada;Spain;Poland;Netherlands;Germany;United Kingdom;Italy | ||
| 42 | NCT04928287 (ClinicalTrials.gov) | June 28, 2021 | 26/5/2021 | Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate) | A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease | Parkinson Disease | Biological: HB-adMSCs;Other: Placebo | Hope Biosciences Stem Cell Research Foundation | Hope Biosciences | Completed | 18 Years | 75 Years | All | 24 | Phase 2 | United States |
| 43 | EUCTR2020-005011-52-FR (EUCTR) | 23/06/2021 | 01/04/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 44 | EUCTR2020-004997-23-PL (EUCTR) | 09/06/2021 | 03/09/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy | ||
| 45 | EUCTR2020-003265-19-DE (EUCTR) | 07/06/2021 | 01/12/2020 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | France;United States;Canada;Spain;Poland;Netherlands;Germany;Italy;United Kingdom | ||
| 46 | NCT04978597 (ClinicalTrials.gov) | May 31, 2021 | 5/7/2021 | Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension | Parkinson | Drug: Opicapone 50 mg;Drug: Placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | 80 Years | All | 324 | Phase 3 | Bulgaria |
| 47 | EUCTR2020-005011-52-IT (EUCTR) | 28/05/2021 | 04/06/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson's Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, with an Open- Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone Product Code: [BIA 9-1067] INN or Proposed INN: OPICAPONE | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 48 | EUCTR2020-004997-23-AT (EUCTR) | 27/05/2021 | 16/03/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | Austria;United Kingdom;Italy;France;United States;Canada;Spain;Poland | ||
| 49 | EUCTR2020-003265-19-ES (EUCTR) | 26/05/2021 | 09/02/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 INN or Proposed INN: - | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Canada;Poland;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 50 | EUCTR2020-004997-23-ES (EUCTR) | 25/05/2021 | 01/09/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | France;United States;Canada;Poland;Spain;Austria;United Kingdom;Italy | ||
| 51 | EUCTR2020-005011-52-BG (EUCTR) | 17/05/2021 | 22/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 52 | EUCTR2020-005011-52-CZ (EUCTR) | 12/05/2021 | 04/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 53 | EUCTR2020-004997-23-FR (EUCTR) | 11/05/2021 | 02/03/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | United States;France;Canada;Spain;Poland;Austria;United Kingdom;Italy | ||
| 54 | NCT04777331 (ClinicalTrials.gov) | May 5, 2021 | 26/2/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease | A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease | Parkinsons Disease | Drug: Prasinezumab;Drug: Placebo | Hoffmann-La Roche | Prothena Biosciences Limited | Recruiting | 50 Years | 85 Years | All | 575 | Phase 2 | United States;Austria;Canada;France;Italy;Luxembourg;Poland;Spain;United Kingdom;Germany |
| 55 | EUCTR2020-003265-19-NL (EUCTR) | 04/05/2021 | 24/02/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 INN or Proposed INN: - Other descriptive name: - | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | United States;France;Canada;Spain;Poland;Germany;Netherlands;United Kingdom;Italy | ||
| 56 | NCT04287543 (ClinicalTrials.gov) | May 2021 | 21/2/2020 | Melatonin on Clock Genes in Parkinson's Disease | Effect of Melatonin Administration on the PER1 and BMAL1 Clock Genes in Patients With Parkinson's Disease | Parkinson Disease | Drug: Melatonin;Drug: Placebos | Instituto Mexicano del Seguro Social | NULL | Withdrawn | 20 Years | N/A | All | 0 | Phase 2/Phase 3 | Mexico |
| 57 | EUCTR2020-003265-19-PL (EUCTR) | 30/04/2021 | 18/01/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | France;United States;Canada;Spain;Poland;Germany;Netherlands;United Kingdom;Italy | ||
| 58 | NCT04867642 (ClinicalTrials.gov) | April 29, 2021 | 27/4/2021 | A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease | A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, and Pharmacokinetics of UCB0022 in Healthy Participants and Participants With Parkinson's Disease | Healthy Study Participants;Parkinson's Disease | Drug: UCB0022;Other: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | 75 Years | All | 100 | Phase 1 | United Kingdom |
| 59 | EUCTR2020-003265-19-FR (EUCTR) | 28/04/2021 | 04/12/2020 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Canada;Spain;Poland;Netherlands;Germany;United Kingdom;Italy | ||
| 60 | NCT04377945 (ClinicalTrials.gov) | April 28, 2021 | 4/5/2020 | Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components | A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components | Dyskinesias;Parkinson Disease | Drug: Part 1, JM-010 component Group A;Drug: Part 1, JM-010 component Group B;Drug: Part 1, JM-010 component Group C;Drug: Part 1, Placebo Group;Drug: Part 2, JM-010 combination Group A;Drug: Part 2, JM-010 combination Group B;Drug: Part 2, JM-010 component Group C;Drug: Part 2, Placebo Group | Bukwang Pharmaceutical | NULL | Recruiting | 18 Years | 85 Years | All | 188 | Phase 2 | United States |
| 61 | EUCTR2018-004892-11-IT (EUCTR) | 22/04/2021 | 07/10/2020 | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients - SteP-on | •Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD•A Modified Hoehn and Yahr stage of = 4 in the off” state;•A stable (4 weeks since last modification) anti-parkinsonian therapy; •The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs frozen” or glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0) MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: XADAGO - 100 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Trade Name: XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO | OSPEDALE SANTA MARIA DELLA MISERICORDIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Phase 3 | Italy | ||
| 62 | EUCTR2020-004997-23-IT (EUCTR) | 19/04/2021 | 08/06/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE - NA | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: [RO7046015] INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy | ||
| 63 | NCT04491383 (ClinicalTrials.gov) | April 1, 2021 | 22/7/2020 | Tocotrienols in Parkinson's Disease (PD) | Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled Trial | Neuro-Degenerative Disease;Parkinson Disease | Drug: Tocovid Suprabio (HOV-12020);Other: Placebo | National Neuroscience Institute | Hovid Berhad | Recruiting | 40 Years | 90 Years | All | 100 | Phase 2 | Singapore |
| 64 | NCT04497168 (ClinicalTrials.gov) | April 1, 2021 | 29/7/2020 | Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease | Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease | Parkinson Disease | Drug: Citalopram 20mg;Drug: Placebo | University of Michigan | National Institute on Aging (NIA) | Recruiting | 65 Years | N/A | All | 58 | Phase 2 | United States |
| 65 | JPRN-jRCTs051200160 | 24/03/2021 | 24/03/2021 | ZEAL study | Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease: A Randomized Single-Blind Placebo-Controlled Trial - ZEAL | Parkinson's disease Parkinson's disease,Somnipathy;D010300 | 70 patients with Parkinson's disease were allocated to Zonisamide tablets (Trelief OD tablets) 1T (25mg) or placebo 1T at a time before going to bed by randomizing soft, and the efficacy of zonisamide tablet (Trelief OD tablets) for sleep is investigated comparing the parallel-group before and after administration | Hiroshi Kataoka | NULL | Recruiting | >= 41age old | Not applicable | Both | 70 | Phase 2-3 | Japan |
| 66 | NCT04986982 (ClinicalTrials.gov) | February 25, 2021 | 27/7/2021 | OpiCapone Effect on Motor Fluctuations and pAiN | Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain. | Parkinson Disease | Drug: Opicapone 50 mg;Other: Matching placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 140 | Phase 4 | United Kingdom |
| 67 | JPRN-jRCTs041190126 | 22/02/2021 | 10/03/2020 | Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease | Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease - NaT-PROBEi | Lewy body disease (Parkinson's disease and dementia with Lewy bodies) | Arm zonisamide: 1.Two tablets of zonisamide 25mg after breakfast for 4 weeks 2.Four tablets of zonisamide 25mg after breakfast for 92 weeks Arm placebo: 1.Two tablets of placebo after breakfast for 4 weeks 2.Four tablets of placebo after breakfast for 92 weeks | Katsuno Masahisa | Japan Agency for Medical Research and Development | Not Recruiting | >= 50age old | < 80age old | Both | 30 | Phase 2 | Japan |
| 68 | NCT04350177 (ClinicalTrials.gov) | February 16, 2021 | 26/12/2019 | A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants and Parkinson's Patients | A Phase I, Randomized Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers With Extension Into Parkinson's Patients | Healthy Elderly;Parkinson Disease | Drug: IkT-148009;Drug: Placebo | Inhibikase Therapeutics, Inc. | NULL | Completed | 55 Years | 70 Years | All | 101 | Phase 1 | United States |
| 69 | NCT04643327 (ClinicalTrials.gov) | February 9, 2021 | 18/11/2020 | Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease | Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study | Parkinson Disease;Mild Cognitive Impairment;Memory Impairment | Drug: Levetiracetam;Drug: Placebo | The University of Queensland | Johns Hopkins University;Cleveland Clinic Lou Ruvo Center for Brain Health;Royal Brisbane and Women's Hospital;Queensland University of Technology | Recruiting | N/A | N/A | All | 28 | Phase 2 | Australia |
| 70 | EUCTR2020-002010-41-IT (EUCTR) | 21/01/2021 | 25/01/2021 | Phase II trial investigating Uncontrollable voluntary movements in PD | A randomized, double-blind, placebo-controlled phase IIB study evaluating the efficacy of mesdopetam on DAILY on-time without troublesome dyskinesia in patients with Parkinson's disease - NA | Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mesdopetam Product Code: [IRL790] INN or Proposed INN: mesdopetam Product Name: Mesdopetam Product Code: [IRL790] INN or Proposed INN: mesdopetam Product Name: mesdopetam Product Code: [IRL790] INN or Proposed INN: Mesdopetam | Integrative Research Laboratories Sweden AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | France;United States;Serbia;Poland;Israel;Italy | ||
| 71 | NCT04625361 (ClinicalTrials.gov) | January 20, 2021 | 9/11/2020 | Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects | A Single Center, Randomized, Double-Blind, Placebo-Controlled Study of Single/Multiple Ascending Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Single Center, Randomized, Double-Blind, Two Periods, Crossover, Food Effect Study of HEC122505MsOH Tablets in Healthy Chinese Subjects | Parkinson Disease | Drug: HEC122505MsOH | Sunshine Lake Pharma Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 102 | Phase 1 | China |
| 72 | EUCTR2020-001175-32-PT (EUCTR) | 15/01/2021 | 30/09/2020 | Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s disease | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone 50 mg hard capsules INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 73 | EUCTR2019-002949-38-BG (EUCTR) | 13/01/2021 | 21/12/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 74 | NCT04277247 (ClinicalTrials.gov) | January 12, 2021 | 10/2/2020 | Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's Disease | Botulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control Study | Dystonia Disorder;Parkinson Disease | Drug: Botulinum toxin type A;Drug: Placebo | University of Calgary | Allergan | Recruiting | 30 Years | 100 Years | All | 40 | Phase 2/Phase 3 | Canada |
| 75 | EUCTR2019-002951-40-BG (EUCTR) | 11/01/2021 | 05/01/2021 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 76 | NCT04658186 (ClinicalTrials.gov) | December 30, 2020 | 1/12/2020 | A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease | Early-stage Parkinson's Disease | Drug: UCB0599;Drug: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 40 Years | 75 Years | All | 490 | Phase 2 | United States;Canada;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 77 | JPRN-jRCTs031200172 | 23/12/2020 | 26/10/2020 | Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipation | Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD | Parkinson's disease, chronic constipation Parkinson's syndrome,chronic constipation,Symptomatic constipation | Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment. | Hatano Taku | Mochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd. | Not Recruiting | >= 20age old | Not applicable | Both | 100 | N/A | Japan |
| 78 | EUCTR2020-002010-41-FR (EUCTR) | 22/12/2020 | 09/09/2020 | NA | A randomized, double-blind, placebo-controlled phase IIB study evaluating the efficacy of mesdopetam on DAILY on-time without troublesome dyskinesia in patients with Parkinson’s disease | Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mesdopetam Product Code: IRL790 INN or Proposed INN: Mesdopetam Product Name: mesdopetam Product Code: IRL790 INN or Proposed INN: Mesdopetam Product Name: mesdopetam Product Code: IRL790 INN or Proposed INN: Mesdopetam | Integrative Research Laboratories Sweden AB (IRLAB) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | United States;Serbia;France;Poland;Israel;Italy | ||
| 79 | NCT04685265 (ClinicalTrials.gov) | December 22, 2020 | 17/12/2020 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of anle138b, and to Characterise the Effect of Food of anle138b in Mild to Moderate Parkinson's Disease | Parkinson Disease | Drug: anle138b;Drug: Placebo | MODAG GmbH | Aptuit (Verona) Srl, an Evotec Company;Quotient Sciences;Nottingham University Hospitals NHS Trust | Active, not recruiting | 40 Years | 80 Years | All | 72 | Phase 1 | United Kingdom |
| 80 | EUCTR2020-001175-32-IT (EUCTR) | 17/12/2020 | 15/06/2021 | Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson's disease | Randomized, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson's disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 81 | NCT04651153 (ClinicalTrials.gov) | December 14, 2020 | 25/11/2020 | A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) | A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's Disease | Parkinson's Disease | Drug: UCB7853;Other: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | 80 Years | All | 57 | Phase 1 | Netherlands;United Kingdom |
| 82 | NCT03968133 (ClinicalTrials.gov) | December 10, 2020 | 28/5/2019 | Treating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic | Treating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic - a Randomized, Placebo-controlled Trial | Parkinson Disease;Anxiety | Dietary Supplement: Probiotic;Dietary Supplement: Placebo | University of British Columbia | The W. Garfield Weston Foundation | Recruiting | 40 Years | 80 Years | All | 72 | Phase 2 | Canada |
| 83 | NCT04506073 (ClinicalTrials.gov) | November 9, 2020 | 16/7/2020 | Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD | Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease: Phase IIa Double-blind Randomized Placebo Controlled Trial | Parkinson's Disease | Drug: MSC+placebo;Drug: MSC;Drug: Placebo | The University of Texas Health Science Center, Houston | Michael J. Fox Foundation for Parkinson's Research | Active, not recruiting | 50 Years | 79 Years | All | 45 | Phase 2 | United States |
| 84 | NCT04620382 (ClinicalTrials.gov) | November 9, 2020 | 27/10/2020 | Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients | Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients | Neurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease | Drug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compression | Vanderbilt University Medical Center | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 40 Years | 80 Years | All | 31 | Early Phase 1 | United States |
| 85 | EUCTR2019-002951-40-IT (EUCTR) | 30/10/2020 | 21/01/2021 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Product Name: Tavapadon 0.25mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 86 | NCT04435431 (ClinicalTrials.gov) | October 29, 2020 | 15/6/2020 | A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia | A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease | Parkinson Disease | Drug: Mesdopetam;Drug: Placebo | Integrative Research Laboratories AB | NULL | Completed | 30 Years | 79 Years | All | 156 | Phase 2 | United States;France;Israel;Italy;Poland;Serbia |
| 87 | NCT04542499 (ClinicalTrials.gov) | October 27, 2020 | 2/9/2020 | Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) | Parkinson Disease | Drug: Tavapadon;Drug: Placebo | Cerevel Therapeutics, LLC | NULL | Recruiting | 40 Years | 80 Years | All | 368 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Serbia;Spain;Ukraine |
| 88 | NCT03947216 (ClinicalTrials.gov) | October 23, 2020 | 7/5/2019 | Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease. | Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease | Parkinson Disease | Drug: Active drug: pimavanserin 17mg (2 strength tablets);Drug: Placebo: 2 tablets containing same excipients except active compound;Behavioral: Assessment of severity of ICD (impulse control disorders);Behavioral: Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors;Behavioral: Assessment of quality of life;Behavioral: Assessment of depression;Behavioral: Assessment of cognition;Behavioral: Assessment of severity of Parkinson Disease;Procedure: Blood analysis;Procedure: Cardiac monitoring | University Hospital, Strasbourg, France | NS-PARK;EUCLID Clinical Trial Platform;F-CRIN | Recruiting | 35 Years | 75 Years | All | 130 | Phase 2 | France |
| 89 | NCT04334317 (ClinicalTrials.gov) | October 21, 2020 | 30/3/2020 | A Study of TAK-071 in People With Parkinson Disease | A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls | Parkinson Disease;Healthy Participants | Drug: TAK-071;Drug: Placebo | Takeda | Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 85 Years | All | 64 | Phase 2 | United States |
| 90 | NCT04380142 (ClinicalTrials.gov) | October 19, 2020 | 6/5/2020 | Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease | A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951 | AbbVie | NULL | Completed | 30 Years | N/A | All | 174 | Phase 3 | United States;Australia |
| 91 | EUCTR2020-001175-32-GB (EUCTR) | 29/09/2020 | 07/08/2020 | Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease. | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations andassociated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;Italy;United Kingdom | ||
| 92 | EUCTR2019-002949-38-DE (EUCTR) | 07/09/2020 | 21/01/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 552 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 93 | NCT04524351 (ClinicalTrials.gov) | August 14, 2020 | 11/8/2020 | Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD) or Early Parkinson's Disease (PD) | Alzheimer Disease;Parkinson Disease | Drug: Posiphen | Annovis Bio Inc. | Parexel | Completed | 45 Years | N/A | All | 75 | Phase 1/Phase 2 | United States |
| 94 | NCT04449484 (ClinicalTrials.gov) | August 4, 2020 | 23/4/2019 | Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: MEDI1341;Other: Placebo | AstraZeneca | Takeda | Completed | 40 Years | 85 Years | All | 25 | Phase 1 | United States |
| 95 | EUCTR2019-002951-40-DE (EUCTR) | 29/07/2020 | 12/02/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 96 | NCT04722211 (ClinicalTrials.gov) | July 6, 2020 | 15/1/2021 | Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease. | Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease. | Parkinson Disease | Dietary Supplement: PS128;Dietary Supplement: placebo | Professor Lu Neurological Clinic | NULL | Recruiting | 45 Years | 80 Years | All | 120 | N/A | Taiwan |
| 97 | EUCTR2019-002951-40-HU (EUCTR) | 02/07/2020 | 29/04/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 98 | EUCTR2019-002951-40-CZ (EUCTR) | 03/06/2020 | 25/02/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 99 | EUCTR2019-002949-38-IT (EUCTR) | 21/05/2020 | 21/01/2021 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY,AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY,AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL) - TEMPO-1 TRIAL | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Product Name: Tavapadon 0.25mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 100 | EUCTR2019-002950-22-IT (EUCTR) | 21/05/2020 | 15/06/2021 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease | A Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO 2 Trial) - TEMPO-2 Trial | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Other descriptive name: TAVAPADON Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Other descriptive name: TAVAPADON Product Name: Tavapadon 0.25mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Other descriptive name: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 296 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 101 | NCT03568968 (ClinicalTrials.gov) | May 15, 2020 | 14/6/2018 | A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease | A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK Study | Parkinson Disease | Dietary Supplement: Nicotinamide Riboside;Drug: Placebo | Haukeland University Hospital | NULL | Recruiting | 18 Years | N/A | All | 400 | N/A | Norway |
| 102 | EUCTR2019-002949-38-PL (EUCTR) | 13/05/2020 | 20/02/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 103 | NCT04571164 (ClinicalTrials.gov) | May 11, 2020 | 21/9/2020 | A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | Parkinson Disease | Drug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheres | Luye Pharma Group Ltd. | Parexel | Recruiting | 30 Years | N/A | All | 294 | Phase 3 | China |
| 104 | EUCTR2019-002950-22-HU (EUCTR) | 06/05/2020 | 12/03/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease | A Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO 2 Trial) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 296 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany | ||
| 105 | EUCTR2019-002951-40-ES (EUCTR) | 14/04/2020 | 06/03/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 106 | EUCTR2019-002949-38-ES (EUCTR) | 07/04/2020 | 28/02/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 107 | NCT04342273 (ClinicalTrials.gov) | March 31, 2020 | 8/4/2020 | A Through QT/QTc Study of KW-6356 | A Through QT/QTc Study of KW-6356 in Japanese Healthy Adults | Parkinson's Disease | Drug: KW-6356;Drug: Placebo;Drug: Moxifloxacin | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | 54 Years | All | 128 | Phase 1 | Japan |
| 108 | EUCTR2020-000686-16-NL (EUCTR) | 26/03/2020 | 09/03/2020 | Validation of finger tapping in PD patients | Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson’s Disease patients. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 125 Product Name: SINEMET Product Code: RVG 08740 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopamonohydraat Other descriptive name: CARBIDOPA MONOHYDRATE | Centre for Human Drug Research | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 109 | NCT04269642 (ClinicalTrials.gov) | March 19, 2020 | 13/1/2020 | SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease | Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease | Early Parkinson's Disease | Drug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mg | Peptron, Inc. | NULL | Active, not recruiting | 40 Years | 75 Years | All | 99 | Phase 2 | Korea, Republic of |
| 110 | EUCTR2017-003415-19-IT (EUCTR) | 10/03/2020 | 19/05/2021 | A Clinical Study in Parkinson’s Disease Patients With Moderate to Severe Abnormal Movements to See If JM-010 is Effective and Safe/Tolerable. | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010 | Parkinson’s Disease Patients With Moderate to Severe Dyskinesia MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan | Contera Pharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 2 | France;Spain;Germany;Italy | ||
| 111 | EUCTR2019-002949-38-CZ (EUCTR) | 04/03/2020 | 19/12/2019 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) - TEMPO-1 Trial | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany | ||
| 112 | NCT04127695 (ClinicalTrials.gov) | March 3, 2020 | 9/10/2019 | A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ABBV-0805;Drug: Placebo ABBV-0805 | AbbVie | NULL | Withdrawn | N/A | 85 Years | All | 0 | Phase 1 | United States;Puerto Rico |
| 113 | NCT04154072 (ClinicalTrials.gov) | February 27, 2020 | 4/11/2019 | A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease | Parkinson Disease | Drug: NLY01;Drug: Vehicle | Neuraly, Inc. | NULL | Active, not recruiting | 30 Years | 80 Years | All | 255 | Phase 2 | United States;Canada |
| 114 | EUCTR2019-002949-38-HU (EUCTR) | 06/02/2020 | 17/12/2019 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Hungary;United States;Ukraine;Spain;Canada;Czech Republic;Sweden;Poland;Italy;Israel;Australia;Bulgaria;France;Serbia;Germany | ||
| 115 | NCT04251585 (ClinicalTrials.gov) | February 4, 2020 | 28/1/2020 | Intranasal Insulin in Parkinson's Disease | Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease | Parkinson Disease | Drug: Regular Novolin R;Drug: Placebo | HealthPartners Institute | NULL | Recruiting | 41 Years | 89 Years | All | 30 | Phase 2 | United States |
| 116 | EUCTR2018-003289-15-DE (EUCTR) | 28/01/2020 | 08/02/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany | ||
| 117 | NCT04322227 (ClinicalTrials.gov) | January 23, 2020 | 29/1/2020 | Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects | Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects | Parkinson Disease;Healthy | Drug: Foliglurax 10 mg (treatment A);Drug: Foliglurax 30 mg (treatment B);Drug: Placebo (treatment C) | H. Lundbeck A/S | NULL | Terminated | 50 Years | 70 Years | All | 6 | Phase 1 | France |
| 118 | NCT04220762 (ClinicalTrials.gov) | January 21, 2020 | 17/12/2019 | A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients | A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study | Parkinson Disease | Drug: WIN-1001X;Drug: Placebo | Medi Help Line | NULL | Recruiting | 30 Years | N/A | All | 188 | Phase 2 | Korea, Republic of |
| 119 | NCT04305002 (ClinicalTrials.gov) | January 21, 2020 | 20/2/2020 | Exenatide Treatment in Parkinson's Disease | Effect of Exenatide on Disease Progression in Early Parkinson's Disease | Parkinson Disease | Drug: Exenatide;Drug: Placebo | Center for Neurology, Stockholm | Karolinska Institutet | Active, not recruiting | 25 Years | 80 Years | All | 60 | Phase 2 | Sweden |
| 120 | NCT04232969 (ClinicalTrials.gov) | January 20, 2020 | 10/1/2020 | Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease | A Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease | Parkinson's Disease | Drug: Exenatide extended release 2mg (Bydureon) | University College, London | NULL | Active, not recruiting | 25 Years | 80 Years | All | 194 | Phase 3 | United Kingdom |
| 121 | NCT04369430 (ClinicalTrials.gov) | January 16, 2020 | 13/4/2020 | Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment | Parkinson Disease | Drug: AKST4290;Drug: Placebo | Alkahest, Inc. | NULL | Completed | 50 Years | 80 Years | All | 110 | Phase 2 | United States;Estonia;Germany;Poland;Slovakia;Hungary |
| 122 | EUCTR2019-001657-42-SK (EUCTR) | 14/01/2020 | 01/10/2019 | A study to learn how well the drug AKST4290 works and how safeAKST4290 is in people who have Parkinson's disease that are takingdopamine based medication. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate theEfficacy and Safety of AKST4290 in Subjects with Parkinson's Disease onStable Dopaminergic Treatment. - N/A | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AKST4290 Product Code: AKST4290 INN or Proposed INN: AKST4290 Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE | Alkahest, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Estonia;Slovakia;Poland;Germany | ||
| 123 | EUCTR2018-003289-15-PT (EUCTR) | 13/01/2020 | 21/08/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Denmark;Australia;Peru;Bulgaria;Germany;New Zealand | ||
| 124 | NCT04223193 (ClinicalTrials.gov) | January 6, 2020 | 7/1/2020 | Flexible-Dose Trial in Early Parkinson's Disease (PD) | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial) | Parkinson Disease | Drug: Tavapadon;Drug: Placebo | Cerevel Therapeutics, LLC | NULL | Recruiting | 40 Years | 80 Years | All | 296 | Phase 3 | United States;Australia;France;Germany;Hungary;Italy;Poland;Serbia;Spain;Ukraine |
| 125 | NCT04226248 (ClinicalTrials.gov) | January 2, 2020 | 5/12/2019 | CHIEF PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease) | CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease: A Phase 3 Randomised, Double-blind Placebo-controlled Trial of Rivastigmine to Prevent Falls in Parkinson's Disease. | Parkinson Disease | Drug: Rivastigmine Transdermal System;Other: Placebo Transdermal System | University of Bristol | Royal United Hospitals Bath NHS Foundation Trust | Recruiting | 18 Years | N/A | All | 600 | Phase 3 | United Kingdom |
| 126 | NCT04687878 (ClinicalTrials.gov) | January 1, 2020 | 28/12/2020 | The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients | Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial | Parkinson Disease | Drug: Insulin;Drug: Normal saline | dr.dargahi | NULL | Recruiting | 17 Years | N/A | All | 40 | Phase 2 | Iran, Islamic Republic of |
| 127 | NCT03808961 (ClinicalTrials.gov) | January 1, 2020 | 16/1/2019 | Niacin for Parkinsons Disease | NAPS: Niacin for Parkinsons Disease | Parkinson's Disease | Dietary Supplement: Niacin;Dietary Supplement: Niacinamide;Other: Placebo | VA Office of Research and Development | NULL | Recruiting | 35 Years | N/A | All | 100 | N/A | United States |
| 128 | NCT04152655 (ClinicalTrials.gov) | January 1, 2020 | 7/10/2019 | A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease | A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD) | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Idebenone;Drug: Placebo oral tablet | Second Affiliated Hospital, School of Medicine, Zhejiang University | Peking Union Medical College Hospital;Beijing Hospital;Beijing Tiantan Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Jiangsu Province Nanjing Brain Hospital;The First Affiliated Hospital of Anhui Medical University;Huashan Hospital;Tongji Hospital;Second Affiliated Hospital of Soochow University;Guizhou Medical University;The First Affiliated Hospital of Guangzhou Medical University;Peking University Shenzhen Hospital;West China Hospital;Wuhan Union Hospital, China;Sir Run Run Shaw Hospital;The Affiliated Hospital of Hangzhou Normal University;The First Affiliated Hospital of Dalian Medical University;Qilu Hospital of Shandong University | Recruiting | 18 Years | N/A | All | 180 | Phase 2/Phase 3 | China |
| 129 | NCT04164121 (ClinicalTrials.gov) | December 17, 2019 | 12/11/2019 | A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers | A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers | Parkinson Disease | Drug: Phenlarmide Tablets;Drug: Placebos | Yiling Pharmaceutical Inc. | NULL | Completed | 18 Years | 65 Years | All | 36 | Phase 1 | China |
| 130 | NCT04201093 (ClinicalTrials.gov) | December 13, 2019 | 13/12/2019 | Fixed-Dose Trial in Early Parkinson's Disease (PD) | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL) | Parkinson Disease | Drug: Tavapadon;Drug: Placebo | Cerevel Therapeutics, LLC | NULL | Recruiting | 40 Years | 80 Years | All | 522 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Israel;Italy;Poland;Spain;Ukraine |
| 131 | NCT04249544 (ClinicalTrials.gov) | December 3, 2019 | 28/1/2020 | Social Decision Making in Parkinson's Disease | Cognitive and Neural Mechanisms of Impaired Social Decision-Making in Parkinson's Patients Taking Dopamine Agonists | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Vanderbilt University Medical Center | United States Department of Defense | Recruiting | 45 Years | 80 Years | All | 60 | Phase 1 | United States |
| 132 | EUCTR2018-003089-14-GB (EUCTR) | 03/12/2019 | 07/10/2019 | Can suppressing the immune system with azathioprine slow down the progression of Parkinson's disease? | Azathioprine Immunosuppression and Disease Modification in Parkinson’s Disease (AZA-PD): a randomised double-blind placebo-controlled phase II trial - AZA-PD | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Azathioprine INN or Proposed INN: Azathioprine | Cambridge University Hospitals NHS Foundation Trust and University of Cambridge | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United Kingdom | ||
| 133 | NCT03436953 (ClinicalTrials.gov) | December 2019 | 7/2/2018 | A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Tremor Associated With Parkinson's Disease | Parkinson's Disease;Tremor | Drug: CX-8998;Drug: Placebo | Jazz Pharmaceuticals | NULL | Withdrawn | 40 Years | 80 Years | All | 0 | Phase 2 | United States |
| 134 | NCT04768023 (ClinicalTrials.gov) | November 18, 2019 | 14/2/2021 | 12 Weeks Vitamin D Supplementation and Physical Activity in PD Patients With DBS | Influence of 12 Weeks Vitamin D Supplementation Combined With Physical Activity on Blood and Functional Parameters and Quality of Life in Parkinson's Disease Patients Treated With Deep Brain Stimulation | Vitamin D Deficiency;Parkinson Disease | Drug: Juvit D3;Behavioral: steps per day;Drug: Placebo | Medical University of Gdansk | NULL | Enrolling by invitation | 40 Years | 90 Years | All | 72 | N/A | Poland |
| 135 | NCT03924414 (ClinicalTrials.gov) | November 15, 2019 | 2/4/2019 | Trial of Parkinson's And Zoledronic Acid | TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease | Parkinson Disease;Osteoporosis;Parkinsonism;Parkinson's Disease and Parkinsonism;Atypical Parkinsonism;Progressive Supranuclear Palsy;Multiple System Atrophy;Vascular Parkinsonism;Dementia With Lewy Bodies | Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: Placebo | California Pacific Medical Center Research Institute | National Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's Foundation | Recruiting | 60 Years | N/A | All | 3500 | Phase 4 | United States |
| 136 | NCT04148391 (ClinicalTrials.gov) | November 14, 2019 | 30/10/2019 | NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking) | A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia | Mild Cognitive Impairment;Mild Dementia;Parkinson Disease;Lewy Body Disease | Drug: Placebo Oral Capsule;Drug: NYX-458 | Aptinyx | CogState Ltd.;Worldwide Clinical Trials | Active, not recruiting | 50 Years | 80 Years | All | 99 | Phase 2 | United States |
| 137 | EUCTR2018-002942-35-GB (EUCTR) | 31/10/2019 | 05/09/2019 | A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo, and standard psychological care, for depression in Parkinson’s disease | A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo and standard psychological care for depression in Parkinson’s Disease - Antidepressants Trial in Parkinson's Disease (ADepT-PD) | Depression in Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Escitalopram INN or Proposed INN: Escitalopram oxalate Trade Name: Nortriptyline Product Name: Nortriptyline INN or Proposed INN: Nortriptyline hydrochloride | University College London Comprehensive Clinical Trials Unit | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 408 | Phase 3 | United Kingdom | ||
| 138 | NCT03652870 (ClinicalTrials.gov) | October 31, 2019 | 8/8/2018 | Antidepressants Trial in Parkinson's Disease | A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's Disease | Depression;Parkinson Disease | Drug: Nortriptyline;Drug: Escitalopram;Drug: Placebo | University College, London | London North West Healthcare NHS Trust;King's College London;University Hospital Plymouth NHS Trust;NHS Lothian | Recruiting | 18 Years | 85 Years | All | 408 | Phase 3 | United Kingdom |
| 139 | NCT04164758 (ClinicalTrials.gov) | October 23, 2019 | 13/11/2019 | Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine | A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine | Parkinson's Disease | Drug: Pimavanserin;Other: Placebo;Drug: Quetiapine | ACADIA Pharmaceuticals Inc. | NULL | Terminated | 50 Years | 85 Years | All | 11 | Phase 2 | United States |
| 140 | EUCTR2019-001657-42-DE (EUCTR) | 22/10/2019 | 11/06/2019 | A study to learn how well the drug AKST4290 works and how safe AKST4290 is in people who have Parkinson's disease that are taking dopamine based medication. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson's Disease on Stable Dopaminergic Treatment - N/A | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AKST4290 Product Code: AKST4290 INN or Proposed INN: AKST4290 Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE | Alkahest, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Estonia;Slovakia;Poland;Germany | ||
| 141 | EUCTR2018-003337-15-ES (EUCTR) | 17/10/2019 | 30/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Slovakia;Poland;Spain;India | ||
| 142 | NCT04157933 (ClinicalTrials.gov) | October 16, 2019 | 1/11/2019 | Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease | A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's Disease | Parkinson's Disease | Drug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossover | Alexza Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 35 | Phase 1 | Netherlands |
| 143 | NCT04165837 (ClinicalTrials.gov) | October 14, 2019 | 13/11/2019 | Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects | Parkinson's Disease | Drug: FB-101;Drug: Placebo | 1ST Biotherapeutics, Inc. | NULL | Completed | 19 Years | 55 Years | All | 24 | Phase 1 | United States |
| 144 | EUCTR2018-003289-15-BG (EUCTR) | 10/10/2019 | 24/07/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 145 | NCT03987750 (ClinicalTrials.gov) | October 2019 | 12/6/2019 | Safinamide for Levodopa-induced Dyskinesia (PD-LID) | A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations | Dyskinesia, Drug-Induced;Parkinson Disease | Drug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placebo | Zambon SpA | NULL | Withdrawn | 30 Years | N/A | All | 0 | Phase 3 | NULL |
| 146 | NCT03905811 (ClinicalTrials.gov) | September 24, 2019 | 1/4/2019 | A Pilot Study of Terazosin for Parkinson's Disease | A Pilot Study of Terazosin for Parkinson's Disease | Parkinson Disease | Drug: Terazosin 5 MG;Drug: Placebo oral capsule | Jordan Schultz | University of Iowa | Completed | 40 Years | 90 Years | All | 13 | Phase 1/Phase 2 | United States |
| 147 | NCT04006925 (ClinicalTrials.gov) | September 10, 2019 | 27/6/2019 | Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate | Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Sodium Oxybate;Other: Placebo | Stanford University | Jazz Pharmaceuticals | Completed | 40 Years | 85 Years | All | 24 | Phase 4 | United States |
| 148 | EUCTR2018-003028-35-GB (EUCTR) | 04/09/2019 | 15/11/2019 | A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease. | A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease. - Phase 3 Trial of exenatide for Parkinson’s disease | Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Bydureon Product Name: Bydureon INN or Proposed INN: Exenatide | University College London Comprehensive Clinical Trial Unit | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 149 | NCT04075318 (ClinicalTrials.gov) | August 29, 2019 | 5/8/2019 | Study of UB-312 in Healthy Participants and Parkinson's Disease Patients | A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's Disease | Parkinson's Disease;Parkinsonism | Biological: UB-312;Biological: Placebo | United Neuroscience Ltd. | Centre for Human Drug Research, Netherlands;Worldwide Clinical Trials;Vaxxinity, Inc. | Active, not recruiting | 40 Years | 85 Years | All | 70 | Phase 1 | Netherlands |
| 150 | NCT04006210 (ClinicalTrials.gov) | August 27, 2019 | 30/6/2019 | Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations | A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Study of the Efficacy, Safety, and Tolerability of Continuous SC ND0612 Infusion vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations | Parkinson's Disease | Combination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mg | NeuroDerm Ltd. | NULL | Active, not recruiting | 30 Years | 80 Years | All | 381 | Phase 3 | United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom |
| 151 | NCT03976349 (ClinicalTrials.gov) | August 12, 2019 | 4/6/2019 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease | A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson's Disease | Parkinson's Disease | Drug: BIIB094;Drug: Placebo | Biogen | Ionis Pharmaceuticals, Inc. | Recruiting | 35 Years | 80 Years | All | 82 | Phase 1 | United States;Canada;Israel;Norway;Spain;United Kingdom |
| 152 | NCT04043338 (ClinicalTrials.gov) | August 11, 2019 | 24/7/2019 | Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects | Parkinson's Disease | Drug: XC130-A10H;Drug: Placebo | Xoc Pharmaceuticals | Celerion | Active, not recruiting | 18 Years | 75 Years | All | 56 | Phase 1 | United States |
| 153 | EUCTR2018-003289-15-IT (EUCTR) | 02/08/2019 | 18/01/2021 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: na Product Code: [TD-9855] INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855 | THERAVANCE BIOPHARMA ANTIBIOTICS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Czechia;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Denmark;Bulgaria;Germany | ||
| 154 | ChiCTR1900023725 | 2019-08-01 | 2019-06-09 | Study for the Role of Butylphthalide in Delaying the progression of Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS) | Study for the Role of Butylphthalide in Delaying the progression of Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS) | Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS) | PD-Placebo:Placebo;PD-Butylphthalide:Butylphthalide;VP-Placebo:Placebo;VP-Butylphthalide:Butylphthalide;MSA-Placebo:Placebo;MSA-Butylphthalide :Butylphthalide ;PSP-Placebo:Placebo;PSP-Butylphthalide:Butylphthalide; | Zhujiang Hospital of Southern Medical University | NULL | Pending | 18 | 80 | Male | PD-Placebo:50;PD-Butylphthalide:50;VP-Placebo:50;VP-Butylphthalide:50;MSA-Placebo:50;MSA-Butylphthalide :50;PSP-Placebo:50;PSP-Butylphthalide:50; | China | |
| 155 | NCT03881371 (ClinicalTrials.gov) | August 1, 2019 | 18/3/2019 | A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa | Parkinson Disease | Drug: Safinamide;Other: Placebo | Zambon SpA | NULL | Completed | 18 Years | N/A | All | 307 | Phase 3 | China |
| 156 | NCT04056689 (ClinicalTrials.gov) | July 23, 2019 | 12/8/2019 | Study to Evaluate DNL151 in Subjects With Parkinson's Disease | A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: DNL151;Drug: Placebo | Biogen | NULL | Completed | 30 Years | 75 Years | All | 36 | Phase 1 | United States;Belgium;Netherlands;United Kingdom |
| 157 | EUCTR2018-003289-15-PL (EUCTR) | 19/07/2019 | 07/05/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine chydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 158 | NCT03575195 (ClinicalTrials.gov) | July 15, 2019 | 21/6/2018 | Microbiota Intervention to Change the Response of Parkinson's Disease | Microbiota Intervention to Change the Response of Parkinson's Disease | Parkinson Disease | Drug: Rifaximin;Other: Placebo | University of California, San Francisco | Nova Southeastern University;Gateway Institute for Brain Research | Recruiting | 30 Years | N/A | All | 86 | Phase 1/Phase 2 | United States |
| 159 | NCT05146921 (ClinicalTrials.gov) | July 4, 2019 | 2/11/2021 | Gut Health and Probiotics in Parkinson's (SymPD) | Gut Health and Probiotics in Parkinson's (SymPD) | Parkinson Disease | Dietary Supplement: Multi-strain probiotic;Other: Placebo | King's College Hospital NHS Trust | King's College London | Active, not recruiting | 18 Years | N/A | All | 60 | N/A | United Kingdom |
| 160 | EUCTR2018-003289-15-DK (EUCTR) | 02/07/2019 | 14/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
| 161 | NCT03977441 (ClinicalTrials.gov) | July 2019 | 12/5/2019 | the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease | A Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's Disease | Parkinson Disease;Depression;Sleep Disorders;Circadian Rhythm Disorders | Drug: Agomelatine or PIacebo | Second Affiliated Hospital of Soochow University | NULL | Not yet recruiting | 30 Years | 75 Years | All | 240 | Phase 4 | NULL |
| 162 | EUCTR2018-003219-23-GB (EUCTR) | 28/06/2019 | 04/06/2019 | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease) | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease): A phase 3 randomised double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease - CHIEF-PD | This trial will investigate the effectiveness of Rivastigmine on prevention of falls in patients with Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Code: N/A INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Trade Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h Product Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Product Name: Rivastigmine transdermal system 13.3 mg/24 h Product Code: RIV-TDS 13.3 mg/24 h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) | University of Bristol | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Kingdom | ||
| 163 | EUCTR2018-003289-15-ES (EUCTR) | 26/06/2019 | 27/06/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Denmark;Germany | ||
| 164 | EUCTR2018-003337-15-HU (EUCTR) | 18/06/2019 | 12/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Phase 2 | United States;Hungary;Slovakia;Spain;Poland;India | ||
| 165 | EUCTR2018-003337-15-SK (EUCTR) | 05/06/2019 | 26/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Phase 2 | United States;Hungary;Slovakia;Spain;Poland;India | ||
| 166 | EUCTR2018-003289-15-HU (EUCTR) | 04/06/2019 | 05/04/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Denmark;Bulgaria;Germany | ||
| 167 | NCT03971617 (ClinicalTrials.gov) | May 29, 2019 | 30/5/2019 | Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease | Parkinson Disease | Drug: Hydrogen;Drug: Placebo oral tablet | Stony Brook University | NULL | Terminated | 40 Years | 80 Years | All | 2 | Phase 2/Phase 3 | United States |
| 168 | EUCTR2018-003289-15-AT (EUCTR) | 15/05/2019 | 22/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 169 | NCT03552068 (ClinicalTrials.gov) | May 15, 2019 | 17/5/2018 | Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: | Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial | Parkinson's Disease;Mpulse Control Disorders | Drug: placebo;Drug: Clonidine | Hospices Civils de Lyon | NULL | Completed | 30 Years | 80 Years | All | 38 | Phase 2 | France |
| 170 | NCT03671785 (ClinicalTrials.gov) | May 15, 2019 | 12/9/2018 | Study of the Fecal Microbiome in Patients With Parkinson's Disease | A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease | Parkinson Disease | Drug: PRIM-DJ2727;Drug: Placebo oral capsule | The University of Texas Health Science Center, Houston | Kelsey Research Foundation | Active, not recruiting | 55 Years | 75 Years | All | 12 | Phase 1 | United States |
| 171 | EUCTR2018-003289-15-GB (EUCTR) | 08/05/2019 | 28/12/2018 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled,Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 172 | NCT04875962 (ClinicalTrials.gov) | May 6, 2019 | 3/5/2021 | A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD) | A Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: UCB0599;Drug: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 40 Years | 80 Years | All | 31 | Phase 1 | United States |
| 173 | NCT03899324 (ClinicalTrials.gov) | April 26, 2019 | 29/3/2019 | Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease | A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease | Parkinson Disease | Drug: Bumetanide white, oblong, scored tablet;Drug: Placebo white, oblong, scored tablet | B&A Therapeutics | NULL | Recruiting | 40 Years | 80 Years | All | 40 | Phase 2 | France |
| 174 | EUCTR2018-003289-15-EE (EUCTR) | 11/04/2019 | 30/01/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 175 | NCT03661125 (ClinicalTrials.gov) | April 11, 2019 | 4/9/2018 | SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis | A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis. | Parkinson Disease Psychosis | Drug: Saracatinib;Drug: Placebo Oral Tablet | King's College London | AstraZeneca;King's College Hospital NHS Trust | Recruiting | 40 Years | N/A | All | 30 | Early Phase 1 | United Kingdom |
| 176 | NCT03841604 (ClinicalTrials.gov) | April 9, 2019 | 30/1/2019 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain | Idiopathic Parkinson Disease | Drug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placebo | Zambon SpA | NULL | Completed | 30 Years | N/A | All | 71 | Phase 4 | Austria;France;Germany;Italy;Spain |
| 177 | EUCTR2017-002426-20-FR (EUCTR) | 05/04/2019 | 26/11/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria | ||
| 178 | EUCTR2016-000657-12-GR (EUCTR) | 04/04/2019 | 11/01/2019 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Taiwan;United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden | ||
| 179 | NCT03858270 (ClinicalTrials.gov) | April 1, 2019 | 2/10/2018 | Inhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine | Inhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine | Parkinson Disease | Drug: Memantine;Other: Placebo | Wayne State University | NULL | Recruiting | 45 Years | 85 Years | All | 50 | Phase 3 | United States |
| 180 | NCT03922711 (ClinicalTrials.gov) | March 26, 2019 | 17/4/2019 | A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease | A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe) | Parkinson Disease | Drug: Pridopidine;Drug: Placebo | Prilenia | NULL | Terminated | 30 Years | 85 Years | All | 23 | Phase 2 | United States |
| 181 | NCT03716570 (ClinicalTrials.gov) | March 12, 2019 | 22/10/2018 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease | A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease | Parkinson's Disease | Drug: BIIB054;Drug: Placebo | Biogen | NULL | Terminated | 40 Years | 80 Years | All | 24 | Phase 1 | Japan |
| 182 | NCT03816020 (ClinicalTrials.gov) | March 9, 2019 | 7/12/2018 | NAD-supplementation in Drug naïve Parkinson's Disease | NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease | Parkinson Disease;Neurodegenerative Diseases | Dietary Supplement: Nicotinamide Riboside;Other: Placebo | Haukeland University Hospital | NULL | Completed | 18 Years | N/A | All | 30 | N/A | Norway |
| 183 | NCT03830528 (ClinicalTrials.gov) | February 26, 2019 | 3/2/2019 | A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects | A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults | Parkinson's Disease | Drug: KW-6356 Low Dose;Drug: KW-6356 Middle Dose;Drug: KW-6356 High Dose;Drug: KW-6356 X Dose;Drug: KW-6356 Y Dose;Drug: Placebo | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | 44 Years | Male | 48 | Phase 1 | Japan |
| 184 | NCT03829657 (ClinicalTrials.gov) | February 22, 2019 | 10/1/2019 | Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension;MSA;Parkinson's Disease (PD);Pure Autonomic Failure (PAF) | Drug: ampreloxetine;Drug: Placebo | Theravance Biopharma | NULL | Active, not recruiting | 30 Years | N/A | All | 203 | Phase 3 | United States;Argentina;Australia;Austria;Bulgaria;Canada;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;New Zealand;Poland;Portugal;Russian Federation;Spain;Ukraine;United Kingdom |
| 185 | EUCTR2017-002426-20-IT (EUCTR) | 21/02/2019 | 07/10/2020 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson's Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | Germany;Italy;France;Spain;Austria | ||
| 186 | NCT03655236 (ClinicalTrials.gov) | February 18, 2019 | 18/8/2018 | PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease | Early Parkinson Disease | Drug: K0706;Other: placebo | Sun Pharma Advanced Research Company Limited | NULL | Recruiting | 50 Years | N/A | All | 504 | Phase 2 | United States;Hungary;India;Poland;Slovakia;Spain |
| 187 | NCT03413384 (ClinicalTrials.gov) | February 15, 2019 | 8/1/2018 | To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia | A Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia | Parkinson's Disease Dementia | Drug: Ceftriaxone;Other: Placebo | BrainX Corporation | Virginia Contract Research Organization Co., Ltd. | Recruiting | 50 Years | 80 Years | All | 106 | Phase 2 | Taiwan |
| 188 | EUCTR2017-003458-18-SE (EUCTR) | 23/01/2019 | 10/12/2018 | A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesia | A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia | Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IRL790 Product Code: IRL790 INN or Proposed INN: IRL790 | Integrative Research Laboratories AB (IRLAB) | NULL | Not Recruiting | Female: yes Male: yes | 74 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Sweden | ||
| 189 | EUCTR2017-002426-20-AT (EUCTR) | 22/01/2019 | 03/12/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 4 | Spain;Austria | ||
| 190 | EUCTR2018-002877-23-AT (EUCTR) | 21/01/2019 | 07/12/2018 | Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD | Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD | Social functioning in Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Syntocinon 40 IU/ml nasal spray INN or Proposed INN: Synthetic Oxytocin Other descriptive name: OXYTOCIN SYNTHETIC | Abteilung für Neurologie der Medizinischen Universität Innsbruck | NULL | Not Recruiting | Female: no Male: yes | 76 | Phase 2 | Austria | ||
| 191 | JPRN-UMIN000035602 | 2019/01/11 | 21/01/2019 | Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease | Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease - Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease | Parkinson's disease | hydrogen gas16 weeks inhalation two times of the inhalation for 60 minutes per day 8 weeks obsebation after the inhalation placebo gas 16 weeks inhalation two times of the inhalation for 60 minutes per day 8 weeks obsebation after the inhalation | Juntendo University Koshigaya Hospital | NULL | Complete: follow-up complete | 40years-old | 80years-old | Male and Female | 20 | Not selected | Japan |
| 192 | NCT03727295 (ClinicalTrials.gov) | January 1, 2019 | 30/10/2018 | Idebenone Treatment of Early Parkinson's Diseasesymptoms | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor Symptoms | Oxidative Stress is an Important Cause of Parkinson's Disease | Drug: Idebenone/placebo | Second Affiliated Hospital of Soochow University | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | 30 Years | 80 Years | All | 180 | Phase 4 | NULL |
| 193 | ChiCTR1800019942 | 2018-12-31 | 2018-12-09 | A Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s Disease | A Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s Disease | Parkinson’s Disease | Experimental group:Zishen Pingchan Granules combined with Pramipexole;Control group:Zishen Pingchan Granules placebo combined with Pramipexole; | The Affiliated Brain Hospital of Nanjing Medical University( Nanjing Brain Hospital) | NULL | Pending | 30 | 85 | Both | Experimental group:150;Control group:150; | China | |
| 194 | NCT03840005 (ClinicalTrials.gov) | December 18, 2018 | 11/2/2019 | Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The UP Study | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial To Assess The Safety And Tolerability Of 30mg/kg Daily Ursodeoxycholic Acid (UDCA) In Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: Ursonorm | Sheffield Teaching Hospitals NHS Foundation Trust | JP Moulton Charitable Foundation;PRO.MED.CS Praha a.s.;Clinical Trials Research Unit, University of Sheffield | Completed | 18 Years | 75 Years | All | 31 | Phase 2 | United Kingdom |
| 195 | NCT03781791 (ClinicalTrials.gov) | December 10, 2018 | 27/11/2018 | Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET) | Constipation;Parkinson Disease | Drug: Active Investigational Treatment ENT-01;Drug: Placebo Treatment | Enterin Inc. | NULL | Completed | 30 Years | 90 Years | All | 144 | Phase 2 | United States |
| 196 | NCT03710707 (ClinicalTrials.gov) | December 4, 2018 | 15/10/2018 | Study to Evaluate DNL201 in Subjects With Parkinson's Disease | A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: DNL201;Drug: Placebo | Denali Therapeutics Inc. | NULL | Completed | 30 Years | 80 Years | All | 29 | Phase 1 | United States |
| 197 | NCT03823638 (ClinicalTrials.gov) | November 20, 2018 | 20/11/2018 | Safety, Tolerability and Effects of Mannitol in Parkinson's Disease | A Phase II Single Center, Randomized, Double Blind and Placebo Controlled Study Assessing the Safety, Tolerability and Effects of Progressively Increased Dose of Oral Mannitol in Parkinson's Disease | Parkinson Disease | Dietary Supplement: Oral D-Mannitol of Placebo | Hadassah Medical Organization | NULL | Recruiting | 40 Years | 75 Years | All | 60 | Phase 2 | Israel |
| 198 | NCT03713957 (ClinicalTrials.gov) | November 12, 2018 | 18/10/2018 | A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment | Parkinson Disease | Drug: GRF6021;Other: Placebo | Alkahest, Inc. | Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 85 Years | All | 79 | Phase 2 | United States;Australia;France |
| 199 | EUCTR2018-001887-46-GB (EUCTR) | 08/11/2018 | 19/06/2019 | Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial to assess the safety and tolerability Of 30mg/kg daily Ursodeoxycholic Acid (UDCA) in Patients with Parkinson’s Disease (PD) - Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | Parkinson’s disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ursonorm Product Name: Ursonorm INN or Proposed INN: Ursodeoxycholic acid | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 200 | NCT03670953 (ClinicalTrials.gov) | November 6, 2018 | 12/9/2018 | A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease (Disorder) | Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placebo | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 631 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 201 | NCT04629404 (ClinicalTrials.gov) | November 5, 2018 | 5/11/2020 | A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's Disease | Parkinson Disease | Drug: LY03003;Drug: Placebo | Luye Pharma Group Ltd. | NULL | Completed | 30 Years | N/A | All | 32 | Phase 1 | China |
| 202 | JPRN-JapicCTI-184111 | 31/10/2018 | 18/09/2018 | A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations | A Phase 2b Study of KW-6356 in Patients with Parkinson's Disease on Treatment with Levodopa-containing Preparations | Parkinson's Disease | Intervention name : KW-6356 INN of the intervention : - Dosage And administration of the intervention : oral administration Control intervention name : placebo INN of the control intervention : - Dosage And administration of the control intervention : oral administration | Kyowa Kirin Co., Ltd. | NULL | complete | 20 | 80 | BOTH | 486 | Phase 2 | Japan |
| 203 | EUCTR2016-002033-30-NL (EUCTR) | 31/10/2018 | 15/11/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 204 | EUCTR2017-003415-19-ES (EUCTR) | 31/10/2018 | 20/08/2018 | A Clinical Study in Parkinson’s Disease Patients With Moderate to Severe Abnormal Movements to See If JM-010 is Effective and Safe/Tolerable. | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations Of JM-010 | Parkinson’s Disease Patients With Moderate to Severe Dyskinesia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan | Contera Pharma | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Spain;Germany | ||
| 205 | EUCTR2017-002426-20-ES (EUCTR) | 19/10/2018 | 20/08/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria;Italy | ||
| 206 | NCT04451096 (ClinicalTrials.gov) | October 6, 2018 | 19/6/2020 | Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation | Probiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinson's Disease Patients With Constipation: A Randomised Controlled Study | Parkinson Disease;Constipation | Dietary Supplement: Probiotics with prebiotic;Dietary Supplement: Placebo | National University of Malaysia | NULL | Completed | 18 Years | N/A | All | 48 | Phase 3 | Malaysia |
| 207 | EUCTR2016-004610-95-DE (EUCTR) | 01/10/2018 | 27/02/2018 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 357 | Phase 2 | France;United States;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy | ||
| 208 | NCT03703570 (ClinicalTrials.gov) | September 29, 2018 | 5/10/2018 | A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations | A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations | Parkinson's Disease | Drug: KW-6356;Drug: Placebo | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | 80 Years | All | 502 | Phase 2 | Japan |
| 209 | NCT03665454 (ClinicalTrials.gov) | September 24, 2018 | 1/8/2018 | PF 06412562 in Subjects With Advanced Stage Parkinson's Disease | A Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's Disease | Parkinson Disease | Drug: PF-06412562;Drug: Standard of Care Placebo | Milton S. Hershey Medical Center | Pfizer | Completed | N/A | N/A | All | 8 | Phase 1 | United States |
| 210 | NCT03582137 (ClinicalTrials.gov) | September 17, 2018 | 17/4/2018 | A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease | Parkinson Disease | Drug: Cannabidiol;Other: Placebo | University of Colorado, Denver | Colorado Department of Public Health and Environment | Completed | 40 Years | 85 Years | All | 74 | Phase 2 | United States |
| 211 | NCT03608371 (ClinicalTrials.gov) | August 31, 2018 | 9/5/2018 | BTRX-246040 Study in Subjects With Parkinson's Disease With Motor Fluctuations | Phase 2A, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BTRX-246040 in Parkinson's Disease Subjects With Motor Fluctuations | Parkinson Disease;Motor Disorder | Drug: BTRX-246040;Drug: Placebo | BlackThorn Therapeutics, Inc. | NULL | Completed | 30 Years | 76 Years | All | 24 | Phase 2 | United States |
| 212 | NCT03229174 (ClinicalTrials.gov) | August 23, 2018 | 21/4/2017 | Brain Perfusion & Oxygenation in Parkinson's Disease With NOH | Evaluation of Brain Perfusion and Oxygenation in PD Patients With Neurogenic Orthostatic Hypotension: 4 Week Comparison of Droxidopa Versus Placebo | Parkinson Disease;Neurogenic Orthostatic Hypotension | Drug: Droxidopa;Drug: Placebo | William Ondo, MD | Lundbeck LLC | Completed | 18 Years | 85 Years | All | 17 | Phase 4 | United States |
| 213 | NCT03621046 (ClinicalTrials.gov) | August 20, 2018 | 6/6/2018 | Use of Low-dose Zolpidem in Parkinson's Disease | A Placebo Controlled Double Blind Randomised Controlled Proof of Concept Study of Zolpidem for the Treatment of Motor and Cognitive Deficits in Late-stage Parkinson's | Parkinson Disease | Drug: Zolpidem;Other: Placebo | Aston University | University Hospital Birmingham NHS Foundation Trust | Completed | 40 Years | 80 Years | All | 28 | Phase 2 | United Kingdom |
| 214 | NCT03567447 (ClinicalTrials.gov) | August 17, 2018 | 21/5/2018 | Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH) | Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH) | Parkinson Disease;Falls Patient | Drug: Droxidopa;Other: Placebo | St. Joseph's Hospital and Medical Center, Phoenix | H. Lundbeck A/S;Arizona State University | Recruiting | 30 Years | 83 Years | All | 10 | Phase 2 | United States |
| 215 | EUCTR2016-004610-95-FR (EUCTR) | 08/08/2018 | 01/03/2018 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 311 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 216 | ChiCTR1800016949 | 2018-08-01 | 2018-07-04 | Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease | Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease | Parkinson's disease | Rasagiline early start group:rasagiline-rasagiline;Rasagiline delay start group:placebo-rasagiline; | Beijing Hospital | NULL | Pending | 30 | 80 | Both | Rasagiline early start group:130;Rasagiline delay start group:130; | China | |
| 217 | NCT04455555 (ClinicalTrials.gov) | August 1, 2018 | 28/6/2020 | Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease | Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease | Parkinson's Disease | Drug: LY03003( the name of rotigotine);Other: Placebo | Peking University Third Hospital | NULL | Completed | 18 Years | N/A | All | 294 | Phase 3 | China |
| 218 | ChiCTR1800017084 | 2018-08-01 | 2018-07-11 | Investigation of new approaches and technologies in the management of Parkinson's disease | The efficacy of Butylphthalide on cognitive impairment of patients with idiopathic PD and DBS patients: A Randomized, double-blind, placebo-controlled, multicenter trial | Parkinson's disease | Butylphthalide group:Butylphthalide, 2 capsules/time, 3 times/day, for 48 weeks;Control group:Placebo, 2 capsules/time, 3 times/day, for 48 weeks; | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | NULL | Recruiting | 18 | 80 | Both | Butylphthalide group:140;Control group:140; | Phase 4 | China |
| 219 | NCT03599726 (ClinicalTrials.gov) | July 30, 2018 | 29/6/2018 | Improving Walking Automaticity in Parkinson's Disease: Levodopa or Donepezil | Improving Walking Automaticity in Parkinson's Disease: Levodopa or Donepezil | Parkinson Disease | Drug: Donepezil;Drug: Placebo | Oregon Health and Science University | Medical Research Foundation, Oregon | Completed | 50 Years | 90 Years | All | 20 | Early Phase 1 | United States |
| 220 | NCT03611569 (ClinicalTrials.gov) | July 25, 2018 | 26/7/2018 | Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease | Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease | Healthy;Parkinson Disease | Drug: Lu AF82422;Drug: Placebo | H. Lundbeck A/S | NULL | Completed | 18 Years | 80 Years | All | 74 | Phase 1 | United States |
| 221 | NCT03594656 (ClinicalTrials.gov) | July 15, 2018 | 11/7/2018 | Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease | Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial | Parkinson Disease | Drug: Ganoderma;Drug: Placebos | Xuanwu Hospital, Beijing | NULL | Recruiting | 30 Years | 80 Years | All | 288 | Phase 3 | China |
| 222 | NCT03774459 (ClinicalTrials.gov) | July 9, 2018 | 8/12/2018 | ANAVEX2-73 Study in Parkinson's Disease Dementia | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With Dementia | Parkinsons Disease With Dementia | Drug: High dose ANAVEX2-73;Drug: Mid dose ANAVEX2-73;Drug: Placebo oral capsule | Anavex Life Sciences Corp. | Anavex Germany GmbH | Completed | 50 Years | 85 Years | All | 132 | Phase 2 | Australia;Spain |
| 223 | EUCTR2017-004335-36-ES (EUCTR) | 04/07/2018 | 11/04/2018 | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. - A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 | Cognition in Parkinson’s Disease with dementia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ANAVEX2-73 INN or Proposed INN: ANAVEX2-73 Product Name: ANAVEX2-73 INN or Proposed INN: ANAVEX2-73 | Anavex Life Sciences Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | Spain | ||
| 224 | NCT03562494 (ClinicalTrials.gov) | June 28, 2018 | 16/5/2018 | VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1) | A Randomized, Sham Surgery Controlled, Double-blind, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Moderate to Advanced Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Biological: VY-AADC02;Other: Sham (Placebo) Surgery | Neurocrine Biosciences | Voyager Therapeutics | Active, not recruiting | 40 Years | 75 Years | All | 85 | Phase 2 | United States |
| 225 | NCT03439943 (ClinicalTrials.gov) | June 13, 2018 | 13/2/2018 | Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease | Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease | Parkinson Disease | Drug: Lixisenatide;Drug: placebo | University Hospital, Toulouse | Cure Parkinson;Réseau NS-Park;EUCLID;Sanofi | Active, not recruiting | 40 Years | 75 Years | All | 156 | Phase 2 | France |
| 226 | EUCTR2016-004610-95-ES (EUCTR) | 18/05/2018 | 07/03/2018 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 311 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 227 | EUCTR2017-004475-31-CZ (EUCTR) | 09/05/2018 | 09/05/2018 | Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease. | Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease | Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL | Theranexus S.A. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Germany | ||
| 228 | NCT03541356 (ClinicalTrials.gov) | May 8, 2018 | 5/4/2018 | Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal | A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients | Parkinson's Disease | Combination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mg | Impel NeuroPharma Inc. | NULL | Completed | 40 Years | 80 Years | All | 32 | Phase 2 | Australia |
| 229 | EUCTR2016-004610-95-GB (EUCTR) | 01/05/2018 | 27/12/2017 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 357 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom | ||
| 230 | EUCTR2017-004475-31-HU (EUCTR) | 17/04/2018 | 09/02/2018 | Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease. | Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease | Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL | Theranexus S.A. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Hungary;United States;France;Germany | ||
| 231 | NCT03368170 (ClinicalTrials.gov) | April 12, 2018 | 5/12/2017 | Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia | A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia | Parkinson Disease | Drug: Mesdopetam (IRL790) | Integrative Research Laboratories AB | The Clinical Trial Company | Completed | 18 Years | 79 Years | All | 75 | Phase 2 | Sweden;United Kingdom |
| 232 | EUCTR2016-002033-30-IT (EUCTR) | 10/04/2018 | 20/01/2021 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: Carbidopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;Hungary;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 233 | EUCTR2016-000657-12-AT (EUCTR) | 03/04/2018 | 17/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 234 | EUCTR2017-004297-34-GB (EUCTR) | 31/03/2018 | 22/06/2018 | Use of low-dose zolpidem in Parkinson's. | A placebo controlled double blind randomised controlled proof of concept study of zolpidem for the treatment of motor and cognitive deficits in late-stage Parkinson’s - Zolpidem for treatment of motor and cognitive deficits in Parkinson's | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Stilnoct Product Name: Stilnoct Product Code: 207-3120 INN or Proposed INN: Zolpidem Tartrate | Aston University | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | United Kingdom | ||
| 235 | EUCTR2016-004610-95-AT (EUCTR) | 23/03/2018 | 04/01/2018 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 357 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy | ||
| 236 | EUCTR2016-004610-95-IT (EUCTR) | 22/03/2018 | 14/01/2021 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson¿s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson¿s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB054] INN or Proposed INN: HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 311 | Phase 2 | France;United States;Canada;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 237 | NCT03301272 (ClinicalTrials.gov) | March 22, 2018 | 13/9/2017 | Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease | Effectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot Study | Parkinson Disease | Drug: Onabotulinumtoxin A Injection;Other: Placebo | University of North Carolina, Chapel Hill | NULL | Completed | 45 Years | 80 Years | All | 16 | Phase 2 | United States |
| 238 | NCT03462641 (ClinicalTrials.gov) | March 9, 2018 | 6/3/2018 | Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm | Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson Disease-Flumazenil Arm | Parkinson Disease | Drug: Flumazenil;Drug: Placebo | University of Michigan | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 50 Years | 99 Years | All | 26 | Phase 1/Phase 2 | United States |
| 239 | NCT03189563 (ClinicalTrials.gov) | February 6, 2018 | 12/6/2017 | Safety and Efficacy of DA-9805 for Parkinson's Disease | A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of DA-9805 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: DA-9805 45mg;Drug: DA-9805 90mg;Other: Placebo | Dong-A ST Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 60 | Phase 2 | United States |
| 240 | NCT02940912 (ClinicalTrials.gov) | January 31, 2018 | 14/10/2016 | Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Parkinson Disease | Drug: Apomorphine;Drug: Placebo | Clinique Beau Soleil | NULL | Active, not recruiting | 35 Years | 90 Years | All | 45 | Phase 4 | France |
| 241 | NCT03440112 (ClinicalTrials.gov) | January 29, 2018 | 26/1/2018 | Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm | Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson | Parkinson Disease | Drug: Clarithromycin (Not used as of 4/2020);Drug: Placebo (Not used as of 4/2020);Drug: Transdermal flumazenil (Added 4/2020);Drug: Placebo (Added 4/2020) | Nicolaas Bohnen, MD, PhD | National Institute of Neurological Disorders and Stroke (NINDS) | Recruiting | 50 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
| 242 | NCT03331848 (ClinicalTrials.gov) | January 15, 2018 | 1/11/2017 | Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED) | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED) | Parkinson Disease | Drug: Placebo oral capsule;Drug: PXT002331 - 20mg | Prexton Therapeutics | NULL | Withdrawn | 35 Years | 85 Years | All | 0 | Phase 2 | NULL |
| 243 | NCT03318523 (ClinicalTrials.gov) | January 10, 2018 | 19/10/2017 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: BIIB054 | Biogen | NULL | Terminated | 40 Years | 80 Years | All | 357 | Phase 2 | United States;Austria;Canada;France;Germany;Israel;Italy;Spain;United Kingdom |
| 244 | NCT04968613 (ClinicalTrials.gov) | January 1, 2018 | 27/6/2021 | Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease | Dopaminergic Mechanism of Temporal Working Memory Impairment in Parkinson's Disease | Parkinson Disease;Memory Impairment | Drug: Madopar monotherapy;Drug: senfrol monotherapy;Drug: placebo monotherapy | Peking University Third Hospital | Chinese Academy of Sciences | Recruiting | 50 Years | 80 Years | All | 150 | Phase 4 | China |
| 245 | EUCTR2017-000087-15-DE (EUCTR) | 21/12/2017 | 17/05/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson's Disease with A 6-Year all- Participants-on-Treatment Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015/PRASINEZUMAB (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE WITH A 6-YEAR ALL-PARTICIPANTSON-TREATMENT EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015/PRASINEZUMAB INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Spain;Austria;Germany | ||
| 246 | EUCTR2017-003254-17-ES (EUCTR) | 21/12/2017 | 22/11/2017 | Safety and efficacy of Safinamide (Xadago®) in apathy associated with Parkinson's disease | A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Safinamide on Apathy in Patients With Parkinson's Disease | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE | Institut de Recerca Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 4 | Spain | ||
| 247 | EUCTR2017-003458-18-GB (EUCTR) | 19/12/2017 | 27/09/2017 | A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesia | A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia | Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IRL790 Product Code: IRL790 INN or Proposed INN: IRL790 | Integrative Research Laboratories AB (IRLAB) | NULL | Not Recruiting | Female: yes Male: yes | 74 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom;Sweden | ||
| 248 | EUCTR2017-000877-35-IT (EUCTR) | 04/12/2017 | 10/11/2020 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson's Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson's Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ31-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: [JNJ31-31001074] INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate | BENEVOLENTAI BIO | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czechia;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy | ||
| 249 | NCT03377322 (ClinicalTrials.gov) | December 1, 2017 | 7/12/2017 | Trial of Probiotics for Constipation in Parkinson's Disease | A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease | Parkinson Disease | Drug: Probiotic Capsule;Drug: Placebo Capsule | University of Malaya | NULL | Completed | 40 Years | 85 Years | All | 72 | N/A | Malaysia |
| 250 | EUCTR2016-002033-30-GB (EUCTR) | 27/11/2017 | 05/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 251 | NCT03194217 (ClinicalTrials.gov) | November 10, 2017 | 19/6/2017 | BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness | Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD). | Excessive Daytime Sleepiness;Parkinson Disease | Drug: BEN-2001;Drug: Placebo | BenevolentAI Bio | NULL | Completed | 50 Years | 80 Years | All | 244 | Phase 2 | United States |
| 252 | NCT03305809 (ClinicalTrials.gov) | November 9, 2017 | 4/10/2017 | A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) | Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) | Lewy Body Dementia | Drug: LY3154207;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 40 Years | 85 Years | All | 344 | Phase 2 | United States;Canada;Puerto Rico;China |
| 253 | EUCTR2016-002033-30-HU (EUCTR) | 08/11/2017 | 19/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 254 | EUCTR2017-000877-35-DE (EUCTR) | 19/10/2017 | 04/09/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and effiCacy in treAtment of exceSsive daytime sleePiness (EDS) in PARkinson’s Disease (PD). CASPAR study. - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy | ||
| 255 | NCT03272165 (ClinicalTrials.gov) | October 17, 2017 | 29/6/2017 | Single Ascending Dose Study of MEDI1341 in Healthy Volunteers | A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers | Parkinson's Disease | Drug: MEDI1341;Drug: Placebo | AstraZeneca | Covance;MMS Holdings, Inc;Catalent;Takeda | Completed | 18 Years | 80 Years | All | 50 | Phase 1 | United States;United Kingdom |
| 256 | NCT03205488 (ClinicalTrials.gov) | October 16, 2017 | 28/6/2017 | Nilotinib in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's Disease | Parkinson Disease | Drug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg);Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1);Drug: Placebo | Northwestern University | University of Rochester;University of Iowa;Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 79 Years | All | 76 | Phase 2 | United States |
| 257 | NCT04045678 (ClinicalTrials.gov) | October 10, 2017 | 30/7/2019 | A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 30 | Phase 1 | China |
| 258 | EUCTR2017-001673-17-FI (EUCTR) | 03/10/2017 | 29/08/2017 | A study to evaluate the safety and tolerability of IRL752 treatment inpatients with Parkinson's disease dementia. | A randomized, double-blind, placebo-controlled, multi-centre phase IIastudy evaluating the safety and tolerability of IRL752 in patients withParkinson's Disease Dementia | Dementia in Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IRL752 INN or Proposed INN: IRL752 | Integrative Research Laboratories AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Finland;Sweden | ||
| 259 | NCT03769896 (ClinicalTrials.gov) | October 3, 2017 | 6/12/2018 | Nabilone for Non-motor Symptoms in Parkinson's Disease | Nabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study | Parkinson Disease | Drug: Nabilone 0.25 mg;Drug: Placebo | Medical University Innsbruck | NULL | Completed | 30 Years | 100 Years | All | 48 | Phase 2 | Austria |
| 260 | NCT03257046 (ClinicalTrials.gov) | September 28, 2017 | 14/8/2017 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease | A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease | Parkinson Disease | Drug: ITI-214;Other: Placebo | Intra-Cellular Therapies, Inc. | NULL | Completed | 50 Years | N/A | All | 40 | Phase 1/Phase 2 | United States |
| 261 | EUCTR2015-004175-73-FI (EUCTR) | 27/09/2017 | 07/07/2016 | A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease. | A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity. | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 17 | Phase 1;Phase 2 | Finland | ||
| 262 | NCT03295786 (ClinicalTrials.gov) | September 26, 2017 | 14/9/2017 | Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease | Phase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's Disease | Parkinson Disease;Movement Disorders;Neurodegenerative Diseases;Nervous System Diseases;Brain Diseases | Drug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery System | Herantis Pharma Plc. | Renishaw plc. | Completed | 35 Years | 75 Years | All | 17 | Phase 1/Phase 2 | Finland;Sweden |
| 263 | EUCTR2017-000192-86-AT (EUCTR) | 15/09/2017 | 10/08/2017 | Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...) | Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study | Subjects with non-motor symptoms of Parkinson´s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Nabilone INN or Proposed INN: NABILONE | Medizinische Universität Innsbruck, Universitätsklinik für Neurologie | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria | ||
| 264 | NCT03306329 (ClinicalTrials.gov) | September 13, 2017 | 25/9/2017 | DNS-7801 vs. Placebo in Parkinson's Disease | A Phase 2a, Double-Blind, Placebo-Controlled Two-Part Study To Investigate the Safety and Efficacy of Increasing Doses Of DNS-7801 In Parkinson's Disease (PD) Subjects With Motor Fluctuations | Parkinson's Disease | Drug: DNS-7801 (low-dose);Drug: DNS-7801 (high dose);Drug: Placebo | Dart NeuroScience, LLC | NULL | Terminated | 30 Years | N/A | All | 5 | Phase 2 | United States |
| 265 | ChiCTR-INR-17012013 | 2017-09-01 | 2017-07-17 | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Parkinson‘s disease, Depression | BTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection; | Shanghai Tongji Hospital, Tongji University | NULL | Pending | 18 | 80 | Both | BTX-A:40;Placebo:40; | China | |
| 266 | EUCTR2017-000087-15-AT (EUCTR) | 17/08/2017 | 18/05/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab(PRX002) in Participants with Early Parkinson's Disease with A 6-Year all-Participants-on-Treatment Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015/PRASINEZUMAB (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE WITH A 6-YEAR ALL-PARTICIPANTSONTREATMENT EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Spain;Austria;Germany | ||
| 267 | NCT04162275 (ClinicalTrials.gov) | August 15, 2017 | 22/9/2019 | A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects | A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects | Parkinson Disease | Drug: Finamine tablets;Drug: Placebo tablets | Yiling Pharmaceutical Inc. | NULL | Completed | 18 Years | 65 Years | All | 34 | Phase 1 | China |
| 268 | EUCTR2017-000877-35-CZ (EUCTR) | 09/08/2017 | 05/06/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 269 | EUCTR2017-000877-35-GB (EUCTR) | 08/08/2017 | 17/07/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 270 | NCT03187301 (ClinicalTrials.gov) | August 3, 2017 | 7/6/2017 | A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF Episodes | A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson's Disease;Off Episodes of Parkinson Disease | Drug: APL-130277;Drug: Placebo;Drug: Moxifloxacin | Sunovion | NULL | Completed | 18 Years | N/A | All | 48 | Phase 2 | United States;Italy |
| 271 | EUCTR2017-000877-35-ES (EUCTR) | 03/08/2017 | 09/06/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United Kingdom;United States;Czech Republic;Poland;Spain;Germany;Italy | ||
| 272 | EUCTR2017-000087-15-FR (EUCTR) | 27/07/2017 | 30/10/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Spain;Austria;Germany | ||
| 273 | EUCTR2017-000087-15-ES (EUCTR) | 26/07/2017 | 08/06/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Spain;Austria;Germany | ||
| 274 | NCT03412513 (ClinicalTrials.gov) | July 17, 2017 | 21/1/2018 | Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease | Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial | Overactive Bladder;Parkinson Disease | Drug: Mirabegron;Drug: Placebo | Seoul National University Hospital | NULL | Unknown status | 40 Years | 80 Years | All | 144 | Phase 4 | Korea, Republic of |
| 275 | NCT03026231 (ClinicalTrials.gov) | July 15, 2017 | 11/1/2017 | Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients | A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease | Parkinson's Disease | Biological: PRIM-DJ2727;Drug: Placebo (for PRIM-DJ2727) | The University of Texas Health Science Center, Houston | Kelsey Research Foundation | Withdrawn | 45 Years | 70 Years | All | 0 | Phase 1/Phase 2 | United States |
| 276 | EUCTR2017-000135-14-ES (EUCTR) | 07/07/2017 | 09/06/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;Italy;United Kingdom | ||
| 277 | NCT03162874 (ClinicalTrials.gov) | July 4, 2017 | 19/5/2017 | Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) | Parkinson Disease | Drug: Placebo oral capsule;Drug: PXT002331 - dose 1;Drug: PXT002331 - dose 2 | Prexton Therapeutics | NULL | Completed | 35 Years | 85 Years | All | 157 | Phase 2 | Austria;France;Germany;Italy;Spain;United Kingdom |
| 278 | NCT04146519 (ClinicalTrials.gov) | July 1, 2017 | 18/10/2019 | Parkinson's Disease Therapy Using Cell Technology | Developent and Implement a Method of Parkinson's Disease Therapy Using Cell Technology | Transplantation:Mesenchymal Stem Cell Transplantation | Biological: Autologous mesenchymal stem cells;Other: Placebo | Belarusian Medical Academy of Post-Graduate Education | NULL | Recruiting | 18 Years | 69 Years | All | 50 | Phase 2/Phase 3 | Belarus |
| 279 | NCT04403399 (ClinicalTrials.gov) | June 29, 2017 | 21/5/2020 | Crossover Target Engagement Study of Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease (Project #3 - Experiment 3 [UdallP3E3]) | Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiment 3 - Project #3 | Parkinson's Disease | Drug: Varenicline;Drug: Placebo | University of Michigan | NULL | Completed | 45 Years | N/A | All | 34 | Phase 2 | United States |
| 280 | NCT03100149 (ClinicalTrials.gov) | June 27, 2017 | 29/3/2017 | A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment Extension | Parkinson's Disease | Drug: RO7046015;Drug: Placebo | Hoffmann-La Roche | Prothena Biosciences Limited | Active, not recruiting | 40 Years | 80 Years | All | 316 | Phase 2 | United States;Austria;France;Germany;Spain |
| 281 | NCT03195231 (ClinicalTrials.gov) | June 25, 2017 | 20/6/2017 | Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease | Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial. | Antidepressive Agents | Drug: Wuling Powder;Drug: Placebo | Beijing Hospital | Tongji Hospital;Shanghai Tong Ren Hospital;The First Hospital of Hebei Medical University | Not yet recruiting | 40 Years | N/A | All | 120 | Phase 4 | NULL |
| 282 | EUCTR2017-000135-14-GB (EUCTR) | 15/06/2017 | 17/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 283 | NCT03083132 (ClinicalTrials.gov) | June 13, 2017 | 7/3/2017 | Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD) | Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's Disease | Parkinson Disease | Drug: modafinil 50mg;Drug: Placebo oral capsule | University of Arkansas | NULL | Completed | 50 Years | 90 Years | All | 23 | Early Phase 1 | United States |
| 284 | EUCTR2017-000135-14-DE (EUCTR) | 06/06/2017 | 10/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;Italy;United Kingdom | ||
| 285 | EUCTR2017-000135-14-IT (EUCTR) | 30/05/2017 | 04/11/2020 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | Studio di fase IIa, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilit¿ del trattamento orale con PXT002331 (foliglurax) della durata di 28 giorni nella riduzione delle complicazioni motorie dovute alla terapia con levodopa nei pazienti affetti da malattia di Parkinson che manifestano deterioramento da fine dose e discinesia indotta da levodopa (AMBLED) - AMBLED Study | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax | PREXTON THERAPEUTICS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 286 | EUCTR2017-000135-14-AT (EUCTR) | 26/05/2017 | 08/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 287 | NCT03242499 (ClinicalTrials.gov) | May 15, 2017 | 1/8/2017 | Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease | Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease: a Single-center, Double-blind, Placebo-controlled Randomized Trial | Parkinson Disease | Drug: Lovastatin;Drug: Placebo | National Taiwan University Hospital | NULL | Recruiting | 30 Years | 90 Years | All | 80 | Phase 2 | Taiwan |
| 288 | NCT03047629 (ClinicalTrials.gov) | May 11, 2017 | 3/2/2017 | Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation | A Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related Constipation | Parkinson's Disease;Constipation | Drug: ENT-01;Other: Placebo | Enterin Inc. | NULL | Completed | 30 Years | 86 Years | All | 50 | Phase 1/Phase 2 | United States |
| 289 | NCT02702076 (ClinicalTrials.gov) | May 2017 | 2/3/2016 | Apomorphine in Parkinson's Disease Patients With Visual Hallucinations | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinations | Parkinson's Disease;Hallucinations, Visual | Drug: Apomorphine;Drug: Placebo | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 35 | Phase 2 | Netherlands |
| 290 | ChiCTR-IPR-17011155 | 2017-04-20 | 2017-04-16 | Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease | Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease | Parkinson’s disease | treatment group:dihydroergotoxine mesylate 2.5 mg, twice daily, two weeks;intervention group:identical placebo 2.5 mg, twice daily, two weeks; | Nanjing First Hospital Affiliated to Nanjing Medical University | NULL | Recruiting | 18 | 80 | Both | treatment group:10;intervention group:10; | China | |
| 291 | NCT03011476 (ClinicalTrials.gov) | April 11, 2017 | 27/12/2016 | Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease | Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance | Parkinson Disease | Drug: Donepezil;Drug: Placebos | Kyung Hee University Hospital | NULL | Unknown status | 40 Years | 75 Years | All | 20 | Phase 4 | Korea, Republic of |
| 292 | NCT02953665 (ClinicalTrials.gov) | April 3, 2017 | 21/10/2016 | Safety and Efficacy of Liraglutide in Parkinson's Disease | A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease | Parkinson Disease | Drug: Liraglutide;Drug: Placebo | Cedars-Sinai Medical Center | The Cure Parkinson's Trust;Novo Nordisk A/S | Completed | 25 Years | 85 Years | All | 63 | Phase 2 | United States |
| 293 | NCT02970019 (ClinicalTrials.gov) | March 30, 2017 | 18/11/2016 | Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease | A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706. | Parkinson Disease | Drug: K0706;Drug: Placebo | Sun Pharma Advanced Research Company Limited | NULL | Completed | 18 Years | 65 Years | All | 60 | Phase 1 | United States |
| 294 | EUCTR2016-001575-71-ES (EUCTR) | 16/03/2017 | 17/01/2017 | A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE | A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Spain;Israel;Germany | ||
| 295 | NCT03068481 (ClinicalTrials.gov) | February 20, 2017 | 26/2/2017 | Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease | A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease | Parkinson Disease | Drug: KDT-3594;Drug: Placebo | Kissei Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | 74 Years | All | 36 | Phase 1 | Japan |
| 296 | EUCTR2016-000657-12-IT (EUCTR) | 16/02/2017 | 08/02/2017 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 000000 Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 00000 Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 297 | EUCTR2016-000657-12-DE (EUCTR) | 26/01/2017 | 17/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 298 | JPRN-UMIN000043848 | 2017/01/10 | 29/04/2021 | The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder | The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder : A randomized controlled trial - SEMPDOABRCT | Overactive bladder | Treatment group receiving daily mirabegron 50mg for 12 weeks Placebo group | Al Zahraa Hospital | NULL | Complete: follow-up complete | 40years-old | 70years-old | Male and Female | 110 | Not applicable | Asia(except Japan) |
| 299 | EUCTR2016-000657-12-PT (EUCTR) | 09/01/2017 | 25/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Germany;Norway;Japan;Portugal;United States;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Sweden | ||
| 300 | NCT03330470 (ClinicalTrials.gov) | January 1, 2017 | 17/10/2017 | Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease | Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease | Subjective Cognitive Impairment;Mild Cognitive Impairment;Parkinson Disease;Healthy Volunteers | Behavioral: exercise;Dietary Supplement: carnosine supplementation;Behavioral: stretching;Dietary Supplement: supplementation with placebo | Slovak Academy of Sciences | Comenius University;University Hospital Bratislava;National Cheng Kung University | Recruiting | 55 Years | 80 Years | All | 100 | N/A | Slovakia;Taiwan |
| 301 | NCT03037203 (ClinicalTrials.gov) | January 2017 | 23/1/2017 | A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness | A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness | Excessive Sleepiness;Parkinson Disease | Drug: JZP-110;Other: Placebo | Jazz Pharmaceuticals | NULL | Completed | 35 Years | 80 Years | All | 66 | Phase 2 | United States |
| 302 | NCT02954978 (ClinicalTrials.gov) | January 2017 | 1/11/2016 | Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | Parkinson Disease;Parkinsons Disease With Dementia | Drug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna] | Georgetown University | NULL | Active, not recruiting | 40 Years | 90 Years | All | 75 | Phase 2 | United States |
| 303 | NCT03034564 (ClinicalTrials.gov) | January 2017 | 25/1/2017 | A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease | Parkinson Disease;Fatigue;Parkinsonism | Drug: Northera;Drug: Placebo Oral Tablet | The Cooper Health System | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 4 | United States |
| 304 | NCT02969369 (ClinicalTrials.gov) | December 31, 2016 | 17/11/2016 | A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis | A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis | Parkinson Disease Psychosis | Drug: SEP-363856;Drug: Placebo capsule | Sunovion | NULL | Completed | 55 Years | 105 Years | All | 39 | Phase 2 | United States |
| 305 | EUCTR2016-001575-71-DE (EUCTR) | 23/12/2016 | 26/09/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE | A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Spain;Israel;Germany | ||
| 306 | EUCTR2016-002033-30-BE (EUCTR) | 19/12/2016 | 21/11/2016 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 307 | NCT02906020 (ClinicalTrials.gov) | December 15, 2016 | 14/9/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant. | Parkinson's Disease | Drug: venglustat GZ/SAR402671;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | 80 Years | All | 270 | Phase 2 | United States;Austria;Canada;France;Germany;Greece;Israel;Italy;Japan;Norway;Portugal;Singapore;Spain;Sweden;Taiwan;United Kingdom |
| 308 | NCT02789020 (ClinicalTrials.gov) | December 2016 | 20/5/2016 | Image Parkinson's Disease Progression Study | Image Parkinson's Disease Progression Study | Parkinson's Disease | Drug: Rasagiline;Other: Placebo;Device: Magnetic Resonance Imaging;Device: functional Magnetic Resonance Imaging;Other: Physical Function Performance Test | University of Florida | National Institute of Neurological Disorders and Stroke (NINDS) | Active, not recruiting | 40 Years | 77 Years | All | 96 | Phase 2 | United States |
| 309 | EUCTR2016-002033-30-FR (EUCTR) | 29/11/2016 | 12/01/2017 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden | ||
| 310 | EUCTR2015-004912-39-ES (EUCTR) | 25/11/2016 | 17/05/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson's Disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Spain;Germany;Japan;United Kingdom | ||
| 311 | EUCTR2016-000102-11-NL (EUCTR) | 23/11/2016 | 08/11/2016 | Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. | Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. - Apomorphine in PD patients with visual hallucinations: a RCT | Parkinson's disease patients with refractory visual hallucinations MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: APO-go Product Name: Apomorphine | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2;Phase 3 | Netherlands | |||
| 312 | EUCTR2016-000657-12-SE (EUCTR) | 09/11/2016 | 12/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden | ||
| 313 | EUCTR2016-001762-29-IT (EUCTR) | 08/11/2016 | 25/05/2017 | A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) | A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) - CTH-201 | Parkinson's Disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Trade Name: AVALOX - 400 | SUNOVION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Italy | ||
| 314 | NCT03531060 (ClinicalTrials.gov) | November 8, 2016 | 10/4/2018 | A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia | A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID). | Parkinson Disease | Drug: IRL790;Drug: Placebo | Integrative Research Laboratories AB | NULL | Completed | 50 Years | 85 Years | All | 15 | Phase 1/Phase 2 | NULL |
| 315 | EUCTR2016-002033-30-ES (EUCTR) | 03/11/2016 | 25/08/2016 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden | ||
| 316 | NCT03022799 (ClinicalTrials.gov) | November 2016 | 27/12/2016 | Phase I, KM-819 in Healthy Subjects for Parkinson's Disease | A First in Human, Randomized, Double-blind, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Single and Multiple Oral Doses of KM-819 in Healthy Young Adult and Elderly Subjects | Parkinson's Disease | Drug: KM-819;Drug: Placebo | Kainos Medicine Inc. | NULL | Completed | 19 Years | 45 Years | All | 88 | Phase 1 | Korea, Republic of |
| 317 | EUCTR2016-000657-12-ES (EUCTR) | 20/10/2016 | 24/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 318 | NCT02847650 (ClinicalTrials.gov) | October 17, 2016 | 25/7/2016 | Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE | Parkinson Disease | Drug: Placebo;Drug: PF-06649751 | Pfizer | NULL | Terminated | 45 Years | 80 Years | All | 57 | Phase 2 | United States;France;Germany;Israel |
| 319 | NCT02728843 (ClinicalTrials.gov) | October 12, 2016 | 31/3/2016 | Study of Parkinson's Early Stage With Deferiprone | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Deferiprone;Drug: Placebo | ApoPharma | NULL | Completed | 18 Years | 80 Years | All | 140 | Phase 2 | Canada;France;Germany;United Kingdom |
| 320 | NCT02910102 (ClinicalTrials.gov) | October 2016 | 16/9/2016 | Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia | A Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease Dementia | Alzheimer's Disease;Dementia With Lewy Bodies;Parkinson's Disease Dementia | Drug: RVT-101 35 mg;Drug: Placebo | Axovant Sciences Ltd. | NULL | Completed | 50 Years | 89 Years | All | 38 | Phase 2 | United States |
| 321 | NCT02818777 (ClinicalTrials.gov) | October 2016 | 6/5/2016 | A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease | Parkinson's Disease | Drug: cannabidiol | University of Colorado, Denver | Colorado Department of Public Health and Environment;GW Research Ltd | Completed | 40 Years | 80 Years | All | 13 | Phase 2 | United States |
| 322 | NCT02803749 (ClinicalTrials.gov) | October 2016 | 14/6/2016 | Buspirone in Parkinson's Disease | The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease | Parkinson Disease;Anxiety | Drug: Buspirone;Drug: Placebo | University of Rochester | Michael J. Fox Foundation for Parkinson's Research | Completed | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 323 | NCT03462680 (ClinicalTrials.gov) | September 28, 2016 | 22/2/2018 | GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures | GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures | Parkinson's Disease | Dietary Supplement: niacin;Other: placebo | VA Office of Research and Development | NULL | Completed | 35 Years | N/A | All | 47 | N/A | United States |
| 324 | JPRN-JapicCTI-163395 | 01/9/2016 | 04/10/2016 | An Early Phase 2 Study of KW-6356 in Subject with Early Parkinson's Disease. | An Early Phase 2 Study of KW-6356 in Subject with Early Parkinson's Disease. | Parkinson's disease | Intervention name : KW-6356 Dosage And administration of the intervention : oral administration Control intervention name : placebo Dosage And administration of the control intervention : oral administration | Kyowa Hakko Kirin Co., Ltd. | NULL | 20 | 80 | BOTH | 150 | Phase 2 | NULL | |
| 325 | NCT02897063 (ClinicalTrials.gov) | September 2016 | 7/9/2016 | Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure | The Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2 | Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease;Orthostatic Hypotension | Drug: Droxidopa;Drug: Midodrine;Drug: Placebo | Vanderbilt University Medical Center | NULL | Recruiting | 40 Years | 80 Years | All | 34 | Phase 1 | United States |
| 326 | NCT02385500 (ClinicalTrials.gov) | September 2016 | 4/3/2015 | Fesoterodine on Urgency Episodes in Parkinson's Disease Population | Randomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease Population | Urinary Bladder, Overactive;Parkinson Disease | Drug: Fesoterodine;Drug: Placebo | Sir Mortimer B. Davis - Jewish General Hospital | NULL | Terminated | 50 Years | 85 Years | All | 5 | Phase 4 | Canada |
| 327 | NCT02601586 (ClinicalTrials.gov) | September 2016 | 17/8/2015 | Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease | Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial | Parkinson Disease | Drug: PR Oxycodone;Drug: Levodopa;Drug: Oxycodone Placebo;Drug: Levodopa placebo | University Hospital, Toulouse | NULL | Completed | 40 Years | 75 Years | All | 67 | Phase 2/Phase 3 | France |
| 328 | NCT02939391 (ClinicalTrials.gov) | September 2016 | 17/10/2016 | A Study of KW-6356 in Subjects With Early Parkinson's Disease | An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease | Parkinson's Disease | Drug: KW-6356;Drug: Placebo | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | 80 Years | All | 175 | Phase 2 | Japan |
| 329 | NCT02365870 (ClinicalTrials.gov) | August 2016 | 11/2/2015 | Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment | Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment | Anxiety Disorders;Parkinson Disease | Drug: rotigotine transdermal patch;Drug: placebo | Johns Hopkins University | National Institute on Aging (NIA) | Terminated | 21 Years | 89 Years | All | 4 | Phase 4 | United States |
| 330 | NCT02782481 (ClinicalTrials.gov) | August 2016 | 22/5/2016 | A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations | A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations | Parkinson's Disease | Drug: ND0612;Drug: Placebo | NeuroDerm Ltd. | NULL | Withdrawn | 30 Years | 80 Years | All | 0 | Phase 3 | Israel |
| 331 | NCT02789592 (ClinicalTrials.gov) | July 2016 | 31/5/2016 | Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease | A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placebo | Seoul National University Hospital | Kuhnil Pharmaceutical Co., Ltd. | Not yet recruiting | 30 Years | N/A | Both | 30 | Phase 2 | Korea, Republic of |
| 332 | NCT02382198 (ClinicalTrials.gov) | July 2016 | 21/1/2015 | Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease | A Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's Disease | Sialorrhea;Parkinson's Disease | Drug: Glycopyrrolate;Drug: Placebo | Ottawa Hospital Research Institute | NULL | Unknown status | 30 Years | N/A | All | 28 | Phase 2 | Canada |
| 333 | EUCTR2015-004912-39-DE (EUCTR) | 14/06/2016 | 11/02/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Spain;Germany;Japan;United Kingdom | ||
| 334 | JPRN-UMIN000022529 | 2016/06/01 | 01/06/2016 | Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease | Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease - Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease | Parkinson's disease | 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg) Washout 6days 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap Washout 6days 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg) | Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 8 | Phase 3 | Japan |
| 335 | NCT02838797 (ClinicalTrials.gov) | June 2016 | 16/6/2016 | RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease | RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease | Parkinson's Disease;Gastroparesis;Constipation | Drug: RQ-00000010;Drug: Placebo | Virginia Commonwealth University | Michael J. Fox Foundation for Parkinson's Research;RaQualia Pharma Inc. | Completed | 18 Years | N/A | All | 51 | Phase 1 | United States |
| 336 | NCT02642393 (ClinicalTrials.gov) | June 2016 | 19/12/2015 | Study of Urate Elevation in Parkinson's Disease, Phase 3 | A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease | Parkinson's Disease | Drug: Inosine;Drug: Placebo | Michael Alan Schwarzschild | The Parkinson Study Group;Michael J. Fox Foundation for Parkinson's Research;University of Rochester;National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 30 Years | N/A | All | 298 | Phase 3 | United States;Puerto Rico |
| 337 | NCT02807675 (ClinicalTrials.gov) | June 2016 | 17/6/2016 | A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder) | A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's Disease | Parkinson's Disease | Drug: CVT-301, LIP;Other: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 36 | Phase 1 | United States |
| 338 | EUCTR2016-000679-25-ES (EUCTR) | 31/05/2016 | 18/03/2016 | Clinical study for the assessment of security of candesartan in Parkinson?s disease population and its potential benefit in cognitive impairment associated to Parkinson?s disease. | A prospective, randomized, double-blind and placebo-controlled, parallel group, phase II study to compare the efficacy and safety of candesartan versus placebo on cognitive impairment associated with Parkinson?s disease. Exploratory study. | Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Parapres | INSTITUT DE RECERCA HSCSP | NULL | Not Recruiting | Female: yes Male: yes | 56 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain | ||
| 339 | EUCTR2016-000636-18-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunuvion Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 3 | Canada;United States;United Kingdom | ||
| 340 | NCT02705755 (ClinicalTrials.gov) | May 2016 | 7/3/2016 | TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) | A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension | Neurogenic Orthostatic Hypotension;Multiple System Atrophy (MSA) With Orthostatic Hypotension;Pure Autonomic Failure;Parkinson Disease;Hypotension, Orthostatic;Orthostatic Hypotension;Pure Autonomic Failure With Orthostatic Hypotension;Parkinson Disease With Orthostatic Hypotension | Drug: TD-9855;Drug: Placebo | Theravance Biopharma | NULL | Completed | 40 Years | N/A | All | 34 | Phase 2 | United States |
| 341 | NCT02812147 (ClinicalTrials.gov) | May 2016 | 25/5/2016 | Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease | Effect of L-Dihydoxyphenylserine (L-DOPS, Northera) a Central and Peripheral Norepinephrine Agent on Locomotion, Postural Stability (Balance), and Fall Risk Reduction in Parkinson Disease (PD) | Parkinson Disease | Drug: L-DOPS;Drug: Placebo | St. Joseph's Hospital and Medical Center, Phoenix | Arizona State University, Tempe | Active, not recruiting | 30 Years | 83 Years | All | 20 | Phase 2 | United States |
| 342 | EUCTR2014-005630-60-AT (EUCTR) | 12/04/2016 | 04/12/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 343 | EUCTR2015-005067-17-CZ (EUCTR) | 01/04/2016 | 25/01/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson’s Disease Patients with OFF episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | United States;Czech Republic;Canada;Spain;Poland | ||
| 344 | NCT02729714 (ClinicalTrials.gov) | April 2016 | 26/1/2016 | A Pilot Study of Suvorexant for Insomnia in Parkinson Disease | A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease | Insomnia | Drug: Suvorexant;Drug: Placebo | Burdick, Daniel, M.D. | Merck Sharp & Dohme LLC | Completed | 30 Years | 80 Years | All | 20 | Phase 4 | United States |
| 345 | NCT02775591 (ClinicalTrials.gov) | April 2016 | 9/5/2016 | Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms | Effect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled Trial | Parkinson Disease;Dyspepsia | Drug: DA-9701;Drug: DA-9701 placebo | Seoul National University Hospital | Samsung Medical Center;Korea University Guro Hospital;Hanyang University;Seoul Veterans Hospital;SMG-SNU Boramae Medical Center | Completed | 50 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of |
| 346 | NCT03173781 (ClinicalTrials.gov) | April 2016 | 10/8/2016 | Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease | Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease | Parkinson's Disease | Drug: droxidopa;Drug: Placebo | Colorado Springs Neurological Associates | H. Lundbeck A/S | Completed | 18 Years | N/A | All | 21 | N/A | United States |
| 347 | EUCTR2015-001523-24-FR (EUCTR) | 25/03/2016 | 20/04/2016 | Evaluation of the pain relief of prolonged-release oxycodone and of L-Dopa, versus placebo, in Parkinson's disease. | Evaluation of the analgesic effects of prolonged-release oxycodone and of L-Dopa, versus placebo, on central neuropathic pain in Parkinson's disease : OXYDOPA trial - OXYDOPA | Central neuropathic pain in Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: oxycontin LP 5mg Product Name: Oxycontin LP 5mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: oxycontin LP 10mg Product Name: Oxycontin LP 10mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: oxycontin LP 20mg Product Name: Oxycontin LP 20mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: Modopar 125 Product Name: Modopar 125 INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: BENSERAZIDE Trade Name: Modopar 62,5 Product Name: Modopar 62,5 INN or Proposed INN: levodopa Other descriptive name: LEVODOPA | UHToulouse | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2;Phase 3 | France | ||
| 348 | JPRN-jRCTs061180060 | 22/03/2016 | 18/03/2019 | Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Parkinson's disease;D010300 | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP) | Nagai Masahiro | NULL | Complete | >= 20age old | Not applicable | Both | 100 | Phase 2 | Japan |
| 349 | EUCTR2015-003679-31-ES (EUCTR) | 21/03/2016 | 13/01/2016 | New therapeutic strategy in Parkinson?s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson?s disease: a multicentre, parallel-group, placebo-controlled, randomized clinical trial of deferiprone - FAIRPARK II | De Novo Parkinson?s disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ferriprox 500 mg Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 338 | Phase 3 | Spain | ||
| 350 | EUCTR2015-005067-17-ES (EUCTR) | 14/03/2016 | 17/02/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson?s Disease Patients with OFF episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson?s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD?) | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, a wholly owned subsidiary of Acorda Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
| 351 | NCT02787590 (ClinicalTrials.gov) | March 8, 2016 | 26/5/2016 | Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease | Simvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity. | Parkinson Disease | Drug: Simvastatin;Drug: Matched Placebo (for Simvastatin) | University Hospital Plymouth NHS Trust | University of Plymouth | Completed | 40 Years | 90 Years | All | 235 | Phase 2 | United Kingdom |
| 352 | NCT02687542 (ClinicalTrials.gov) | March 3, 2016 | 29/1/2016 | Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson Disease | Drug: Placebo;Drug: PF-06649751 low dose (1 mg QD);Drug: PF-06649751 middle dose 1 (3 mg QD);Drug: PF-06649751 middle dose 2 (7 mg QD);Drug: PF-06649751 high dose (15 mg QD) | Pfizer | NULL | Terminated | 40 Years | 85 Years | All | 108 | Phase 2 | United States;Canada;France;Germany;Japan;Spain |
| 353 | NCT02605434 (ClinicalTrials.gov) | March 2016 | 5/11/2015 | A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients | Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- Sinemet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 420 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary |
| 354 | NCT02708186 (ClinicalTrials.gov) | March 2016 | 10/3/2016 | Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD) | A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD) | Dementia With Lewy Bodies;REM Sleep Behavior Disorder;Parkinson's Disease Dementia | Drug: Nelotanserin;Drug: Placebo | Axovant Sciences Ltd. | NULL | Completed | 50 Years | N/A | All | 34 | Phase 2 | United States |
| 355 | NCT02655315 (ClinicalTrials.gov) | February 9, 2016 | 7/1/2016 | Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease | Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone | Parkinson Disease | Drug: Deferiprone;Drug: Placebo | University Hospital, Lille | European Commission;ApoPharma | Completed | N/A | 80 Years | All | 372 | Phase 2 | Austria;Czechia;France;Germany;Netherlands;Portugal;Spain;United Kingdom;Czech Republic |
| 356 | JPRN-UMIN000020527 | 2016/02/01 | 01/02/2016 | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Parkinson's disease | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years Lactose as a placebo for 2 years | Ehime University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Phase 2 | Japan |
| 357 | NCT02641054 (ClinicalTrials.gov) | February 2016 | 7/12/2015 | Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease | Double-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge Test | Idiopathic Parkinson Disease | Drug: CVXL-0107;Drug: Placebo;Drug: Levodopa | CleveXel Pharma | NULL | Completed | 40 Years | 75 Years | All | 21 | Phase 2 | France |
| 358 | NCT02683629 (ClinicalTrials.gov) | February 2016 | 8/2/2016 | Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease | A Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease | Parkinson's Disease | Biological: NTCELL Implantation;Other: Sham Surgery | Living Cell Technologies | Statistecol Consultants Limited | Completed | 40 Years | 65 Years | All | 18 | Phase 2 | New Zealand |
| 359 | JPRN-JapicCTI-153112 | 22/1/2016 | 25/12/2015 | ONO-2370 Phase 2 study(ONO-2370-02) | ONO-2370 a Phase 2 Double-Blind, Randomised, Placebo-Controlled, Parallel-Group study, and an Open-Label, Uncontrolled, Multicenter, Long-term, Extension study(ONO-2370-02) | Parkinson's disease | Intervention name : ONO-2370 INN of the intervention : Opicapone Dosage And administration of the intervention : ONO-2370 once-daily Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Once-daily placebo equivalent to active control | ONO PHARMACEUTICAL CO.,LTD. | NULL | complete | 30 | 83 | BOTH | 399 | Phase 2 | Japan |
| 360 | NCT03258294 (ClinicalTrials.gov) | January 13, 2016 | 20/8/2017 | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial | Parkinson's Disease | Drug: Melatonin(Circadin®);Drug: Placebo Oral Tablet | KIMJisun | Kuhnil Pharmaceutical Co., Ltd. | Enrolling by invitation | 55 Years | N/A | All | 82 | Phase 4 | NULL |
| 361 | NCT02768077 (ClinicalTrials.gov) | January 2016 | 9/5/2016 | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease | Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial | Parkinson's Disease | Drug: Melatonin(Circadin®);Drug: Placebo | Kuhnil Pharmaceutical Co., Ltd. | NULL | Enrolling by invitation | 55 Years | N/A | Both | 100 | Phase 4 | NULL |
| 362 | NCT02589340 (ClinicalTrials.gov) | January 2016 | 23/10/2015 | Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia | Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia | Parkinson's Disease;Dyskinesias;Movement Disorders | Drug: Buspirone;Drug: Placebo | Oregon Health and Science University | Portland VA Medical Center | Terminated | 18 Years | 99 Years | All | 6 | Phase 1 | United States |
| 363 | NCT02639221 (ClinicalTrials.gov) | January 2016 | 17/12/2015 | A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects | PXT002331 A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects | Parkinson's Disease | Drug: PXT002331 | Prexton Therapeutics | NULL | Completed | 18 Years | 60 Years | Both | 64 | Phase 1 | United Kingdom |
| 364 | EUCTR2014-002600-24-AT (EUCTR) | 30/12/2015 | 25/09/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 365 | JPRN-JapicCTI-153057 | 14/12/2015 | 02/11/2015 | ME2125 Phase III (ME2125-4) | A Phase III, Long-Term Treatment Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon | Parkinson's disease | Intervention name : ME2125 (safinamide mesilate) INN of the intervention : safinamide Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning. | Meiji Seika Pharma Co., Ltd. | NULL | complete | 30 | BOTH | 200 | Phase 3 | Japan | |
| 366 | EUCTR2014-002600-24-IT (EUCTR) | 11/12/2015 | 16/02/2018 | Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Safinamide Product Code: na INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO Trade Name: Xadago INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 367 | EUCTR2014-005630-60-ES (EUCTR) | 11/12/2015 | 05/10/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD | Parkinson´s Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 368 | EUCTR2014-002600-24-SE (EUCTR) | 03/12/2015 | 30/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 369 | NCT02470780 (ClinicalTrials.gov) | December 2015 | 4/6/2015 | Treating Bacterial Overgrowth in Parkinson's Disease | Treating Bacterial Overgrowth in Parkinson's Disease | Parkinson's Disease;Small Intestinal Bacterial Overgrowth | Drug: Rifaximin;Drug: Placebo | University of Cincinnati | NULL | Completed | 18 Years | N/A | All | 24 | Phase 2/Phase 3 | United States |
| 370 | NCT02616120 (ClinicalTrials.gov) | December 2015 | 20/11/2015 | Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease | Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients | Parkinson's Disease | Drug: SQJZ herbal mixtures;Drug: Placebo | Dongzhimen Hospital, Beijing | NULL | Recruiting | 18 Years | 80 Years | All | 240 | Phase 2 | China |
| 371 | NCT02536976 (ClinicalTrials.gov) | December 2015 | 28/8/2015 | Mirabegron in Parkinson Disease and Impaired Cognition | A Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired Cognition | Parkinson Disease;Overactive Bladder;Impaired Cognition | Drug: mirabegron;Drug: Placebo | HealthPartners Institute | NULL | Completed | 25 Years | 80 Years | All | 7 | Phase 4 | United States |
| 372 | JPRN-JapicCTI-153056 | 24/11/2015 | 02/11/2015 | ME2125 Phase II/III (ME2125-3) | A Phase II/III, Double-Blind, Placebo-Controlled Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon | Parkinson's disease | Intervention name : ME2125 (safinamide mesilate) INN of the intervention : safinamide Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning. | Meiji Seika Pharma Co., Ltd. | NULL | complete | 30 | BOTH | 410 | Phase 2-3 | Japan | |
| 373 | EUCTR2014-002600-24-ES (EUCTR) | 19/11/2015 | 05/10/2015 | Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 374 | NCT02565628 (ClinicalTrials.gov) | November 16, 2015 | 28/9/2015 | PF-06669571 In Subjects With Idiopathic Parkinson's Disease | A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease. | Idiopathic Parkinson's Disease | Drug: PF-06669571;Drug: Placebo | Pfizer | NULL | Completed | N/A | N/A | All | 20 | Phase 1 | United States |
| 375 | JPRN-UMIN000019676 | 2015/11/10 | 10/11/2015 | The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease | The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease | Parkinson's disease | taking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks | Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | 100years-old | Male and Female | 20 | Not selected | Japan |
| 376 | EUCTR2015-000148-40-GB (EUCTR) | 09/11/2015 | 16/09/2015 | A trial comparing simvastatin to placebo as a neuronal protective treatment for Parkinson's disease. | Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity. - Simvastatin as a neuroprotective treatment for moderate PD (PD STAT) | Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Simvastatin INN or Proposed INN: Simvastatin | Plymouth Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| 377 | EUCTR2014-002600-24-GB (EUCTR) | 03/11/2015 | 28/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden | ||
| 378 | NCT02914366 (ClinicalTrials.gov) | November 2015 | 8/9/2016 | Ambroxol as a Treatment for Parkinson's Disease Dementia | Ambroxol as a Novel Disease Modifying Treatment for Parkinson's Disease Dementia | Parkinson's Disease Dementia | Drug: Ambroxol;Other: Placebo | Lawson Health Research Institute | Weston Brain Institute;Western University, Canada;London Health Sciences Centre | Active, not recruiting | 50 Years | N/A | All | 55 | Phase 2 | Canada |
| 379 | NCT02632279 (ClinicalTrials.gov) | November 2015 | 26/11/2015 | Tryptophan Depletion in PD Patients Treated With STN DBS | Tryptophan Depletion in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus: Effects on Mood and Motor Functions | Parkinson's Disease | Dietary Supplement: Tryptophan (TRP) depletion;Dietary Supplement: Placebo;Device: Stimulator ON;Device: Stimulator OFF | Maastricht University Medical Center | Netherlands Brain Foundation | Terminated | N/A | N/A | All | 7 | N/A | Netherlands |
| 380 | NCT02758730 (ClinicalTrials.gov) | November 2015 | 26/4/2016 | Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients | A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBA | Parkinson's Disease | Biological: AFFITOPE® PD01A + Adjuvant;Biological: Adjuvant without active component | Affiris AG | University Hospital Tuebingen | Withdrawn | 40 Years | 80 Years | Both | 0 | Phase 1 | Germany |
| 381 | EUCTR2014-005630-60-DE (EUCTR) | 29/10/2015 | 07/07/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 382 | NCT02562768 (ClinicalTrials.gov) | September 30, 2015 | 28/9/2015 | A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease | Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease | Parkinson's Disease | Drug: LY3154207;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 20 Years | N/A | All | 80 | Phase 1 | United States |
| 383 | EUCTR2014-005630-60-CZ (EUCTR) | 23/09/2015 | 10/07/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc. (a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 384 | EUCTR2014-005630-60-IT (EUCTR) | 23/09/2015 | 17/01/2022 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 Other descriptive name: TOZADENANT | BIOTIE THERAPIES INC. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Canada;Spain;Austria;Germany;Italy | ||
| 385 | EUCTR2015-000373-13-DE (EUCTR) | 18/08/2015 | 18/05/2015 | A study to examine the effectiveness and safety of a new drug for involuntary muscle movements in patients with Parkinson’s disease | Phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period cross-over, dose-range finding study to evaluate the safety, tolerability and efficacy of Eltoprazine in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. | Parkinson’s disease levodopa induced dyskinesia (PD-LID) MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE | Amarantus BioScience Holdings, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Germany;Sweden | ||
| 386 | NCT02459886 (ClinicalTrials.gov) | July 1, 2015 | 29/5/2015 | Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease | A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease | Parkinson's Disease;Healthy | Drug: BIIB054;Drug: Placebo | Biogen | NULL | Completed | 40 Years | 80 Years | All | 66 | Phase 1 | United States |
| 387 | NCT02453386 (ClinicalTrials.gov) | July 2015 | 21/5/2015 | Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD) | Idiopathic Parkinson's Disease | Drug: tozadenant;Drug: placebo | Biotie Therapies Inc. | NULL | Terminated | 30 Years | 80 Years | All | 449 | Phase 3 | United States;Austria;Canada;Czechia;Germany;Italy;Spain;Czech Republic |
| 388 | NCT02469090 (ClinicalTrials.gov) | June 18, 2015 | 9/6/2015 | Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease, Off Episodes | Drug: APL-130277;Drug: Placebo | Sunovion | NULL | Completed | 18 Years | N/A | All | 141 | Phase 3 | United States;Canada;United Kingdom |
| 389 | JPRN-jRCTs061180028 | 11/05/2015 | 26/02/2019 | Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine | Parkinson's disease;D010300 | The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. | Ando Rina | NULL | Complete | 20 years old | None | Both | 50 | Phase 2 | Japan |
| 390 | EUCTR2010-024424-26-SK (EUCTR) | 05/05/2015 | 28/04/2015 | Clinical study for the evaluation of the safety and efficacy of masitinib in patients suffering from parkinson's disease | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo on cognitive impairment associated with Parkinson's disease | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Slovakia;Spain;Romania;Bulgaria;South Africa;Germany | ||
| 391 | NCT02439125 (ClinicalTrials.gov) | May 2015 | 13/4/2015 | A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients | Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease | Parkinson's Disease;Dyskinesia | Drug: Eltoprazine HCl;Drug: Placebo | Amarantus BioScience Holdings, Inc. | NULL | Active, not recruiting | 30 Years | 85 Years | Both | 60 | Phase 2 | United States |
| 392 | NCT02439203 (ClinicalTrials.gov) | May 2015 | 30/4/2015 | Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010 | Parkinson's Disease;Levodopa Induced Dyskinesia (LID) | Drug: JM-010;Drug: Placebo | Bukwang Pharmaceutical | Contera Pharma ApS | Completed | 18 Years | N/A | Both | 30 | Phase 2 | South Africa |
| 393 | JPRN-JapicCTI-152870 | 11/4/2015 | 14/04/2015 | A parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA | A phase III parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA | Parkinson's disease | Intervention name : HP-3000 (ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily Control intervention name : Ropinirole hydrochloride extended-release tablet Dosage And administration of the control intervention : Oral, once daily Control intervention name : Ropinirole hydrochloride extended-release tablet placebo Dosage And administration of the control intervention : Oral, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 3 | NULL | ||
| 394 | NCT02424708 (ClinicalTrials.gov) | April 2015 | 15/4/2015 | Phase IIb Study of Intranasal Glutathione in Parkinson's Disease | Phase IIb Study of Intranasal Glutathione in Parkinson's Disease | Parkinson's Disease | Drug: Reduced Glutathione 100mg;Drug: Reduced Glutathione 200mg;Drug: Placebo | Bastyr University | Michael J. Fox Foundation for Parkinson's Research | Completed | 21 Years | N/A | Both | 45 | Phase 2 | United States |
| 395 | NCT02066571 (ClinicalTrials.gov) | March 2015 | 18/2/2014 | Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease | A Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's Disease | Parkinson's Disease;Freezing of Gait;Cognitive Ability, General | Drug: Droxidopa;Drug: sugar pill | Henry Ford Health System | NULL | Enrolling by invitation | 30 Years | N/A | Both | 20 | Phase 2 | United States |
| 396 | NCT02373072 (ClinicalTrials.gov) | March 2015 | 20/2/2015 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease | A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson Disease | Drug: PF-06649751;Drug: Trimethobenzamide Hydrochloride;Drug: Placebo | Pfizer | NULL | Completed | N/A | N/A | All | 18 | Phase 1 | United States;Belgium |
| 397 | NCT02337725 (ClinicalTrials.gov) | February 7, 2015 | 9/1/2015 | A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 80 Years | All | 244 | Phase 3 | Japan |
| 398 | NCT02337738 (ClinicalTrials.gov) | January 27, 2015 | 9/1/2015 | A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off | Parkinson's Disease | Drug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 79 Years | All | 404 | Phase 2/Phase 3 | Japan |
| 399 | NCT02258152 (ClinicalTrials.gov) | December 22, 2014 | 3/10/2014 | SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) | SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) | Parkinson's Disease Dementia (PDD) | Drug: SYN120;Drug: Placebo | Biotie Therapies Inc. | Michael J. Fox Foundation for Parkinson's Research;Massachusetts General Hospital;Acorda Therapeutics | Completed | 50 Years | N/A | All | 82 | Phase 2 | United States |
| 400 | NCT02267434 (ClinicalTrials.gov) | December 2014 | 4/9/2014 | Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease | A Randomized, Placebo-controlled, Parallel Group, Patient-blinded, Multi-center, Phase I Pilot Study to Assess Tolerability and Safety of Two Doses of AFFITOPE® PD03A Formulated With Adjuvant to Patients With Early Parkinson's Disease | Parkinson Disease;Neurodegenerative Diseases | Biological: Low dose AFFITOPE® PD03A + Adjuvant;Biological: High dose AFFITOPE® PD03A + Adjuvant;Biological: Adjuvant without active component | Affiris AG | PROSENEX AmbulatoriumbetriebsGMBH;Medical University Innsbruck;Forschungszentrum Juelich | Completed | 45 Years | 70 Years | Both | 36 | Phase 1 | Austria |
| 401 | EUCTR2014-001132-10-FR (EUCTR) | 18/11/2014 | 18/06/2015 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson’s Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | United States;France;Canada;Spain;Germany | |||
| 402 | NCT02240030 (ClinicalTrials.gov) | November 2014 | 11/9/2014 | Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) | Idiopathic Parkinson's Disease | Drug: CVT-301 Low Dose;Drug: CVT-301 High Dose;Other: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 351 | Phase 3 | United States;Canada;Czechia;Poland;Spain;Czech Republic |
| 403 | NCT02168842 (ClinicalTrials.gov) | November 2014 | 18/6/2014 | Efficacy of Isradipine in Early Parkinson Disease | Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease | Parkinson Disease | Drug: Isradipine;Drug: Placebo (for Isradipine) | University of Rochester | National Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's Research;The Parkinson Study Group | Completed | 30 Years | N/A | All | 336 | Phase 3 | United States;Canada |
| 404 | EUCTR2014-001131-36-ES (EUCTR) | 23/10/2014 | 03/09/2014 | A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 405 | EUCTR2014-001132-10-ES (EUCTR) | 23/10/2014 | 02/09/2014 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 406 | NCT02274766 (ClinicalTrials.gov) | October 2014 | 22/10/2014 | Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study) | Dyskinesia;Levodopa-Induced Dyskinesia (LID);Parkinson's Disease (PD) | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 77 | Phase 3 | United States;Austria;France;Germany;Spain |
| 407 | JPRN-UMIN000016893 | 2014/09/22 | 01/04/2015 | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine. | PD patients | The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. | Ehime University HospitalDept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Phase 2 | Japan |
| 408 | NCT02153645 (ClinicalTrials.gov) | August 18, 2014 | 30/5/2014 | Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. | A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias | Parkinson's Disease;Levodopa Induced Dyskinesias (LID) | Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tablets | Adamas Pharmaceuticals, Inc. | NULL | Terminated | 30 Years | 85 Years | All | 87 | Phase 3 | United States;Canada;France;Germany;Spain |
| 409 | NCT02153632 (ClinicalTrials.gov) | July 30, 2014 | 30/5/2014 | Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias | Parkinson's Disease;Levodopa Induced Dyskinesia (LID) | Drug: amantadine HCl ER;Drug: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Terminated | 30 Years | 85 Years | All | 135 | Phase 3 | United States;Canada;France;Germany;Spain |
| 410 | NCT02472210 (ClinicalTrials.gov) | July 2014 | 11/6/2015 | The Use of Botox in Advanced Parkinson's Patients Experiencing Pain | A Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot Study | Parkinson's Disease | Drug: Botulinum Toxin | University Health Network, Toronto | NULL | Active, not recruiting | 18 Years | N/A | Both | 14 | Phase 4 | NULL |
| 411 | EUCTR2013-000980-10-DK (EUCTR) | 06/06/2014 | 09/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Austria;Denmark;Netherlands;Germany | ||
| 412 | NCT02157714 (ClinicalTrials.gov) | June 2014 | 4/6/2014 | Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease | Parkinson's Disease | Drug: PRX002;Other: Placebo | Prothena Biosciences Limited | Hoffmann-La Roche | Completed | 40 Years | 80 Years | Both | 64 | Phase 1 | United States |
| 413 | NCT01971242 (ClinicalTrials.gov) | June 2014 | 23/10/2013 | Trial of Exenatide for Parkinson's Disease | A Randomised, Double Blind, Placebo Controlled, Single Centre, 60 Week Trial of Exenatide Once Weekly for the Treatment of Moderate Severity Parkinson's Disease | Parkinson's Disease | Drug: Exenatide;Other: Placebo | University College, London | NULL | Completed | 25 Years | 75 Years | Both | 60 | Phase 2 | United Kingdom |
| 414 | NCT02136914 (ClinicalTrials.gov) | May 2014 | 9/5/2014 | ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study) | Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study) | Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 126 | Phase 3 | United States;Canada |
| 415 | EUCTR2012-005539-10-DE (EUCTR) | 29/04/2014 | 18/12/2013 | Clinical study to investigate the efficacy and safety of two dose levels of NT 201 versus placebo in treating chronic troublesome sialorrhea in various neurological conditions. | Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation | Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury. MedDRA version: 18.1;Level: PT;Classification code 10039424;Term: Salivary hypersecretion;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A | Merz Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Poland;Germany | ||
| 416 | EUCTR2013-002254-70-PL (EUCTR) | 28/04/2014 | 03/02/2014 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 417 | EUCTR2013-003363-64-GB (EUCTR) | 03/04/2014 | 11/03/2014 | Trial of Exenatide for Parkinson's disease | A randomised, double blind, placebo controlled, single centre, 60 week trial of Exenatide once weekly for the treatment of moderate severity Parkinson’s disease. - Exenatide-PD | Parkinson's Disease MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Bydureon Product Name: Exenatide INN or Proposed INN: exenatide | University College London | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United Kingdom | ||
| 418 | NCT02111122 (ClinicalTrials.gov) | April 2014 | 8/4/2014 | Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease | A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease | Sleep-wake Disturbances in Motor-phase Parkinson's Disease | Drug: Sodium Oxybate;Drug: Placebo | Christian Baumann | NULL | Completed | 18 Years | 90 Years | All | 16 | Phase 2 | Switzerland |
| 419 | NCT01738178 (ClinicalTrials.gov) | April 2014 | 28/11/2012 | Caffeine as a Therapy for Parkinson's Disease | Caffeine as a Therapeutic Agent in Parkinson's Disease | Parkinson's Disease | Drug: Caffeine;Drug: Placebo | McGill University Health Center | Pontifícia Universidade Católica do Paraná;University of Calgary;University of Newfoundland and Eastern Health;University Health Network, Toronto;UBC Hospital;Movement Disorder Clinic - Deer Lodge Centre;The Ottawa Hospital | Completed | 45 Years | 75 Years | All | 119 | Phase 3 | Brazil;Canada |
| 420 | NCT02091739 (ClinicalTrials.gov) | April 2014 | 18/3/2014 | Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions | Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions | Chronic Troublesome Sialorrhea;Parkinson's Disease;Post-stroke;Traumatic Brain Injury | Drug: IncobotulinumtoxinA (100 Units);Drug: IncobotulinumtoxinA (75 Units);Drug: Placebo | Merz Pharmaceuticals GmbH | NULL | Completed | 18 Years | 80 Years | All | 184 | Phase 3 | Germany;Poland;United States |
| 421 | EUCTR2013-002254-70-CZ (EUCTR) | 05/03/2014 | 02/12/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's DiseaseRandomizovaná, multicentrická, dvojite zaslepená, placebem kontrolovaná, 12týdenní studie fáze 3 hodnotící úcinnost perorálního istradefylinu 20 a 40 mg/den v lécbe subjektu se stredne závažnou až závažnou Parkinsonovou nemocí | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 422 | EUCTR2013-000980-10-FR (EUCTR) | 03/03/2014 | 22/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 423 | NCT02006121 (ClinicalTrials.gov) | March 3, 2014 | 22/11/2013 | Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease | Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment | Parkinson's Disease | Drug: Apomorphine hydrochloride;Drug: Placebo | Britannia Pharmaceuticals Ltd. | NULL | Completed | 30 Years | N/A | All | 107 | Phase 3 | Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom |
| 424 | NCT02006290 (ClinicalTrials.gov) | March 2014 | 5/12/2013 | Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease | A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease | Parkinson's Disease | Drug: PF-06412562;Drug: Placebo | Pfizer | NULL | Completed | 30 Years | 75 Years | Both | 19 | Phase 1 | United States |
| 425 | NCT02095171 (ClinicalTrials.gov) | March 2014 | 14/3/2014 | Single Ascending Dose Study of PRX002 in Healthy Subjects | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects | Parkinson's Disease | Drug: PRX002;Other: Placebo | Prothena Biosciences Limited | Hoffmann-La Roche | Completed | 21 Years | 65 Years | Both | 40 | Phase 1 | United States |
| 426 | NCT02092181 (ClinicalTrials.gov) | March 2014 | 7/3/2014 | A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO) | A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO) | Parkinsons Disease | Drug: Mirabegron;Drug: Placebo | Daniel Burdick, MD | Astellas Pharma US, Inc. | Completed | 30 Years | 85 Years | All | 30 | Phase 4 | United States |
| 427 | NCT02111330 (ClinicalTrials.gov) | March 2014 | 20/3/2014 | Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy Volunteers | Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy Volunteers | Parkinson Disease | Drug: PBF-509;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Palo Biofarma, S.L | Completed | 18 Years | 45 Years | Both | 16 | Phase 1 | Spain |
| 428 | EUCTR2013-002254-70-DE (EUCTR) | 28/02/2014 | 19/11/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 429 | EUCTR2013-002254-70-IT (EUCTR) | 21/02/2014 | 27/11/2013 | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Hakko Kirin Pharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy | ||
| 430 | EUCTR2013-000980-10-ES (EUCTR) | 12/02/2014 | 12/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 431 | EUCTR2013-000980-10-NL (EUCTR) | 06/02/2014 | 27/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Germany;Netherlands | ||
| 432 | NCT02064166 (ClinicalTrials.gov) | February 2014 | 13/2/2014 | Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin. | A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy | Parkinson Disease;Multiple System Atrophy | Drug: Intranasal Insulin | Peter Novak | NULL | Completed | 18 Years | N/A | All | 15 | Phase 2 | United States |
| 433 | NCT02108704 (ClinicalTrials.gov) | December 2013 | 4/4/2014 | Helicobacter Pylori Eradication Study in Parkinson's Disease | Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial | Parkinson's Disease;Helicobacter Pylori Infection | Drug: Helicobacter pylori eradication therapy;Drug: Placebo | University of Malaya | NULL | Completed | 18 Years | N/A | All | 75 | N/A | Malaysia |
| 434 | NCT02103465 (ClinicalTrials.gov) | December 2013 | 26/3/2014 | Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease | Late Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of Rotigotine | Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | Azienda Ospedaliera Cardinale G. Panico | NULL | Terminated | 70 Years | N/A | Both | 80 | Phase 2 | Italy |
| 435 | NCT01883505 (ClinicalTrials.gov) | December 2013 | 9/6/2013 | A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 | A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612 | Parkinson's Disease | Drug: Levodopa and carbidopa;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 30 | Phase 2 | Israel |
| 436 | NCT01968460 (ClinicalTrials.gov) | December 2013 | 15/10/2013 | Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease | A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease | Parkinson's Disease | Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),;Drug: Placebo;Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), | Pharma Two B Ltd. | NULL | Completed | 35 Years | 75 Years | All | 149 | Phase 2/Phase 3 | United States;Israel |
| 437 | NCT04044547 (ClinicalTrials.gov) | November 22, 2013 | 30/7/2019 | A Study of LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 60 | Phase 1 | NULL |
| 438 | EUCTR2012-002840-26-RO (EUCTR) | 12/11/2013 | 17/07/2014 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 439 | NCT01856738 (ClinicalTrials.gov) | November 2013 | 14/5/2013 | Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease | Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial. | Parkinson's Disease | Drug: Rivastigmine;Drug: Placebo (for rivastigmine) | VU University Medical Center | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Atrium Medical Center;University Medical Center Groningen;Leiden University Medical Center;University Medical Center Nijmegen;International Parkinson Fonds Germany GmbH;ZonMw: The Netherlands Organisation for Health Research and Development | Terminated | 40 Years | N/A | All | 91 | Phase 4 | Netherlands |
| 440 | NCT01927055 (ClinicalTrials.gov) | November 2013 | 16/8/2013 | A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy | A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy | Symptomatic Neurogenic Orthostatic Hypotension;Parkinson's Disease;Multiple Systems Atrophy;Pure Autonomic Failure;Dopamine Beta Hydroxylase Deficiency | Drug: Droxidopa;Drug: Placebo | Chelsea Therapeutics | NULL | Terminated | 18 Years | N/A | All | 61 | Phase 3 | United States |
| 441 | EUCTR2011-004438-32-DE (EUCTR) | 23/10/2013 | 13/08/2013 | The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying | A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC | Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Australia;Germany;United Kingdom;Sweden | |||
| 442 | EUCTR2013-000980-10-AT (EUCTR) | 18/10/2013 | 31/07/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 443 | NCT01968031 (ClinicalTrials.gov) | October 2013 | 18/10/2013 | A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Istradefylline 40 mg;Drug: Istradefylline 20 mg;Drug: Placebo | Kyowa Hakko Kirin Pharma, Inc. | Kyowa Kirin Co., Ltd. | Completed | 30 Years | N/A | All | 613 | Phase 3 | United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic |
| 444 | NCT01955616 (ClinicalTrials.gov) | September 2013 | 25/9/2013 | A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Pharmacodynamics, Efficacy and Safety of RM-131 Administered to Patients With Parkinson's Disease and Chronic Constipation Dissatisfied With Current Therapy | Parkinson's Disease | Drug: RM-131;Drug: Placebo | Motus Therapeutics, Inc. | Michael J. Fox Foundation for Parkinson's Research | Terminated | 18 Years | 80 Years | Both | 18 | Phase 2 | United States |
| 445 | NCT01929317 (ClinicalTrials.gov) | August 28, 2013 | 22/8/2013 | A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients. | A Study ROP116991, Clinical Evaluation of 18 to 24mg/Day Ropinirole CR for Parkinson's Disease. | Parkinson Disease | Drug: Ropinirole CR 2mg tablet;Drug: Ropinirole CR 8mg tablet;Drug: Ropinirole CR matching Placebo tablet | GlaxoSmithKline | NULL | Terminated | 20 Years | N/A | All | 81 | Phase 3 | Japan |
| 446 | EUCTR2013-001722-25-NL (EUCTR) | 27/08/2013 | 12/08/2013 | Rivastigmine as an early treatment for visual hallucinations in Parkinson’s disease (CHEVAL) | Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson’s disease: a multi-center placebo-controlled trial (CHEVAL) - CHEVAL | Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rivastigmine CF | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 168 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 447 | EUCTR2011-004438-32-SE (EUCTR) | 26/08/2013 | 01/07/2013 | The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying | A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC | Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.0;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Australia;Germany;United Kingdom;Sweden | |||
| 448 | NCT01767129 (ClinicalTrials.gov) | July 2013 | 9/1/2013 | Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients | A Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients. | Dyskinesia;Parkinson's Disease | Drug: AVP-923-45;Drug: Placebo | Avanir Pharmaceuticals | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 14 | Phase 2 | United States;Canada |
| 449 | NCT01879748 (ClinicalTrials.gov) | June 2013 | 13/6/2013 | A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline | A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian Subjects | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 20 Years | 50 Years | Both | 64 | Phase 1 | United States |
| 450 | NCT01765257 (ClinicalTrials.gov) | June 2013 | 8/1/2013 | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study. | Drug-naïve Patients With Parkinson's Disease;Apathy | Drug: AZILECT®;Drug: Placebo | University Hospital, Clermont-Ferrand | H. Lundbeck A/S, TEVA;CHU Purpan (Toulouse);Hôpital Haut-Levêque (Pessac);Centre Hospitalier de la Côte Basque;Centre Hospitalier Universitaire de Poitiers (Poitiers);CHU de Rennes (Rennes);University Hospital, Lille;CHU Dupuytren (Limoges);University Hospital, Caen;Hôpital Caremeau (NIMES);Centre Hospitalier Pays D'Aix;Hôpital de la Timone (MARSEILLE);University Hospital, Rouen;Centre Hospitalier Universitaire, Amiens;Centre Hospitalier Universitaire de Saint Etienne;Fondation Rothschild Paris | Not yet recruiting | 30 Years | 70 Years | Both | 50 | Phase 4 | France |
| 451 | NCT01850381 (ClinicalTrials.gov) | June 2013 | 7/5/2013 | Phase 2A Study of GM 608 in Mild to Moderate Parkinson Disease | GM 608 in A Phase IIA Pilot Double-blinded, Randomized, Placebo Controlled Trial in Mild to Moderate Parkinson Disease | Parkinson's Disease | Drug: GM608;Drug: Placebo Comparator | Genervon Biopharmaceuticals, LLC | Columbia University | Completed | 30 Years | N/A | All | 6 | Phase 2 | United States |
| 452 | EUCTR2012-005822-31-IT (EUCTR) | 13/05/2013 | 20/03/2013 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Parkinson's Disease MedDRA version: 15.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;United Kingdom;Italy | ||
| 453 | NCT02473562 (ClinicalTrials.gov) | May 2013 | 12/6/2015 | Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease | Varenicline, a Partial Nicotinic Receptor Agonist for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: a Placebo-controlled Cross-over Pilot Study | Parkinson's Disease | Drug: Varenicline;Drug: Placebo (for varenicline) | VU University Medical Center | Centre for Human Drug Research, Netherlands | Terminated | N/A | N/A | All | 22 | Phase 4 | Netherlands |
| 454 | NCT03022201 (ClinicalTrials.gov) | May 2013 | 23/11/2016 | Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease | Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial | Parkinson's Disease,Idiopathic | Drug: DA-9701;Drug: Domperidone;Drug: Placebo domperidone;Drug: Placebo DA-9701 | Seoul National University Hospital | NULL | Completed | 20 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
| 455 | EUCTR2012-002840-26-BG (EUCTR) | 26/04/2013 | 06/02/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 456 | EUCTR2012-005822-31-GB (EUCTR) | 18/04/2013 | 05/03/2013 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) - Inhaled CVT-301 in Subjects with Parkinson’s Disease | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;Italy;United Kingdom | ||
| 457 | EUCTR2012-002608-42-GB (EUCTR) | 07/04/2013 | 01/11/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | ||
| 458 | NCT01777555 (ClinicalTrials.gov) | April 2013 | 23/1/2013 | Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Idiopathic Parkinson's Disease | Drug: CVT-301;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 80 Years | All | 89 | Phase 2 | United States;Italy;Serbia;United Kingdom |
| 459 | NCT02005029 (ClinicalTrials.gov) | April 2013 | 18/9/2013 | Erythromycin in Parkinson's Disease | Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics | Parkinson's Disease;Levodopa | Drug: Erythromycin;Drug: placebo | Virginia Commonwealth University | NULL | Completed | 18 Years | 80 Years | All | 18 | N/A | United States |
| 460 | NCT01829867 (ClinicalTrials.gov) | April 2013 | 9/4/2013 | A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031. | A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular Infusion | Parkinson's Disease | Drug: sNN0031 | Newron Sweden AB | NULL | Terminated | 55 Years | 75 Years | Both | 5 | Phase 1 | Sweden |
| 461 | EUCTR2012-002840-26-SI (EUCTR) | 26/03/2013 | 18/03/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | United States;Serbia;Slovenia;Slovakia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 462 | NCT04627155 (ClinicalTrials.gov) | March 15, 2013 | 5/11/2020 | A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003 | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | NULL |
| 463 | JPRN-UMIN000009958 | 2013/03/08 | 01/03/2013 | Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction | Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction - Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction | Parkinson's disease | Donepezil hydrochloride added to standard therapy Placebo added to standard therapy | National Hospital Organization, Sendai-Nishitaga Hospital | NULL | Complete: follow-up complete | 55years-old | 75years-old | Male and Female | 200 | Not applicable | Japan |
| 464 | EUCTR2012-002840-26-AT (EUCTR) | 05/03/2013 | 06/11/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | United States;Serbia;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 465 | JPRN-UMIN000046104 | 2013/03/01 | 21/11/2021 | Research for the development of assessment strategy and treatment for cognitive impairment of Parkinson's disease | Neuroimaging study for the assessment and treatment of cognitive impairment of the patients with Parkinson's disease - RCIP-Nagoya Study: Research for the cognitive impairment of Parkinson's disease in Nagoya | Parkinson's disease | This study followed a randomized double-blind crossover design for the patients with mild cognitive impairments in PD. Patients in the memantine group were given memantine at 5 mg/day in the first week, and the dose was increased by 5 mg/day per week, with the final dose of 20 mg/day. The patients in the placebo group were given a placebo following the same regimen. During maximum dose administration, fMRI scanning and neuropsychological tests were performed. Group comparisons between memantine and placebo were performed to explore the significant differences. | Nagoya City University | NULL | Complete: follow-up complete | 60years-old | 75years-old | Male and Female | 12 | Not applicable | Japan |
| 466 | NCT01789047 (ClinicalTrials.gov) | March 2013 | 7/2/2013 | Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease | Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease | Idiopathic Parkinson's Disease;Drug Induced Dyskinesia | Drug: Topiramate;Drug: Placebo;Drug: Amantadine | Rush University Medical Center | Michael J. Fox Foundation for Parkinson's Research | Terminated | 30 Years | 90 Years | All | 42 | Phase 2 | United States |
| 467 | JPRN-UMIN000010014 | 2013/02/28 | 13/02/2013 | Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease | Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease - Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease | Parkinson's disesase | hydrogen water made by "Suisosui5.0" placebo-water (nitrogen filling water) | Juntendo University School of Medicine, Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 200 | Not selected | Japan |
| 468 | EUCTR2012-002840-26-IT (EUCTR) | 18/02/2013 | 11/01/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PHASE 4 STUDY TO EVALUATE THE EFFICACY OF ROTIGOTINE ON PARKINSON’S DISEASE-ASSOCIATED APATHY, MOTOR SYMPTOMS, AND MOOD | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro INN or Proposed INN: ROTIGOTINE | UCB BIOSCIENCES GMBH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 4 | United States;Hungary;Slovenia;Spain;Ukraine;Turkey;Austria;Bulgaria;Russian Federation;Italy | ||
| 469 | EUCTR2012-002840-26-HU (EUCTR) | 11/02/2013 | 13/12/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 470 | NCT01766128 (ClinicalTrials.gov) | February 2013 | 8/1/2013 | Study of Zonisamide in Early Parkinson Disease | Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease | Parkinson Disease | Drug: Zonisamide;Drug: Placebo | Mazandaran University of Medical Sciences | NULL | Withdrawn | 45 Years | 85 Years | All | 0 | Phase 2/Phase 3 | NULL |
| 471 | NCT01782222 (ClinicalTrials.gov) | February 2013 | 30/1/2013 | Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy | A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood | Idiopathic Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB BIOSCIENCES GmbH | NULL | Completed | 18 Years | N/A | All | 122 | Phase 4 | United States;Austria;Hungary;Poland;Slovakia;Slovenia;Spain |
| 472 | EUCTR2012-002840-26-ES (EUCTR) | 23/01/2013 | 29/11/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 473 | EUCTR2012-002608-42-DE (EUCTR) | 10/01/2013 | 26/09/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 64 | United States;Hungary;Slovakia;Poland;Germany;United Kingdom | |||
| 474 | EUCTR2012-002608-42-HU (EUCTR) | 10/01/2013 | 12/11/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | |||
| 475 | EUCTR2012-002840-26-SK (EUCTR) | 07/01/2013 | 09/03/2016 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 476 | NCT01803945 (ClinicalTrials.gov) | January 2013 | 26/2/2013 | A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease | A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: AVE8112;Drug: Placebo | Michael J. Fox Foundation for Parkinson's Research | Sanofi | Terminated | 35 Years | 70 Years | Both | 32 | Phase 1 | United States |
| 477 | EUCTR2012-002608-42-SK (EUCTR) | 17/12/2012 | 09/03/2016 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | |||
| 478 | NCT01741701 (ClinicalTrials.gov) | December 2012 | 1/12/2012 | A Pilot Study of Oxaloacetate in Subjects With Treated PD | A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD) | Parkinson's Disease | Drug: Oxaloacetate (OAA);Drug: Placebo | University of Kansas Medical Center | Terra Biological LLC | Completed | 30 Years | N/A | All | 33 | Phase 2/Phase 3 | United States |
| 479 | NCT01725802 (ClinicalTrials.gov) | December 2012 | 4/11/2012 | A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | Parkinson's Disease | Drug: levodopa and carbidopa solution for SC administration;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 8 | Phase 1/Phase 2 | Israel |
| 480 | NCT01738191 (ClinicalTrials.gov) | November 2012 | 28/11/2012 | Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) | Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) | Parkinson's Disease;Cognitive Impairment | Drug: Atomoxetine;Drug: Placebo | Medical University of South Carolina | Michael J. Fox Foundation for Parkinson's Research | Completed | 35 Years | 75 Years | All | 30 | Phase 2 | United States |
| 481 | NCT01723228 (ClinicalTrials.gov) | November 2012 | 5/11/2012 | Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease | A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 45 Years | 80 Years | All | 170 | Phase 4 | United States |
| 482 | NCT01744496 (ClinicalTrials.gov) | November 2012 | 5/12/2012 | Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Advanced Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB BIOSCIENCES GmbH | NULL | Completed | 18 Years | N/A | All | 68 | Phase 4 | United States;Germany;Poland;Slovakia;Hungary;Korea, Republic of |
| 483 | NCT03652363 (ClinicalTrials.gov) | October 25, 2012 | 21/8/2018 | GDNF in ideopathicParkinsons Disease | A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal (GDNF) Infusions Administered Via Convection Enhanced Delivery (CED) in Subjects With Parkinson&Apos;s Disease | Idiopathic Parkinson Disease | Drug: glial cell line-derived neurotrophic factor | North Bristol NHS Trust | NULL | Completed | 35 Years | 75 Years | All | 42 | Phase 2 | NULL |
| 484 | NCT01563913 (ClinicalTrials.gov) | October 2012 | 16/3/2012 | Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids | Reducing Dyskinesia in Parkinson Disease With Omega-3 Fatty Acids | Parkinson's Disease | Drug: Docosahexaenoic Acid (DHA);Drug: Placebo | VA Office of Research and Development | Oregon Health and Science University | Completed | 21 Years | 99 Years | All | 33 | Phase 1 | United States |
| 485 | NCT01603069 (ClinicalTrials.gov) | October 2012 | 14/5/2012 | A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: AZD3241 300 mg BID;Drug: AZD3241 600 mg BID;Drug: Placebo | AstraZeneca | NULL | Completed | 30 Years | 80 Years | Both | 51 | Phase 2 | United States |
| 486 | NCT01691924 (ClinicalTrials.gov) | October 2012 | 13/9/2012 | Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers | Randomized, Double Blind, Placebo Controlled First In-human Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers | Parkinson Disease | Drug: PBF-509;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Palo Biofarma, S.L | Completed | 18 Years | 45 Years | Male | 56 | Phase 1 | Spain |
| 487 | NCT01560754 (ClinicalTrials.gov) | October 2012 | 9/3/2012 | Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease | A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess the Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease in Germany and the USA | Parkinson's Disease | Drug: nicotine transdermal patch | James BOYD MD | Michael J. Fox Foundation for Parkinson's Research;Parkinson Study Group (PSG);International Parkinson Fonds (IPF);German Parkinson Study Group (GPS);German Parkinson Society (DPG);Philipps-University Marburg, Germany | Active, not recruiting | 30 Years | N/A | Both | 160 | Phase 2 | United States;Germany |
| 488 | EUCTR2011-003866-34-GB (EUCTR) | 24/09/2012 | 01/05/2012 | Assessing the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD) | A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease | Parkinson's disease MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Glial Cell Line-Derived Neurotrophic Factor (GDNF) INN or Proposed INN: Liatermin Other descriptive name: r-metHuGDNF | North Bristol NHS Trust (NBT) | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 489 | NCT01676103 (ClinicalTrials.gov) | September 2012 | 28/8/2012 | The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease | The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Tyrosine;Other: Placebo Comparator:Sugar Pill | New York Institute of Technology | Michael J. Fox Foundation for Parkinson's Research | Completed | 50 Years | 80 Years | Both | 40 | Phase 1/Phase 2 | United States |
| 490 | EUCTR2011-004803-19-FI (EUCTR) | 16/08/2012 | 16/05/2012 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 491 | EUCTR2012-001530-34-NL (EUCTR) | 09/08/2012 | 09/08/2012 | Vareniciline treatment for Excessive Daytime Sleepiness in Parkinson’s Disease | Varenicline, a partial nicotinic receptor agonist for the treatment of Excessive Daytime Sleepiness in Parkinson’s Disease: a placebo-controlled cross-over study - Vareniciline for Excessive daytime Sleepiness in PArkinson’s disease (VESPA) | Idiopathic Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Champix INN or Proposed INN: VARENICLINE Other descriptive name: VARENICLINE TARTRATE | VU University Medical Center | Center Human Drug Research | Not Recruiting | Female: yes Male: yes | 32 | Phase 3 | Netherlands | ||
| 492 | NCT01646268 (ClinicalTrials.gov) | July 2012 | 18/7/2012 | Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's Disease | IDIOPATHIC PARKINSON'S DISEASE | Drug: Rotigotine;Drug: Placebo Patch | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 249 | Phase 3 | China |
| 493 | NCT01491022 (ClinicalTrials.gov) | July 2012 | 8/12/2011 | A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease | A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease | Parkinson's Disease | Drug: Ampyra first, then Placebo;Drug: placebo first, then Ampyra | University of Miami | Acorda Therapeutics | Completed | 45 Years | 80 Years | All | 22 | Phase 1/Phase 2 | United States |
| 494 | NCT01646255 (ClinicalTrials.gov) | July 2012 | 18/7/2012 | Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa | Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo Patch;Drug: L-dopa | UCB Pharma | UCB Trading (Shanghai) Co. Ltd. | Completed | 30 Years | N/A | All | 346 | Phase 3 | China |
| 495 | NCT01602549 (ClinicalTrials.gov) | July 2012 | 17/5/2012 | A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying | Gastroparesis | Drug: GSK962040 (25 mg tablet);Drug: Placebo | GlaxoSmithKline | NULL | Completed | 40 Years | 80 Years | All | 58 | Phase 2 | Australia;Germany;Sweden;United Kingdom |
| 496 | EUCTR2011-003053-25-GB (EUCTR) | 18/06/2012 | 01/05/2012 | The ReSPonD Study -Rivastigmine to Stabilise gait in Parkinson’s Disease. A study looking at whether Rivastigmine, a drug that can augment mental function, can stabilise walking in people with Parkinson's disease who have fallen. | A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen. - ReSPonD Study - Rivastigmine to Stabilise gait in Parkinson’s Disease | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Exelon ® Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine | Research and Enterprise Department | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 497 | JPRN-JapicCTI-121880 | 11/6/2012 | Phase II clinical study in patients with Parkinson's disease not taking L-DOPA | A randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease not taking L-DOPA | Parkinson's disease | Intervention name : HP-3000(ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 2 | NULL | |||
| 498 | JPRN-JapicCTI-121879 | 07/6/2012 | Phase II clinical study in patients with Parkinson's disease taking L-DOPA | A randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease taking L-DOPA | Parkinson's disease | Intervention name : HP-3000(ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 2 | NULL | |||
| 499 | EUCTR2011-002074-23-AT (EUCTR) | 05/06/2012 | 07/05/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 500 | NCT02786667 (ClinicalTrials.gov) | June 2012 | 18/5/2016 | Non Motors Aspects in De Novo Parkinson's Disease | Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects. | Parkinson Disease;Apathy | Drug: Rotigotine;Drug: Placebo | University Hospital, Grenoble | NULL | Active, not recruiting | 30 Years | 72 Years | All | 199 | Phase 3 | France |
| 501 | NCT01617135 (ClinicalTrials.gov) | May 2012 | 7/5/2012 | Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off Episodes | A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes) | Idiopathic Parkinson's Disease | Drug: CVT-301;Drug: Placebo;Drug: Sinemet (carbidopa/levodopa) | Acorda Therapeutics | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 25 | Phase 2 | Israel;Serbia;United Kingdom |
| 502 | EUCTR2011-004438-32-GB (EUCTR) | 25/04/2012 | 18/04/2012 | The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying | A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC | Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 20.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;United Kingdom;Sweden | ||
| 503 | EUCTR2012-000181-37-GB (EUCTR) | 25/04/2012 | 27/02/2012 | A study investigating the safety of CVT-301 in patients with Parkinson's Disease | A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (Off” Episodes) | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Trade Name: Sinemet® Product Name: SINEMET® Plus 25 mg/100 mg Tablets INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Israel;United Kingdom | ||
| 504 | EUCTR2011-001092-39-IT (EUCTR) | 19/04/2012 | 20/06/2012 | efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesias | A multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesias | L-dopa induced dyskinesias in Parkinson's patients MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: AQW051 Other descriptive name: Not established Product Name: NA Product Code: AQW051 Other descriptive name: Not established | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 72 | United States;Germany;Italy | |||
| 505 | NCT01494532 (ClinicalTrials.gov) | April 2, 2012 | 1/12/2011 | A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease | A Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's Disease | Parkinson Disease | Drug: ropinirole/L-dopa;Drug: placebo/L-dopa | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 352 | Phase 4 | United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 506 | EUCTR2011-005839-91-ES (EUCTR) | 02/04/2012 | 11/01/2012 | Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo. | Gabapentin int he disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo. - IMULPARK | PARKINSON´S DISEASE MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GABAPENTINA KERN PHARMA INN or Proposed INN: GABAPENTINA Other descriptive name: GABAPENTIN | ASOCIACIÓN INSTITUTO BIODONOSTIA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain | ||
| 507 | NCT01491529 (ClinicalTrials.gov) | April 2012 | 12/12/2011 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | All | 154 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 508 | NCT01331122 (ClinicalTrials.gov) | April 2012 | 13/10/2010 | Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease | A Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's Disease | Gait Disorders, Neurologic | Drug: droxidopa | Chelsea Therapeutics | NULL | Withdrawn | 30 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States;Canada |
| 509 | NCT01527695 (ClinicalTrials.gov) | April 2012 | 22/12/2011 | PET Study in Parkinson's Disease Patients | A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mg | AstraZeneca | NULL | Completed | 45 Years | 75 Years | Both | 24 | Phase 2 | Sweden |
| 510 | NCT01486628 (ClinicalTrials.gov) | April 2012 | 4/12/2011 | Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers | A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers | Parkinson's Disease | Drug: ND0612;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 18 Years | 40 Years | Male | 36 | Phase 1 | Israel |
| 511 | NCT01556165 (ClinicalTrials.gov) | April 2012 | 13/3/2012 | Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Parkinson's Disease | Drug: rasagiline;Drug: placebo | H. Lundbeck A/S | NULL | Completed | 35 Years | N/A | All | 130 | Phase 3 | China |
| 512 | NCT01523301 (ClinicalTrials.gov) | April 2012 | 27/1/2012 | Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB Korea Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 380 | Phase 4 | Korea, Republic of |
| 513 | EUCTR2011-002074-23-ES (EUCTR) | 30/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 514 | EUCTR2011-002074-23-SK (EUCTR) | 28/03/2012 | 30/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 515 | EUCTR2011-002074-23-HU (EUCTR) | 21/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 516 | EUCTR2011-002074-23-DE (EUCTR) | 20/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 517 | EUCTR2011-002074-23-IT (EUCTR) | 15/03/2012 | 02/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe Ldopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 518 | EUCTR2011-002901-31-DE (EUCTR) | 08/03/2012 | 06/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 519 | NCT01538329 (ClinicalTrials.gov) | March 4, 2012 | 20/2/2012 | Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease | Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study) | Parkinson Disease | Drug: Amantadine;Drug: placebo | University Hospital, Toulouse | NULL | Completed | 35 Years | N/A | All | 210 | Phase 2 | France |
| 520 | NCT01653132 (ClinicalTrials.gov) | March 2012 | 25/7/2012 | Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism | Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism | Sialorrhea | Drug: Incobotulinum Toxin A;Drug: Placebo | Beth Israel Deaconess Medical Center | NULL | Completed | 18 Years | 90 Years | All | 10 | Phase 2 | United States |
| 521 | NCT01565395 (ClinicalTrials.gov) | March 2012 | 26/3/2012 | Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) | Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) | Parkinson Disease;Amyotrophic Lateral Sclerosis | Drug: Incobotulinum Toxin A;Drug: placebo | Beth Israel Deaconess Medical Center | Merz Pharmaceuticals | Withdrawn | 20 Years | 80 Years | All | 0 | Phase 2 | United States |
| 522 | NCT03061513 (ClinicalTrials.gov) | February 28, 2012 | 13/2/2017 | Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers | Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers | Parkinson Disease | Drug: Ubiquinol;Dietary Supplement: Placebo | Weill Medical College of Cornell University | NULL | Completed | 40 Years | 75 Years | All | 11 | Phase 2 | NULL |
| 523 | EUCTR2011-004803-19-SE (EUCTR) | 22/02/2012 | 16/12/2011 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 524 | EUCTR2011-005054-59-RO (EUCTR) | 21/02/2012 | 13/06/2013 | SYN115 in Parkinson’s disease | A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off - (none) | Parkinson’s disease MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SYN115 Tablets, 60 mg Product Code: SYN115 INN or Proposed INN: tozadenant Other descriptive name: tozadenant | Biotie Therapies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | United States;Canada;Argentina;Ukraine;Romania;Chile | |||
| 525 | NCT01539837 (ClinicalTrials.gov) | February 2012 | 22/2/2012 | A Pilot Clinical Trial With the Iron Chelator Deferiprone in Parkinson's Disease | A Pilot Clinical Trial With the Iron Chelator Deferiprone in Parkinson's Disease | Parkinson's Disease | Drug: Deferiprone 20mg;Drug: Placebo;Drug: Deferiprone 30mg | Imperial College London | NULL | Completed | 50 Years | 75 Years | All | 22 | Phase 2 | United Kingdom |
| 526 | NCT01485172 (ClinicalTrials.gov) | January 31, 2012 | 1/12/2011 | A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease | A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's Disease | Parkinson Disease | Drug: ropinirole monotherapy;Drug: placebo monotherapy | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 186 | Phase 4 | United States;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 527 | NCT01470027 (ClinicalTrials.gov) | January 2012 | 4/11/2011 | N-Acetylcysteine for Neuroprotection in Parkinson's Disease | N-Acetylcysteine for Neuroprotection in Parkinson's Disease | Parkinson Disease | Drug: N-acetylcysteine;Drug: Placebo | Weill Medical College of Cornell University | National Institute on Aging (NIA) | Completed | 50 Years | 75 Years | All | 50 | Phase 1/Phase 2 | United States |
| 528 | NCT01497652 (ClinicalTrials.gov) | January 2012 | 20/12/2011 | A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy | A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy | Parkinson's Disease | Drug: Rasagiline/Placebo;Drug: Rasagiline | Georgetown University | Teva Neuroscience, Inc. | Completed | 40 Years | N/A | Both | 34 | Phase 4 | United States |
| 529 | NCT01536015 (ClinicalTrials.gov) | January 2012 | 15/2/2012 | Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction | Advanced Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB Pharma | NULL | Terminated | 30 Years | N/A | All | 25 | Phase 3 | United States |
| 530 | EUCTR2011-002901-31-HU (EUCTR) | 21/12/2011 | 13/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Czech Republic;Hungary;Spain;Germany;United Kingdom | |||
| 531 | EUCTR2011-002901-31-CZ (EUCTR) | 12/12/2011 | 10/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 532 | NCT01521117 (ClinicalTrials.gov) | December 2011 | 12/1/2012 | The Effect of Donepezil on Gait and Balance in Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Effect of Donepezil on Gait and Balance in Parkinson's Disease | Parkinson's Disease | Drug: Donepezil | Oregon Health and Science University | NULL | Recruiting | N/A | N/A | Both | 12 | Phase 4 | United States |
| 533 | NCT01519271 (ClinicalTrials.gov) | December 2011 | 10/1/2012 | Mild Cognitive Impairment in Parkinson's Disease | A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease | Parkinson's Disease;Mild Cognitive Impairment | Drug: Exelon Patch (rivastigmine transdermal system);Drug: Placebo Patches | University of Pennsylvania | NULL | Completed | 40 Years | 85 Years | All | 28 | Phase 4 | United States |
| 534 | NCT01479530 (ClinicalTrials.gov) | December 2011 | 22/11/2011 | Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China | Parkinson's Disease | Drug: Placebo;Drug: Azilect® | H. Lundbeck A/S | NULL | Completed | 30 Years | N/A | All | 321 | Phase 3 | China |
| 535 | EUCTR2011-002901-31-ES (EUCTR) | 30/11/2011 | 05/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODO | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 536 | EUCTR2011-002901-31-GB (EUCTR) | 25/11/2011 | 21/09/2011 | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - Efficacy of OXN PR in severe Parkinson's disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: Oxycodone hydrochloride INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 537 | EUCTR2011-002073-30-IT (EUCTR) | 14/11/2011 | 06/03/2012 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson's disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10043118;Term: Tardive dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 63 | United States;European Union;Canada;Spain;Germany;Switzerland;Italy | |||
| 538 | NCT01736891 (ClinicalTrials.gov) | November 2011 | 27/11/2012 | Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations | Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China) | Parkinson´s Disease | Drug: Rasagiline;Drug: Placebo | Chongqing Fortune Pharmaceutical Co., Ltd. | Beijing Bionovo Medicine Development Co., Ltd. | Completed | 30 Years | 75 Years | Both | 268 | Phase 3 | China |
| 539 | NCT01457807 (ClinicalTrials.gov) | November 2011 | 10/10/2011 | To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers | A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female Volunteers | Parkinson's Disease | Drug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 | AstraZeneca | NULL | Completed | 30 Years | 65 Years | Both | 24 | Phase 1 | United Kingdom |
| 540 | NCT01385592 (ClinicalTrials.gov) | November 2011 | 28/6/2011 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | Both | 78 | Phase 2 | United States;Canada;France;Germany;Hungary;Italy;Spain |
| 541 | EUCTR2011-000056-42-GB (EUCTR) | 07/10/2011 | 11/08/2011 | Sleep efficiency assessed by Polysomnography (PSG sleep lab testing) in advanced Parkinson's disease | A MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF ROTIGOTINE ON SLEEP EFFICIENCY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE - sleep efficiency assessed by polysomnography in advanced Parkinson's Disease | Advanced Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Celltech, UK - Registered Branch of UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 542 | NCT01439100 (ClinicalTrials.gov) | October 2011 | 21/9/2011 | A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain | Parkinson's Disease With Severe Pain | Drug: Oxycodone/Naloxone Prolonged Release tablets;Drug: Placebo | Mundipharma Research GmbH & Co KG | NULL | Completed | 25 Years | N/A | Both | 172 | Phase 3 | Czech Republic;Germany;Hungary;Poland;Romania;Spain;United Kingdom | |
| 543 | NCT01385735 (ClinicalTrials.gov) | October 2011 | 28/6/2011 | Emotion, Mood and Executive Function in Parkinson`s Disease (PD) | Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson`s Disease | Parkinson Disease | Drug: Rasagiline;Drug: Placebo | St. Josef Hospital Bochum | NULL | Not yet recruiting | 30 Years | 75 Years | Both | 70 | Phase 4 | Germany |
| 544 | NCT01442610 (ClinicalTrials.gov) | October 2011 | 23/9/2011 | Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease | Effects of Rasagiline on Sleep Disturbances in PD: A Single Center, Randomized, Double-blind, Placebo run-in, Polysomnographic Clinical Phase IV Trial | Sleep Disturbances;Parkinsons's Disease | Drug: Rasagiline;Drug: Placebo | Technische Universität Dresden | Teva Pharmaceutical Industries | Completed | 50 Years | 85 Years | Both | 30 | Phase 4 | Germany |
| 545 | EUCTR2010-018534-44-CZ (EUCTR) | 23/09/2011 | 04/07/2011 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 2 | United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom | ||
| 546 | NCT01474421 (ClinicalTrials.gov) | September 15, 2011 | 5/10/2011 | Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias | Dyskinesias;Drug-induced | Drug: AQW051;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 85 Years | All | 71 | Phase 2 | United States;France;Germany;Italy |
| 547 | NCT01178047 (ClinicalTrials.gov) | September 2011 | 6/8/2010 | Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease | A Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: Rasagiline | University of Zurich | H. Lundbeck A/S | Terminated | 40 Years | N/A | Both | 1 | Phase 4 | Switzerland |
| 548 | NCT02170376 (ClinicalTrials.gov) | September 2011 | 19/6/2014 | The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics | The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa/carbidopa | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 80 | Phase 1 | France |
| 549 | EUCTR2010-018534-44-HU (EUCTR) | 30/08/2011 | 08/07/2011 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 2 | France;United States;Serbia;Czech Republic;Hungary;Canada;Poland;Romania;Germany;United Kingdom | ||
| 550 | EUCTR2010-020299-42-DE (EUCTR) | 30/08/2011 | 26/04/2011 | A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients. | A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD | Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE | Philipps-University Marburg | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Germany | ||
| 551 | EUCTR2010-021860-13-BG (EUCTR) | 04/08/2011 | 02/06/2011 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina | |||
| 552 | EUCTR2010-021394-37-BG (EUCTR) | 04/08/2011 | 02/06/2011 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 553 | NCT01370811 (ClinicalTrials.gov) | August 2011 | 8/6/2011 | A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease | A Phase II, Double-blind, Randomized, Placebo-controlled 4-way Crossover Study to Evaluate the Relative Efficacy and Safety of OC Oral Solution (Oxybutynin and Clonidine) for Sialorrhoea in Patients With Parkinson's Disease | Sialorrhoea | Drug: OC oral solution treatment A;Drug: OC oral solution treatment B;Drug: OC oral solution treatment C;Drug: OC oral solution treatment D | Orient Pharma Co., Ltd. | NULL | Completed | 40 Years | 80 Years | Both | 24 | Phase 2 | United States |
| 554 | NCT01634568 (ClinicalTrials.gov) | August 2011 | 20/6/2012 | A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men | A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of V81444 in Healthy Male Volunteers | Parkinson's Disease | Drug: V81444 | Vernalis (R&D) Ltd | NULL | Completed | 18 Years | 45 Years | Male | 49 | Phase 1 | United Kingdom |
| 555 | EUCTR2010-021860-13-IT (EUCTR) | 25/07/2011 | 29/03/2012 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Comtan® INN or Proposed INN: NA | BIAL - PORTELA & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina | |||
| 556 | EUCTR2010-020112-11-LT (EUCTR) | 29/06/2011 | 06/04/2011 | Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) | A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 585 | Phase 3 | United States;Serbia;Mexico;Argentina;Ukraine;Croatia;Lithuania;Chile;South Africa;Russian Federation;Latvia;Colombia | ||
| 557 | EUCTR2011-001092-39-DE (EUCTR) | 29/06/2011 | 17/05/2011 | efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesiasin Parkinson’s patients with moderate to severe L-dopa induced dyskinesias | L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AQW051 Product Code: AQW051 Product Name: AQW051 Product Code: AQW051 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | France;United States;Germany;Italy | |||
| 558 | EUCTR2010-021860-13-CZ (EUCTR) | 24/06/2011 | 09/11/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 559 | EUCTR2010-020112-11-LV (EUCTR) | 21/06/2011 | 08/04/2011 | Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) | A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 | Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 585 | Phase 3 | United States;Serbia;Mexico;Argentina;Ukraine;Lithuania;Croatia;South Africa;Russian Federation;Chile;Colombia;Latvia | ||
| 560 | EUCTR2009-013552-72-PL (EUCTR) | 08/06/2011 | 23/02/2011 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 561 | EUCTR2009-015161-31-PL (EUCTR) | 08/06/2011 | 23/02/2011 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 562 | NCT01382342 (ClinicalTrials.gov) | June 2011 | 23/6/2011 | The Effect of Rasagiline on Cognition in Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Brown University | Teva Pharmaceuticals USA | Completed | 40 Years | N/A | Both | 50 | Phase 4 | United States | |
| 563 | NCT01652534 (ClinicalTrials.gov) | June 2011 | 15/8/2011 | Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease | Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Amantadine;Drug: Placebo | Northwestern University | NULL | Terminated | 18 Years | 85 Years | All | 3 | Phase 3 | United States |
| 564 | EUCTR2010-022517-25-DE (EUCTR) | 30/05/2011 | 14/02/2011 | Safety, tolerability and efficacy of ADX48621 in patients with Parkinson's disease | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant | Addex Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Austria;Germany | ||
| 565 | EUCTR2010-021394-37-AT (EUCTR) | 19/05/2011 | 05/01/2011 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 566 | EUCTR2007-002964-90-BE (EUCTR) | 05/05/2011 | 04/09/2007 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 567 | EUCTR2010-021394-37-SK (EUCTR) | 02/05/2011 | 16/12/2010 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 568 | NCT01520987 (ClinicalTrials.gov) | May 2011 | 26/1/2012 | Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects | Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 65 Years | All | 105 | Phase 1 | United States |
| 569 | NCT01364545 (ClinicalTrials.gov) | May 2011 | 18/5/2011 | Ketogenic Diets for Symptoms of Parkinson's Disease | Ketogenic Diets for Symptoms of Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Ketone ester drink;Dietary Supplement: Placebo (carbohydrate containing) drink | University of Oxford | NULL | Recruiting | 42 Years | N/A | Both | 20 | N/A | United Kingdom |
| 570 | NCT01119131 (ClinicalTrials.gov) | May 2011 | 23/4/2010 | Effects of Vitamin D in Parkinson's Disease (PD) | The Effects of Vitamin D on Balance in Persons With PD | Parkinson Disease;Accidental Falls | Drug: Vitamin D3;Dietary Supplement: calcium;Other: Placebo | VA Office of Research and Development | Oregon Health and Science University | Completed | 50 Years | 99 Years | All | 101 | Phase 2 | United States |
| 571 | NCT01504178 (ClinicalTrials.gov) | May 2011 | 30/12/2011 | Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease | Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease | Parkinson's Disease | Drug: duloxetine;Drug: placebo of duloxetine;Drug: injection of apomorphine;Drug: injection of placebo of apomorphine;Drug: L-Dopa;Drug: injection of placebo of L-Dopa | University Hospital, Toulouse | French Parkinson Association | Completed | 30 Years | 70 Years | All | 28 | Phase 3 | France |
| 572 | EUCTR2010-022366-27-CZ (EUCTR) | 21/04/2011 | 23/11/2010 | BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India | |||
| 573 | EUCTR2010-022366-27-BE (EUCTR) | 18/04/2011 | 01/02/2011 | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Czech Republic;Estonia;Belgium;United Kingdom | ||
| 574 | EUCTR2010-022517-25-AT (EUCTR) | 15/04/2011 | 17/02/2011 | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 14.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant | Addex Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Austria;Germany | ||
| 575 | EUCTR2009-015161-31-DE (EUCTR) | 04/04/2011 | 24/08/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden | ||
| 576 | JPRN-UMIN000005403 | 2011/04/01 | 08/04/2011 | A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease | A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease - EDAP study | Parkinson disease | 5mg of donepezil hydrochloride placebo | Designated Research, National Hospital Organization | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 142 | Phase 3 | Japan |
| 577 | NCT01336088 (ClinicalTrials.gov) | April 2011 | 4/4/2011 | ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ADX48621;Drug: Placebo | Addex Pharma S.A. | NULL | Completed | 30 Years | 75 Years | Both | 83 | Phase 2 | United States;Austria;France;Germany |
| 578 | NCT01313819 (ClinicalTrials.gov) | April 2011 | 10/3/2011 | The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | Parkinson`s Disease;Freezing of Gait | Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 20 | Phase 4 | Korea, Republic of |
| 579 | EUCTR2009-013552-72-BG (EUCTR) | 24/03/2011 | 26/01/2011 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 580 | EUCTR2010-022366-27-GB (EUCTR) | 23/03/2011 | 30/11/2010 | BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India | ||
| 581 | EUCTR2010-018534-44-DE (EUCTR) | 11/03/2011 | 10/08/2010 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 2 | United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom | ||
| 582 | EUCTR2010-021860-13-DE (EUCTR) | 09/03/2011 | 18/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 583 | EUCTR2010-021394-37-CZ (EUCTR) | 09/03/2011 | 14/12/2010 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Hungary;Czech Republic;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 584 | EUCTR2010-021394-37-DE (EUCTR) | 08/03/2011 | 03/12/2010 | Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 585 | EUCTR2009-013552-72-GB (EUCTR) | 07/03/2011 | 07/07/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 586 | EUCTR2009-015161-31-GB (EUCTR) | 07/03/2011 | 01/07/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden | ||
| 587 | EUCTR2010-021394-37-IT (EUCTR) | 01/03/2011 | 28/12/2011 | STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976 | STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976 | subjects with Parkinson’s disease. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy | |||
| 588 | NCT01568073 (ClinicalTrials.gov) | March 2011 | 29/3/2012 | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study | Parkinson's Disease | Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 83 Years | All | 600 | Phase 3 | Portugal;Austria |
| 589 | NCT01283594 (ClinicalTrials.gov) | March 2011 | 24/1/2011 | Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off | A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off | Parkinson's Disease | Drug: Tozadenant (SYN115) 60 mg BID;Drug: Placebo;Drug: Levodopa (L-dopa);Drug: Tozadenant (SYN115) 120 mg BID;Drug: Tozadenant (SYN115) 180 mg BID;Drug: Tozadenant (SYN115) 240 mg BID | Biotie Therapies Inc. | NULL | Completed | 30 Years | 80 Years | All | 420 | Phase 2/Phase 3 | United States;Argentina;Canada;Chile;Romania;Ukraine |
| 590 | NCT01227655 (ClinicalTrials.gov) | March 2011 | 22/10/2010 | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients. | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study. | Parkinson's Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 83 Years | All | 427 | Phase 3 | Portugal |
| 591 | NCT01280123 (ClinicalTrials.gov) | March 2011 | 3/12/2010 | Pioglitazone in Early Parkinson's Disease | A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease | Parkinson's Disease | Drug: Pioglitazone;Drug: placebo | University of Rochester | National Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 210 | Phase 2 | United States |
| 592 | NCT01294800 (ClinicalTrials.gov) | February 25, 2011 | 10/2/2011 | A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402) | A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402) | Parkinson's Disease | Drug: Preladenant;Drug: Placebo tablet to match Preladenant | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 450 | Phase 2 | Japan |
| 593 | EUCTR2010-022363-35-DE (EUCTR) | 18/02/2011 | 19/10/2010 | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Madopar LT Product Name: Levodopa / Benserazid Product Code: LD / BE INN or Proposed INN: LEVODOPA Other descriptive name: - INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE Other descriptive name: - Trade Name: Neupro Product Name: Rotigotin Product Code: RO INN or Proposed INN: ROTIGOTINE Other descriptive name: - | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 594 | EUCTR2009-015161-31-BG (EUCTR) | 17/02/2011 | 02/02/2011 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden | ||
| 595 | EUCTR2010-021860-13-SK (EUCTR) | 17/02/2011 | 09/12/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 596 | EUCTR2010-021394-37-ES (EUCTR) | 17/02/2011 | 22/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Enfermedad de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: NEUPRO 2 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 4 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 6 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 8 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Belgium;Spain;Austria;Bulgaria;Germany;Italy | ||
| 597 | EUCTR2010-021394-37-HU (EUCTR) | 14/02/2011 | 13/12/2010 | Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinson’s disease | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 598 | EUCTR2009-017174-20-AT (EUCTR) | 09/02/2011 | 07/12/2010 | A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study | Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany;Canada;France;Austria;South Africa | |||
| 599 | NCT02880033 (ClinicalTrials.gov) | February 2011 | 3/8/2016 | Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes | Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis | Parkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron Overload | Drug: deferiprone;Drug: placebo | University Hospital, Lille | NULL | Completed | 18 Years | 80 Years | All | 90 | N/A | France |
| 600 | NCT01313845 (ClinicalTrials.gov) | February 2011 | 10/3/2011 | Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease | Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease | Parkinson's Disease | Drug: amantadine sulfate;Drug: 0.9% sodium chloride | Jee-Young Lee | Seoul National University Boramae Hospital;Samsung Medical Center;Seoul National University Bundang Hospital;Hanyang University | Completed | 30 Years | 79 Years | Both | 46 | Phase 4 | Korea, Republic of |
| 601 | NCT01300819 (ClinicalTrials.gov) | February 2011 | 18/2/2011 | Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms | Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Other: Placebo;Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 349 | Phase 4 | Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Hungary;Italy;Romania;Slovakia;Spain;Switzerland |
| 602 | EUCTR2009-015161-31-PT (EUCTR) | 28/01/2011 | 29/10/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 603 | EUCTR2010-021860-13-AT (EUCTR) | 27/01/2011 | 11/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina | |||
| 604 | EUCTR2010-021860-13-RO (EUCTR) | 27/01/2011 | 25/07/2011 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | ||
| 605 | EUCTR2010-021394-37-BE (EUCTR) | 25/01/2011 | 14/12/2010 | Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 606 | EUCTR2010-021860-13-ES (EUCTR) | 24/01/2011 | 27/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 607 | EUCTR2009-015161-31-CZ (EUCTR) | 17/01/2011 | 28/07/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 608 | EUCTR2009-013552-72-CZ (EUCTR) | 17/01/2011 | 28/07/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 609 | NCT01268891 (ClinicalTrials.gov) | January 2011 | 30/12/2010 | Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in Korea | Parkinson's Disease | Drug: Placebo;Drug: Azilect® | H. Lundbeck A/S | NULL | Completed | 30 Years | N/A | All | 132 | Phase 3 | Korea, Republic of |
| 610 | NCT01229332 (ClinicalTrials.gov) | January 2011 | 3/10/2010 | A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients | A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Saline;Drug: Carbidopa | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 24 | Phase 1/Phase 2 | Israel |
| 611 | NCT01340885 (ClinicalTrials.gov) | January 2011 | 19/4/2011 | Cognitive Decline in Non-demented PD | Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study | Parkinson's Disease | Drug: Strattera;Drug: Exelon;Other: Placebo | Oregon Health and Science University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | N/A | All | 9 | Phase 4 | United States |
| 612 | EUCTR2010-021860-13-LV (EUCTR) | 22/12/2010 | 14/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 613 | EUCTR2010-021860-13-PT (EUCTR) | 22/12/2010 | 08/11/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina | |||
| 614 | EUCTR2008-004146-88-DE (EUCTR) | 20/12/2010 | 15/10/2010 | An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 615 | EUCTR2010-022366-27-EE (EUCTR) | 10/12/2010 | 03/11/2010 | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Czech Republic;Estonia;Belgium;United Kingdom | |||
| 616 | EUCTR2009-015161-31-NL (EUCTR) | 09/12/2010 | 09/08/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden;United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India | ||
| 617 | EUCTR2009-015161-31-IT (EUCTR) | 06/12/2010 | 28/09/2010 | A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND | A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND | Parkinson`s Disease MedDRA version: 9.1;Level: PT;Classification code 10061536 | Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Trade Name: Azilect INN or Proposed INN: Rasagiline | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Finland;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden | ||
| 618 | EUCTR2009-013552-72-IT (EUCTR) | 06/12/2010 | 04/11/2010 | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - ND | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - ND | Parkinson`s Disease MedDRA version: 9.1;Level: PT;Classification code 10061536 | Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Trade Name: Azilect INN or Proposed INN: Rasagiline | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;United Kingdom;Italy;Sweden | ||
| 619 | EUCTR2009-013552-72-SE (EUCTR) | 02/12/2010 | 06/10/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 620 | EUCTR2009-015161-31-SE (EUCTR) | 02/12/2010 | 06/10/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 621 | NCT01244269 (ClinicalTrials.gov) | December 2010 | 18/11/2010 | The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease. | Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease. | Parkinson's Disease | Drug: Methylphenidate;Drug: Placebo 10;Drug: Placebo 20 | Laval University | Fonds de la Recherche en Santé du Québec;Quebec Memory and Motor Skills Disorders Research Center | Terminated | N/A | 75 Years | Both | 6 | Phase 4 | Canada |
| 622 | EUCTR2010-021860-13-LT (EUCTR) | 30/11/2010 | 28/09/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina | |||
| 623 | EUCTR2010-020109-34-ES (EUCTR) | 29/11/2010 | 23/09/2010 | Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. | Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. | Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamida Product Code: NW-1015 Other descriptive name: Safinamida | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain;Italy | ||
| 624 | EUCTR2010-020109-34-IT (EUCTR) | 24/11/2010 | 27/12/2010 | A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND | A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND | Cognition in non-demented patients with idiopathic Parkinson’s disease MedDRA version: 9.1;Level: PT;Classification code 10061536 | Product Name: SAFINAMIDE Product Code: NW-1015 | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain;Italy | ||
| 625 | NCT01227265 (ClinicalTrials.gov) | November 19, 2010 | 22/10/2010 | Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) | A Phase 3, 12 Week, Double-blind, Placebo-controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease. | Parkinson Disease;Idiopathic Parkinson Disease;Idiopathic Parkinson's Disease | Drug: Preladenant;Drug: Placebo | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 476 | Phase 3 | Argentina;Chile;Colombia;Croatia;Latvia;Lithuania;Mexico;Russian Federation;Serbia;South Africa;Ukraine;United States |
| 626 | NCT01215227 (ClinicalTrials.gov) | November 18, 2010 | 4/10/2010 | An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153) | Parkinson Disease;Idiopathic Parkinson Disease | Drug: Preladenant;Drug: Rasagiline;Drug: Placebo to preladenant;Drug: Placebo to rasagiline | Merck Sharp & Dohme Corp. | NULL | Terminated | 30 Years | 85 Years | All | 839 | Phase 3 | Argentina;Austria;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;France;India;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Sweden;Ukraine;United Kingdom;United States |
| 627 | EUCTR2010-021860-13-HU (EUCTR) | 11/11/2010 | 27/09/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 628 | EUCTR2009-015161-31-AT (EUCTR) | 03/11/2010 | 17/08/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 629 | NCT01060878 (ClinicalTrials.gov) | November 2010 | 1/2/2010 | Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD) | Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks | Parkinson's Disease | Drug: PYM50028;Drug: Placebo | Phytopharm | NULL | Completed | 35 Years | 75 Years | Both | 425 | Phase 2 | United States;Canada;Czech Republic;France;Germany;Hungary;Poland;Romania;Serbia;United Kingdom |
| 630 | EUCTR2009-013552-72-ES (EUCTR) | 26/10/2010 | 27/07/2010 | Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE | Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE | Enfermendad de Parkinson MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagilina mesilato Other descriptive name: RASAGILINA MESILATO | Schering Corporation, división Schering-Plough Research | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden | ||
| 631 | EUCTR2010-018534-44-GB (EUCTR) | 22/10/2010 | 09/08/2010 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom | ||
| 632 | EUCTR2009-013552-72-HU (EUCTR) | 21/10/2010 | 11/08/2010 | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy | Parkinson's disease | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Czech Republic;Hungary;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden | ||
| 633 | EUCTR2009-015161-31-FR (EUCTR) | 19/10/2010 | 29/07/2010 | A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease | A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesilate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden | ||
| 634 | EUCTR2009-015928-28-SE (EUCTR) | 07/10/2010 | 13/08/2010 | A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09 | A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09 | Dyskinesias related to levodopa treatment in Parkinson´s disease | Product Name: Eltoprazine HCl Product Code: Eltoprazine HCl | PsychoGenics Inc | NULL | Not Recruiting | Female: yes Male: yes | 24 | Sweden | |||
| 635 | EUCTR2007-002964-90-CZ (EUCTR) | 06/10/2010 | 27/08/2010 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria | ||
| 636 | NCT01216904 (ClinicalTrials.gov) | October 2010 | 6/10/2010 | Nicotine Treatment of Impulsivity in Parkinson's Disease | Nicotine Treatment of Impulsivity in Parkinson's Disease: A Pilot Study | Parkinson's Disease | Drug: nicotine patch;Drug: placebo | University of Vermont | Parkinson's Disease Foundation;The Parkinson Study Group | Recruiting | 18 Years | N/A | Both | 20 | Phase 4 | United States |
| 637 | EUCTR2009-013552-72-FI (EUCTR) | 07/09/2010 | 02/07/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 638 | NCT01211587 (ClinicalTrials.gov) | September 2010 | 28/9/2010 | A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease | A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive Impairment | Parkinson's Disease With Cognitive Impairments | Drug: safinamide;Drug: placebo | Newron | NULL | Completed | 45 Years | 80 Years | Both | 103 | Phase 2 | United States;Spain |
| 639 | EUCTR2009-015161-31-FI (EUCTR) | 17/08/2010 | 23/06/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 640 | NCT01785628 (ClinicalTrials.gov) | August 2010 | 24/6/2011 | The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease | Parkinson's Disease With Dementia | Dietary Supplement: Sarcosine Capsule;Dietary Supplement: Placebo Capsule | China Medical University Hospital | National Science Council, Taiwan | Completed | N/A | N/A | All | 30 | N/A | Taiwan | |
| 641 | NCT01155466 (ClinicalTrials.gov) | July 14, 2010 | 30/6/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938) | Parkinson Disease | Drug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Placebo to Preladenant Tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo to Rasagiline capsule | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 778 | Phase 3 | Austria;Brazil;Bulgaria;Canada;Czech Republic;Finland;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States |
| 642 | NCT01155479 (ClinicalTrials.gov) | July 6, 2010 | 30/6/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease | Parkinson Disease | Drug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo for Rasagiline 1 mg capsule;Drug: Placebo for Preladenant | Merck Sharp & Dohme Corp. | NULL | Terminated | 30 Years | 85 Years | All | 1022 | Phase 3 | Argentina;Bulgaria;Canada;Chile;Colombia;Czech Republic;Finland;France;Germany;Hungary;India;Israel;Italy;Mexico;Peru;Poland;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States |
| 643 | NCT01174004 (ClinicalTrials.gov) | July 2010 | 30/7/2010 | A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: pimavanserin tartrate;Drug: placebo | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 199 | Phase 3 | United States;Canada |
| 644 | NCT01171313 (ClinicalTrials.gov) | July 2010 | 26/7/2010 | A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects | A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations | Parkinson's Disease | Drug: XP21279 and carbidopa (experimental);Drug: Sinemet (comparator);Drug: Placebo for XP21279 and carbidopa;Drug: Placebo for Sinemet | XenoPort, Inc. | NULL | Completed | 30 Years | 80 Years | All | 35 | Phase 2 | United States |
| 645 | EUCTR2009-013886-24-SE (EUCTR) | 08/06/2010 | 21/12/2009 | Efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Czech Republic;Germany;Sweden | |||
| 646 | NCT01227681 (ClinicalTrials.gov) | June 2010 | 22/10/2010 | Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease | A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease | Parkinson Disease | Drug: G-CSF;Drug: Placebo | Buddhist Tzu Chi General Hospital | NULL | Terminated | 40 Years | 65 Years | All | 4 | Phase 2 | Taiwan |
| 647 | NCT01176240 (ClinicalTrials.gov) | June 2010 | 30/7/2010 | A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease | A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease | Orthostatic Hypotension;Parkinson's Disease | Drug: Droxidopa;Other: Placebo | Chelsea Therapeutics | NULL | Completed | 18 Years | N/A | All | 225 | Phase 3 | United States |
| 648 | NCT01140841 (ClinicalTrials.gov) | June 2010 | 8/6/2010 | A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa | A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose-Escalation Study of Safety and Tolerability of Oromucosal Fipamezole ODT in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa | Parkinson's Disease | Drug: Fipamezole ODT;Drug: Placebo | Valeant Pharmaceuticals International, Inc. | NULL | Completed | 30 Years | 75 Years | Both | 40 | United States | |
| 649 | EUCTR2009-016143-19-AT (EUCTR) | 26/05/2010 | 12/05/2010 | Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie | Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie | Parkinson's disease | Trade Name: Amantadin-ratiopharm 100mg Other descriptive name: AMANTADINE HYDROCHLORIDE | CHU de Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 66 | France;Austria | |||
| 650 | NCT01532115 (ClinicalTrials.gov) | May 2010 | 23/1/2012 | Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women | A Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: moxifloxacin | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | Both | 64 | Phase 1 | France |
| 651 | NCT01113320 (ClinicalTrials.gov) | April 2010 | 8/4/2010 | Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects | A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias | Parkinson's Disease | Drug: Placebo;Drug: Safinamide | Newron | NULL | Completed | 30 Years | N/A | Both | 26 | Phase 2 | Austria;Canada;France;Germany;South Africa |
| 652 | EUCTR2009-017174-20-DE (EUCTR) | 15/03/2010 | 07/01/2010 | A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study | Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 24 | France;Canada;Austria;South Africa;Germany | |||
| 653 | EUCTR2009-013886-24-DE (EUCTR) | 03/03/2010 | 29/10/2009 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Czech Republic;Germany;Sweden | |||
| 654 | NCT01055379 (ClinicalTrials.gov) | March 2010 | 22/1/2010 | Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn | A Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO Study | Depressive Symptoms;Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Lundbeck Italia S.p.A. | Teva Pharmaceutical Industries | Completed | 40 Years | 80 Years | All | 121 | Phase 4 | Italy |
| 655 | NCT01092065 (ClinicalTrials.gov) | March 2010 | 22/3/2010 | Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia | A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia | Parkinson's Disease | Drug: AFQ056 with L-dopa;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 80 Years | All | 23 | Phase 2 | United States |
| 656 | NCT01066442 (ClinicalTrials.gov) | March 2010 | 9/2/2010 | Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease | A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase | Parkinson's Disease | Drug: BF2.649 (Pitolisant) | Bioprojet | NULL | Completed | 30 Years | 80 Years | Both | 273 | Phase 3 | Germany |
| 657 | EUCTR2009-017174-20-FR (EUCTR) | 24/02/2010 | 18/01/2010 | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. | Idiopathic Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Austria;Germany | ||
| 658 | EUCTR2007-002963-28-DE (EUCTR) | 17/02/2010 | 22/12/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 659 | NCT01154166 (ClinicalTrials.gov) | February 15, 2010 | 29/6/2010 | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | Parkinson Disease | Drug: ReQuip PR;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 347 | Phase 3 | China |
| 660 | NCT01568047 (ClinicalTrials.gov) | February 2010 | 29/3/2012 | Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients | Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon) | Parkinson's Disease | Drug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 40 | Phase 2 | Romania;Ukraine |
| 661 | NCT02169414 (ClinicalTrials.gov) | February 2010 | 24/1/2012 | Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics | Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067 5 mg;Drug: BIA 9-1067 25 mg;Drug: levodopa/carbidopa 100/25;Drug: Placebo;Drug: levodopa/benserazide 100/25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 74 | Phase 1 | France |
| 662 | JPRN-UMIN000007497 | 2010/01/01 | 14/03/2012 | Trial of molecular hydrogen water in Parkinson disease | Trial of molecular hydrogen water in Parkinson disease - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease | Parkinson disease | The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks. Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 18 | Not applicable | Japan |
| 663 | JPRN-UMIN000003080 | 2010/01/01 | 30/01/2010 | Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease | Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease - EDP2010 study | Parkinson's disease | Donepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks) Placebo | Clinical Research Center, Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | 40years-old | 75years-old | Male and Female | 30 | Not applicable | Japan |
| 664 | NCT01058291 (ClinicalTrials.gov) | January 2010 | 27/1/2010 | Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500 | Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease) | Parkinson's Disease | Drug: KW-6500;Drug: KW-6500 Placebo | Kyowa Hakko Kirin Co., Ltd | NULL | Completed | 20 Years | N/A | All | 31 | Phase 3 | Japan |
| 665 | NCT01071395 (ClinicalTrials.gov) | January 2010 | 17/2/2010 | Validation of Dyskinesia Rating Scales | Validation of Dyskinesia Rating Scales | Parkinson's Disease | Drug: Amantadine;Drug: Placebo | Rush University Medical Center | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 90 Years | All | 68 | Phase 4 | United States;Austria;Canada;France |
| 666 | NCT01018264 (ClinicalTrials.gov) | January 2010 | 19/11/2009 | Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease | URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease | Overactive Bladder in Parkinson's Disease | Drug: solifenacin succinate (VESIcare);Drug: placebo | University of South Florida | NULL | Completed | 40 Years | 80 Years | All | 23 | Phase 4 | United States |
| 667 | EUCTR2009-012897-12-RO (EUCTR) | 08/12/2009 | 30/03/2015 | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | Parkinson’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 | Product Name: BIA 9-1067 Product Code: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Restex Tabletten INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE | BIAL-Portela & Ca, SA | NULL | Not Recruiting | Female: yes Male: yes | 32 | Romania | |||
| 668 | NCT01036139 (ClinicalTrials.gov) | December 2009 | 11/12/2009 | Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease | A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase | Parkinson's Disease | Drug: BF2.649 (pitolisant) | Bioprojet | NULL | Completed | 30 Years | 80 Years | Both | 268 | Phase 3 | France |
| 669 | NCT01168596 (ClinicalTrials.gov) | December 2009 | 19/2/2010 | Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease | Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease: A Bi-Center, Placebo-Controlled Study (The REST Fatigue Trial) | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | University of Florida | NULL | Completed | 40 Years | 85 Years | All | 30 | Phase 4 | United States |
| 670 | NCT01049984 (ClinicalTrials.gov) | December 2009 | 13/1/2010 | Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease | A Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Neuroscience, Inc. | H. Lundbeck A/S | Completed | 30 Years | N/A | All | 328 | Phase 4 | United States |
| 671 | NCT00660387 (ClinicalTrials.gov) | December 2009 | 15/4/2008 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 35 | Phase 3 | United States;New Zealand |
| 672 | EUCTR2009-013886-24-CZ (EUCTR) | 26/11/2009 | 18/11/2009 | A Randomized, Multicenter, 12-Week, Double-blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson Disease, followed by a 9-months Open-Label Extension Phase - HARPS-2 | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Germany;Czech Republic;Sweden | ||||
| 673 | EUCTR2009-013885-14-FR (EUCTR) | 23/11/2009 | 25/09/2009 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Phase 3 | France;Spain | ||
| 674 | EUCTR2009-013670-41-CZ (EUCTR) | 18/11/2009 | 07/09/2009 | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Orfadin INN or Proposed INN: NITISINONE | Synosia Therapeutics AG | NULL | Not Recruiting | Female: yes Male: yes | 126 | Czech Republic;France | |||
| 675 | EUCTR2009-013885-14-ES (EUCTR) | 12/11/2009 | 23/09/2009 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas. | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas. | Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson. MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Phase 3 | France;Spain | ||
| 676 | NCT01519284 (ClinicalTrials.gov) | November 2009 | 23/1/2012 | Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic | A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 82 | Phase 1 | Portugal |
| 677 | NCT01007630 (ClinicalTrials.gov) | November 2009 | 3/11/2009 | A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients | A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | The Parkinson's Institute | Teva Neuroscience, Inc. | Active, not recruiting | N/A | 90 Years | Both | 36 | Phase 4 | United States |
| 678 | NCT01023282 (ClinicalTrials.gov) | November 2009 | 1/12/2009 | Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients | Randomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary Measure | Parkinson's Disease;Tolerability | Drug: ACR325;Drug: Placebo | NeuroSearch A/S | NULL | Completed | 30 Years | 75 Years | Both | 22 | Phase 1 | Germany |
| 679 | NCT01052831 (ClinicalTrials.gov) | November 2009 | 15/1/2010 | Naltrexone for Impulse Control Disorders in Parkinson's Disease | Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease | Impulse Control Disorder;Parkinson Disease | Drug: Naltrexone;Drug: Placebo | University of Pennsylvania | Michael J. Fox Foundation for Parkinson's Research | Completed | 18 Years | 85 Years | All | 50 | Phase 4 | United States |
| 680 | EUCTR2008-004146-88-PL (EUCTR) | 19/10/2009 | 31/08/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 681 | EUCTR2009-013670-41-FR (EUCTR) | 16/10/2009 | 11/09/2009 | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Orfadin INN or Proposed INN: NITISINONE | Synosia Therapeutics AG | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | France;Czech Republic | ||
| 682 | NCT00914095 (ClinicalTrials.gov) | October 2009 | 2/6/2009 | Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II) | Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentric Trial | Parkinson's Disease;Gait Disorders, Neurologic;Dementia | Drug: methylphenidate;Drug: placebo | University Hospital, Lille | NULL | Completed | 30 Years | 80 Years | Both | 69 | Phase 4 | France |
| 683 | NCT01028586 (ClinicalTrials.gov) | October 2009 | 7/12/2009 | MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) | A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide, MAO-B inhibitor;Drug: Placebo | Newron | NULL | Terminated | 30 Years | 80 Years | Both | 507 | Phase 3 | Switzerland |
| 684 | NCT00943748 (ClinicalTrials.gov) | October 2009 | 20/7/2009 | Efficacy and Safety of the Iron Chelator Deferiprone in Parkinson's Disease | Efficacy and Safety of the Iron Chelator Deferiprone on Iron Overload in the Brain in Parkinson's Disease | Parkinson's Disease | Drug: deferiprone;Drug: placebo | University Hospital, Lille | NULL | Completed | 30 Years | 80 Years | Both | 40 | Phase 2/Phase 3 | France |
| 685 | NCT01108029 (ClinicalTrials.gov) | October 2009 | 20/7/2009 | Study of Memantine for Gait Disorders And Attention Deficit In Parkinson's Disease | Study of Memantine to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Monocentric Trial | Parkinson's Disease;Gait Disorders, Neurologic | Drug: memantine;Drug: placebo | University Hospital, Lille | NULL | Completed | 30 Years | 80 Years | Both | 28 | Phase 4 | France |
| 686 | NCT00957918 (ClinicalTrials.gov) | October 2009 | 11/8/2009 | Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy | Randomized, Double-Blind, Parallel Group, Placebo Controlled Safety, Tolerability and Efficacy Study of NP002 in Subjects With Idiopathic Parkinson's Disease With Dyskinesias Due to Levodopa Therapy | Parkinson's Disease | Drug: nicotine;Other: placebo comparator | Neuraltus Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 83 Years | Both | 65 | Phase 1/Phase 2 | United States |
| 687 | NCT01016470 (ClinicalTrials.gov) | October 2009 | 28/9/2009 | Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease | Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s Disease | Parkinson`s Disease | Dietary Supplement: VIUSID/ALZER;Dietary Supplement: Placebo | Catalysis SL | NULL | Completed | 20 Years | 90 Years | Both | 100 | Phase 3 | Cuba |
| 688 | NCT01026428 (ClinicalTrials.gov) | September 2009 | 1/12/2009 | A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics | A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Safinamide + Levodopa;Other: Placebo + Levodopa | Newron | NULL | Completed | 30 Years | N/A | Both | 24 | Phase 1/Phase 2 | Italy |
| 689 | NCT00907972 (ClinicalTrials.gov) | September 2009 | 22/5/2009 | The Effects of Vitamin D and Bone Loss in Parkinson's Disease | Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study | Parkinson Disease | Dietary Supplement: Vitamin D3;Other: Placebo | Memorial Medical Center | Department of Defense | Completed | 18 Years | N/A | Both | 23 | Phase 2 | United States |
| 690 | NCT00909883 (ClinicalTrials.gov) | September 2009 | 19/5/2009 | Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles) | Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles) | Parkinson's Disease;Foot Dystonia | Drug: Botulinum Toxin: Xeomin;Drug: Placebo | University Hospital, Clermont-Ferrand | Merz Pharma France | Recruiting | 30 Years | 75 Years | Both | 45 | Phase 3 | France |
| 691 | NCT00986414 (ClinicalTrials.gov) | September 2009 | 29/9/2009 | Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Parkinson Disease;Dyskinesias | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 80 Years | All | 260 | Phase 2 | Australia;Canada;Finland;France;Germany;Italy;Japan;Spain |
| 692 | EUCTR2008-004146-88-BG (EUCTR) | 13/08/2009 | 13/07/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 693 | EUCTR2008-008712-98-DE (EUCTR) | 07/08/2009 | 13/07/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 198 | France;Finland;Spain;Germany;Italy | |||
| 694 | EUCTR2008-004146-88-PT (EUCTR) | 31/07/2009 | 14/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 695 | EUCTR2009-011736-35-FR (EUCTR) | 27/07/2009 | 06/08/2009 | Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS | Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS | Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: LODALÈS® Product Code: simvastatine | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | France | ||
| 696 | NCT00909545 (ClinicalTrials.gov) | July 2009 | 26/5/2009 | Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease | A Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson Disease | Parkinson Disease | Drug: Isradipine CR 5mg;Drug: Isradipine CR 10mg;Drug: Isradipine CR 20mg;Drug: Placebo | Northwestern University | Michael J. Fox Foundation for Parkinson's Research;Northwestern University Dixon Fund;The Parkinson Study Group | Completed | 30 Years | N/A | All | 99 | Phase 2 | United States;Canada |
| 697 | NCT00955526 (ClinicalTrials.gov) | July 2009 | 7/8/2009 | Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3) | Parkinson's Disease | Drug: Istradefylline;Drug: Placebo | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 20 Years | N/A | Both | 373 | Phase 3 | Japan |
| 698 | EUCTR2008-001966-10-EE (EUCTR) | 16/06/2009 | 13/05/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 699 | EUCTR2008-004146-88-ES (EUCTR) | 16/06/2009 | 16/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 700 | EUCTR2008-008712-98-FR (EUCTR) | 10/06/2009 | 28/04/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | France;Finland;Spain;Germany;Italy | |||
| 701 | EUCTR2008-004146-88-CZ (EUCTR) | 08/06/2009 | 07/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 702 | EUCTR2009-010193-38-LV (EUCTR) | 04/06/2009 | 24/08/2009 | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 703 | EUCTR2009-010193-38-LT (EUCTR) | 02/06/2009 | 26/03/2009 | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Pharmaceuticals a Division of IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 704 | NCT01628926 (ClinicalTrials.gov) | June 2009 | 24/6/2012 | A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients | A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962;Drug: Ropinirole;Drug: Placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 420 | Phase 3 | Japan |
| 705 | NCT00833690 (ClinicalTrials.gov) | June 2009 | 27/1/2009 | Safety of Urate Elevation in Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease | Parkinson Disease | Drug: Placebo;Drug: inosine | The Parkinson Study Group | Massachusetts General Hospital;Harvard School of Public Health;University of Rochester;Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 75 | Phase 2 | United States |
| 706 | EUCTR2008-001966-10-AT (EUCTR) | 27/05/2009 | 08/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 707 | EUCTR2008-004146-88-IT (EUCTR) | 26/05/2009 | 27/04/2009 | A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study | A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study | Idiopatic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Safinamide INN or Proposed INN: Safinamide Product Name: Safinamide INN or Proposed INN: Safinamide | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 708 | EUCTR2008-004146-88-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 709 | EUCTR2008-001966-10-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Other descriptive name: NW-1015 Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Estonia;Hungary;Slovakia;Austria;United Kingdom | ||
| 710 | EUCTR2008-004146-88-FI (EUCTR) | 19/05/2009 | 06/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 711 | EUCTR2008-008712-98-FI (EUCTR) | 18/05/2009 | 08/04/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 198 | Finland;Germany;France;Spain;Italy | |||
| 712 | EUCTR2008-008712-98-IT (EUCTR) | 14/05/2009 | 05/05/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND | moderate to severe levodopa induced dyskinesia with Parkinson`s disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Code: AFQ056 Product Code: AFQ056 Product Code: AFQ056 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 234 | Finland;Germany;France;Spain;Italy | |||
| 713 | EUCTR2008-001966-10-GB (EUCTR) | 12/05/2009 | 27/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 714 | EUCTR2009-010193-38-EE (EUCTR) | 07/05/2009 | 15/04/2009 | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 715 | EUCTR2008-001966-10-HU (EUCTR) | 04/05/2009 | 06/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 716 | EUCTR2007-002963-28-BG (EUCTR) | 03/05/2009 | 21/05/2009 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 717 | NCT00902941 (ClinicalTrials.gov) | May 2009 | 13/5/2009 | Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline | Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline | Parkinson´s Disease | Drug: Azilect 1mg;Drug: Placebo | Technische Universität Dresden | NULL | Completed | 18 Years | 64 Years | Both | 34 | Phase 4 | Germany |
| 718 | NCT00907595 (ClinicalTrials.gov) | May 2009 | 20/5/2009 | Treating Sleep/Wake Cycle Disturbances in Basal Ganglia Disorders With Ramelteon | Treating Sleep Wake Cycle Disturbances in Basal Ganglia Neurodegenerative Disorder Subjects With Ramelteon- A Double Blind, Placebo Controlled Trial | Huntington's Disease;Parkinson's Disease;Dementia With Lewy Bodies;Sleep Disorders;Circadian Dysregulation | Drug: Ramelteon;Drug: Placebo | Massachusetts General Hospital | NULL | Withdrawn | 20 Years | 90 Years | Both | 0 | N/A | United States |
| 719 | EUCTR2008-002769-30-IT (EUCTR) | 30/04/2009 | 22/04/2009 | A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics | A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics | Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113 | Product Name: Safinamide INN or Proposed INN: Safinamide INN or Proposed INN: NACOM levodopa+cardidopa | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 720 | NCT00845000 (ClinicalTrials.gov) | April 21, 2009 | 13/2/2009 | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) | Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients | Parkinson Disease | Drug: SCH 420814 10 mg;Drug: SCH 420814 100 mg;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa | Merck Sharp & Dohme Corp. | Oregon Health and Science University | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 721 | EUCTR2007-001095-36-SK (EUCTR) | 09/04/2009 | 09/04/2008 | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 625 | Phase 3 | Hungary;Slovakia | ||
| 722 | EUCTR2007-002964-90-AT (EUCTR) | 02/04/2009 | 13/02/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 723 | EUCTR2007-002963-28-PL (EUCTR) | 02/04/2009 | 27/02/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 724 | JPRN-JapicCTI-090888 | 01/4/2009 | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | Parkinson's Disease Treated Concomitantly with L-dopa | Intervention name : SPM 962 Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day Control intervention name : Ropinirole Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day. Control intervention name : Placebo Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day. | Otsuka Pharmaceutical Co., Ltd. | NULL | 30 | 79 | BOTH | 400 | Phase 3 | NULL | ||
| 725 | JPRN-UMIN000001841 | 2009/04/01 | 02/04/2009 | A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life | A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life - RCT with vitamin D for Parkinson disease | Parkinson disease | Vitamin D3 placebo | Jikei University School of Medicine | NULL | Complete: follow-up complete | 45years-old | 85years-old | Male and Female | 120 | Not selected | Japan |
| 726 | NCT00880620 (ClinicalTrials.gov) | April 2009 | 3/4/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: IPX066 95 mg LD;Drug: IPX066 145 mg LD;Drug: IPX066 195 mg LD;Drug: IPX066 245 mg LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 381 | Phase 3 | United States;Canada;Estonia;Latvia;Lithuania;Romania;Ukraine |
| 727 | NCT01568034 (ClinicalTrials.gov) | April 2009 | 29/3/2012 | A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 | A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor | Parkinson's Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 75 Years | All | 10 | Phase 2 | Portugal;Romania;Ukraine |
| 728 | NCT00875316 (ClinicalTrials.gov) | April 2009 | 2/4/2009 | Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients | A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month | Parkinson's Disease | Drug: Cogane™ (PYM50028) | Phytopharm | NULL | Completed | 40 Years | 80 Years | Both | 36 | Phase 1 | United Kingdom |
| 729 | EUCTR2008-004447-11-GB (EUCTR) | 27/03/2009 | 07/01/2009 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;United Kingdom;Italy | ||
| 730 | EUCTR2007-002963-28-PT (EUCTR) | 26/03/2009 | 07/01/2009 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A-Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1036 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 731 | EUCTR2007-002964-90-FR (EUCTR) | 09/03/2009 | 12/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 732 | NCT00767091 (ClinicalTrials.gov) | March 2009 | 1/9/2008 | Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentric Trial | Parkinson's Disease;Apathy;no Dementia | Drug: rivastigmine;Drug: placebo | University Hospital, Lille | NULL | Completed | 15 Years | 80 Years | Both | 40 | Phase 3 | France |
| 733 | NCT00888004 (ClinicalTrials.gov) | March 2009 | 23/4/2009 | Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients | A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias | Parkinson's Disease;L-dopa Induced Dyskinesia | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany |
| 734 | NCT00866502 (ClinicalTrials.gov) | March 2009 | 18/3/2009 | A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump. | Parkinson's Disease | Drug: sNN0031;Drug: Placebo | Newron Sweden AB | Medtronic;Quintiles | Completed | 30 Years | 75 Years | Both | 12 | Phase 1/Phase 2 | Sweden |
| 735 | NCT01533116 (ClinicalTrials.gov) | March 2009 | 24/1/2012 | Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide | Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: levodopa/carbidopa;Drug: levodopa/benserazide | Bial - Portela C S.A. | NULL | Completed | 25 Years | 45 Years | All | 52 | Phase 1 | Canada |
| 736 | NCT00908076 (ClinicalTrials.gov) | February 2009 | 21/5/2009 | Amitiza in Constipation Associated With PD (Parkinson's Disease) | Randomized Double-Blind Placebo-Controlled Trial of Lubiprostone in the Treatment of Constipation Associated With Parkinson's Disease | Parkinson's Disease | Drug: LUBIPROSTONE | Baylor College of Medicine | University of South Florida | Completed | 18 Years | 85 Years | All | 78 | Phase 4 | United States |
| 737 | NCT00627640 (ClinicalTrials.gov) | February 2009 | 13/2/2008 | Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa | A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine | Idiopathic Parkinson's Disease | Drug: Safinimide 50-100 mg/day;Drug: Matching Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 549 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Estonia;France;Germany;Hungary;India;Israel;Korea, Republic of;Malaysia;Netherlands;New Zealand;Slovakia;Spain;Switzerland;Taiwan;Thailand;United Kingdom |
| 738 | NCT00806468 (ClinicalTrials.gov) | February 2009 | 9/12/2008 | Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease | A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease | Parkinson Disease | Drug: Desmotabs | Johannes Gutenberg University Mainz | NULL | Terminated | 18 Years | 85 Years | Male | 1 | Phase 4 | Germany |
| 739 | EUCTR2007-007853-30-SE (EUCTR) | 28/01/2009 | 21/12/2007 | A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump. | A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump. | Idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb - III) | Product Name: sNN0031 Product Code: sNN0031 | NeuroNova AB | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 740 | EUCTR2007-002963-28-CZ (EUCTR) | 19/01/2009 | 30/10/2007 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 741 | NCT02169466 (ClinicalTrials.gov) | January 2009 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBS | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 22 | Phase 1 | Portugal |
| 742 | NCT00357994 (ClinicalTrials.gov) | January 2009 | 27/7/2006 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 36 | Phase 3 | United States;Germany |
| 743 | EUCTR2008-003966-25-DE (EUCTR) | 23/12/2008 | 04/11/2008 | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10064016;Term: Nocturnal polyuria MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Trade Name: Desmotabs® 0,2 mg Tabletten Product Name: Desmotabs® 0,2mg Tabletten INN or Proposed INN: Desmopressin Acetat | Universität Mainz, Klinik und Poliklinik für Neurologie | NULL | Not Recruiting | Female: no Male: yes | 20 | Germany | |||
| 744 | NCT00809302 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED) | Early Parkinson Disease | Drug: aplindore MR tablets or Placebo | Neurogen Corporation | NULL | Terminated | 30 Years | N/A | Both | 9 | Phase 2 | United States |
| 745 | NCT00740714 (ClinicalTrials.gov) | December 2008 | 22/8/2008 | Effects of Coenzyme Q10 (CoQ) in Parkinson Disease | Effects of Coenzyme Q10 in Parkinson Disease - Phase III | Parkinson Disease | Drug: Coenzyme Q10 with vitamin E;Drug: placebo with vitamin E | Weill Medical College of Cornell University | National Institute of Neurological Disorders and Stroke (NINDS);University of Rochester | Terminated | 30 Years | N/A | All | 600 | Phase 3 | United States;Canada |
| 746 | EUCTR2008-004943-12-SK (EUCTR) | 24/11/2008 | 10/10/2008 | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | Early Stage Parkinson’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Solvay Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Slovakia | ||
| 747 | EUCTR2007-003051-36-BE (EUCTR) | 06/11/2008 | 21/05/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Austria;Sweden;Portugal;Spain;Belgium | |||
| 748 | NCT00629161 (ClinicalTrials.gov) | November 2008 | 25/2/2008 | Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease | Parkinson Disease | Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant);Drug: placebo | Fudan University | NULL | Recruiting | 50 Years | N/A | Both | 144 | Phase 2/Phase 3 | China | |
| 749 | EUCTR2007-004890-24-PT (EUCTR) | 07/10/2008 | 25/06/2008 | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy | Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride | Juvantia Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Portugal;France | ||
| 750 | EUCTR2008-003869-72-PT (EUCTR) | 03/10/2008 | 25/06/2008 | A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR | A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR | Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Code: BIA 9-1067 | Bial - Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Portugal | |||
| 751 | NCT02169453 (ClinicalTrials.gov) | October 2008 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® CR 100/25 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 12 | Phase 1 | Canada |
| 752 | EUCTR2007-003051-36-AT (EUCTR) | 10/09/2008 | 29/04/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 753 | EUCTR2007-003051-36-PT (EUCTR) | 05/09/2008 | 27/05/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 754 | NCT00755027 (ClinicalTrials.gov) | September 2008 | 17/9/2008 | Rasagiline and Apathy in Parkinson's Disease | A Randomised Placebo-controlled Trial of Rasagiline in Parkinson Disease Patients With Symptoms of Apathy | Parkinson's Disease | Drug: Rasagiline | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Completed | 18 Years | 80 Years | Both | 40 | Phase 4 | Spain |
| 755 | NCT02169895 (ClinicalTrials.gov) | September 2008 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Benserazide: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa® | Bial - Portela C S.A. | NULL | Completed | 25 Years | 45 Years | Male | 16 | Phase 1 | Canada |
| 756 | NCT00758849 (ClinicalTrials.gov) | September 2008 | 24/9/2008 | Fipamezole in Neurogenic Orthostatic Hypotension | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's Disease | Symptomatic Neurogenic Orthostatic Hypotension (NOH);Parkinson's Disease;Multiple System Atrophy | Drug: Placebo;Drug: Fipamezole | Juvantia Pharma Ltd | Santhera Pharmaceuticals | Not yet recruiting | 30 Years | 80 Years | Both | 24 | Phase 2 | France;Portugal |
| 757 | NCT02169479 (ClinicalTrials.gov) | September 2008 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® 100/25 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 16 | Phase 1 | Canada |
| 758 | NCT00656253 (ClinicalTrials.gov) | August 2008 | 7/4/2008 | Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson Disease | Parkinson's Disease | Drug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.);Drug: Placebo | Fudan University | China's Ministry of Health; Administration of Traditional Chinese Medicine (SATCM) | Completed | 50 Years | N/A | Both | 158 | Phase 2/Phase 3 | China | |
| 759 | EUCTR2007-003051-36-ES (EUCTR) | 01/07/2008 | 05/05/2008 | Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psicosis en la enfermedad de Parkinson.Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 760 | EUCTR2007-003051-36-SE (EUCTR) | 30/06/2008 | 16/05/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 761 | EUCTR2007-002963-28-IT (EUCTR) | 30/06/2008 | 04/01/2008 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: safinamide Product Name: safinamide | MERCK SERONO INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 666 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 762 | EUCTR2007-002964-90-HU (EUCTR) | 03/06/2008 | 15/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A.-Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 763 | EUCTR2007-004890-24-FR (EUCTR) | 07/05/2008 | 09/05/2008 | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy | Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride | Juvantia Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Portugal;France | ||
| 764 | EUCTR2006-006752-35-DE (EUCTR) | 06/05/2008 | 23/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 765 | NCT01416818 (ClinicalTrials.gov) | May 2008 | 11/8/2011 | Treatment of Depression in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled Study of Xiaoyao Pill Treatment of Depression in Patients With Parkinson's Disease | Depression in Parkinson's Disease | Drug: Xiaoyao Pill;Drug: Bupleurum+Ginkgo;Drug: placebo | Xuanwu Hospital, Beijing | NULL | Recruiting | 30 Years | 80 Years | Both | 60 | Phase 2 | China |
| 766 | EUCTR2007-002906-23-BG (EUCTR) | 16/04/2008 | 07/07/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | United Kingdom;France;Bulgaria | |||
| 767 | NCT02071810 (ClinicalTrials.gov) | April 2008 | 19/1/2012 | Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067 | A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 34 | Phase 1 | France |
| 768 | NCT00605553 (ClinicalTrials.gov) | April 2008 | 15/1/2008 | Study to Evaluate SYN115 in Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: Tozadenant | Biotie Therapies Inc. | NULL | Completed | 40 Years | 75 Years | All | 30 | Phase 2 | United States |
| 769 | EUCTR2007-001095-36-HU (EUCTR) | 27/03/2008 | 06/02/2008 | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary | |||
| 770 | EUCTR2006-003732-30-PL (EUCTR) | 27/03/2008 | 08/01/2008 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Early Parkinson's Disease MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Product Name: Lisuride TTS 10cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,088 INN or Proposed INN: PRAMIPEXOLE Product Name: Lisuride TTS 20cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,18 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,35 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,7 INN or Proposed INN: PRAMIPEXOLE | NeuroBiotec Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Germany;Italy;Poland | |||
| 771 | EUCTR2007-002964-90-GB (EUCTR) | 20/03/2008 | 14/01/2009 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 605 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 772 | NCT00607451 (ClinicalTrials.gov) | March 2008 | 22/1/2008 | Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia | A Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced Dyskinesia | Levodopa-induced Dyskinesia | Drug: Neu-120 | Neurim Pharmaceuticals Ltd. | NULL | Terminated | 30 Years | 80 Years | All | 8 | Phase 1/Phase 2 | Israel |
| 773 | NCT00761137 (ClinicalTrials.gov) | March 2008 | 25/9/2008 | Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | Sialorrhea Secondary to Parkinson's Disease | Drug: 0.3 mg tropicamide;Drug: 1 mg tropicamide;Drug: 3 mg tropicamide;Drug: 0 mg tropicamide | NeuroHealing Pharmaceuticals Inc. | Michael J. Fox Foundation for Parkinson's Research | Completed | 50 Years | 80 Years | All | 19 | Phase 2 | Argentina |
| 774 | EUCTR2007-002964-90-DE (EUCTR) | 28/02/2008 | 17/12/2008 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 484 | Phase 3 | France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom | ||
| 775 | EUCTR2007-002964-90-EE (EUCTR) | 13/02/2008 | 02/01/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 776 | EUCTR2007-002195-34-FR (EUCTR) | 04/02/2008 | 07/12/2007 | Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups. | Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups. | Fatigue symptoms in Parkinson's disease. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DEBRUMYL Product Code: DC158AM INN or Proposed INN: Heptaminol hydrochloride INN or Proposed INN: Deanol pyroglutamate | PIERRE FABRE MEDICAMENT | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 777 | EUCTR2007-002467-27-GB (EUCTR) | 24/01/2008 | 26/11/2007 | Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate | Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate | Patients with idiopathic Parkinson's disease and levodopa-induced dyskinesias MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1;Classification code 10061536;Term: Parkinson's disease;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders | Product Name: Topiramate INN or Proposed INN: TOPIRAMATE | Salford Royal NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 778 | EUCTR2006-006752-35-IT (EUCTR) | 21/01/2008 | 24/04/2007 | PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER | PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER | Idiopathic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro Trade Name: Neupro Trade Name: Neupro Trade Name: Neupro | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 336 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 779 | EUCTR2007-002964-90-ES (EUCTR) | 18/01/2008 | 30/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 780 | EUCTR2007-002963-28-ES (EUCTR) | 17/01/2008 | 16/11/2007 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1036 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 781 | NCT00601523 (ClinicalTrials.gov) | January 2008 | 15/1/2008 | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). | Parkinson Disease | Drug: Placebo;Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 511 | Phase 3 | United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina |
| 782 | NCT00623324 (ClinicalTrials.gov) | January 2008 | 14/2/2008 | The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease | A Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's Disease | Early Stage Parkinson's Disease | Drug: Aplindore;Drug: Placebo | Ligand Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 40 | Phase 2 | United States |
| 783 | NCT00664209 (ClinicalTrials.gov) | January 2008 | 21/4/2008 | Treating H. Pylori in Parkinson's Patients With Motor Fluctuations | Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease | Parkinson's Disease;Helicobacter Infections;Motor Fluctuations | Drug: clartihromycin, amoxicillin, and omeprazole;Drug: placebo | University of California, Los Angeles | Michael J. Fox Foundation for Parkinson's Research | Terminated | N/A | N/A | Male | 64 | Phase 3 | United States |
| 784 | EUCTR2006-003732-30-IT (EUCTR) | 31/12/2007 | 13/02/2008 | Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I | Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I | Diagnosys of Early-stage idiopathic Parkinson's Disease for longest 1 year MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: lisuride TTS INN or Proposed INN: Lisuride Trade Name: mirapexin INN or Proposed INN: Pramipexole | NEUROBIOTEC GMBH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;Italy;Poland | |||
| 785 | EUCTR2007-004400-12-ES (EUCTR) | 27/12/2007 | 03/01/2008 | ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy | ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy | Apatía en la Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Azilect INN or Proposed INN: RASAGILINE | Institut de Recerca de l'Hospital de la santa Creu i Sant Pau | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 786 | EUCTR2007-002963-28-FI (EUCTR) | 12/12/2007 | 18/10/2007 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany | ||
| 787 | EUCTR2007-002964-90-NL (EUCTR) | 11/12/2007 | 11/12/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 788 | EUCTR2007-002963-28-SK (EUCTR) | 06/12/2007 | 16/04/2008 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 789 | EUCTR2007-002964-90-SK (EUCTR) | 06/12/2007 | 16/04/2008 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 790 | EUCTR2007-002964-90-FI (EUCTR) | 04/12/2007 | 18/10/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria | ||
| 791 | NCT00526630 (ClinicalTrials.gov) | December 2007 | 5/9/2007 | Methylphenidate for the Treatment of Gait Impairment in Parkinson's Disease | Methylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over Study | Parkinson's Disease;Gait Impairment | Drug: Methylphenidate (MPD);Drug: Placebo | University of Cincinnati | Michael J. Fox Foundation for Parkinson's Research | Completed | 35 Years | 85 Years | All | 23 | Phase 4 | United States |
| 792 | NCT00584025 (ClinicalTrials.gov) | December 2007 | 21/12/2007 | Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease | Parkinson's Disease | Drug: levetiracetam;Drug: Placebo | University of South Florida | NULL | Withdrawn | 30 Years | 80 Years | All | 0 | Phase 4 | United States | |
| 793 | NCT00577460 (ClinicalTrials.gov) | December 2007 | 19/12/2007 | Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 391 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 794 | EUCTR2007-002906-23-GB (EUCTR) | 14/11/2007 | 15/08/2007 | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | United Kingdom;Bulgaria;France | |||
| 795 | NCT00632762 (ClinicalTrials.gov) | November 2007 | 20/2/2008 | Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK) | Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK. | Parkinson's Disease | Drug: mantadix | University Hospital, Toulouse | NULL | Completed | 30 Years | 80 Years | Both | 80 | Phase 4 | France |
| 796 | NCT00584090 (ClinicalTrials.gov) | November 2007 | 21/12/2007 | Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease | Urinary Incontinence;Parkinson's Disease | Drug: Solifenacin Succinate (VESIcare);Drug: Placebo | University of South Florida | NULL | Withdrawn | 30 Years | 80 Years | Both | 0 | Phase 4 | United States | |
| 797 | NCT00605683 (ClinicalTrials.gov) | November 2007 | 19/12/2007 | MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist | A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide (as add-on therapy) | Newron | NULL | Completed | 30 Years | 80 Years | Both | 679 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel |
| 798 | EUCTR2007-002906-23-FR (EUCTR) | 25/10/2007 | 21/08/2007 | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2;Phase 3 | France;Bulgaria;United Kingdom | ||
| 799 | EUCTR2007-002900-16-DE (EUCTR) | 01/10/2007 | 21/08/2007 | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa | The main objective of this study is to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias. | Product Code: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 34 | Germany | |||
| 800 | NCT00582673 (ClinicalTrials.gov) | October 2007 | 21/12/2007 | Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa | A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa | Parkinson's Disease | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 85 Years | Both | 31 | Phase 2 | Germany |
| 801 | NCT00642928 (ClinicalTrials.gov) | October 2007 | 21/3/2008 | Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients | Randomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD) | Excessive Daytime Sleepiness;Parkinson's Disease | Drug: Placebo;Drug: BF 2.649 5 mg;Drug: BF 2.649 10 mg;Drug: BF 2.649 20 mg;Drug: BF 2.649 40 mg | Bioprojet | NULL | Completed | 18 Years | N/A | Both | 108 | Phase 2 | France |
| 802 | NCT01520727 (ClinicalTrials.gov) | October 2007 | 18/1/2012 | A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects | A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 64 | Phase 1 | France |
| 803 | NCT00559871 (ClinicalTrials.gov) | October 2007 | 15/11/2007 | Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Efficacy, Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease Patients. | Parkinson's Disease | Drug: fipamezole | Juvantia Pharma Ltd | Santhera Pharmaceuticals | Completed | 30 Years | N/A | Both | 180 | Phase 2 | United States;India |
| 804 | NCT00566462 (ClinicalTrials.gov) | October 2007 | 29/11/2007 | Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT | Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT | Parkinson's Disease | Drug: perampanel;Drug: placebo | Eisai Inc. | NULL | Terminated | 30 Years | N/A | All | 1 | Phase 2 | United States |
| 805 | EUCTR2006-002937-20-HU (EUCTR) | 20/09/2007 | 17/05/2007 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 806 | NCT00524914 (ClinicalTrials.gov) | September 2007 | 4/9/2007 | Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study | Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study. | Parkinson's Disease | Drug: apomorphine;Drug: placebo | University Hospital, Toulouse | NULL | Completed | 30 Years | 70 Years | Both | 16 | N/A | France |
| 807 | NCT00537485 (ClinicalTrials.gov) | September 2007 | 27/9/2007 | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa | Early Parkinson's Disease | Drug: SPM 962;Drug: placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 180 | Phase 2/Phase 3 | Japan |
| 808 | EUCTR2007-003512-57-FR (EUCTR) | 24/08/2007 | 23/07/2007 | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Excessive daytime sleepiness associated to Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10041014;Term: Sleepiness MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 | Bioprojet | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | France | ||
| 809 | EUCTR2007-000074-23-HU (EUCTR) | 10/08/2007 | 01/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 810 | NCT00442780 (ClinicalTrials.gov) | August 2007 | 1/3/2007 | Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease | Parkinson's Disease | Drug: BIIB014;Drug: Placebo | Biogen Idec | NULL | Completed | 30 Years | N/A | Both | 36 | Phase 2 | Israel;Poland;Serbia;Former Serbia and Montenegro |
| 811 | NCT01286935 (ClinicalTrials.gov) | August 2007 | 23/8/2010 | 18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD | A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 544 | Phase 3 | NULL |
| 812 | EUCTR2006-006752-35-GB (EUCTR) | 23/07/2007 | 13/01/2009 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH, UCB Group | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 813 | NCT00522379 (ClinicalTrials.gov) | July 2007 | 28/8/2007 | Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch | A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 514 | Phase 3 | United States;Chile;India;Mexico;Peru |
| 814 | NCT00515437 (ClinicalTrials.gov) | July 2007 | 10/8/2007 | A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | Drooling | Biological: Botulinum Toxin Type B (Myobloc);Biological: Matched placebo to Myobloc | Solstice Neurosciences | NULL | Completed | 18 Years | 85 Years | All | 54 | Phase 2 | United States |
| 815 | EUCTR2006-006752-35-HU (EUCTR) | 22/06/2007 | 12/04/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 816 | EUCTR2007-000074-23-CZ (EUCTR) | 18/06/2007 | 31/05/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 817 | EUCTR2006-000678-57-CZ (EUCTR) | 18/06/2007 | 02/08/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 818 | EUCTR2007-000073-39-CZ (EUCTR) | 18/06/2007 | 18/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 819 | EUCTR2007-000073-39-SK (EUCTR) | 14/06/2007 | 09/04/2008 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Finland;Austria;Germany | ||
| 820 | EUCTR2007-000074-23-SK (EUCTR) | 14/06/2007 | 09/04/2008 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 821 | EUCTR2007-000073-39-HU (EUCTR) | 14/06/2007 | 31/05/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Finland;Hungary;Czech Republic;Austria | ||
| 822 | EUCTR2006-005861-21-IT (EUCTR) | 11/06/2007 | 05/01/2007 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | Patients with idiopathic Parkinson's disease with motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Italy | ||
| 823 | EUCTR2006-006684-22-FR (EUCTR) | 08/06/2007 | 27/03/2007 | Evaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSK | Evaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSK | maladie de parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10013916;Term: Dyskinesia | Trade Name: MANTADIX | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 824 | JPRN-UMIN000000780 | 2007/06/01 | 01/08/2007 | A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease | A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease - The usefulness of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease | Parkinson's disease | An observation period (2 to 3 weeks) An administration of amantadine hydrochloride (27 days) A wash out period (15 days) An administration of placebo (27 days) An observation period (2 to 3 weeks) An administration of placebo (27 days) A wash out period (15 days) An administration of amantadine hydrochloride (27 days) | Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders | Musashi Hospital, National Center of Neurology and Psychiatry, JapanEhime University Hospital | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 60 | Not applicable | Japan |
| 825 | NCT00571285 (ClinicalTrials.gov) | June 2007 | 7/12/2007 | Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease | Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Vitamin D3;Dietary Supplement: Vitamin D3 - high dose;Dietary Supplement: Placebo | Emory University | NULL | Terminated | 18 Years | 89 Years | All | 31 | Phase 4 | United States |
| 826 | NCT00477672 (ClinicalTrials.gov) | June 2007 | 22/5/2007 | A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate (ACP-103);Drug: Placebo | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 298 | Phase 3 | United States;Bulgaria;France;India;Russian Federation;Ukraine;United Kingdom |
| 827 | NCT00696215 (ClinicalTrials.gov) | June 2007 | 10/6/2008 | The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease | The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Over 3 Months | Parkinson's Disease | Drug: placebo;Drug: rasagiline | Istanbul University | NULL | Recruiting | N/A | N/A | Both | 40 | Phase 4 | Turkey |
| 828 | EUCTR2007-000073-39-AT (EUCTR) | 30/05/2007 | 05/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 829 | EUCTR2007-000074-23-AT (EUCTR) | 30/05/2007 | 05/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 830 | EUCTR2007-000073-39-DE (EUCTR) | 29/05/2007 | 26/02/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Czech Republic;Finland;Austria;Germany | ||
| 831 | EUCTR2007-000074-23-ES (EUCTR) | 29/05/2007 | 02/03/2010 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. | Pacientes varones o mujeres, diagnosticados de enfermedad de Parkinson idiopática, al menos dos años antes, con 30 años o más de edad en el momento del diagnóstico, con un estadío entre 2 y 4 en la escala modificada de Hoehn y Yahr en el periodo on.Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 832 | EUCTR2006-006752-35-ES (EUCTR) | 27/05/2007 | 27/03/2007 | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 833 | EUCTR2007-000074-23-IT (EUCTR) | 17/05/2007 | 06/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND | Patients with advanced idiopathic Parkinson s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Trade Name: Sifrol Trade Name: Sifrol | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 834 | EUCTR2007-000074-23-GB (EUCTR) | 11/05/2007 | 29/03/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 835 | EUCTR2006-006752-35-FI (EUCTR) | 09/05/2007 | 21/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 836 | EUCTR2007-000074-23-SE (EUCTR) | 02/05/2007 | 02/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 837 | NCT00477802 (ClinicalTrials.gov) | May 2007 | 22/5/2007 | Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease | Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease: A Double-Blind, Randomized, Placebo Controlled, Cross-Over Design Study | Parkinson Disease | Biological: Botulinum Toxin Type A;Biological: Placebo | University of Cincinnati | Allergan | Terminated | 35 Years | 75 Years | Both | 8 | Phase 4 | United States |
| 838 | NCT00505843 (ClinicalTrials.gov) | May 2007 | 24/7/2007 | A Study of MK0657 in Parkinson's Disease Patients (0657-006) | A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's Disease | Parkinson's Disease | Drug: MK0657;Drug: Comparator: Placebo (unspecified);Drug: Comparator: levodopa;Drug: Comparator: carbidopa | Merck Sharp & Dohme Corp. | NULL | Completed | 40 Years | 80 Years | Both | 18 | Phase 1 | United States |
| 839 | NCT00479401 (ClinicalTrials.gov) | May 2007 | 25/5/2007 | Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients | A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD). | Early Parkinson Disease (Early PD) | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 539 | Phase 3 | United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil |
| 840 | NCT00474058 (ClinicalTrials.gov) | May 2007 | 14/5/2007 | Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine | Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 287 | Phase 3 | United States;Australia;Austria;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom |
| 841 | NCT00489255 (ClinicalTrials.gov) | May 2007 | 20/6/2007 | Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment | A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent Off Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo | Parkinson's Disease | Drug: Tigan®;Drug: Placebo | Ipsen | INC Research Limited | Completed | 18 Years | N/A | All | 117 | Phase 4 | United States |
| 842 | EUCTR2006-002937-20-ES (EUCTR) | 27/04/2007 | 26/04/2007 | Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras | Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras | Enfermedad de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 843 | EUCTR2007-000073-39-FI (EUCTR) | 25/04/2007 | 06/03/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 844 | EUCTR2006-006752-35-AT (EUCTR) | 17/04/2007 | 21/05/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 845 | NCT00438607 (ClinicalTrials.gov) | April 2007 | 20/2/2007 | Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With Levodopa | Parkinson's Disease | Drug: BIIB014;Drug: Placebo | Biogen Idec | NULL | Completed | 30 Years | N/A | Both | 83 | Phase 2 | India;Israel;United Kingdom |
| 846 | NCT00466167 (ClinicalTrials.gov) | April 2007 | 25/4/2007 | Pivotal Study in Advanced Parkinsons Disease Patients | A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD). | Parkinson Disease | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 517 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 847 | NCT00459420 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Parkinson's Disease;Excessive Daytime Somnolence | Drug: Caffeine 100-200 mg BID;Drug: placebo | Ron Postuma | Canadian Institutes of Health Research (CIHR);University of Toronto | Completed | 18 Years | N/A | Both | 58 | Phase 2/Phase 3 | Canada |
| 848 | EUCTR2006-002937-20-FR (EUCTR) | 12/03/2007 | 12/02/2007 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Phase 3 | France;Hungary;Czech Republic;Estonia;Spain;Lithuania;Latvia;Italy | ||
| 849 | NCT01693081 (ClinicalTrials.gov) | March 2007 | 21/9/2012 | Phase IIa Multicentre Study Investigating of VR040 in Parkinson's Disease | A Clinic-Based, Phase IIa, Double-Blind, Placebo- Controlled, Ascending-Dose, Multicentre Study of Safety, Tolerability, Efficacy and Pharmacokinetics of VR040 in Parkinson's Disease | Parkinson's Disease | Drug: VR040/Aspirair® inhaler;Drug: placebo | South Glasgow University Hospitals NHS Trust | Vectura Limited | Completed | 30 Years | 90 Years | Both | 47 | Phase 2 | Serbia;United Kingdom |
| 850 | NCT00449865 (ClinicalTrials.gov) | March 2007 | 20/3/2007 | NET-PD LS-1 Creatine in Parkinson's Disease | A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1) | Parkinson's Disease | Drug: creatine;Other: placebo | University of Rochester | National Institute of Neurological Disorders and Stroke (NINDS) | Terminated | N/A | N/A | All | 1741 | Phase 3 | United States;Canada |
| 851 | NCT00451633 (ClinicalTrials.gov) | March 2007 | 21/3/2007 | The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations | A Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Withdrawn | 30 Years | 80 Years | Both | 0 | Phase 2 | Germany;Italy |
| 852 | NCT00406588 (ClinicalTrials.gov) | March 2007 | 30/11/2006 | SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | Advanced Stage Parkinson's Disease | Drug: Pardoprunox;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 295 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine |
| 853 | NCT00455507 (ClinicalTrials.gov) | March 2007 | 2/4/2007 | A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study) | Parkinson's Disease | Drug: Istradefylline;Drug: Placebo | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 20 Years | N/A | Both | 363 | Phase 2 | Japan |
| 854 | EUCTR2006-005714-12-IT (EUCTR) | 27/02/2007 | 03/08/2007 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations MedDRA version: 6.1;Level: HLT;Classification code 10034005 | Product Name: E2007 Product Code: E2007 INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS Trade Name: SINEMET INN or Proposed INN: levodopa-carbidopa | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
| 855 | EUCTR2005-002038-36-GR (EUCTR) | 27/02/2007 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 856 | EUCTR2006-005182-20-LT (EUCTR) | 13/02/2007 | 20/12/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 280 | Latvia;Lithuania | |||
| 857 | EUCTR2006-005182-20-LV (EUCTR) | 02/02/2007 | 28/12/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 280 | Latvia;Lithuania | |||
| 858 | EUCTR2006-003732-30-DE (EUCTR) | 31/01/2007 | 29/11/2006 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Early Parkinson's Disease MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Product Name: Lisuride TTS 10cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,088 INN or Proposed INN: PRAMIPEXOLE Product Name: Lisuride TTS 20cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,18 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,35 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,7 INN or Proposed INN: PRAMIPEXOLE | Axxonis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Germany;Italy;Poland | |||
| 859 | EUCTR2006-000678-57-FR (EUCTR) | 09/01/2007 | 10/10/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;France;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom | ||
| 860 | NCT00855686 (ClinicalTrials.gov) | January 2007 | 3/3/2009 | Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies | A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Parkinson's Disease Dementia;Dementia With Lewy Bodies | Drug: Memantine;Drug: Placebo | H. Lundbeck A/S | NULL | Completed | 50 Years | N/A | Both | 199 | Phase 4 | Germany |
| 861 | NCT01187966 (ClinicalTrials.gov) | January 2007 | 31/5/2010 | Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease | A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 669 | Phase 3 | NULL |
| 862 | EUCTR2006-000678-57-PT (EUCTR) | 29/12/2006 | 10/08/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 863 | EUCTR2006-000678-57-DE (EUCTR) | 22/12/2006 | 06/10/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 376 | Portugal;United Kingdom;Czech Republic;Germany;Netherlands;France;Estonia;Italy;Lithuania | |||
| 864 | EUCTR2006-005509-79-GB (EUCTR) | 21/12/2006 | 07/12/2006 | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periods | Product Name: apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United Kingdom | ||
| 865 | EUCTR2006-005860-14-IT (EUCTR) | 19/12/2006 | 17/03/2009 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy | ||
| 866 | EUCTR2006-003490-27-GB (EUCTR) | 19/12/2006 | 29/09/2006 | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa | Parkinson's disease MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Product Code: BIIB014 Product Code: BIIB014 Product Code: BIIB014 | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 137 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 867 | EUCTR2005-000314-12-DE (EUCTR) | 19/12/2006 | 25/01/2007 | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Spain;Germany | ||
| 868 | EUCTR2006-002937-20-CZ (EUCTR) | 14/12/2006 | 24/10/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 869 | EUCTR2006-002937-20-EE (EUCTR) | 11/12/2006 | 19/10/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 870 | EUCTR2006-005140-89-NL (EUCTR) | 11/12/2006 | 01/12/2006 | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD). MedDRA version: 9.1;Level: PT;Classification code 10061536 | Trade Name: Selegiline HCl 5 PCH Trade Name: Nardil Product Name: Rasagiline 1mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate Product Name: Rasagiline 2 mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate | TEVA Pharmaceuticals Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Netherlands | ||
| 871 | EUCTR2006-002937-20-LT (EUCTR) | 04/12/2006 | 02/11/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 872 | EUCTR2005-002038-36-FR (EUCTR) | 01/12/2006 | 24/08/2010 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 873 | NCT01964573 (ClinicalTrials.gov) | December 2006 | 14/10/2013 | Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects | A Single-site, Randomized, Double-blind, Placebo-controlled, Repeated-dose Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in 2 Different Dosages (2 mg / 24 Hours [10 cm2], 4 mg / 24 Hours [20 cm2]) in Healthy Korean Subjects | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 19 Years | 45 Years | Both | 48 | Phase 1 | Korea, Republic of |
| 874 | NCT00853879 (ClinicalTrials.gov) | December 2006 | 26/2/2009 | An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease | An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12;Dietary Supplement: B6, B12, L-methylfolate;Dietary Supplement: B6, B12, Placebo | North Shore Long Island Jewish Health System | NULL | Terminated | 30 Years | N/A | Both | 150 | N/A | United States |
| 875 | EUCTR2005-002038-36-DE (EUCTR) | 29/11/2006 | 19/01/2007 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;France;Spain;Italy;Greece;Austria | |||
| 876 | NCT00406029 (ClinicalTrials.gov) | November 20, 2006 | 30/11/2006 | Dyskinesia in Parkinson's Disease (Study P04501) | A Phase 2, 12-Week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias | Parkinson Disease;Movement Disorders;Central Nervous System Diseases;Neurodegenerative Diseases;Brain Diseases | Drug: Preladenant;Drug: Placebo;Drug: L-dopa;Drug: Other Parkinson's Disease treatments | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | N/A | All | 253 | Phase 2 | Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Italy;New Zealand;Peru;Singapore;South Africa;Spain;United States |
| 877 | EUCTR2006-000678-57-GB (EUCTR) | 14/11/2006 | 30/05/2007 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydro | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Portugal;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom | ||
| 878 | EUCTR2006-001793-24-PT (EUCTR) | 07/11/2006 | 31/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Trade Name: COMTAN® Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| 879 | EUCTR2006-000678-57-LT (EUCTR) | 07/11/2006 | 07/09/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 880 | EUCTR2006-004582-33-GB (EUCTR) | 03/11/2006 | 23/01/2012 | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | Hypomobility (off or freezing) episodes associated with advanced Parkinson's disease | Product Name: Apomorphine hydrochloride Product Code: VR040 | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | United Kingdom | ||
| 881 | EUCTR2006-000678-57-EE (EUCTR) | 03/11/2006 | 01/09/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 882 | EUCTR2006-002937-20-LV (EUCTR) | 01/11/2006 | 02/11/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 883 | NCT00335166 (ClinicalTrials.gov) | November 2006 | 8/6/2006 | SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease | A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease. | Early Stage Parkinson Disease | Drug: Pardaprunox;Drug: pramipexole;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 330 | Phase 3 | United States;Australia;Czech Republic;Estonia;France;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom |
| 884 | NCT00360308 (ClinicalTrials.gov) | November 2006 | 2/8/2006 | Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Placebo;Drug: E2007 | Eisai Limited | NULL | Terminated | 30 Years | N/A | All | 723 | Phase 3 | France |
| 885 | NCT00402233 (ClinicalTrials.gov) | November 2006 | 19/11/2006 | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 31 Years | N/A | All | 312 | Phase 4 | United States |
| 886 | EUCTR2005-002038-36-GB (EUCTR) | 31/10/2006 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Code: Lu 00-800 INN or Proposed INN: memantine hydrochloride | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 887 | NCT00373087 (ClinicalTrials.gov) | October 2006 | 6/9/2006 | COMT Polymorphism and Entacapone Efficacy | Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease | Parkinson's Disease | Drug: entacapone;Drug: l dopa versus placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 30 Years | N/A | Both | 60 | Phase 4 | France |
| 888 | NCT00590122 (ClinicalTrials.gov) | October 2006 | 28/12/2007 | Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study | COMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL | Parkinson's Disease | Drug: Parcopa;Drug: carbidopa-levodopa | Baylor College of Medicine | UCB Pharma | Completed | 31 Years | 80 Years | Both | 20 | Phase 4 | United States |
| 889 | NCT03103399 (ClinicalTrials.gov) | September 26, 2006 | 28/3/2017 | Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon | A Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon Treated With Levodopa/Carbidopa or Levodopa/Benserazide | Parkinson Disease | Drug: Comtan®;Drug: Nebicapone;Drug: Levodopa/DDCI;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 30 Years | 80 Years | All | 254 | Phase 2 | NULL |
| 890 | EUCTR2005-002038-36-AT (EUCTR) | 22/09/2006 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;United Kingdom;France;Spain;Italy;Greece;Austria | |||
| 891 | EUCTR2005-005146-39-IT (EUCTR) | 14/09/2006 | 06/12/2006 | A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND | A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND | Moderate to severe Parkinson s disease with motor fluctuation and dyskinesias. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Code: SCH 420814 Product Code: SCH 420814 | Schering Plough Research Institute | NULL | Not Recruiting | Female: yes Male: yes | 160 | Italy | |||
| 892 | EUCTR2006-000678-57-IT (EUCTR) | 14/09/2006 | 26/06/2007 | A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND | A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: Pramipexole INN or Proposed INN: Pramipexole Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 | SOLVAY PHARMACEUTICALS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 893 | EUCTR2005-001006-12-CZ (EUCTR) | 06/09/2006 | 24/08/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Czech Republic;Austria;Germany;Italy | ||
| 894 | EUCTR2005-004949-34-SE (EUCTR) | 06/09/2006 | 27/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 895 | EUCTR2005-006033-32-SE (EUCTR) | 15/08/2006 | 22/06/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 896 | EUCTR2005-004314-33-PT (EUCTR) | 09/08/2006 | 10/05/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Hungary;Portugal;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 897 | EUCTR2005-004949-34-DE (EUCTR) | 04/08/2006 | 30/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: SIFROL Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 898 | EUCTR2006-000678-57-NL (EUCTR) | 03/08/2006 | 04/04/2007 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 899 | NCT00368108 (ClinicalTrials.gov) | August 2006 | 22/8/2006 | Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparator | Eisai Inc. | NULL | Completed | 30 Years | N/A | All | 752 | Phase 3 | United States;Canada |
| 900 | NCT01628848 (ClinicalTrials.gov) | August 2006 | 24/6/2012 | A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients | A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962;Drug: Placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 174 | Phase 2 | Japan |
| 901 | EUCTR2006-001793-24-AT (EUCTR) | 31/07/2006 | 24/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| 902 | EUCTR2006-000391-32-NL (EUCTR) | 18/07/2006 | 10/05/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Germany;Netherlands;United Kingdom | ||
| 903 | NCT03097211 (ClinicalTrials.gov) | July 17, 2006 | 27/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Nebicapone | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 38 | Phase 1 | Portugal |
| 904 | EUCTR2006-000391-32-DE (EUCTR) | 04/07/2006 | 27/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Netherlands | |||
| 905 | NCT00408915 (ClinicalTrials.gov) | July 2006 | 5/12/2006 | Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion | Double-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral Therapy | Parkinson's Disease | Drug: Continuous Subcutaneous Lisuride Infusion | Axxonis Pharma AG | NULL | Completed | 18 Years | 75 Years | Both | 60 | Phase 3 | Germany |
| 906 | EUCTR2005-004314-33-DE (EUCTR) | 21/06/2006 | 01/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;United Kingdom;Germany;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 907 | EUCTR2005-004949-34-GB (EUCTR) | 19/06/2006 | 24/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 908 | EUCTR2005-006033-32-SK (EUCTR) | 13/06/2006 | 02/05/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 909 | EUCTR2006-000391-32-GB (EUCTR) | 06/06/2006 | 21/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Netherlands;Germany;United Kingdom | ||
| 910 | NCT00269516 (ClinicalTrials.gov) | June 2006 | 22/12/2005 | SLV308 for Treatment of Patients With Early Parkinson's Disease | A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease | Early Stage Parkinson's Disease | Drug: pardoprunox;Drug: Pardoprunox;Drug: Placebo | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 468 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro |
| 911 | EUCTR2005-004949-34-ES (EUCTR) | 29/05/2006 | 21/04/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 912 | EUCTR2005-004314-33-ES (EUCTR) | 19/05/2006 | 15/03/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Hungary;Estonia;Belgium;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 913 | EUCTR2005-004949-34-FI (EUCTR) | 17/05/2006 | 21/04/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | Boehringer Ingelheim Finland Ky | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 914 | NCT00329056 (ClinicalTrials.gov) | May 2006 | 22/5/2006 | A Trial of MitoQ for the Treatment of People With Parkinson's Disease | A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease | Parkinson's Disease | Drug: MitoQ | Antipodean Pharmaceuticals, Inc. | NULL | Completed | 30 Years | N/A | Both | 128 | Phase 2 | Australia;New Zealand |
| 915 | NCT00321854 (ClinicalTrials.gov) | May 2006 | 3/5/2006 | Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD) | A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease. | Parkinson Disease | Drug: pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | 79 Years | All | 535 | Phase 4 | United States;Austria;Finland;France;Germany;Italy;Japan;Spain;Sweden;United Kingdom |
| 916 | NCT00324896 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone | Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone | Parkinson's Disease;Insomnia | Drug: eszopiclone;Other: placebo | University of Medicine and Dentistry of New Jersey | Sunovion | Completed | 35 Years | 85 Years | All | 30 | Phase 3 | United States |
| 917 | NCT00291733 (ClinicalTrials.gov) | May 2006 | 14/2/2006 | Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease | Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial | Levodopa Induced Dyskinesia | Drug: Levetiracetam;Drug: Placebo | 1st Hospital of Social Security Services | UCB Pharma | Active, not recruiting | 30 Years | 80 Years | Both | 50 | Phase 2 | Greece |
| 918 | NCT03094156 (ClinicalTrials.gov) | April 26, 2006 | 23/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 39 | Phase 1 | Portugal |
| 919 | EUCTR2005-006033-32-FI (EUCTR) | 20/04/2006 | 06/03/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 920 | EUCTR2005-004949-34-AT (EUCTR) | 18/04/2006 | 21/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Austria GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden | |||
| 921 | EUCTR2005-001006-12-AT (EUCTR) | 02/04/2006 | 28/02/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Trade Name: Sifrol, 0,35 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Sifrol, 0,70 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Cabaseril, 1,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Trade Name: Cabaseril, 2,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;Czech Republic;Italy;Austria | ||
| 922 | NCT00294554 (ClinicalTrials.gov) | April 2006 | 21/2/2006 | Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia | Double-Blind Placebo-Controlled Trial of Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia | Parkinson's Disease;Cognitive Impairment;Dementia | Drug: Memantine;Drug: Placebo Oral Tablet | Johns Hopkins University | Forest Laboratories | Completed | 50 Years | N/A | All | 20 | N/A | United States |
| 923 | NCT00461942 (ClinicalTrials.gov) | April 2006 | 17/4/2007 | Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | Parkinson's Disease | Drug: Green Tea Polyphenols (EGCG/ECG) | Xuanwu Hospital, Beijing | Ministry of Health, China;Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | Both | 480 | Phase 2 | China |
| 924 | NCT00646204 (ClinicalTrials.gov) | April 2006 | 28/12/2007 | Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease | A 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASE | Parkinson's Disease | Drug: Memantine;Drug: placebo | Baylor College of Medicine | Forest Laboratories | Completed | 18 Years | 80 Years | Both | 40 | Phase 4 | United States |
| 925 | EUCTR2005-004109-27-SE (EUCTR) | 24/03/2006 | 24/01/2006 | A double-blind, placebo-controlled multi-centre trial of memantine in patients with Parkinsons’ disease dementia or dementia with Lewy bodies - MEMDLBPDD | A double-blind, placebo-controlled multi-centre trial of memantine in patients with Parkinsons’ disease dementia or dementia with Lewy bodies - MEMDLBPDD | Parkinsons disease (PD)and dementia with Lewy bodies (DLB) are both common disease of the elderly. The majority of patients who survive for more than 10 years with PD eventually develope dementia (PDD). The brain changes and clinical presentations of PDD and DLB are similar. The clinical characteristics are cognitive impairment with pronounced visuospatial and executive impairment, visual hallucinations, parkinsonism, fluctuations in cognition and REM sleep disorder. | Trade Name: Ebixa Product Name: Ebixa | Neuropsychiatric clinic | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Sweden | |||
| 926 | EUCTR2005-001006-12-DE (EUCTR) | 09/03/2006 | 05/09/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Czech Republic;Austria;Germany;Italy | ||
| 927 | EUCTR2005-003788-22-SE (EUCTR) | 03/03/2006 | 19/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 1 | Finland;Germany;United Kingdom;Spain;Italy;Sweden | ||
| 928 | EUCTR2005-004314-33-HU (EUCTR) | 01/03/2006 | 20/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 929 | EUCTR2005-004314-33-GB (EUCTR) | 01/03/2006 | 29/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 930 | NCT00307450 (ClinicalTrials.gov) | March 2006 | 27/3/2006 | Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease | Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study | Parkinson's Disease | Drug: Levetiracetam | Technische Universität Dresden | UCB GmbH, Huettenstrasse 205, 50170 Kerpen, Germany | Completed | 30 Years | 80 Years | Both | 34 | Phase 4 | Germany |
| 931 | NCT00297778 (ClinicalTrials.gov) | March 2006 | 28/2/2006 | Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms | A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms | Parkinson Disease;Depression | Drug: Pramipexole;Other: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | 80 Years | All | 296 | Phase 4 | Austria;Finland;France;Germany;Italy;Netherlands;Norway;Romania;Russian Federation;South Africa;Spain;Sweden;Ukraine;United Kingdom |
| 932 | EUCTR2005-003788-22-AT (EUCTR) | 22/02/2006 | 18/01/2006 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Austria GmbH | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 1 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 933 | EUCTR2005-003788-22-ES (EUCTR) | 09/02/2006 | 28/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Mirapexin / Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España S.A. | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 934 | EUCTR2005-004290-19-GB (EUCTR) | 03/02/2006 | 09/01/2006 | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536 | Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Austria;Germany;United Kingdom | ||
| 935 | EUCTR2005-004314-33-SE (EUCTR) | 03/02/2006 | 13/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 936 | EUCTR2005-004314-33-BE (EUCTR) | 02/02/2006 | 24/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 937 | EUCTR2005-004314-33-LT (EUCTR) | 01/02/2006 | 03/01/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Sweden;Lithuania | |||
| 938 | EUCTR2005-003788-22-DE (EUCTR) | 01/02/2006 | 07/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 1 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 939 | EUCTR2005-004314-33-CZ (EUCTR) | 01/02/2006 | 11/01/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Czech Republic;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 940 | NCT00630500 (ClinicalTrials.gov) | February 2006 | 27/2/2008 | Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB) | A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Dementia Associated With Parkinson's Disease;Dementia With Lewy Bodies | Drug: Memantine;Drug: Placebo | Helse Stavanger HF | King's College London;Lund University | Completed | N/A | N/A | Both | 75 | Phase 2 | Norway;Sweden;United Kingdom |
| 941 | NCT00286897 (ClinicalTrials.gov) | February 2006 | 3/2/2006 | The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Limited | NULL | Completed | 30 Years | N/A | Both | 702 | Phase 3 | Austria;Belgium;Czech Republic;Estonia;France;Germany;Hungary;Israel;Italy;Lithuania;Poland;Portugal;Serbia;South Africa;Spain;Sweden;United Kingdom;Former Serbia and Montenegro |
| 942 | NCT00296192 (ClinicalTrials.gov) | February 2006 | 22/2/2006 | Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms | A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of OFF Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease | Parkinson's Disease | Drug: Rotigotine nasal spray;Other: Placebo | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 82 | Phase 2 | Germany |
| 943 | EUCTR2005-004314-33-IT (EUCTR) | 31/01/2006 | 07/09/2007 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND | Parkinson's Desease patients with Motor Fluctuations who are on optimised and stabilised therapy with Levodopa. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 900 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 944 | EUCTR2005-004290-19-DE (EUCTR) | 25/01/2006 | 05/12/2005 | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536 | Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Spain | |||
| 945 | EUCTR2005-004314-33-EE (EUCTR) | 17/01/2006 | 24/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 946 | EUCTR2005-003788-22-FI (EUCTR) | 17/01/2006 | 07/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Finland Ky | Not Recruiting | Female: yes Male: yes | 318 | Phase 1 | Finland;Germany;United Kingdom;Spain;Italy;Sweden | |||
| 947 | EUCTR2005-003788-22-GB (EUCTR) | 06/01/2006 | 11/11/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 948 | NCT00279825 (ClinicalTrials.gov) | January 2006 | 18/1/2006 | Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: CD-LD IR;Drug: CD-LD CR;Drug: IPX054 200 mg Placebo;Drug: IPX054 250 mg Placebo;Drug: CD-LD IR Placebo;Drug: CD-LD CR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 16 | Phase 2 | United States |
| 949 | NCT01683292 (ClinicalTrials.gov) | January 2006 | 7/9/2012 | Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease | An Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's Disease | Parkinson's Disease | Drug: Inhaled VR040;Drug: Placebo for VR040 | South Glasgow University Hospitals NHS Trust | Vectura Limited | Completed | 30 Years | N/A | Both | 29 | Phase 2 | United Kingdom |
| 950 | NCT00292227 (ClinicalTrials.gov) | January 2006 | 14/2/2006 | Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease | Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-stage Idiopathic Parkinson's Disease: A Thorough QT/QTc Trial. | Parkinson's Disease | Drug: Rotigotine;Other: Placebo;Drug: Moxifloxacin infusion;Other: Placebo infusion | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 130 | Phase 1 | South Africa |
| 951 | EUCTR2005-005120-13-GB (EUCTR) | 21/12/2005 | 02/11/2005 | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s disease | Product Name: Apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom | ||
| 952 | EUCTR2005-002432-10-MT (EUCTR) | 25/11/2005 | 10/10/2005 | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | Parkinson Disease late stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 60 | Malta | |||
| 953 | EUCTR2005-001416-42-PT (EUCTR) | 07/11/2005 | 25/08/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Hungary;Portugal;Germany;United Kingdom;Spain;Italy | |||
| 954 | NCT00256204 (ClinicalTrials.gov) | November 2005 | 16/11/2005 | A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease | A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | Parkinson's Disease | Drug: Rasagiline Mesylate;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | 80 Years | All | 1174 | Phase 3 | Argentina;Austria;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom;United States |
| 955 | NCT00253084 (ClinicalTrials.gov) | November 2005 | 11/11/2005 | Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease | A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 2 | United States |
| 956 | NCT00250393 (ClinicalTrials.gov) | November 2005 | 4/11/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease | Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy] | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 30 Years | N/A | Both | 64 | Phase 2 | Japan |
| 957 | EUCTR2005-000314-12-ES (EUCTR) | 14/10/2005 | 08/09/2005 | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: piribedil Product Code: S 90049 - F36 INN or Proposed INN: piribedil Product Name: piribedil Product Code: S 90049 - F38 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Spain;Germany | ||
| 958 | NCT00517842 (ClinicalTrials.gov) | October 2005 | 15/8/2007 | A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease | A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease | Parkinson Disease | Drug: ViNeuro | Hospital Authority, Hong Kong | Vigconic (International) Ltd. | Completed | 30 Years | N/A | Both | 160 | N/A | China |
| 959 | NCT00912808 (ClinicalTrials.gov) | October 2005 | 2/6/2009 | Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease | A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's | Parkinson's Disease | Drug: Donepezil;Drug: Sugar Pill (placebo) | Oregon Health and Science University | NULL | Completed | 21 Years | N/A | All | 23 | N/A | NULL |
| 960 | NCT00134251 (ClinicalTrials.gov) | October 2005 | 22/8/2005 | Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease | Parkinson's Disease | Drug: SLV308 | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | Phase 3 | Bulgaria;Malta;Serbia;Former Serbia and Montenegro | |
| 961 | EUCTR2005-001416-42-HU (EUCTR) | 27/09/2005 | 20/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;Germany;United Kingdom;Spain;Italy | |||
| 962 | EUCTR2005-001416-42-GB (EUCTR) | 15/09/2005 | 13/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: Azilect Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: Rasagiline Product Code: TVP-1012 | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom | ||
| 963 | EUCTR2005-001416-42-DE (EUCTR) | 01/09/2005 | 17/10/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;United Kingdom;Germany;Spain;Italy | |||
| 964 | NCT00165789 (ClinicalTrials.gov) | September 2005 | 12/9/2005 | A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States |
| 965 | NCT02774564 (ClinicalTrials.gov) | September 2005 | 13/5/2016 | Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Carbidopa | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single Dose of Controlled-release 200/50 mg Levodopa/Carbidopa (Sinemet® cr 200/50): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Sinemet® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 16 | Phase 1 | Portugal |
| 966 | NCT02778594 (ClinicalTrials.gov) | September 2005 | 18/5/2016 | Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide (Madopar® HBS 125): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy Volunteers | Parkinson's Disease (PD) | Drug: BIA 3-202;Drug: Placebo;Drug: levodopa 100 mg / benserazide 25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 17 | Phase 1 | Portugal |
| 967 | NCT00224263 (ClinicalTrials.gov) | September 2005 | 20/9/2005 | Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCI | Parkinson's Disease | Drug: Lingzhi (Ganoderma) | Xuanwu Hospital, Beijing | NULL | Completed | 30 Years | 80 Years | Both | 360 | Phase 2 | China |
| 968 | EUCTR2005-001416-42-AT (EUCTR) | 24/08/2005 | 20/07/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom | |||
| 969 | EUCTR2005-001416-42-ES (EUCTR) | 28/07/2005 | 28/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom | ||
| 970 | EUCTR2004-000835-27-ES (EUCTR) | 18/07/2005 | 23/05/2006 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Early idiopathic Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.P.A | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 3 | Spain;Italy | ||
| 971 | EUCTR2005-004290-19-AT (EUCTR) | 17/07/2005 | 06/12/2005 | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536 | Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Spain;Austria;Germany;United Kingdom | |||
| 972 | EUCTR2005-001416-42-IT (EUCTR) | 14/07/2005 | 21/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | Neuroprotective early treatment of Parkinson's disease subjects MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: NA Product Code: NA Other descriptive name: NA Product Name: rasagiline Product Code: TVP-1012 | TEVA | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Hungary;Germany;United Kingdom;Spain;Italy | ||||
| 973 | NCT00125138 (ClinicalTrials.gov) | July 2005 | 27/7/2005 | Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease | Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's Disease | Parkinson's Disease;Psychotic Disorders | Drug: Melperone HCl;Drug: Placebo | Lundbeck LLC | NULL | Completed | N/A | N/A | All | 90 | Phase 2 | United States;India;Italy |
| 974 | EUCTR2005-004314-33-AT (EUCTR) | 16/06/2005 | 05/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 975 | NCT00086190 (ClinicalTrials.gov) | June 2005 | 28/6/2004 | Study of Antidepressants in Parkinson's Disease | Study of Antidepressants in Parkinson's Disease | Parkinson Disease;Depression | Drug: paroxetine;Drug: venlafaxine;Other: placebo | University of Rochester | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 30 Years | N/A | All | 115 | Phase 3 | United States;Canada;Puerto Rico |
| 976 | NCT00642889 (ClinicalTrials.gov) | June 2005 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension) | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 227 | Phase 3 | NULL |
| 977 | NCT03093389 (ClinicalTrials.gov) | May 11, 2005 | 22/3/2017 | Tolerability and Steady-state Pharmacokinetics of BIA 6-512 | A Double-blind, Randomised, Placebo-controlled, Rising Multiple-dose Study to Investigate the Tolerability and Steady-state Pharmacokinetics of BIA 6-512 (Trans-resveratrol) in Healthy Volunteers | Parkinson Disease | Drug: BIA 6-512;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 40 | Phase 1 | Portugal |
| 978 | NCT00163085 (ClinicalTrials.gov) | May 2005 | 9/9/2005 | The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Explore The Efficacy And Safety Of The NR2B NMDA Antagonist CP-101,606 In Patients With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: NR2B NMDA Antagonist CP-101,606 (traxoprodil) | Pfizer | NULL | Completed | 30 Years | 80 Years | Both | 12 | Phase 2 | United States |
| 979 | NCT00199433 (ClinicalTrials.gov) | May 2005 | 12/9/2005 | A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients | A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease | Parkinson's Disease;Movement Disorder Syndrome | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 160 | Phase 2 | United States |
| 980 | EUCTR2004-000817-20-IT (EUCTR) | 06/04/2005 | 13/04/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: istradefylline Product Code: KW-6002 Other descriptive name: NA Trade Name: COMTAN 200* 60 CPR 200 MG Product Name: NA Product Code: NA INN or Proposed INN: Entacapone | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 981 | NCT00199355 (ClinicalTrials.gov) | April 2005 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa] | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 30 Years | N/A | Both | 75 | Phase 2 | Japan |
| 982 | EUCTR2004-001593-10-GB (EUCTR) | 21/03/2005 | 25/08/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: SARIZOTAN Product Code: EMD128130 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;United Kingdom | ||
| 983 | NCT02834507 (ClinicalTrials.gov) | March 2005 | 13/7/2016 | Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients | A Double-blind, Randomised, Placebo- and Active-controlled, Cross-over Study to Investigate the Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: Placebo;Drug: BIA 3-202;Drug: Comtan®;Drug: Sinemet® | Bial - Portela C S.A. | NULL | Completed | 30 Years | 75 Years | Both | 19 | Phase 2 | NULL |
| 984 | EUCTR2004-001594-25-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Austria | ||
| 985 | EUCTR2004-000817-20-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Lithuania;Austria;Latvia;Italy | |||
| 986 | EUCTR2004-001594-25-FI (EUCTR) | 30/12/2004 | 26/10/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain | ||
| 987 | EUCTR2004-000817-20-ES (EUCTR) | 10/12/2004 | 04/05/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtan Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 988 | EUCTR2004-000835-27-IT (EUCTR) | 03/12/2004 | 21/07/2005 | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| 989 | EUCTR2004-001593-10-IT (EUCTR) | 02/12/2004 | 03/01/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan hydrochloride Product Code: EMD 128130 INN or Proposed INN: Sarizotan hydrochloride | MERCK S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | United Kingdom;Italy | |||
| 990 | EUCTR2004-000833-12-ES (EUCTR) | 02/12/2004 | 23/11/2004 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | Early idiopathic Parkinson’s disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Spain;Italy | ||
| 991 | EUCTR2004-000833-12-IT (EUCTR) | 02/12/2004 | 15/03/2005 | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| 992 | NCT00643045 (ClinicalTrials.gov) | December 2004 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 269 | Phase 3 | NULL |
| 993 | EUCTR2004-001594-25-ES (EUCTR) | 24/11/2004 | 02/11/2004 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan Product Code: EMD 128130 INN or Proposed INN: Sarizotan Hydrochloride | MERCK KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Austria | ||
| 994 | EUCTR2004-000817-20-GB (EUCTR) | 08/11/2004 | 11/02/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | ||
| 995 | NCT03091868 (ClinicalTrials.gov) | November 3, 2004 | 21/3/2017 | Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 80 | Phase 1 | Portugal |
| 996 | NCT00199394 (ClinicalTrials.gov) | November 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin UK, Ltd. | NULL | Completed | 30 Years | N/A | Both | 405 | Phase 3 | United Kingdom |
| 997 | EUCTR2004-000817-20-LV (EUCTR) | 22/10/2004 | 27/10/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 998 | NCT00105508 (ClinicalTrials.gov) | September 30, 2004 | 15/3/2005 | Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan;Drug: Placebo | EMD Serono | NULL | Completed | 30 Years | N/A | All | 506 | Phase 3 | United States |
| 999 | EUCTR2004-000817-20-LT (EUCTR) | 16/09/2004 | 07/01/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 1000 | NCT00105521 (ClinicalTrials.gov) | September 2004 | 15/3/2005 | Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan HC1 | EMD Serono | NULL | Completed | 30 Years | N/A | All | 594 | Phase 3 | United States |
| 1001 | NCT00296959 (ClinicalTrials.gov) | September 2004 | 23/2/2006 | Topiramate as a Treatment for Levodopa-Induced Dyskinesia in Parkinson's Disease | Anti-Dyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients With Parkinson's Disease and Levodopa-Induced Dyskinesias | Parkinson's Disease | Drug: topiramate (drug) | University Health Network, Toronto | NULL | Terminated | 30 Years | 75 Years | Both | 20 | Phase 2 | Canada |
| 1002 | NCT00199420 (ClinicalTrials.gov) | July 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 580 | Phase 3 | United States |
| 1003 | NCT00304161 (ClinicalTrials.gov) | July 2004 | 15/3/2006 | Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease | Depression Diagnosis and Treatment in Parkinson Disease | Depressive Disorder;Parkinson Disease | Drug: Atomoxetine;Drug: Placebo | University of Pennsylvania | National Institute of Mental Health (NIMH) | Completed | 30 Years | 79 Years | All | 55 | Phase 4 | United States |
| 1004 | NCT00199407 (ClinicalTrials.gov) | June 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 230 | Phase 3 | United States |
| 1005 | NCT03091543 (ClinicalTrials.gov) | May 4, 2004 | 21/3/2017 | Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg | Parkinson Disease | Drug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg dose | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | Portugal |
| 1006 | NCT01172379 (ClinicalTrials.gov) | May 2004 | 26/7/2010 | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period Dyskinesias | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period Dyskinesias | Parkinson's Disease | Drug: E2007;Other: Placebo Comparator | Eisai Limited | NULL | Completed | 30 Years | 75 Years | Both | 2 | Phase 2 | Czech Republic;France;Germany;Italy;Serbia;Spain |
| 1007 | NCT00244387 (ClinicalTrials.gov) | March 2004 | 24/10/2005 | Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa | A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa | Parkinson Disease, Idiopathic | Drug: SPM 962 | UCB Pharma | NULL | Completed | 30 Years | N/A | Both | 506 | Phase 3 | Germany |
| 1008 | NCT00220272 (ClinicalTrials.gov) | January 2004 | 16/9/2005 | Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease | A Phase II, Randomized, Multicenter, Multinational, Double-Blind, Placebo-Controlled, Study of the Effect of SR57667B on Dopaminergic Nigro-Striatal Function Assessed by 18F-Dopa PET Imaging in Outpatients With Early Parkinson's Disease | Parkinson Disease | Drug: SR57667B | Sanofi | NULL | Completed | 35 Years | N/A | Both | 183 | Phase 2 | Canada;Finland;France;Netherlands;Spain;Switzerland;United Kingdom |
| 1009 | NCT00234676 (ClinicalTrials.gov) | October 2003 | 5/10/2005 | POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease | A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study for the Safety, Tolerability and Efficacy of Estrogen Replacement Therapy (Conjugated Equine Estrogens 0.625 mg Daily) in Post Menopausal Women With Parkinson's Disease | Parkinson's Disease | Drug: Premarin ® | The Parkinson Study Group | Wyeth is now a wholly owned subsidiary of Pfizer;Joseph and Rosalyn Newman Foundation | Completed | N/A | 75 Years | Female | 23 | Phase 2 | United States |
| 1010 | NCT00180037 (ClinicalTrials.gov) | September 2003 | 9/9/2005 | Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease | Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease | Parkinson's Disease | Drug: Coenzyme Q10 Nanodispersion (Nanoquinone);Drug: Placebo | Technische Universität Dresden | Deutsche Parkinson-Vereinigung e.V.;MSE Pharmazeutika GmbH, Bad Homburg | Completed | 40 Years | 75 Years | Both | 132 | Phase 3 | Germany |
| 1011 | NCT00070941 (ClinicalTrials.gov) | July 2003 | 9/10/2003 | SAM-e for the Treatment of Depression in Patients With Parkinson's Disease | SAM-e Treatment of Depression in Parkinson's Disease. | Parkinson's Disease;Depression | Drug: SAM-e;Drug: oral escitalopram;Drug: placebo | New York University School of Medicine | National Center for Complementary and Integrative Health (NCCIH);Office of Dietary Supplements (ODS) | Completed | 30 Years | 80 Years | All | 29 | Phase 2/Phase 3 | United States |
| 1012 | NCT00228150 (ClinicalTrials.gov) | July 2003 | 26/9/2005 | Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease | A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease | Parkinson Disease | Drug: SR57667B | Sanofi | NULL | Completed | 35 Years | N/A | Both | 564 | Phase 2 | Austria;Canada;Denmark;France;Germany;Morocco;Netherlands;Portugal;South Africa;Spain;Sweden;Tunisia;United Kingdom |
| 1013 | NCT00666653 (ClinicalTrials.gov) | July 2003 | 23/4/2008 | Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease | Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease: a Double-Blind Placebo Controlled Crossover Study | Parkinson's Disease | Drug: pramipexole | Oregon Health and Science University | Boehringer Ingelheim | Completed | 30 Years | 80 Years | Both | 13 | Phase 1 | United States |
| 1014 | NCT00240409 (ClinicalTrials.gov) | July 2003 | 14/10/2005 | Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease | A Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine | Boehringer Ingelheim | NULL | Completed | 30 Years | 80 Years | Both | 208 | Phase 3 | China |
| 1015 | NCT00062738 (ClinicalTrials.gov) | June 2003 | 12/6/2003 | Treatment of Depression in Parkinson's Disease Trial | Treatment of Depression in Patients With Parkinson's Disease | Parkinson Disease;Depression | Drug: paroxetine;Drug: Nortriptyline;Other: placebo | Rutgers, The State University of New Jersey | GlaxoSmithKline | Completed | 35 Years | 80 Years | All | 52 | Phase 2 | United States |
| 1016 | NCT00148486 (ClinicalTrials.gov) | June 2003 | 7/9/2005 | A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE) | A Fourteen-week Placebo-controlled Dose-response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE) | Parkinson Disease | Drug: NS 2330 | Boehringer Ingelheim | NULL | Completed | 40 Years | 80 Years | Both | 261 | Phase 2 | United States;Canada |
| 1017 | NCT00381472 (ClinicalTrials.gov) | June 2003 | 26/9/2006 | Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 393 | Phase 3 | United States;Belgium;Czech Republic;France;Germany;Hungary;Italy;Poland;Spain |
| 1018 | NCT00058838 (ClinicalTrials.gov) | April 2003 | 14/4/2003 | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease | A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease. | Parkinson Disease | Drug: sumanirole | Pfizer | NULL | Completed | 30 Years | N/A | Both | 854 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Colombia;France;Germany;Greece;Italy;Mexico;Peru;Puerto Rico;Spain |
| 1019 | NCT00148512 (ClinicalTrials.gov) | March 2003 | 7/9/2005 | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS) | Parkinson Disease | Drug: 1. Tesofensine (NS 2330) | Boehringer Ingelheim | NULL | Completed | 42 Years | 80 Years | Both | 254 | Phase 2 | Austria;France;Germany;Netherlands;Spain;United Kingdom;El Salvador |
| 1020 | NCT00115427 (ClinicalTrials.gov) | March 2003 | 22/6/2005 | Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease | Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Liatermin (r-metHuGDNF) | Amgen | NULL | Completed | 35 Years | 70 Years | Both | Phase 1 | United States | |
| 1021 | NCT01327859 (ClinicalTrials.gov) | March 2003 | 30/3/2011 | Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With Dementia | A 52-week, Multicentre Open Label Extension Study of the Safety Tolerability and Efficacy of Donepezil (Aricept) in Parkinson's Disease (PD) Patients With Dementia | Parkinson's Disease;Dementia | Drug: Prior Donepezil 5mg;Drug: Prior Donzepezil 10mg;Drug: Prior Placebo | Eisai Inc. | NULL | Completed | 40 Years | N/A | Both | 357 | Phase 3 | United Kingdom |
| 1022 | NCT00451815 (ClinicalTrials.gov) | January 2003 | 31/1/2006 | BIIB014 Phase 2a Monotherapy | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Oral Dose Administration of BIIB014 in Subjects With Early Parkinson’s Disease | Parkinson's Disease | Drug: active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.;Drug: placebo | Biogen Idec | NULL | Withdrawn | 30 Years | 78 Years | Both | Phase 2 | NULL | |
| 1023 | NCT00206687 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | STEPS Trial - Spheramine Safety and Efficacy Study | Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease | Parkinson Disease | Biological: Spheramine (BAY86-5280);Procedure: Placebo | Bayer | Titan Pharmaceuticals | Terminated | 30 Years | 70 Years | Both | 71 | Phase 2 | United States;Germany;Spain;Austria;France |
| 1024 | NCT00209508 (ClinicalTrials.gov) | November 2002 | 13/9/2005 | 2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 2-Year Study To Evaluate The Effects Of GPI 1485 On [123I]b-CIT/SPECT Scanning And Clinical Efficacy In Symptomatic PD Patients Receiving Dopamine Agonist Therapy. | Parkinson's Disease | Drug: GPI 1485 | Eisai Inc. | Symphony Neuro Development Company | Completed | 40 Years | 80 Years | Both | 200 | Phase 2 | NULL |
| 1025 | NCT00314288 (ClinicalTrials.gov) | July 2002 | 12/4/2006 | Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia | A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan HCl | EMD Serono | NULL | Completed | 30 Years | N/A | All | 360 | Phase 2 | United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Portugal;Romania;South Africa;United Kingdom |
| 1026 | NCT00456586 (ClinicalTrials.gov) | April 2002 | 3/4/2007 | 12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa | A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: KW-6002 (istradefylline) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 180 | Phase 2 | United States |
| 1027 | NCT00456794 (ClinicalTrials.gov) | March 2002 | 3/4/2007 | 12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa | A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 325 | Phase 2 | United States |
| 1028 | NCT00040404 (ClinicalTrials.gov) | March 2002 | 26/6/2002 | Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease | Parkinson Disease | Drug: CEP-1347 10mg;Drug: CEP1347 25mg;Drug: CEP-1347 50mg;Other: Placebo Comparator | Cephalon | H. Lundbeck A/S;The Parkinson Study Group | Terminated | 30 Years | N/A | Both | 806 | Phase 2/Phase 3 | United States;Canada;Puerto Rico |
| 1029 | NCT00030979 (ClinicalTrials.gov) | February 2002 | 15/2/2002 | Donepezil to Treat Dementia in Parkinson's Disease | Donepezil for Dementia in Parkinson's Disease: A Randomized, Double Blinded Placebo Controlled Crossover Trial | Parkinson Disease | Drug: Donepezil | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 28 | Phase 4 | United States |
| 1030 | NCT02162979 (ClinicalTrials.gov) | February 2002 | 26/12/2007 | Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease | A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease | Parkinson's Disease | Drug: sildenafil;Drug: Placebo | Loma Linda University | NULL | Terminated | 18 Years | 80 Years | All | 2 | Phase 2 | United States |
| 1031 | NCT00407212 (ClinicalTrials.gov) | January 2002 | 30/11/2006 | A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease | Parkinson's Disease | Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt) | Novartis | NULL | Completed | 30 Years | 80 Years | Both | 301 | Phase 1/Phase 2 | United States;Brazil;Canada;France;Germany;Italy;Netherlands;Portugal;United Kingdom |
| 1032 | NCT00036218 (ClinicalTrials.gov) | December 2001 | 8/5/2002 | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease. | A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease. | Parkinson Disease | Drug: sumanirole;Drug: ropinirole | Pfizer | NULL | Completed | 30 Years | N/A | Both | 600 | Phase 3 | United States;Argentina;Mexico;Puerto Rico |
| 1033 | NCT02772627 (ClinicalTrials.gov) | September 2001 | 12/5/2016 | Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 in Healthy Volunteers. | Parkinson's Disease | Drug: Nebicapone;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 22 | Phase 1 | Portugal |
| 1034 | NCT00200525 (ClinicalTrials.gov) | July 2001 | 13/9/2005 | Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease | A Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing-Off Effects Associated With Late-Stage PD After Apomorphine Use | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 60 | Phase 3 | NULL |
| 1035 | NCT02763852 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 18 | Phase 1 | Portugal |
| 1036 | NCT02763839 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Sinemet 25/100 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 19 | Phase 1 | Portugal |
| 1037 | NCT00145171 (ClinicalTrials.gov) | February 2001 | 2/9/2005 | A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients. | Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg. | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 3 | NULL |
| 1038 | NCT02763800 (ClinicalTrials.gov) | September 2000 | 4/5/2016 | Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202 | Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 35 Years | Male | 33 | Phase 1 | United Kingdom |
| 1039 | NCT00203034 (ClinicalTrials.gov) | May 2000 | 13/9/2005 | Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations | A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: rasagiline mesylate;Drug: 1.0 mg rasagiline mesylate;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 472 | Phase 3 | United States |
| 1040 | NCT02763787 (ClinicalTrials.gov) | April 2000 | 4/5/2016 | Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202 | A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Single Doses of BIA 3-202 in Healthy Volunteers. | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 35 Years | Male | 71 | Phase 1 | United Kingdom |
| 1041 | NCT00037830 (ClinicalTrials.gov) | November 1999 | 22/5/2002 | GM1 Ganglioside Effects on Parkinson's Disease | The Study of GM1 Ganglioside, A Potential New Parkinson's Disease Medication | Parkinson Disease | Drug: GM1 ganglioside;Drug: Placebo | Thomas Jefferson University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 39 Years | 85 Years | All | 94 | Phase 2 | United States |
| 1042 | NCT00200512 (ClinicalTrials.gov) | September 1999 | 13/9/2005 | Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months | A Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing Off Effects Associated With Late Stage Parkinson's Disease | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 16 | Phase 2/Phase 3 | United Kingdom |
| 1043 | NCT02172573 (ClinicalTrials.gov) | April 1999 | 20/6/2014 | Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease | A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine;Drug: Placebo pramipexole;Drug: Placebo bromocriptine | Boehringer Ingelheim | NULL | Completed | 20 Years | N/A | Both | 315 | Phase 3 | NULL |
| 1044 | NCT02177357 (ClinicalTrials.gov) | November 1998 | 24/6/2014 | Pramipexole in Untreated and Levodopa-treated Parkinson's Disease Patients | Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | Both | 150 | Phase 3 | NULL |
| 1045 | NCT00203060 (ClinicalTrials.gov) | July 1997 | 13/9/2005 | Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa | A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa | Parkinson's Disease | Drug: Rasagiline Mesylate;Drug: placebo | Teva Neuroscience, Inc. | NULL | Completed | 35 Years | N/A | Both | 404 | Phase 3 | United States |
| 1046 | EUCTR2020-006067-28-BE (EUCTR) | 18/11/2021 | A study to investigate if CST-103 and CST-107 has an effect on the brain in patients with progressive disease of the nervous system. | A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 co-administered with CST-107 on the Central Nervous System in Subjects with Neurodegenerative Disorders - PD Effects of CST-103/CST-107 on CNS in Neurodegenerative Disorders | Patients with Parkinson’s Disease with REM sleep behaviour disorder, Mild Cognitive Impairment, Dementia with Lewy Bodies and Parkinson’s Disease Dementia. MedDRA version: 24.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10009846;Term: Cognitive impairment;Classification code 10067889;Term: Dementia with Lewy bodies;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Spiropent Product Name: Spiropent Product Code: CST-103 INN or Proposed INN: Clenbuterol Hydrochloride Product Name: Nadolol Product Code: CST-107 INN or Proposed INN: Nadolol | CuraSen Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Belgium;Australia;United Kingdom;New Zealand | |||
| 1047 | EUCTR2011-002073-30-DE (EUCTR) | 20/09/2011 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | France;United States;Hungary;Canada;Spain;Germany;Italy | ||||
| 1048 | JPRN-JapicCTI-121954 | Phase III study on FPF1100NW monotherapy | Randomized, double-blind, placebo-controlled study on FPF1100NW monotherapy with early Parkinson's disease patients (Phase III study) | Early Parkinson's disease | Intervention name : FPF1100NW INN of the intervention : Selegiline Dosage And administration of the intervention : oral Control intervention name : null | FP Pharmaceutical Corp. | NULL | 20 | 74 | BOTH | 280 | Phase 3 | NULL | |||
| 1049 | EUCTR2009-013552-72-DE (EUCTR) | 23/08/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | |||
| 1050 | EUCTR2008-004447-11-DE (EUCTR) | 17/10/2008 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;Italy;United Kingdom |
11. 重症筋無力症
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05390840 (ClinicalTrials.gov) | August 2022 | 20/5/2022 | A Study to Investigate the Effect on Central Macular Thickness of Treatment With MG-O-1002 Eye Drops in Participants Aged Over 45 With Neovascular Age-related Macular Degeneration (nAMD) | A Phase II Trial to Evaluate the Efficacy and Safety of Topical Ocular MG-O-1002 in Patients With Neovascular Age-Related Macular Degeneration (nAMD) | Age-Related Macular Degeneration | Drug: MG-O-1002;Other: Placebo | Theratocular Biotek Co. | NULL | Not yet recruiting | 45 Years | N/A | All | 36 | Phase 2 | NULL |
| 2 | NCT05067348 (ClinicalTrials.gov) | July 21, 2022 | 23/9/2021 | Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis | A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: Tocilizumab Injectable Product | Tang-Du Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 64 | Phase 2 | China |
| 3 | NCT05403541 (ClinicalTrials.gov) | June 27, 2022 | 26/5/2022 | Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis | A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG) | Generalized Myasthenia Gravis | Drug: Batoclimab 680 mg SC weekly;Drug: Batoclimab 340 mg SC weekly;Drug: Matching Placebo SC;Drug: Batoclimab 340 mg SC bi-weekly | Immunovant Sciences GmbH | NULL | Recruiting | 18 Years | N/A | All | 210 | Phase 3 | United States;Georgia;Italy;Poland;Romania |
| 4 | JPRN-jRCT2021210024 | 15/02/2022 | 30/07/2021 | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Myasthenia Gravis | Satralizumab: 120 mg or 180mg SC injection every 4 weeks (Q4W) | Ivana Vodopivec | NULL | Recruiting | >= 12age old | Not applicable | Both | 240 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;China;Denmark;France;Germany;Italy;Republic of Korea;Netherlands;Poland;Russian Federation;Spain;Taiwan;Turkey;Japan |
| 5 | EUCTR2021-001229-26-ES (EUCTR) | 21/01/2022 | 14/12/2021 | Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis | A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALXN2050 INN or Proposed INN: N/A Other descriptive name: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | United States;Taiwan;Canada;Spain;Korea, Democratic People's Republic of;Germany;Italy | ||
| 6 | JPRN-jRCT2021210027 | 20/01/2022 | 13/08/2021 | A Study of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia Gravis | Nipocalimab (JNJ-80202135, M281) Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion from OLE Day 1 to 24 weeks. Participants who are stable on the q2w dosing regimen can be transitioned to a dosing regimen every 4 weeks (q4w) during OLE phase Placebo Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase. | Nakano Masayoshi | NULL | Pending | >= 18age old | Not applicable | Both | 180 | Phase 3 | Belgium;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;Kingdom Of Great Britain And Northern Ireland;Italy;Mexico;Poland;Russian Federation;Sweden;Turkey;United States Of America;Japan |
| 7 | EUCTR2020-005732-29-DK (EUCTR) | 13/01/2022 | 25/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 8 | EUCTR2021-003898-59-ES (EUCTR) | 12/01/2022 | 14/10/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutininb Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Canada;Poland;Spain;Russian Federation;Germany;United Kingdom;Italy;Japan;China | ||
| 9 | EUCTR2021-003898-59-PL (EUCTR) | 11/01/2022 | 25/11/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutinib Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;China;Japan | ||
| 10 | NCT04982289 (ClinicalTrials.gov) | January 1, 2022 | 21/6/2021 | Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis | A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: ALXN1830;Other: Placebo | Alexion Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 11 | NCT05218096 (ClinicalTrials.gov) | December 30, 2021 | 16/12/2021 | Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis;Myasthenia Gravis | Drug: ALXN2050;Drug: Placebo | Alexion Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 70 | Phase 2 | United States;Canada;Germany;Italy;Korea, Republic of;Spain;Taiwan |
| 12 | EUCTR2021-001229-26-IT (EUCTR) | 21/12/2021 | 19/10/2021 | Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis | A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants withGeneralized Myasthenia Gravis - - | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Menveo Product Name: Menveo Product Code: [N/A] INN or Proposed INN: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN Other descriptive name: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN INN or Proposed INN: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 ADSORBED ON ALUMINUM HYDROXIDE Other descriptive name: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO INN or Proposed INN: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN Other descriptive name: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN INN or Proposed INN: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN Other descriptive name: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN Trade Name: Velamox Product Name: Velamox Product Code: [N/A] | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | United States;Taiwan;Canada;Spain;Germany;Italy;Korea, Republic of | ||
| 13 | NCT05070858 (ClinicalTrials.gov) | December 14, 2021 | 27/9/2021 | A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia Gravis | Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Symptomatic Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Pozelimab + Cemdisiran;Drug: Cemdisiran;Other: Placebo;Drug: Pozelimab | Regeneron Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 235 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Denmark;France;Italy;Japan;Korea, Republic of;Poland;Spain;Taiwan;Turkey;United Kingdom |
| 14 | EUCTR2020-005732-29-PL (EUCTR) | 10/12/2021 | 24/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 15 | NCT05132569 (ClinicalTrials.gov) | December 3, 2021 | 12/11/2021 | Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG) | Myasthenia Gravis | Drug: Tolebrutininb;Drug: Placebo | Sanofi | NULL | Terminated | 18 Years | 85 Years | All | 6 | Phase 3 | United States;Canada;China;Hungary;Italy;Japan;Poland;Spain;United Kingdom |
| 16 | EUCTR2021-003898-59-HU (EUCTR) | 30/11/2021 | 04/12/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - URSA | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutininb Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;Italy;China | ||
| 17 | EUCTR2020-005732-29-DE (EUCTR) | 19/11/2021 | 23/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 18 | EUCTR2021-003898-59-IT (EUCTR) | 12/11/2021 | 06/10/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - . | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutininb Product Code: [SAR442168] INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;China;Italy | ||
| 19 | EUCTR2020-005732-29-SE (EUCTR) | 03/11/2021 | 24/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 20 | EUCTR2020-004436-21-DE (EUCTR) | 02/11/2021 | 16/03/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 21 | EUCTR2020-005732-29-CZ (EUCTR) | 21/10/2021 | 15/07/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 22 | NCT04963270 (ClinicalTrials.gov) | October 19, 2021 | 7/7/2021 | A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Satralizumab;Other: Placebo | Hoffmann-La Roche | Chugai Pharmaceutical | Recruiting | 12 Years | N/A | All | 240 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;China;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Taiwan;Turkey |
| 23 | NCT04965987 (ClinicalTrials.gov) | October 2021 | 10/6/2021 | Oxaloacetate in Myasthenia Gravis | A Phase I, Double-Blind, Pilot Study of Oxaloacetate in Myasthenia Gravis | Myasthenia Gravis | Drug: Oxaloacetate;Drug: Placebo | University of Kansas Medical Center | Terra Biological LLC | Not yet recruiting | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 24 | EUCTR2020-004436-21-PL (EUCTR) | 27/09/2021 | 28/04/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 25 | NCT05039190 (ClinicalTrials.gov) | September 25, 2021 | 29/8/2021 | Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients | A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: HBM9161 Injection (680mg);Drug: Placebo | Harbour BioMed (Guangzhou) Co. Ltd. | NULL | Completed | 18 Years | 99 Years | All | 132 | Phase 3 | China |
| 26 | EUCTR2020-005732-29-ES (EUCTR) | 03/09/2021 | 26/08/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Myasthenia gravis (MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 27 | EUCTR2020-005732-29-IT (EUCTR) | 20/08/2021 | 12/10/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis - N/A | Myasthenia gravis (MG);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Nipocalimab Product Code: [JNJ-80202135] INN or Proposed INN: Nipocalimab Other descriptive name: M281 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 28 | JPRN-jRCT2021210003 | 18/08/2021 | 21/04/2021 | Myasthenia Gravis Inebilizumab Trial | A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults with Myasthenia Gravis - VIB0551.P3.S1 | AChR-Ab+ or MuSK-Ab+ generalized Myasthenia Gravis | (RCP: Randomized Controlled Period) Treatment group 1: AChR-Ab positive population (active) - inebilizumab 300 mg administered intravenously (IV) on Days 1, 15, and 183 of the RCP Treatment group 2: AChR-Ab positive population (placebo) - IV placebo on Days 1, 15, and 183 of the RCP Treatment group 3: MuSK-Ab positive population (active) - inebilizumab 300 mg IV on Days 1 and 15 of the 26-week RCP Treatment group 4: MuSK-Ab positive population (placebo) - IV placebo on Days 1 and 15 of the 26-week RCP | Katayama Sota | NULL | Recruiting | >= 18age old | Not applicable | Both | 16 | Phase 3 | USA;Ukraine;China;Argentina;Brazil;Canada;France;Denmark;Germany;Israel;India;Italy;Poland;Spain;Belarus;Russia;Taiwan;Turkey;South Korea;Japan |
| 29 | EUCTR2020-004436-21-DK (EUCTR) | 11/08/2021 | 11/03/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB Product Name: Satralizumab Product Code: Ro 533-3787/F01-06 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 30 | EUCTR2020-004436-21-NL (EUCTR) | 05/08/2021 | 06/04/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB Product Name: Satralizumab Product Code: Ro 533-3787/F01-06 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 31 | EUCTR2020-000949-14-DE (EUCTR) | 30/07/2021 | 08/12/2020 | Inebilizumab efficacy and safety in adults with myasthenia gravis | A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) | Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Uplizna Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 32 | NCT04951622 (ClinicalTrials.gov) | July 15, 2021 | 30/6/2021 | A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: Nipocalimab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 190 | Phase 3 | United States;Australia;Belgium;Canada;China;Colombia;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Poland;Spain;Sweden;Taiwan;United Kingdom;Russian Federation;Turkey |
| 33 | EUCTR2020-004436-21-ES (EUCTR) | 17/06/2021 | 02/09/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB | Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 34 | EUCTR2020-004436-21-IT (EUCTR) | 21/05/2021 | 08/06/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS - - | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: [RO5333787] INN or Proposed INN: SATRALIZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 35 | EUCTR2020-000949-14-DK (EUCTR) | 24/02/2021 | 24/11/2020 | Inebilizumab efficacy and safety in adults with myasthenia gravis | A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) | Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Uplizna Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 36 | EUCTR2020-000949-14-FR (EUCTR) | 16/11/2020 | 08/10/2020 | Inebilizumab efficacy and safety in adults with myasthenia gravis | A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) | Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 3 | Ukraine;United States;Belarus;Finland;Spain;Guatemala;Turkey;Russian Federation;Israel;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 37 | NCT04524273 (ClinicalTrials.gov) | August 30, 2020 | 10/8/2020 | Myasthenia Gravis Inebilizumab Trial | A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis | Myasthenia Gravis | Drug: inebilizumab;Drug: IV Placebo | Viela Bio (acquired by Horizon Therapeutics) | NULL | Recruiting | 18 Years | N/A | All | 270 | Phase 3 | United States;Argentina;Belarus;Brazil;Canada;China;Denmark;France;Germany;India;Israel;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Turkey;Ukraine |
| 38 | EUCTR2019-003383-47-IT (EUCTR) | 12/08/2020 | 25/09/2020 | A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia Gravis | A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - - | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TAK-079 Product Code: [TAK-079, TSF-021, TSF79] INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 Product Name: metilprdnisolone Product Code: [-] INN or Proposed INN: METILPREDNISOLONE Other descriptive name: methylprednisolone Product Name: difenidramina Product Code: [NA] INN or Proposed INN: DIFENIDRAMINA CLORIDRATO Other descriptive name: diphenhydramine hydrochloride Product Name: paracetamolo Product Code: [acetominofene] INN or Proposed INN: PARACETAMOLO Other descriptive name: acetaminophen | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Serbia;Canada;Spain;Poland;Italy | ||
| 39 | NCT04346888 (ClinicalTrials.gov) | July 23, 2020 | 13/4/2020 | A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: HBM9161 Injection (680mg and 340 mg);Drug: Placebos;Drug: HBM9161 Injection (340 mg) | Harbour BioMed (Guangzhou) Co. Ltd. | NULL | Completed | 18 Years | 99 Years | All | 30 | Phase 2 | China |
| 40 | EUCTR2018-003243-39-PT (EUCTR) | 15/06/2020 | 06/02/2020 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 41 | EUCTR2019-001564-30-ES (EUCTR) | 13/05/2020 | 11/11/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United Kingdom;Japan;Italy;United States;France;Canada;Spain;Norway;Germany | ||
| 42 | EUCTR2019-001564-30-DE (EUCTR) | 31/03/2020 | 01/10/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan INN or Proposed INN: Zilucoplan Product Name: Zilucoplan INN or Proposed INN: Zilucoplan Product Name: Zilucoplan INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | France;United States;Canada;Spain;Poland;Norway;Germany;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 43 | JPRN-JapicCTI-205207 | 11/3/2020 | 04/03/2020 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized myasthenia gravis | Intervention name : Rozanolixizumab INN of the intervention : rozanolixizumab Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages (dose 1 and dose 2) in dosage regimen 1 and 2. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | complete | 18 | BOTH | 18 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 44 | EUCTR2018-003243-39-GB (EUCTR) | 11/02/2020 | 08/10/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 45 | NCT04159805 (ClinicalTrials.gov) | January 20, 2020 | 8/11/2019 | A Study of TAK-079 in People With Generalized Myasthenia Gravis | A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: TAK-079;Drug: TAK-079 Placebo | Takeda | NULL | Completed | 18 Years | N/A | All | 36 | Phase 2 | United States;Canada;Italy;Poland;Serbia;Spain |
| 46 | EUCTR2019-001564-30-IT (EUCTR) | 10/01/2020 | 07/01/2021 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan Product Code: [na] INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy | ||
| 47 | EUCTR2018-003243-39-CZ (EUCTR) | 02/01/2020 | 13/09/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 48 | EUCTR2019-000968-18-PL (EUCTR) | 19/12/2019 | 09/07/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany | ||
| 49 | EUCTR2019-000968-18-DE (EUCTR) | 15/11/2019 | 10/07/2019 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 50 | EUCTR2019-000968-18-GB (EUCTR) | 14/11/2019 | 28/06/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Russian Federation;Hong Kong;Hungary;United States;United Kingdom;Spain;Canada;Czech Republic;Belgium;Taiwan;Denmark;Poland;Italy;France;Germany | ||
| 51 | EUCTR2019-000968-18-CZ (EUCTR) | 11/11/2019 | 13/08/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 52 | EUCTR2019-001564-30-GB (EUCTR) | 29/10/2019 | 01/11/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom | ||
| 53 | EUCTR2019-000968-18-BE (EUCTR) | 14/10/2019 | 14/08/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 54 | EUCTR2018-003243-39-AT (EUCTR) | 09/10/2019 | 26/04/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 55 | EUCTR2019-000968-18-HU (EUCTR) | 25/09/2019 | 23/07/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany | ||
| 56 | EUCTR2019-000968-18-IT (EUCTR) | 25/09/2019 | 27/01/2021 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 57 | EUCTR2018-003243-39-DK (EUCTR) | 20/09/2019 | 22/05/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 58 | EUCTR2019-000968-18-DK (EUCTR) | 06/09/2019 | 24/06/2019 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 59 | EUCTR2019-000968-18-ES (EUCTR) | 28/08/2019 | 12/09/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 60 | EUCTR2018-003243-39-DE (EUCTR) | 30/07/2019 | 25/03/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Ultomiris 1,100 mg/11 mL Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Portugal | ||
| 61 | EUCTR2018-003243-39-NL (EUCTR) | 22/07/2019 | 01/05/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 62 | EUCTR2018-003243-39-IT (EUCTR) | 17/06/2019 | 22/01/2021 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - NA | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: [ALXN1210] | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 3 | Portugal;United States;Czechia;Spain;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 63 | NCT03971422 (ClinicalTrials.gov) | June 3, 2019 | 29/5/2019 | A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma SRL | NULL | Completed | 18 Years | N/A | All | 200 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;United Kingdom |
| 64 | EUCTR2018-003243-39-ES (EUCTR) | 21/05/2019 | 27/05/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Spain;Denmark;Austria;Israel;Netherlands;Germany;Japan;Italy;Switzerland;Korea, Republic of | ||
| 65 | NCT03863080 (ClinicalTrials.gov) | May 21, 2019 | 20/2/2019 | A Study of RVT-1401 in Myasthenia Gravis (MG) Patients | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients | Myasthenia Gravis | Drug: RVT-1401;Drug: Placebo | Immunovant Sciences GmbH | NULL | Completed | 18 Years | N/A | All | 17 | Phase 2 | United States;Canada |
| 66 | EUCTR2018-002132-25-NL (EUCTR) | 30/04/2019 | 26/09/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 67 | NCT03772587 (ClinicalTrials.gov) | April 10, 2019 | 10/12/2018 | A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: M281;Other: Placebo | Momenta Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 68 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 68 | NCT03914638 (ClinicalTrials.gov) | April 1, 2019 | 11/4/2019 | Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis | Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis | Myasthenia Gravis | Drug: Salbutamol 4Mg Tablet;Drug: Placebo oral capsule | University of Aarhus | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2/Phase 3 | Denmark |
| 69 | NCT03920293 (ClinicalTrials.gov) | March 26, 2019 | 16/4/2019 | Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Biological: Ravulizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 175 | Phase 3 | United States;Austria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Spain;Switzerland |
| 70 | EUCTR2018-002247-28-BE (EUCTR) | 18/03/2019 | 05/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 71 | EUCTR2018-002247-28-PL (EUCTR) | 27/02/2019 | 31/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy | ||
| 72 | EUCTR2018-002132-25-CZ (EUCTR) | 25/02/2019 | 01/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 73 | EUCTR2018-002132-25-DE (EUCTR) | 22/02/2019 | 12/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 74 | EUCTR2018-002247-28-GB (EUCTR) | 05/02/2019 | 30/11/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom | ||
| 75 | EUCTR2018-002247-28-IT (EUCTR) | 04/02/2019 | 04/11/2020 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis - VIVACITY | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: [M281] INN or Proposed INN: M281 | MOMENTA PHARMACEUTICALS, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 76 | EUCTR2018-002132-25-HU (EUCTR) | 28/01/2019 | 16/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 77 | EUCTR2018-002132-25-BE (EUCTR) | 21/01/2019 | 16/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 78 | EUCTR2018-002132-25-FR (EUCTR) | 15/01/2019 | 29/10/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 79 | EUCTR2018-002247-28-ES (EUCTR) | 14/12/2018 | 18/01/2019 | To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 80 | EUCTR2018-002132-25-DK (EUCTR) | 13/12/2018 | 28/09/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 81 | EUCTR2018-002132-25-IT (EUCTR) | 27/11/2018 | 12/02/2021 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness. - NA | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: [ARGX-113] INN or Proposed INN: Efgartigimod | ARGEN-X BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 82 | NCT03669588 (ClinicalTrials.gov) | September 5, 2018 | 6/9/2018 | An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness | Generalized Myasthenia Gravis | Biological: ARGX-113;Biological: Placebo | argenx | NULL | Completed | 18 Years | N/A | All | 167 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom |
| 83 | NCT03165435 (ClinicalTrials.gov) | July 2018 | 17/5/2017 | A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Active Targeted Immunotherapy CV-MG01 in Patients With Moderate to Severe Myasthenia Gravis. | Myasthenia Gravis, Generalized | Biological: CV-MG01;Biological: Placebo | CuraVac | Aepodia;University Hospital, Antwerp | Withdrawn | 18 Years | N/A | All | 0 | Phase 2/Phase 3 | Belgium;Netherlands |
| 84 | NCT03510546 (ClinicalTrials.gov) | April 9, 2018 | 6/4/2018 | Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis | Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis | Myasthenia Gravis | Drug: Pyridostigmine;Drug: Placebo oral capsule | University of Aarhus | Aarhus University Hospital | Recruiting | 18 Years | 90 Years | All | 44 | Phase 4 | Denmark |
| 85 | NCT03304054 (ClinicalTrials.gov) | March 7, 2018 | 28/9/2017 | Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG | A Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients | Myasthenia Gravis, Generalized | Drug: Amifampridine Phosphate;Drug: Placebo Oral Tablet | Catalyst Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 86 | EUCTR2017-004018-25-IT (EUCTR) | 22/02/2018 | 19/01/2021 | Clinical study evaluating the effect of Amifampridine phosphate in patients with MuSK antibody positive myasthenia gravis, and a sample of AchR antibody positive myasthenia gravis patients | A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients with MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients - MSK-002 | MuSK antibody positive myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE Product Name: Amifampridina fosfato Product Code: [Amifampridina fosfato] INN or Proposed INN: AMIFAMPRIDINA | CATALYST PHARMACEUTICALS INC. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Canada;Italy | ||
| 87 | EUCTR2017-000323-27-NL (EUCTR) | 03/08/2017 | 18/04/2017 | A study to evaluate the efficacy of CV-MG01 (Myasterix), a therapy for Myasthenia gravis | A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study | Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate | CuraVac Europe SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Phase 2;Phase 3 | Belgium;Netherlands | ||
| 88 | EUCTR2017-000323-27-BE (EUCTR) | 19/06/2017 | 13/04/2017 | A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis | A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study | Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate | CuraVac Europe SA | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2;Phase 3 | Belgium;Netherlands | ||
| 89 | EUCTR2016-002698-36-CZ (EUCTR) | 26/05/2017 | 03/04/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 90 | EUCTR2016-002698-36-ES (EUCTR) | 25/05/2017 | 31/03/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 91 | EUCTR2016-002698-36-DK (EUCTR) | 19/05/2017 | 07/04/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 92 | NCT03052751 (ClinicalTrials.gov) | May 15, 2017 | 10/2/2017 | Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis | Myasthenia Gravis | Drug: UCB7665;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 43 | Phase 2 | United States;Belgium;Canada;Czechia;Denmark;Germany;Spain |
| 93 | EUCTR2016-002698-36-DE (EUCTR) | 09/02/2017 | 28/11/2016 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 94 | EUCTR2016-002698-36-BE (EUCTR) | 30/01/2017 | 29/11/2016 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany | ||
| 95 | NCT02965573 (ClinicalTrials.gov) | December 30, 2016 | 20/10/2016 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | Myasthenia Gravis | Biological: ARGX-113;Drug: Placebo | argenx | Quintiles, Inc. | Completed | 18 Years | N/A | All | 24 | Phase 2 | United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden |
| 96 | EUCTR2016-002938-73-NL (EUCTR) | 08/12/2016 | 03/10/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden | ||
| 97 | EUCTR2016-002938-73-IT (EUCTR) | 01/12/2016 | 22/02/2018 | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 Other descriptive name: ARGX-113 | ARGEN-X BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Netherlands;Italy;Sweden | ||
| 98 | EUCTR2016-002938-73-ES (EUCTR) | 08/11/2016 | 26/09/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden | ||
| 99 | EUCTR2016-002938-73-BE (EUCTR) | 31/10/2016 | 13/09/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden | ||
| 100 | NCT02950155 (ClinicalTrials.gov) | October 16, 2016 | 28/10/2016 | A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis | A Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab (Mabthera®) in Patients With New Onset Generalized Myasthenia Gravis (MG) | Generalized Myasthenia Gravis | Drug: Rituximab;Drug: Sodium Chloride solution | Fredrik Piehl | NULL | Active, not recruiting | 18 Years | N/A | All | 47 | Phase 3 | Sweden |
| 101 | EUCTR2015-005749-30-SE (EUCTR) | 23/06/2016 | 28/04/2016 | A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenght | A randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study - Rinomax | New onset myasthenia gravis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB | Karolinska Institutet | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Sweden | ||
| 102 | EUCTR2014-003997-18-DE (EUCTR) | 30/05/2016 | 27/07/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | Lithuania;Germany;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;France;United States | ||
| 103 | NCT02609022 (ClinicalTrials.gov) | March 2016 | 13/11/2015 | Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis | A First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia Gravis | Myasthenia Gravis | Biological: CV-MG01;Biological: Placebo | CuraVac | Aepodia;University Hospital, Antwerp;Leiden University Medical Center | Completed | 18 Years | 64 Years | All | 24 | Phase 1/Phase 2 | Belgium |
| 104 | EUCTR2013-005099-17-DE (EUCTR) | 18/11/2015 | 28/07/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 105 | EUCTR2014-003997-18-BE (EUCTR) | 06/10/2015 | 18/01/2016 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 106 | EUCTR2013-005099-17-BE (EUCTR) | 06/10/2015 | 15/01/2016 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 107 | EUCTR2015-003127-62-IT (EUCTR) | 02/10/2015 | 17/03/2017 | A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia Gravis | A Randomized, Placebo-Controlled, Pilot Crossover Study to Evaluate the Effect of Amifampridine Phosphate(3,4-Diaminopyridine Phosphate) in Patients with MuSK Antibody Positive Myasthenia Gravis - MuSK-001 | Patients with MuSK Antibody Positive Myasthenia Gravis MedDRA version: 19.1;Level: LLT;Classification code 10062976;Term: Neuromuscular weakness;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE Product Name: AMIFAMPRIDINA INN or Proposed INN: AMIFAMPRIDINA | FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 108 | NCT02565576 (ClinicalTrials.gov) | September 29, 2015 | 23/6/2015 | Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Preliminarily Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of CFZ533 in Patients With Moderate to Severe Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: Placebo;Drug: CFZ533 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 44 | Phase 2 | Canada;Denmark;Germany;Russian Federation;Taiwan |
| 109 | EUCTR2014-003997-18-CZ (EUCTR) | 10/09/2015 | 17/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 110 | EUCTR2013-005099-17-CZ (EUCTR) | 10/09/2015 | 17/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Estonia;Czech Republic;Canada;Belgium;Poland;Lithuania;Germany | ||
| 111 | EUCTR2015-000097-35-DK (EUCTR) | 03/09/2015 | 16/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 Other descriptive name: CFZ533 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Canada;Denmark;Russian Federation;Germany | ||
| 112 | EUCTR2015-000097-35-DE (EUCTR) | 02/09/2015 | 05/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 Other descriptive name: CFZ533 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Taiwan;Canada;Denmark;Russian Federation;Germany | ||
| 113 | NCT02473952 (ClinicalTrials.gov) | August 2015 | 14/6/2015 | A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: IGIV-C;Drug: Placebo | Grifols Therapeutics LLC | NULL | Completed | 18 Years | 85 Years | All | 62 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic |
| 114 | EUCTR2013-005099-17-HU (EUCTR) | 13/07/2015 | 26/05/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany | ||
| 115 | EUCTR2014-003997-18-HU (EUCTR) | 13/07/2015 | 26/05/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany | ||
| 116 | EUCTR2014-003997-18-LT (EUCTR) | 07/07/2015 | 25/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 117 | EUCTR2013-005099-17-LT (EUCTR) | 07/07/2015 | 25/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Canada;Czech Republic;Belgium;Hungary;United States;Poland;Lithuania;France;Germany;Estonia | ||
| 118 | EUCTR2014-003997-18-EE (EUCTR) | 22/06/2015 | 26/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany | ||
| 119 | EUCTR2013-005099-17-EE (EUCTR) | 22/06/2015 | 26/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics LLC | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany | ||
| 120 | NCT02473965 (ClinicalTrials.gov) | June 2015 | 14/6/2015 | Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of lGIV-C as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: IGIV-C;Drug: Placebo | Grifols Therapeutics LLC | NULL | Completed | 18 Years | 85 Years | All | 60 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic |
| 121 | EUCTR2013-003589-15-CZ (EUCTR) | 22/04/2015 | 26/02/2015 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden;United Kingdom | ||
| 122 | EUCTR2013-003589-15-HU (EUCTR) | 31/03/2015 | 20/01/2015 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 123 | NCT02301624 (ClinicalTrials.gov) | November 12, 2014 | 22/11/2014 | Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis | A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG) | Refractory Generalized Myasthenia Gravis | Biological: Eculizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 117 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;Finland;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom |
| 124 | EUCTR2013-003589-15-NL (EUCTR) | 09/09/2014 | 24/02/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden | ||
| 125 | EUCTR2013-003589-15-FI (EUCTR) | 04/06/2014 | 09/05/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden | ||
| 126 | EUCTR2013-003589-15-BE (EUCTR) | 28/05/2014 | 10/02/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 127 | EUCTR2013-003589-15-FR (EUCTR) | 20/05/2014 | 17/06/2015 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| 128 | NCT02110706 (ClinicalTrials.gov) | May 2014 | 7/4/2014 | BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis | B Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia Gravis | Myasthenia Gravis | Drug: Rituximab;Drug: Placebo | Yale University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 21 Years | 90 Years | All | 52 | Phase 2 | United States |
| 129 | EUCTR2013-003589-15-DK (EUCTR) | 29/04/2014 | 04/03/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden | ||
| 130 | EUCTR2013-003589-15-GR (EUCTR) | 29/04/2014 | 31/03/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden | ||
| 131 | EUCTR2013-003589-15-DE (EUCTR) | 07/04/2014 | 20/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden | ||
| 132 | EUCTR2013-003589-15-ES (EUCTR) | 24/02/2014 | 27/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden | ||
| 133 | EUCTR2013-003589-15-IT (EUCTR) | 11/02/2014 | 17/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden | ||
| 134 | EUCTR2013-003589-15-SE (EUCTR) | 03/02/2014 | 16/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 135 | EUCTR2013-003589-15-GB (EUCTR) | 03/02/2014 | 17/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 136 | NCT01997229 (ClinicalTrials.gov) | December 2013 | 18/11/2013 | Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study) | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG) | Refractory Generalized Myasthenia Gravis | Biological: Eculizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 125 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom;Czech Republic |
| 137 | NCT01480596 (ClinicalTrials.gov) | April 2013 | 27/10/2011 | The Evaluation of Belimumab in Myasthenia Gravis (MG) | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis (MG) | Myasthaenia Gravis | Biological: Belimumab;Other: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 40 | Phase 2 | United States;Canada;Germany;Italy |
| 138 | JPRN-UMIN000007679 | 2012/04/01 | 09/04/2012 | Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients | Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients - Efficacy and safety of tacrolimus in ocular myasthenia gravis | Myasthenia gravis | Administration of tacrolimus 3 mg/day Administration of prednisolone 5 mg/day anticholinesterases | Department of Neurology, Chiba University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 139 | EUCTR2011-002068-26-IT (EUCTR) | 28/12/2011 | 15/12/2011 | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) - Evaluate the Use of Belimumab in Myasthenia Gravis (MG) | Subjects with Generalized Myasthenia Gravis (MG) MedDRA version: 14.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BENLYSTA® (belimumab) INN or Proposed INN: BELIMUMAB | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 42 | United States;Canada;Germany;Italy | |||
| 140 | NCT00995722 (ClinicalTrials.gov) | December 2011 | 14/10/2009 | Efficacy of Prednisone In the Treatment of Ocular Myasthenia | Efficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' Study | Ocular Myasthenia Gravis | Drug: Prednisone;Drug: Placebo | Michael Benatar | University of Miami;University of Rochester | Terminated | 18 Years | N/A | All | 11 | Phase 3 | United States;Canada |
| 141 | EUCTR2011-002068-26-DE (EUCTR) | 24/11/2011 | 05/10/2011 | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG). | Myasthenia Gravis MedDRA version: 17.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BENLYSTA® (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 42 | United States;Canada;Germany;Italy | |||
| 142 | NCT01325571 (ClinicalTrials.gov) | March 2011 | 16/3/2011 | A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis | A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy | Myasthenia Gravis | Drug: Tacrolimus capsule;Drug: Placebo | Astellas Pharma Inc | Astellas Pharma China, Inc. | Completed | 18 Years | 70 Years | Both | 83 | Phase 3 | China |
| 143 | NCT01268280 (ClinicalTrials.gov) | December 2010 | 28/12/2010 | Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis | A Phase II, Double-Blind, Randomized, Three-Way Crossover, Placebo-Controlled, Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis on Standard Therapy | Myasthenia Gravis | Drug: Placebo;Drug: 250 mg CK-2017357;Drug: 500 mg CK-2017357 | Cytokinetics | National Institute of Neurological Disorders and Stroke (NINDS) | Terminated | 18 Years | 80 Years | All | 32 | Phase 2 | United States |
| 144 | EUCTR2009-014669-13-GB (EUCTR) | 29/12/2009 | 23/10/2009 | A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001 | A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001 | Generalized Myasthenia Gravis (gMG) MedDRA version: 12.0;Level: LLT;Classification code 10028417;Term: Myasthenia gravis | Trade Name: SOLIRIS Product Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | Alexion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | United Kingdom | |||
| 145 | NCT00814138 (ClinicalTrials.gov) | April 2009 | 23/12/2008 | Efficacy of Methotrexate in Myasthenia Gravis | Phase II Trial of Methotrexate in Myasthenia Gravis | Myasthenia Gravis | Drug: Methotrexate;Other: Placebo | University of Kansas Medical Center | NULL | Completed | 18 Years | N/A | All | 50 | Phase 2 | United States;Canada |
| 146 | NCT00727194 (ClinicalTrials.gov) | October 2008 | 30/7/2008 | Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis | A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With Immunosuppressants | Myasthenia Gravis | Drug: eculizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Terminated | 18 Years | 80 Years | All | 14 | Phase 2 | United States;Canada;United Kingdom |
| 147 | EUCTR2007-002817-37-IT (EUCTR) | 29/07/2008 | 30/06/2008 | A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND | A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND | Patients affected with MG showing clinically meaningful improvement after therapeutic plasmapheresis. MedDRA version: 9.1;Level: LLT;Classification code 10028417;Term: Myasthenia gravis | Product Name: PIXANTRONE Product Code: BBR 2778 INN or Proposed INN: pixantrone | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy | |||
| 148 | EUCTR2006-004374-27-DE (EUCTR) | 12/10/2006 | 07/09/2006 | Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent | Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent | Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0) | Trade Name: Mutagrip Product Name: Mutagrip | Philipps-University | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 149 | NCT00309088 (ClinicalTrials.gov) | April 2006 | 29/3/2006 | FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients | FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients | Myasthenia Gravis | Drug: tacrolimus;Drug: placebo | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 80 | Phase 3 | Japan |
| 150 | EUCTR2005-000343-28-IT (EUCTR) | 29/03/2006 | 15/03/2006 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND | Myasthenia Gravis MedDRA version: 6.1;Level: PT;Classification code 10028417 | Trade Name: cellcept INN or Proposed INN: Mycophenolic acid | ASPREVA PHARMACEUTICALS CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 136 | United Kingdom;Germany;Spain;Italy | |||
| 151 | EUCTR2005-000343-28-DE (EUCTR) | 19/12/2005 | 10/05/2005 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | Myasthenia Gravis MedDRA version: 8.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis | Trade Name: Cellcept 500 mg tablets Product Name: CellCept 500 mg tablets INN or Proposed INN: mycophenolate mofetil | Aspreva Pharmaceuticals Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Spain;Germany;Italy;United Kingdom | |||
| 152 | EUCTR2004-000596-34-HU (EUCTR) | 30/09/2005 | 08/06/2005 | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | Myasthenia gravis MedDRA version: 7;Level: PT;Classification code 10028417 | Trade Name: CellCept®500 mg tablets Product Name: CellCept 500 mg film-coated tablets INN or Proposed INN: mycophenolate mofetil | F. Hoffmann-La Roche Ltd as part of the Aspreva Rare Disease Program | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 153 | EUCTR2005-000343-28-GB (EUCTR) | 05/09/2005 | 28/06/2005 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | Myasthenia Gravis MedDRA version: 7;Level: PT;Classification code 10028417 | Product Name: CellCept 500 mg tablets INN or Proposed INN: mycophenolate mofetil | Aspreva Pharmaceutical Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Germany;United Kingdom;Spain;Italy | |||
| 154 | EUCTR2004-000596-34-ES (EUCTR) | 01/09/2005 | 05/07/2005 | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | Myasthenia gravis MedDRA version: 7;Level: PT;Classification code 10028417 | Trade Name: CellCept®500 mg tablets Product Name: CellCept 500 mg film-coated tablets INN or Proposed INN: mycophenolate mofetil | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | Hungary;Czech Republic;Spain;Italy | ||
| 155 | EUCTR2004-000596-34-IT (EUCTR) | 01/06/2005 | 20/06/2005 | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG) | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG) | Myastenia gravis MedDRA version: 6.1;Level: PT;Classification code 10028417 | Trade Name: CELLCEPT INN or Proposed INN: Mycophenolic acid | ASPREVA PHARMACEUTICALS CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 156 | EUCTR2004-000596-34-CZ (EUCTR) | 19/05/2005 | 06/05/2005 | A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis | A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis | Myasthenia gravis MedDRA version: 7.1;Level: LLT;Classification code 10028417 | Trade Name: CellCept 500 mg Product Name: CellCept | F.Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 157 | NCT00683969 (ClinicalTrials.gov) | August 2004 | 19/5/2008 | A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: mycophenolate mofetil (CellCept);Drug: placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 80 Years | Both | 136 | Phase 3 | United States;Canada;Former Serbia and Montenegro;France;Germany;India;Israel;Italy;Mexico;Netherlands;Russian Federation;Spain;Ukraine;United Kingdom |
| 158 | NCT00408213 (ClinicalTrials.gov) | June 2004 | 5/12/2006 | A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis. | A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone | Myasthenia Gravis Generalised | Drug: mycophenolate mofetil [CellCept];Drug: Placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 80 Years | Both | 136 | Phase 3 | United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands |
| 159 | NCT00306033 (ClinicalTrials.gov) | March 2004 | 21/3/2006 | Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis | IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial | Myasthenia Gravis | Drug: Intravenous ImmuneGlobulin | University Health Network, Toronto | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 3 | Canada |
| 160 | EUCTR2020-004436-21-FR (EUCTR) | 12/04/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05179577 (ClinicalTrials.gov) | June 2023 | 12/11/2021 | A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006) | Spasticity | Drug: Arbaclofen;Drug: Placebo | RVL Pharmaceuticals, Inc. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 442 | Phase 3 | NULL |
| 2 | NCT04150549 (ClinicalTrials.gov) | June 2023 | 11/10/2019 | FMT for MS Patients | Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial | Multiple Sclerosis | Biological: Fecal Microbial Transplants | Lawson Health Research Institute | NULL | Not yet recruiting | 18 Years | 55 Years | All | 34 | Phase 2 | NULL |
| 3 | NCT05359653 (ClinicalTrials.gov) | March 22, 2023 | 28/4/2022 | Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy | A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy | Multiple Sclerosis (MS);Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Chronic Progressive;Multiple Sclerosis Relapse;Multiple Sclerosis Brain Lesion;Multiple Sclerosis Benign | Drug: Clemastine Fumarate;Drug: Placebo | University of California, San Francisco | United States Department of Defense | Not yet recruiting | 18 Years | 55 Years | All | 74 | Phase 1/Phase 2 | United States |
| 4 | NCT05740722 (ClinicalTrials.gov) | March 1, 2023 | 30/1/2023 | Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis | Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study | Multiple Sclerosis;Progressive Multiple Sclerosis | Dietary Supplement: Nicotinamid riboside;Dietary Supplement: Placebo | Haukeland University Hospital | NULL | Not yet recruiting | 18 Years | 65 Years | All | 300 | Phase 2 | Norway |
| 5 | NCT05539729 (ClinicalTrials.gov) | February 8, 2023 | 12/9/2022 | Vancomycin Study in Multiple Sclerosis (MS) | Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis | Multiple Sclerosis | Drug: Vancomycin;Drug: Placebo | Icahn School of Medicine at Mount Sinai | Doris Duke Charitable Foundation | Recruiting | 18 Years | 45 Years | All | 40 | Phase 1 | United States |
| 6 | NCT05285891 (ClinicalTrials.gov) | January 12, 2023 | 8/3/2022 | Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis | Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05) | Multiple Sclerosis | Drug: Ocrelizumab;Drug: Placebo for Ocrelizumab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence (ACE);Rho Federal Systems Division, Inc.;Genentech, Inc. | Recruiting | 18 Years | 55 Years | All | 175 | Phase 4 | United States |
| 7 | EUCTR2022-003170-23-FI (EUCTR) | 20/12/2022 | 30/09/2022 | Hydroxychloroquine in progressive MS | Prospective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral hydroxychloroquine 200 mg BID for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS) | Progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Oxiklorin Product Name: Oxiklorin INN or Proposed INN: Hydroxychloroquine sulfate | Varsinais-Suomen sairaanhoitopiirin kuntayhtymä | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Finland | ||
| 8 | NCT05630547 (ClinicalTrials.gov) | December 19, 2022 | 7/11/2022 | A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis | A Phase 2 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effect of SAR443820 on Serum Neurofilament Levels in Participants With Multiple Sclerosis, Followed by an Open-label Long-term Extension Period | Multiple Sclerosis | Drug: SAR443820;Other: Placebo | Sanofi | NULL | Recruiting | 18 Years | 60 Years | All | 168 | Phase 2 | Belgium;Canada;China;France;Italy;Poland;Spain |
| 9 | EUCTR2021-000639-30-DE (EUCTR) | 16/12/2022 | 24/01/2022 | A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse. | A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, PlaceboControlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse | Patients with primary progressive or secondary progressive multiple sclerosis without relapse MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Russian Federation;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Greece;Canada;Sweden;Norway;Finland;Poland;South Africa;Italy;Israel;France;Bulgaria;Germany | ||
| 10 | NCT05730699 (ClinicalTrials.gov) | December 12, 2022 | 7/2/2023 | Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE) | A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica Spectrum Disorders | Biological: divozilimab;Drug: Placebo | Biocad | NULL | Recruiting | 18 Years | N/A | All | 105 | Phase 3 | Russian Federation |
| 11 | NCT05418010 (ClinicalTrials.gov) | December 1, 2022 | 17/2/2022 | Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS) | AttackMS: Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation | Multiple Sclerosis;Clinically Isolated Syndrome of Demyelination | Drug: Tysabri Injectable Product;Drug: Placebo | Queen Mary University of London | Biogen;UCL Queen Square Institute of Neurology;Moorfields Eye Hospital NHS Foundation Trust;Barts & The London NHS Trust | Recruiting | 18 Years | 45 Years | All | 40 | Phase 2 | United Kingdom |
| 12 | NCT05551598 (ClinicalTrials.gov) | November 15, 2022 | 20/9/2022 | Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Randomized, Double-blind, Placebo-controlled Phase ? Clinical Study to Evaluate the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: Mitoxantrone Hydrochloride Liposome Injection | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | NULL | Not yet recruiting | 18 Years | 60 Years | All | 45 | Phase 2 | NULL |
| 13 | NCT05092191 (ClinicalTrials.gov) | November 10, 2022 | 1/9/2021 | Cannabis as a Complementary Treatment in Multiple Sclerosis | Efficacy of Cannabinoids to the Current Standard Treatments on Symptom Relief in Persons With Multiple Sclerosis: Randomized Controlled Trial | Multiple Sclerosis | Drug: Cannabis oil vs placebo | Centre hospitalier de l'Université de Montréal (CHUM) | Canadian Institutes of Health Research (CIHR);Multiple Sclerosis Society of Canada | Recruiting | 21 Years | N/A | All | 250 | Phase 2 | Canada |
| 14 | NCT05403138 (ClinicalTrials.gov) | November 1, 2022 | 30/5/2022 | Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders | A Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders (NMOSD) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder;NMO Spectrum Disorder | Drug: Daratumumab;Drug: Placebo | Tianjin Medical University General Hospital | NULL | Recruiting | 18 Years | N/A | All | 72 | Phase 2/Phase 3 | China |
| 15 | NCT05439902 (ClinicalTrials.gov) | October 5, 2022 | 27/6/2022 | Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women | Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women | Multiple Sclerosis;Dysuria;Lower Urinary Tract Symptoms;Voiding Dysfunction;Urinary Retention | Drug: Tamsulosin;Drug: Placebo | Centre Hospitalier Universitaire de Nimes | NULL | Recruiting | 18 Years | N/A | Female | 60 | N/A | France |
| 16 | NCT04880577 (ClinicalTrials.gov) | September 15, 2022 | 30/4/2021 | Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis | Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Fatigue | Drug: TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY];Drug: Placebo | Massachusetts General Hospital | Gilead Sciences | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 17 | NCT05338450 (ClinicalTrials.gov) | August 30, 2022 | 6/4/2022 | Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis | Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis | Multiple Sclerosis;Internuclear Ophthalmoplegia | Drug: Clemastine Fumarate;Drug: Placebo | Amsterdam UMC, location VUmc | NULL | Recruiting | 18 Years | 70 Years | All | 80 | Phase 3 | Netherlands |
| 18 | JPRN-jRCT2071220034 | 02/08/2022 | 03/08/2022 | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib - Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib. | Relapsing Multiple Sclerosis | Core Part -Remibrutinib(LOU064) tablet and matching placebo of teriflunomide capsule -Teriflunomide capsule and matching placebo LOU064 tablet Extension part LOU064 tablet | Yamada Hiroyuki | NULL | Recruiting | >= 18age old | <= 55age old | Both | 30 | Phase 3 | US;Italy;Portugal;South Africa;France;Poland;Slovakia;Slovenia;Spain;Sweden;Turkey;Japan |
| 19 | EUCTR2022-000049-34-ES (EUCTR) | 21/07/2022 | 22/07/2022 | Phase 2 study of SAR443820 in participants with multiple sclerosis (MS) | A Phase 2 double blind, randomized, placebo controlled study evaluating the effect of SAR443820 on serum neurofilament levels in participants with multiple sclerosis, followed by an open label long-term extension period | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR443820 INN or Proposed INN: SAR443820 Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | France;United States;Czechia;Canada;Belgium;Poland;Spain;Germany;Italy;China | ||
| 20 | EUCTR2018-001896-19-DE (EUCTR) | 06/07/2022 | 05/04/2022 | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838-RC INN or Proposed INN: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 2 | Poland;Ukraine;Romania;Bulgaria;Germany | ||
| 21 | NCT05441488 (ClinicalTrials.gov) | June 28, 2022 | 28/6/2022 | Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis | A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse | Progressive Multiple Sclerosis | Drug: Placebo;Drug: Masitinib (4.5) | AB Science | NULL | Recruiting | 18 Years | 65 Years | All | 800 | Phase 3 | France;Greece;Italy;Poland;Russian Federation;Spain;Sweden;Ukraine |
| 22 | NCT05432713 (ClinicalTrials.gov) | May 14, 2022 | 14/6/2022 | A Study of LP-168 in Healthy Volunteers | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LP-168 Following Single and Multiple Oral Administration to Healthy Volunteers | Multiple Sclerosis;NMO Spectrum Disorder | Drug: LP-168 tablet;Drug: LP-168 Placebo tablet | Guangzhou Lupeng Pharmaceutical Company LTD. | NULL | Completed | 18 Years | 55 Years | All | 70 | Phase 1 | China |
| 23 | NCT05349474 (ClinicalTrials.gov) | April 26, 2022 | 21/4/2022 | Metformin Treatment in Progressive Multiple Sclerosis | A Double-blind, Placebo Controlled Trial of Metformin Treatment in Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Metformin 500 Mg Oral Tablet, up to 4 tablets a day;Drug: Placebo oral tablet identical to metformin, up to 4 tablets a day | University of California, Los Angeles | NULL | Recruiting | 30 Years | 65 Years | All | 44 | Early Phase 1 | United States |
| 24 | EUCTR2021-000028-36-LT (EUCTR) | 21/04/2022 | 04/11/2021 | Not applicable | A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 Product Name: Vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1050 | Phase 3 | United States;Belarus;Greece;Ukraine;Lithuania;Russian Federation;North Macedonia;Colombia;India;Mexico;Poland;Bulgaria;Albania;Georgia;Moldova, Republic of | ||
| 25 | NCT05417269 (ClinicalTrials.gov) | April 12, 2022 | 1/6/2022 | IMCY-0141 Safety and Efficacy in Multiple Sclerosis - ISEMIS Study | A Phase I/II Dose Escalation/Adaptive Design Study to Evaluate the Safety and Efficacy of IMCY-0141 in Patients With Relapsing Remitting-Multiple Sclerosis (RR-MS) | Multiple Sclerosis, Relapsing-Remitting | Drug: IMCY-0141;Drug: Placebo;Drug: Dimethyl Fumarate | Imcyse SA | NULL | Recruiting | 18 Years | 45 Years | All | 150 | Phase 1/Phase 2 | Moldova, Republic of |
| 26 | NCT05145361 (ClinicalTrials.gov) | April 7, 2022 | 21/11/2021 | Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) | A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD) | NMO Spectrum Disorder | Drug: B001 injection;Biological: Placebo | Shanghai Pharmaceuticals Holding Co., Ltd | NULL | Recruiting | 18 Years | 70 Years | All | 45 | Early Phase 1 | China |
| 27 | EUCTR2021-000639-30-GR (EUCTR) | 06/04/2022 | 04/02/2022 | A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse. | A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse. | Patients with primary progressive or secondary progressive multiple sclerosis without relapse MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Bulgaria;South Africa;Germany;Sweden | ||
| 28 | NCT05269628 (ClinicalTrials.gov) | March 25, 2022 | 13/2/2022 | Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype | Mechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain Phenotype | Multiple Sclerosis;Sleep;Pain | Drug: Cannabidiol (CBD);Drug: Tetrahydrocannabinol (THC);Drug: Placebo CBD;Drug: Placebo THC | Tiffany J. Braley, MD, MS | National Center for Complementary and Integrative Health (NCCIH) | Recruiting | 18 Years | 65 Years | All | 166 | Phase 2 | United States |
| 29 | EUCTR2021-003772-14-HR (EUCTR) | 11/03/2022 | 14/03/2022 | A Study to Evaluate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis | A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TOINVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;Egypt;Czechia;Slovenia;Slovakia;Morocco;Kenya;Croatia;Norway;Japan | ||
| 30 | NCT05131828 (ClinicalTrials.gov) | March 8, 2022 | 12/11/2021 | CCMR Two: A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial of the Ability of the Combination of Metformin and Clemastine to Promote Remyelination in People With Relapsing-remitting Multiple Sclerosis Already on Disease-modifying Therapy | CCMR Two: A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial of the Ability of the Combination of Metformin and Clemastine to Promote Remyelination in People With Relapsing-remitting Multiple Sclerosis Already on Disease-modifying Therapy | Multiple Sclerosis | Drug: Metformin and clemastine in combination;Drug: Placebo | Cambridge University Hospitals NHS Foundation Trust | University of Cambridge | Recruiting | 25 Years | 50 Years | All | 50 | Phase 2 | United Kingdom |
| 31 | EUCTR2021-000048-23-DE (EUCTR) | 03/03/2022 | 07/10/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;United States;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
| 32 | NCT05119569 (ClinicalTrials.gov) | March 1, 2022 | 29/10/2021 | A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) | A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Fenebrutinib;Drug: Placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 109 | Phase 2 | United States;Bosnia and Herzegovina;Croatia;Czechia;Serbia;Slovakia |
| 33 | NCT04877457 (ClinicalTrials.gov) | February 15, 2022 | 30/4/2021 | Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease. | A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Ocrelizumab in Patients With Radiologically Isolated Syndrome | Radiologically Isolated Syndrome;Multiple Sclerosis | Drug: Ocrelizumab;Other: Placebo | Yale University | Genentech, Inc. | Recruiting | 18 Years | 40 Years | All | 100 | Phase 4 | United States |
| 34 | EUCTR2021-000048-23-NL (EUCTR) | 10/02/2022 | 12/10/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 35 | NCT05123703 (ClinicalTrials.gov) | February 4, 2022 | 16/11/2021 | A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis | A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Ocrelizumab;Other: Ocrelizumab Placebo;Drug: Fingolimod;Other: Fingolimod Placebo | Hoffmann-La Roche | PPD | Recruiting | 10 Years | 17 Years | All | 233 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;Italy;Latvia;Mexico;Poland;Portugal;Serbia;Spain;Ukraine;United Kingdom;Denmark;Netherlands;Romania;Russian Federation;Switzerland;Turkey |
| 36 | EUCTR2020-004306-58-LT (EUCTR) | 28/01/2022 | 25/11/2021 | A study to asses the effects of Nabiximols on spasticity associated with multiple sclerosis. | A randomized double-blind placebo-controlled study of nabiximols in patients with spasticity in multiple sclerosis - RELEASE MSS4 | Symptomatic treatment of spasticity in patients with MS MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Hungary;Canada;Spain;Lithuania;Bulgaria;United Kingdom;Italy | ||
| 37 | EUCTR2021-000028-36-BG (EUCTR) | 18/01/2022 | 08/11/2021 | Not applicable | A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 Product Name: Vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1050 | Phase 3 | Colombia;Russian Federation;United States;Ukraine;Belarus;India;Albania;Greece;Moldova, Republic of;Poland;North Macedonia;Mexico;Georgia;Bulgaria;Lithuania | ||
| 38 | EUCTR2021-000639-30-ES (EUCTR) | 12/01/2022 | 20/09/2021 | A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse. | A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse. | Patients with primary progressive or secondary progressive multiple sclerosis without relapse MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Canada;Poland;South Africa;Bulgaria;Germany;Sweden;Portugal;United States;Greece;Finland;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary | ||
| 39 | NCT05201638 (ClinicalTrials.gov) | January 12, 2022 | 13/12/2021 | Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-2) | Multiple Sclerosis, Relapsing-Remitting | Drug: IMU-838 tablets;Drug: Placebo matching IMU-838 tablets | Immunic AG | NULL | Recruiting | 18 Years | 55 Years | All | 1050 | Phase 3 | United States;Armenia;Bosnia and Herzegovina;Estonia;India;Poland;Romania;Serbia;Turkey;Ukraine |
| 40 | NCT04764383 (ClinicalTrials.gov) | January 1, 2022 | 18/2/2021 | Histaminergic Basis of Fatigue in Multiple Sclerosis | Histaminergic Basis of Fatigue in Multiple Sclerosis | Multiple Sclerosis | Drug: L-Histidine;Drug: Placebo;Drug: Lodosyn | University of Miami | NULL | Withdrawn | 18 Years | 60 Years | All | 0 | Phase 2 | United States |
| 41 | EUCTR2021-000048-23-RO (EUCTR) | 27/12/2021 | 29/04/2022 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 42 | NCT05116540 (ClinicalTrials.gov) | November 24, 2021 | 27/10/2021 | Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis | A Randomized, Double-Blind, Single-Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: HB-adMSCs;Drug: Placebo | Hope Biosciences Stem Cell Research Foundation | NULL | Recruiting | 18 Years | 75 Years | All | 24 | Phase 2 | United States |
| 43 | EUCTR2021-003772-14-CZ (EUCTR) | 18/11/2021 | 27/08/2021 | A Study to Evaluate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis | A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TOINVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;Egypt;Czechia;Czech Republic;Slovenia;Slovakia;Morocco;Kenya;Croatia;Norway;Japan | ||
| 44 | NCT05134441 (ClinicalTrials.gov) | November 18, 2021 | 30/9/2021 | Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1) | Multiple Sclerosis | Drug: IMU-838 tablets;Drug: Placebo matching IMU-838 tablets | Immunic AG | NULL | Recruiting | 18 Years | 55 Years | All | 1050 | Phase 3 | Lithuania;Mexico;Moldova, Republic of;North Macedonia;Ukraine;United States;Albania;Bulgaria;Georgia;India |
| 45 | NCT04815967 (ClinicalTrials.gov) | November 16, 2021 | 11/2/2021 | Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity | Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC in Treatment of Adult Upper Limb Spasticity and Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC | Spasticity;Cerebrovascular Accident;Multiple Sclerosis;Traumatic Brain Injury;Cervical Spinal Cord Injury;Cerebral Palsy | Drug: Phase 2; Low Dose MYOBLOC; High Dose MYOBLOC; Placebo;Drug: Phase 3; MYOBLOC | Supernus Pharmaceuticals, Inc. | Solstice Neurosciences | Active, not recruiting | 18 Years | 80 Years | All | 272 | Phase 2/Phase 3 | United States;Czechia |
| 46 | EUCTR2021-000048-23-PL (EUCTR) | 04/11/2021 | 12/08/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients withProgressive Multiple Sclerosis - CALLIPER study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;United States;Czechia;Canada;Poland;Ukraine;Romania;North Macedonia;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
| 47 | NCT05131971 (ClinicalTrials.gov) | November 1, 2021 | 27/10/2021 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants | A Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3888130B in Healthy Participants Aged 18-55 Inclusive | Multiple Sclerosis | Drug: Placebo;Drug: GSK3888130B | GlaxoSmithKline | NULL | Recruiting | 18 Years | 55 Years | All | 70 | Phase 1 | United Kingdom |
| 48 | NCT05122559 (ClinicalTrials.gov) | November 2021 | 8/11/2021 | Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis | Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Secondary Progressive | Drug: N-acetyl cysteine;Drug: Placebo | Emmanuelle Waubant | United States Department of Defense | Not yet recruiting | 40 Years | 70 Years | All | 98 | Phase 2 | NULL |
| 49 | EUCTR2021-000048-23-BG (EUCTR) | 28/10/2021 | 28/09/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
| 50 | NCT04926818 (ClinicalTrials.gov) | October 5, 2021 | 14/6/2021 | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis | A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension | Multiple Sclerosis (MS) | Drug: Fingolimod;Drug: Ofatumumab;Drug: Siponimod;Other: Fingolimod placebo;Other: Siponimod placebo;Other: Ofatumumab placebo | Novartis Pharmaceuticals | NULL | Recruiting | 10 Years | 17 Years | All | 180 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Croatia;Estonia;France;Germany;Guatemala;India;Israel;Italy;Latvia;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Taiwan;Turkey |
| 51 | NCT05029609 (ClinicalTrials.gov) | October 2021 | 27/8/2021 | Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS | A Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MS | Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple Sclerosis | Drug: Intranasal Foralumab Solution;Drug: Placebo | Tiziana Life Sciences, PLC | NULL | Not yet recruiting | 25 Years | 70 Years | All | 55 | Phase 1 | NULL |
| 52 | NCT05054140 (ClinicalTrials.gov) | September 30, 2021 | 2/9/2021 | Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: IMU-838;Drug: Placebo matching IMU-838 | Immunic AG | NULL | Recruiting | 18 Years | 65 Years | All | 450 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Moldova, Republic of;Netherlands;North Macedonia;Poland;Romania;Serbia;Ukraine |
| 53 | NCT04990219 (ClinicalTrials.gov) | September 27, 2021 | 29/7/2021 | A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis | Interventional, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 1B Study Investigating the Effects of Lu AG06466 for the Treatment of Spasticity in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Lu AG06466;Drug: Placebo | H. Lundbeck A/S | NULL | Terminated | 18 Years | 70 Years | All | 37 | Phase 1 | United States;Germany |
| 54 | NCT04984278 (ClinicalTrials.gov) | August 16, 2021 | 14/7/2021 | Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients With Multiple Sclerosis | Spasticity With Multiple Sclerosis | Drug: Nabiximols;Drug: Placebo | Jazz Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 56 | Phase 3 | United States;Czechia;Poland;Spain;United Kingdom |
| 55 | EUCTR2020-004785-19-DE (EUCTR) | 07/07/2021 | 17/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 56 | EUCTR2020-003271-18-ES (EUCTR) | 01/07/2021 | 05/07/2021 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex 2,7mg/2,5 mg Solucion para pulverizacion bucal Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Czechia;Czech Republic;Poland;Belgium;Spain;Australia;United Kingdom;Sweden | ||
| 57 | NCT04079088 (ClinicalTrials.gov) | June 30, 2021 | 3/9/2019 | Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) | A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Placebo;Drug: BIIB061;Biological: Interferon-beta1;Drug: Glatiramer acetate | Biogen | NULL | Not yet recruiting | 18 Years | 55 Years | All | 300 | Phase 2 | NULL |
| 58 | NCT04695080 (ClinicalTrials.gov) | June 25, 2021 | 6/11/2020 | ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis | ChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function? | Advanced Multiple Sclerosis;Progressive Multiple Sclerosis | Drug: Cladribine (MAVENCLAD®);Drug: Placebo | Queen Mary University of London | National Institute for Health Research, United Kingdom;Merck Serono Limited, UK;Multiple Sclerosis Society of Great Britain & Northern Ireland;National Multiple Sclerosis Society;Barts & The London NHS Trust | Recruiting | 18 Years | N/A | All | 200 | Phase 2/Phase 3 | United Kingdom |
| 59 | EUCTR2020-003271-18-CZ (EUCTR) | 07/06/2021 | 07/04/2021 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Czechia;Czech Republic;Spain;Poland;United Kingdom | ||
| 60 | NCT04879628 (ClinicalTrials.gov) | June 7, 2021 | 6/5/2021 | Proof-of-concept Study for SAR441344 in Relapsing Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: SAR441344 IV;Drug: placebo IV;Drug: SAR441344 SC;Drug: placebo SC;Drug: MRI contrast-enhancing preparations | Sanofi | NULL | Active, not recruiting | 18 Years | 55 Years | All | 129 | Phase 2 | United States;Bulgaria;Canada;Czechia;France;Germany;Russian Federation;Spain;Turkey;Ukraine |
| 61 | NCT05730738 (ClinicalTrials.gov) | June 1, 2021 | 5/12/2021 | Dalfampridine in Egyptian Patients With Multiple Sclerosis | Effect of Dalfampridine on Gait Impairment, Cognition and Fatigue in Egyptian Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Dalfampridine ER, 10 Mg Oral Tablet, Extended Release;Drug: Placebo | Ain Shams University | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | Egypt |
| 62 | EUCTR2020-004785-19-CZ (EUCTR) | 01/06/2021 | 05/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany | ||
| 63 | EUCTR2019-002625-29-CZ (EUCTR) | 18/05/2021 | 10/03/2021 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 3 | Czechia;Czech Republic;Poland;United Kingdom | ||
| 64 | EUCTR2020-000645-14-HR (EUCTR) | 17/05/2021 | 02/09/2021 | PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;Italy;Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland | ||
| 65 | EUCTR2020-004785-19-BG (EUCTR) | 28/04/2021 | 09/03/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 66 | NCT04843813 (ClinicalTrials.gov) | March 26, 2021 | 7/4/2021 | Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients- | Lutein and Multiple Sclerosis Experimental Study (LuMES) | Multiple Sclerosis | Dietary Supplement: Lutein;Dietary Supplement: Placebo | University of Illinois at Urbana-Champaign | Division of Nutritional Sciences, University of Illinois at Urbana-Champaign;National Institutes of Health Rehabilitation Research Resource to Enhance Clinical Trials (REACT) | Recruiting | 18 Years | 64 Years | All | 60 | N/A | United States |
| 67 | NCT04586023 (ClinicalTrials.gov) | March 24, 2021 | 8/10/2020 | Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Fenebrutinib;Drug: Teriflunomide;Drug: Placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 736 | Phase 3 | United States;Austria;Brazil;Bulgaria;Canada;Denmark;France;Greece;Guatemala;India;Italy;Korea, Republic of;Mexico;Poland;Puerto Rico;Russian Federation;Turkey;United Kingdom |
| 68 | NCT04586010 (ClinicalTrials.gov) | March 17, 2021 | 8/10/2020 | A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Fenebrutinib;Drug: Teriflunomide;Drug: Placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 736 | Phase 3 | United States;Argentina;China;Dominican Republic;Finland;Germany;Hong Kong;Hungary;Italy;Mexico;Netherlands;North Macedonia;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Taiwan;Ukraine |
| 69 | NCT04711148 (ClinicalTrials.gov) | March 1, 2021 | 8/1/2021 | A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity | Relapsing Remitting Multiple Sclerosis | Other: placebo;Drug: orelabrutinib | Beijing InnoCare Pharma Tech Co., Ltd. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 160 | Phase 2 | United States;China;Poland;Ukraine |
| 70 | EUCTR2020-000647-30-PT (EUCTR) | 26/02/2021 | 17/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Norway;Japan | ||
| 71 | EUCTR2020-000645-14-PT (EUCTR) | 26/02/2021 | 23/11/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Belarus;Portugal;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 72 | NCT04725175 (ClinicalTrials.gov) | February 26, 2021 | 18/1/2021 | Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers | A Phase I, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PIPE-307 and Food Effect in Normal Healthy Volunteers | Multiple Sclerosis | Drug: PIPE-307;Drug: Placebo oral tablet | Pipeline Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 70 | Phase 1 | Australia |
| 73 | JPRN-jRCT2021200035 | 22/02/2021 | 24/12/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis | Drug: SAR442168 (Tolebrutinib) Pharmaceutical form: Tablet, Route of administration: Oral Drug: Placebo to match SAR442168 (Tolebrutinib) Pharmaceutical form: Tablet, Route of administration: Oral Drug: Teriflunomide HMR1726 Pharmaceutical form: Tablet, Route of administration: Oral Drug: Placebo to match Teriflunomide Pharmaceutical form: Tablet, Route of administration: Oral | Tanaka Tomoyuki | NULL | Not Recruiting | >= 18age old | <= 55age old | Both | 900 | Phase 3 | Bulgaria;Canada;Czechia;Estonia;Spain;United States;Belarus;China;Finland;Germany;Italy;Lithuania;Poland;Romania;Russian Federation;Sweden;Taiwan;Turkey;Ukraine;Denmark;Austria;Mexico;Japan |
| 74 | EUCTR2020-000645-14-BE (EUCTR) | 22/02/2021 | 29/10/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 75 | EUCTR2020-000645-14-NL (EUCTR) | 12/02/2021 | 16/11/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Latvia;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 76 | EUCTR2020-000645-14-DE (EUCTR) | 28/01/2021 | 26/10/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosinekinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 77 | EUCTR2020-000645-14-HU (EUCTR) | 10/01/2021 | 02/11/2020 | PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;Italy;India;France;United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland | ||
| 78 | EUCTR2020-000647-30-NL (EUCTR) | 23/12/2020 | 16/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan | ||
| 79 | EUCTR2020-000645-14-CZ (EUCTR) | 03/12/2020 | 22/10/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 80 | EUCTR2018-005038-39-GB (EUCTR) | 02/12/2020 | 29/09/2020 | A phase 2b study of Cladribine to halt deterioration in people with advanced multiple sclerosis | ChariotMS – A national (UK), multi-centre, randomised, double-blind, placebo-controlled (1:1) phase IIb efficacy trial with cost-utility analysis of cladribine tablets (3.5mg/kg over two years) in people with advanced multiple sclerosis (EDSS 6.5-8.5). Is cladribine superior to placebo in protecting upper limb function? - ChariotMS - Cladribine for people with advanced multiple sclerosis | Advanced Multiple Sclerosis (EDSS 6.5-8.5) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;Level: LLT;Classification code 10078558;Term: Multiple sclerosis plaque;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1;Classification code 10028246;Term: Multiple sclerosis aggravated;Classification code 10078559;Term: Multiple sclerosis brain lesion;System Organ Class: 10028245 - Multiple sclerosis MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10064137;Term: Progression of multiple sclerosis;Classification code 10053395;Term: Progressive multiple sclerosis;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;Level: PTClassification co;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: MAVENCLAD INN or Proposed INN: Cladribine | Queen Mary University of London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United Kingdom | ||
| 81 | EUCTR2019-001967-58-FR (EUCTR) | 20/11/2020 | 27/05/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Poland;Belgium;Germany;Switzerland;Italy | ||
| 82 | EUCTR2020-000645-14-IT (EUCTR) | 11/11/2020 | 15/06/2021 | Primary Progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: [SAR442168] Other descriptive name: PRN2246 | GENZYME CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 83 | NCT04602390 (ClinicalTrials.gov) | November 6, 2020 | 5/10/2020 | Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis | A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis (MS);Relapsing Remitting Multiple Sclerosis | Drug: ANK-700;Drug: Placebo | Anokion SA | NULL | Recruiting | 18 Years | 60 Years | All | 33 | Phase 1 | United States |
| 84 | EUCTR2020-000647-30-CZ (EUCTR) | 05/11/2020 | 08/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan | ||
| 85 | EUCTR2020-000645-14-EE (EUCTR) | 03/11/2020 | 24/08/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 86 | EUCTR2020-000645-14-GR (EUCTR) | 29/10/2020 | 26/10/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Portugal;Belarus;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 87 | EUCTR2020-000647-30-PL (EUCTR) | 28/10/2020 | 30/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (HERCULES) - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Norway;Japan | ||
| 88 | NCT04544449 (ClinicalTrials.gov) | October 26, 2020 | 4/9/2020 | A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis | A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis. | Multiple Sclerosis, Primary Progressive | Drug: Fenebrutinib;Drug: Ocrelizumab;Drug: Placebo matched to ocrelizumab;Drug: Placebo matched to fenebrutinib | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 946 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Bulgaria;Canada;Chile;Colombia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Mexico;North Macedonia;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Belgium;Czechia;New Zealand |
| 89 | EUCTR2019-001967-58-PL (EUCTR) | 26/10/2020 | 25/06/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Belgium;Poland;Germany;Switzerland;Italy | ||
| 90 | EUCTR2020-000647-30-LT (EUCTR) | 22/10/2020 | 14/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan | ||
| 91 | EUCTR2020-000645-14-DK (EUCTR) | 21/10/2020 | 16/10/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia | ||
| 92 | EUCTR2020-000645-14-GB (EUCTR) | 16/10/2020 | 07/10/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 93 | EUCTR2020-000647-30-IT (EUCTR) | 14/10/2020 | 15/06/2021 | nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: - Product Code: [SAR442168] Other descriptive name: PRN2246 | GENZYME CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan | ||
| 94 | EUCTR2020-000645-14-FR (EUCTR) | 13/10/2020 | 27/07/2020 | PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 95 | EUCTR2020-000647-30-FI (EUCTR) | 13/10/2020 | 10/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan | ||
| 96 | EUCTR2020-000647-30-DK (EUCTR) | 08/10/2020 | 11/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan | ||
| 97 | EUCTR2019-003352-37-PL (EUCTR) | 05/10/2020 | 06/07/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 98 | EUCTR2020-000645-14-BG (EUCTR) | 01/10/2020 | 28/07/2020 | Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS | Primary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Serbia;Portugal;Belarus;United Arab Emirates;United States;Saudi Arabia;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Denmark;Australia;Peru;South Africa;Netherlands;Kuwait;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 99 | NCT04203498 (ClinicalTrials.gov) | October 1, 2020 | 17/12/2019 | Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: Nabiximols;Drug: Placebo | Jazz Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 238 | Phase 3 | United States;Czechia;Poland;Romania;United Kingdom |
| 100 | EUCTR2020-000647-30-RO (EUCTR) | 30/09/2020 | 17/05/2022 | NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan | ||
| 101 | NCT04411641 (ClinicalTrials.gov) | September 24, 2020 | 28/5/2020 | Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) | A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: Tolebrutinib;Drug: Placebo to match Tolebrutinib | Sanofi | NULL | Active, not recruiting | 18 Years | 60 Years | All | 1131 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Lithuania;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Spain;Turkey;Ukraine;United Kingdom |
| 102 | EUCTR2020-000647-30-DE (EUCTR) | 16/09/2020 | 29/06/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study ofBruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168(HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan | ||
| 103 | EUCTR2020-000647-30-GR (EUCTR) | 15/09/2020 | 15/09/2020 | NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan | ||
| 104 | EUCTR2020-000647-30-GB (EUCTR) | 09/09/2020 | 07/09/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan | ||
| 105 | EUCTR2020-000647-30-BG (EUCTR) | 27/08/2020 | 16/06/2020 | Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES) | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES | Non-relapsing Secondary Progressive Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan | ||
| 106 | NCT04458051 (ClinicalTrials.gov) | August 13, 2020 | 1/7/2020 | Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) | A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS) | Primary Progressive Multiple Sclerosis | Drug: Tolebrutinib;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 990 | Phase 3 | Switzerland;Turkey;Ukraine;United Kingdom;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Latvia;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Sweden;United States |
| 107 | NCT04338061 (ClinicalTrials.gov) | July 2, 2020 | 6/4/2020 | Study of Evobrutinib in Participants With RMS (evolutionRMS 2) | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2) | Relapsing Multiple Sclerosis | Drug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib) | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | EMD Serono Research & Development Institute, Inc. | Active, not recruiting | 18 Years | 55 Years | All | 1124 | Phase 3 | United States;Belarus;Brazil;Bulgaria;Canada;France;Germany;Greece;India;Italy;Latvia;Lithuania;Malaysia;Moldova, Republic of;Norway;Philippines;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Saudi Arabia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;Turkey;Ukraine |
| 108 | EUCTR2017-003008-30-GB (EUCTR) | 01/07/2020 | 17/05/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 | Multiple Sclerosis (Secondary Progressive) MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets Product Code: Not applicable INN or Proposed INN: Simvastatin | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | ||
| 109 | NCT04338022 (ClinicalTrials.gov) | June 12, 2020 | 6/4/2020 | Study of Evobrutinib in Participants With RMS (evolutionRMS 1) | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1) | Relapsing Multiple Sclerosis | Drug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib) | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | EMD Serono Research & Development Institute, Inc. | Active, not recruiting | 18 Years | 55 Years | All | 1124 | Phase 3 | France;Georgia;Germany;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Finland;United States |
| 110 | EUCTR2019-003352-37-NL (EUCTR) | 11/06/2020 | 24/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 111 | EUCTR2019-004822-15-SE (EUCTR) | 18/05/2020 | 17/01/2020 | A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS) - ProTEct-MS | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab | GeNeuro Innovation SAS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Sweden | ||
| 112 | EUCTR2019-003352-37-DE (EUCTR) | 11/05/2020 | 06/01/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | Germany;Netherlands;Japan;Korea, Republic of;United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark | ||
| 113 | EUCTR2019-002623-14-PL (EUCTR) | 15/04/2020 | 21/01/2020 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czechia;Czech Republic;Poland;Romania;United Kingdom | ||
| 114 | NCT04267926 (ClinicalTrials.gov) | April 1, 2020 | 11/2/2020 | MitoQ for Fatigue in Multiple Sclerosis (MS) | MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial | Multiple Sclerosis;Fatigue | Drug: 20 mg MitoQ;Drug: Placebo;Drug: 40mg of MitoQ | VA Office of Research and Development | NULL | Recruiting | 18 Years | 70 Years | All | 60 | Phase 1/Phase 2 | United States |
| 115 | EUCTR2019-003352-37-AT (EUCTR) | 27/03/2020 | 13/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 116 | EUCTR2019-002623-14-CZ (EUCTR) | 17/03/2020 | 19/12/2019 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray (non-marketed) INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czechia;Czech Republic;Poland;Romania;United Kingdom | ||
| 117 | EUCTR2018-001511-73-DE (EUCTR) | 17/03/2020 | 17/06/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 118 | EUCTR2019-002625-29-GB (EUCTR) | 16/03/2020 | 18/06/2020 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis - Study in MS patient Naïve to treatment with Nabiximols | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Sativex Oromucosal Spray INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 3 | Poland;United Kingdom | ||
| 119 | EUCTR2018-001511-73-IE (EUCTR) | 16/03/2020 | 08/05/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 120 | NCT02057159 (ClinicalTrials.gov) | March 9, 2020 | 4/2/2014 | A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis | A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis | Secondary Progress Multiple Sclerosis;Multiple Sclerosis | Biological: NeuroVax;Biological: IFA Placebo | Immune Response BioPharma, Inc. | cro | Recruiting | 18 Years | 50 Years | All | 200 | Phase 2/Phase 3 | United States |
| 121 | EUCTR2018-001511-73-RO (EUCTR) | 06/03/2020 | 17/03/2022 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 122 | EUCTR2019-003352-37-IT (EUCTR) | 04/03/2020 | 17/06/2021 | A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - NA | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultromiris Product Name: Ravulizumab Product Code: [ALXN1210] | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 123 | EUCTR2018-001511-73-PT (EUCTR) | 02/03/2020 | 30/04/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 124 | EUCTR2019-003352-37-ES (EUCTR) | 25/02/2020 | 14/01/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | Russian Federation;United States;Japan;United Kingdom;Spain;Canada;Austria;Netherlands;Turkey;Denmark;Korea, Republic of;Poland;Italy;Australia;France;Germany | ||
| 125 | NCT04121468 (ClinicalTrials.gov) | February 24, 2020 | 2/10/2019 | A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children With Multiple Sclerosis | A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children With Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: Metformin;Other: Placebo | The Hospital for Sick Children | Queen's University;Ontario Institute for Regenerative Medicine;Unity Health Toronto;Stem Cell Network;Multiple Sclerosis Society of Canada | Recruiting | 10 Years | 25 Years | All | 30 | Phase 1/Phase 2 | Canada |
| 126 | EUCTR2019-002623-14-GB (EUCTR) | 24/02/2020 | 18/03/2020 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis - Nabiximols Oromucosal Spray as Add-on Therapy in Patients with MS | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: UK: Sativex Oromucosal Spray Product Name: UK: Sativex Oromucosal Spray INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czech Republic;Poland;Romania;United Kingdom | ||
| 127 | EUCTR2019-003352-37-DK (EUCTR) | 15/01/2020 | 19/12/2019 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 128 | EUCTR2019-002625-29-PL (EUCTR) | 14/01/2020 | 21/11/2019 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 3 | Czechia;Czech Republic;Poland;United Kingdom | ||
| 129 | EUCTR2018-000001-23-CZ (EUCTR) | 13/01/2020 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol 25 mg/ml, oral drops Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Not Recruiting | Female: yes Male: yes | 548 | Phase 3 | Hungary;Czech Republic;Spain | ||
| 130 | EUCTR2018-001511-73-GB (EUCTR) | 23/12/2019 | 09/04/2019 | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HAND | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HAND | Trade Name: Ocrevus Product Name: Ocrevus Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: no | 1000 | Phase 3 | Portugal;Hungary;Poland;Spain;Ireland;Croatia;Bulgaria;Germany;United Kingdom | |||
| 131 | EUCTR2018-001511-73-HU (EUCTR) | 18/12/2019 | 08/11/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 132 | EUCTR2018-001511-73-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 133 | NCT04201262 (ClinicalTrials.gov) | December 13, 2019 | 11/12/2019 | An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Biological: Ravulizumab | Alexion | NULL | Active, not recruiting | 18 Years | N/A | All | 58 | Phase 3 | United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain;United Kingdom |
| 134 | EUCTR2018-000284-93-EE (EUCTR) | 10/12/2019 | 02/10/2019 | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GA Depot INN or Proposed INN: GLATIRAMER ACETATE | Mapi Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | United States;Serbia;Belarus;Estonia;Ukraine;Russian Federation;Israel;Montenegro;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Croatia;Romania;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 135 | NCT04211740 (ClinicalTrials.gov) | December 6, 2019 | 17/12/2019 | Phase II Clinical Trial of OCH-NCNP1 | Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive | Drug: OCH-NCNP1;Drug: Placebo | National Center of Neurology and Psychiatry, Japan | NULL | Active, not recruiting | 20 Years | 65 Years | All | 30 | Phase 2 | Japan |
| 136 | EUCTR2018-000284-93-BG (EUCTR) | 15/11/2019 | 08/10/2019 | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GA Depot INN or Proposed INN: GLATIRAMER ACETATE | Mapi Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Belarus;Estonia;Ukraine;Russian Federation;Israel;Georgia;Bulgaria;Montenegro;Moldova, Republic of;Bosnia and Herzegovina | ||
| 137 | NCT03910738 (ClinicalTrials.gov) | October 29, 2019 | 1/4/2019 | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection;Drug: Placebo 4 mL Solution for Injection;Procedure: MRI;Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities;Behavioral: Assessment of disability | University Hospital, Strasbourg, France | Bayer;Fédération Hospitalo-Universitaire NEUROGENYCS | Recruiting | 18 Years | 55 Years | Male | 40 | Phase 2 | France |
| 138 | EUCTR2018-001511-73-BG (EUCTR) | 02/10/2019 | 19/06/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 812 | Phase 3 | Serbia;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 139 | EUCTR2018-001511-73-PL (EUCTR) | 30/09/2019 | 06/08/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand | ||
| 140 | EUCTR2017-001224-22-IT (EUCTR) | 24/09/2019 | 20/01/2021 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: N/A Product Name: Opicinumab Product Code: [BIIB033] INN or Proposed INN: Opicinumab | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Sweden;United States;Czechia;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands | ||
| 141 | NCT04035889 (ClinicalTrials.gov) | September 23, 2019 | 25/7/2019 | Melatonin for Sleep in MS | A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS) | Multiple Sclerosis | Dietary Supplement: Melatonin;Dietary Supplement: Placebo | University of California, San Francisco | NULL | Completed | 20 Years | 70 Years | All | 30 | N/A | United States |
| 142 | NCT04121221 (ClinicalTrials.gov) | September 19, 2019 | 8/10/2019 | A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS | A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo | Multiple Sclerosis, Relapsing-Remitting | Drug: GA Depot;Other: Placebo | Mapi Pharma Ltd. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 1016 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Estonia;Georgia;Israel;Moldova, Republic of;Russian Federation;Ukraine |
| 143 | NCT04032171 (ClinicalTrials.gov) | September 10, 2019 | 23/7/2019 | Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety | Relapsing-remitting Multiple Sclerosis | Drug: Evobrutinib;Drug: Avonex®;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Terminated | 18 Years | 55 Years | All | 1 | Phase 3 | United States;Germany |
| 144 | NCT04002934 (ClinicalTrials.gov) | September 10, 2019 | 25/6/2019 | Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis | A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a Remyelinating Agent in Patients With Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Bazedoxifene Acetate | Riley Bove, MD | NULL | Recruiting | 40 Years | 65 Years | Female | 50 | Phase 2 | United States |
| 145 | EUCTR2018-001511-73-IT (EUCTR) | 03/09/2019 | 17/06/2021 | Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - N/A | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: [RO4964913/F07-01] INN or Proposed INN: Ocrelizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;Belarus;United States;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Peru;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand | ||
| 146 | NCT04032158 (ClinicalTrials.gov) | August 26, 2019 | 23/7/2019 | Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS) | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety | Relapsing-remitting Multiple Sclerosis | Drug: Evobrutinib;Drug: Avonex®;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Terminated | 18 Years | 55 Years | All | 3 | Phase 3 | United States;Germany;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;Mexico;Montenegro;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom |
| 147 | EUCTR2018-001511-73-ES (EUCTR) | 21/08/2019 | 04/07/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 148 | NCT04035005 (ClinicalTrials.gov) | August 12, 2019 | 17/7/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis | A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 1000 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Colombia;Croatia;Egypt;France;Georgia;Germany;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Tunisia;Ukraine;United Kingdom;Brazil;Netherlands |
| 149 | EUCTR2018-000516-22-PT (EUCTR) | 08/07/2019 | 27/11/2018 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacyand Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 3 | United States;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Greece;Thailand;Turkey;Israel;Russian Federation;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 150 | NCT03888924 (ClinicalTrials.gov) | June 17, 2019 | 4/9/2018 | Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) | Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) | Multiple Sclerosis | Drug: Bacille Calmette-Guerin vaccine;Drug: Placebo | S. Andrea Hospital | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | Italy |
| 151 | NCT02769689 (ClinicalTrials.gov) | June 12, 2019 | 17/3/2016 | Methylprednisolone During the Switch Between Natalizumab and Fingolimod | Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY) | Multiple Sclerosis | Drug: Methylprednisolone;Drug: Placebo;Drug: natalizumab (NTZ);Drug: fingolimob (FTY) | University Hospital, Clermont-Ferrand | NULL | Recruiting | 18 Years | 65 Years | All | 56 | Phase 4 | France |
| 152 | NCT04056897 (ClinicalTrials.gov) | June 7, 2019 | 12/8/2019 | Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis | International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mg | Biocad | NULL | Active, not recruiting | 18 Years | 60 Years | All | 270 | Phase 2 | Russian Federation |
| 153 | NCT03783416 (ClinicalTrials.gov) | June 1, 2019 | 10/12/2018 | SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis | Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis: A Phase 1b Randomised, Double-blind, Placebo-controlled Trial. | Relapsing Remitting Multiple Sclerosis;Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Drug: Ixazomib (NINLARO®) capsules / Matching placebo capsules | Queen Mary University of London | Takeda Pharmaceuticals International, Inc. | Not yet recruiting | 18 Years | 65 Years | All | 72 | Phase 1 | United Kingdom |
| 154 | NCT03896217 (ClinicalTrials.gov) | May 16, 2019 | 26/10/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A Double-blind, Randomised, Placebo-controlled Single-site Study of High Dose Simvastatin Treatment for Secondary Progressive Multiple Sclerosis: Impact on Vascular Perfusion and Oxidative Damage | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin | University College, London | MS Society | Recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | United Kingdom |
| 155 | NCT03824938 (ClinicalTrials.gov) | April 30, 2019 | 9/1/2019 | Aspirin for Exercise in Multiple Sclerosis (ASPIRE) | Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: Aspirin 650mg Oral Capsule;Drug: Acetaminophen Tablet 650mg;Other: Placebo | Columbia University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | 18 Years | 70 Years | All | 60 | Phase 3 | United States |
| 156 | EUCTR2012-000541-12-HR (EUCTR) | 23/04/2019 | 17/05/2019 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 157 | NCT03710655 (ClinicalTrials.gov) | April 2019 | 6/10/2018 | Evaluate Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality of Life in MS Patients | Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and QOL in MS Patients | Multiple Sclerosis | Drug: Apitox - pure honeybee toxin;Drug: Placebo | Apimeds, Inc. | NULL | Unknown status | 18 Years | 65 Years | All | 468 | Phase 3 | NULL |
| 158 | NCT03889639 (ClinicalTrials.gov) | March 29, 2019 | 1/3/2019 | Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis | A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: SAR442168;Drug: Placebo;Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 130 | Phase 2 | United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Slovakia;Spain;Ukraine;Sweden |
| 159 | NCT03870763 (ClinicalTrials.gov) | March 19, 2019 | 7/3/2019 | Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate;Drug: Peginterferon Beta-1a;Drug: Placebo | Biogen | NULL | Terminated | 10 Years | 17 Years | All | 11 | Phase 3 | United States;Colombia;Estonia;Hungary;Jordan;Korea, Republic of;Malaysia;Mexico;Saudi Arabia;Taiwan;Thailand;Tunisia;Turkey |
| 160 | EUCTR2018-000516-22-HU (EUCTR) | 04/03/2019 | 02/01/2019 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 161 | NCT03737812 (ClinicalTrials.gov) | February 27, 2019 | 6/11/2018 | A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: elezanumab;Drug: placebo | AbbVie | NULL | Completed | 18 Years | 65 Years | All | 123 | Phase 2 | United States;Canada |
| 162 | NCT03756974 (ClinicalTrials.gov) | February 18, 2019 | 20/11/2018 | BX-1 in Spasticity Due to Multiple Sclerosis | A Phase III, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Efficacy and Safety of BX-1 for the Symptomatic Relief of Spasticity in Patients With Multiple Sclerosis (MS) | Spasticity Due to Multiple Sclerosis | Drug: BX-1;Drug: Placebo | Bionorica SE | NULL | Completed | 18 Years | 65 Years | All | 397 | Phase 3 | Czechia;Germany;Hungary;Poland;Spain |
| 163 | NCT03752307 (ClinicalTrials.gov) | February 15, 2019 | 15/11/2018 | Safety and Tolerability of ISX (Isoxsuprine HCL) in MS Relapses | Double-blind, Placebo-controlled, Randomized Study of the Safety and Tolerability of Isoxsuprine HCL Combined With High Dose Steroid Treatment of Multiple Sclerosis (MS) Relapse | Multiple Sclerosis | Drug: Isoxsuprine Hydrochloride;Drug: Placebo;Drug: Corticosteroid | University of New Mexico | NULL | Completed | 18 Years | 50 Years | All | 2 | Phase 1/Phase 2 | United States |
| 164 | NCT03846219 (ClinicalTrials.gov) | January 28, 2019 | 21/1/2019 | MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS) | Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial Assessing the Effect of IMU-838 on Disease Activity, as Measured by Magnetic Resonance Imaging (MRI), as Well as Safety and Tolerability in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: IMU-838 (30 mg/day);Drug: IMU-838 (45 mg/day);Drug: Placebo | Immunic AG | NULL | Active, not recruiting | 18 Years | 55 Years | All | 210 | Phase 2 | Bulgaria;Poland;Romania;Ukraine |
| 165 | NCT04086225 (ClinicalTrials.gov) | January 17, 2019 | 9/9/2019 | Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon® | A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the Pharmacokinetics of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With Relapsing Multiple Sclerosis (RMS). | Relapsing Multiple Sclerosis (RMS) | Drug: Cladribine;Drug: Placebo;Drug: Microgynon® | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Recruiting | 18 Years | 45 Years | Female | 34 | Phase 1 | Germany;Poland |
| 166 | NCT03745144 (ClinicalTrials.gov) | January 17, 2019 | 14/11/2018 | Effects of Cladribine Tablets on the PK of Microgynon® | A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the PK of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With RMS | Relapsing Multiple Sclerosis (RMS) | Drug: Cladribine;Drug: Placebo;Drug: Microgynon® | Merck KGaA, Darmstadt, Germany | NULL | Completed | 18 Years | 45 Years | Female | 24 | Phase 1 | Germany;Poland |
| 167 | EUCTR2018-000516-22-EE (EUCTR) | 14/01/2019 | 17/12/2018 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3- Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Estonia;Taiwan;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 168 | EUCTR2018-001896-19-BG (EUCTR) | 17/12/2018 | 11/10/2018 | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838-RC INN or Proposed INN: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 2 | Poland;Ukraine;Romania;Bulgaria | ||
| 169 | NCT03737851 (ClinicalTrials.gov) | December 11, 2018 | 6/11/2018 | A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: elezanumab;Drug: placebo | AbbVie | NULL | Completed | 18 Years | 65 Years | All | 208 | Phase 2 | United States;Canada |
| 170 | EUCTR2018-002315-98-DK (EUCTR) | 06/12/2018 | 09/07/2018 | The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury. | The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI | Central neuropathic pain and spasticity MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol capsule 5 mg Product Code: N/A INN or Proposed INN: Cannabidiol Other descriptive name: CBD Product Name: Dronabinol capsule 2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC INN or Proposed INN: Cannabidiol Other descriptive name: CBD | Aarhus Universitetshospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Denmark | ||
| 171 | EUCTR2018-000001-23-ES (EUCTR) | 06/11/2018 | 23/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Not Recruiting | Female: yes Male: yes | 548 | Phase 3 | Czech Republic;Hungary;Spain | ||
| 172 | EUCTR2018-000001-23-HU (EUCTR) | 25/10/2018 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol 25 mg/ml, oral drops Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Not Recruiting | Female: yes Male: yes | 548 | Phase 3 | Czech Republic;Hungary;Spain | ||
| 173 | NCT03740295 (ClinicalTrials.gov) | October 5, 2018 | 5/10/2018 | Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis | Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Coconut oil and epigallocatechin gallate;Other: Placebo | Fundación Universidad Católica de Valencia San Vicente Mártir | Valencian Institute of Neurorehabilitation Foundation | Completed | 19 Years | 65 Years | All | 60 | Phase 2 | Spain |
| 174 | NCT03166800 (ClinicalTrials.gov) | September 15, 2018 | 23/5/2017 | MitoQ for Fatigue in Multiple Sclerosis | MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial | Multiple Sclerosis;Fatigue | Drug: Mitoquinone | Oregon Health and Science University | MitoQ Ltd | Completed | 18 Years | 70 Years | All | 9 | Phase 1/Phase 2 | United States |
| 175 | EUCTR2014-000253-36-NL (EUCTR) | 30/08/2018 | 16/04/2018 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2;Phase 3 | Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;India;Peru;Australia;South Africa;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;New Zealand;Japan | ||
| 176 | NCT03000127 (ClinicalTrials.gov) | July 1, 2018 | 17/12/2016 | Testosterone for Fatigue in Men With MS | A Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple Sclerosis | Multiple Sclerosis | Drug: AndroGel 1 % Topical Gel;Drug: Placebos | University of California, Los Angeles | Washington University School of Medicine | Withdrawn | 18 Years | 60 Years | Male | 0 | Phase 2 | United States |
| 177 | NCT03161028 (ClinicalTrials.gov) | July 1, 2018 | 18/5/2017 | Lipoic Acid for Progressive Multiple Sclerosis (MS) | Lipoic Acid for the Treatment of Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Lipoic acid;Drug: Placebo | VA Office of Research and Development | NULL | Active, not recruiting | 18 Years | 70 Years | All | 115 | Phase 2 | United States;Canada |
| 178 | NCT03574428 (ClinicalTrials.gov) | May 8, 2018 | 16/5/2018 | Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers | A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers | Multiple Sclerosis | Drug: GNbAC1;Other: GNbAC1 Placebo | GeNeuro Australia PTY Ltd | NULL | Completed | 18 Years | 55 Years | Male | 24 | Phase 1 | Australia |
| 179 | EUCTR2012-000541-12-BE (EUCTR) | 07/05/2018 | 09/02/2018 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany | ||
| 180 | EUCTR2017-004100-22-HR (EUCTR) | 27/04/2018 | 16/05/2019 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 181 | NCT03436199 (ClinicalTrials.gov) | March 29, 2018 | 12/2/2018 | Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment | A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102, 137 mg;Drug: ADS-5102, 274 mg;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 558 | Phase 3 | United States;Canada |
| 182 | NCT03387046 (ClinicalTrials.gov) | March 26, 2018 | 22/12/2017 | A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS) | Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE) | Multiple Sclerosis, Relapsing-Remitting | Dietary Supplement: D-aspartate;Drug: Placebo;Biological: IFN beta-1a;Drug: Methylprednisolone | Merck KGaA, Darmstadt, Germany | NULL | Terminated | 18 Years | 55 Years | All | 7 | Phase 2 | Italy;Germany |
| 183 | EUCTR2017-004100-22-PL (EUCTR) | 21/03/2018 | 09/02/2018 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 184 | EUCTR2017-004100-22-BG (EUCTR) | 16/03/2018 | 08/01/2018 | Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) | Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen | Osmotica Pharmaceutical US LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 185 | NCT03249714 (ClinicalTrials.gov) | March 15, 2018 | 11/8/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Drug: Ofatumumab;Drug: Matching placebo of ofatumumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 64 | Phase 2 | Japan;Russian Federation |
| 186 | JPRN-JapicCTI-173711 | 15/3/2018 | 14/09/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Intervention name : Ofatumumab INN of the intervention : - Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks | Novartis Pharma K.K. | NULL | complete | 18 | 55 | BOTH | 30 | Phase 2 | Japan, Russia |
| 187 | EUCTR2016-000700-29-BE (EUCTR) | 12/03/2018 | 08/01/2018 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study. - SPI2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: MD1003 INN or Proposed INN: D-BIOTIN | MEDDAY PHARMACEUTICALS SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 188 | NCT03005119 (ClinicalTrials.gov) | March 1, 2018 | 25/12/2016 | Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related Symptoms | A Phase II, Double-blind, Randomized, Placebocontrolled, Parallel-group, Single-center Study to Evaluate the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in Multiple Sclerosis (MS) Patients With Spasticity-related Symptoms | Multiple Sclerosis | Drug: PTL201;Drug: Placebo Oral Capsule | PhytoTech Therapeutics, Ltd. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 70 | Phase 2 | Israel |
| 189 | EUCTR2016-000700-29-HU (EUCTR) | 27/02/2018 | 28/12/2017 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study. - SPI2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: MD1003 INN or Proposed INN: D-BIOTIN | MEDDAY PHARMACEUTICALS SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 190 | EUCTR2016-000700-29-PL (EUCTR) | 15/02/2018 | 15/01/2018 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study. - SPI2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: MD1003 INN or Proposed INN: D-BIOTIN | MEDDAY PHARMACEUTICALS SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 191 | EUCTR2017-001224-22-PL (EUCTR) | 08/02/2018 | 15/11/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 192 | EUCTR2017-001224-22-BE (EUCTR) | 02/02/2018 | 08/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 193 | NCT03330418 (ClinicalTrials.gov) | January 29, 2018 | 31/10/2017 | A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders | A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders. | Neuromyelitis Optica Spectrum Disorders | Biological: Placebo;Biological: RC18 160 mg | RemeGen Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 166 | Phase 3 | China |
| 194 | EUCTR2017-001224-22-DE (EUCTR) | 23/01/2018 | 28/07/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czechia;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 195 | EUCTR2017-001224-22-NL (EUCTR) | 11/01/2018 | 12/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden | ||
| 196 | EUCTR2017-001224-22-GB (EUCTR) | 28/12/2017 | 12/07/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) - EV Substance Code SUB118957 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 197 | EUCTR2017-003328-56-GB (EUCTR) | 19/12/2017 | 31/10/2017 | MS-STAT2 - Multiple Sclerosis – Simvastatin Trial 2 | A phase 3 randomised, double blind, clinical trial investigating the effectiveness of repurposed simvastatin compared to placebo, in secondary progressive multiple sclerosis, in slowing the progression of disability - MS-STAT2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40 mg filmomhulde tabletten Product Name: Simvastatine Sandoz 40 mg filmomhulde tabletten INN or Proposed INN: Simvastatin Trade Name: SimvaHEXAL® 40 mg Filmtabletten Product Name: SimvaHEXAL® 40 mg Filmtabletten INN or Proposed INN: Simvastatin Trade Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG Product Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG INN or Proposed INN: Simvastatin Trade Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película Product Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película INN or Proposed INN: Simvastatin Trade Name: Sivatin 40 mg film-coated tablets Product Name: Sivatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten Product Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten INN or Proposed INN: Simvastatin | University College London Comprehensive Clinical Trials Unit | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1180 | Phase 3 | United Kingdom | ||
| 198 | EUCTR2017-001224-22-CZ (EUCTR) | 19/12/2017 | 14/08/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 199 | NCT02988401 (ClinicalTrials.gov) | December 1, 2017 | 7/12/2016 | Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis | Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive | Drug: Insulin;Drug: Placebo (Sterile diluent) | Johns Hopkins University | United States Department of Defense | Completed | 18 Years | 70 Years | All | 105 | Phase 1/Phase 2 | United States |
| 200 | EUCTR2017-001224-22-ES (EUCTR) | 24/11/2017 | 18/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 201 | NCT03222973 (ClinicalTrials.gov) | November 14, 2017 | 17/7/2017 | Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies | Multiple Sclerosis | Drug: BIIB033 (opicinumab);Drug: Placebo | Biogen | NULL | Terminated | 18 Years | 58 Years | All | 263 | Phase 2 | Netherlands;Poland;Spain;Switzerland;United Kingdom;United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy |
| 202 | EUCTR2017-001224-22-HU (EUCTR) | 31/10/2017 | 01/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 203 | EUCTR2017-002838-23-ES (EUCTR) | 27/10/2017 | 21/07/2017 | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ORY2001 Product Code: ORY2001 INN or Proposed INN: Not yet requested Other descriptive name: PHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR | Oryzon Genomics S. A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain | ||
| 204 | NCT03283826 (ClinicalTrials.gov) | October 19, 2017 | 13/9/2017 | Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis | A Phase 1/2, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Biological: ATA188;Drug: Placebo | Atara Biotherapeutics | NULL | Active, not recruiting | 18 Years | 60 Years | All | 134 | Phase 1/Phase 2 | United States;Australia;Canada |
| 205 | EUCTR2015-005431-41-PL (EUCTR) | 16/10/2017 | 07/04/2016 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of | ||
| 206 | NCT03185065 (ClinicalTrials.gov) | October 4, 2017 | 9/6/2017 | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis | Fatigue in Multiple Sclerosis | Drug: Amantadine;Drug: Modafinil;Drug: Methylphenidate;Drug: Placebos | Johns Hopkins University | Patient-Centered Outcomes Research Institute | Completed | 18 Years | N/A | All | 141 | Phase 3 | United States |
| 207 | EUCTR2012-000541-12-FI (EUCTR) | 03/10/2017 | 17/08/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 208 | EUCTR2012-000541-12-BG (EUCTR) | 28/09/2017 | 04/07/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 209 | NCT03122652 (ClinicalTrials.gov) | September 25, 2017 | 12/4/2017 | Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome | Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study | Multiple Sclerosis | Drug: Teriflunomide 14 MG Oral Tablet [Aubagio];Drug: Placebo Oral Tablet | Centre Hospitalier Universitaire de Nice | Genzyme, a Sanofi Company | Completed | 18 Years | N/A | All | 125 | Phase 3 | France;Switzerland;Turkey;Germany;Martinique;Sweden;United Kingdom |
| 210 | EUCTR2012-000541-12-PL (EUCTR) | 05/09/2017 | 27/07/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 211 | NCT02744222 (ClinicalTrials.gov) | August 10, 2017 | 3/4/2016 | Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis | An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 µg and 240 µg, Versus Avonex® (Biogen Idec Ltd., UK) in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: BCD-054 180 mcg;Biological: Avonex®;Biological: BCD-054 240 mcg;Other: Placebo | Biocad | NULL | Completed | 18 Years | 60 Years | All | 399 | Phase 2/Phase 3 | Russian Federation |
| 212 | EUCTR2016-000700-29-SE (EUCTR) | 07/08/2017 | 14/11/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized-double blind placebo-controlled study. - SPI2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: MD1003 INN or Proposed INN: D-BIOTIN | MEDDAY PHARMACEUTICALS SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 213 | NCT03138421 (ClinicalTrials.gov) | August 1, 2017 | 1/5/2017 | Central Pain Study for ABX-1431 | A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of ABX-1431 in Patients With Central Pain | Neuromyelitis Optica Spectrum Disorder;Transverse Myelitis;Multiple Sclerosis;Longitudinally Extensive Transverse Myelitis | Drug: ABX-1431 HCl;Drug: Placebo | Abide Therapeutics | NULL | Completed | 18 Years | N/A | All | 9 | Phase 1 | United Kingdom |
| 214 | EUCTR2012-000541-12-FR (EUCTR) | 13/06/2017 | 17/07/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 215 | NCT03126760 (ClinicalTrials.gov) | May 22, 2017 | 4/4/2017 | Pilot Study to Assess the Efficacy & Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis | A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis | Relapsing, Remitting Multiple Sclerosis | Drug: Repository Corticotropin Injection;Drug: Placebo | Mallinckrodt | NULL | Terminated | 18 Years | N/A | All | 35 | Phase 4 | United States |
| 216 | EUCTR2011-005249-12-SI (EUCTR) | 15/05/2017 | 13/03/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Russian Federation;United States;Egypt;Portugal;Greece;Netherlands;Morocco;China;Ireland;Poland;Slovenia;Serbia;France;Lithuania;Bulgaria;Bosnia and Herzegovina;Tunisia;Ukraine;Macedonia, the former Yugoslav Republic of;United Kingdom;Spain;Lebanon;Canada;Turkey;Belgium;Italy;Israel;Australia;Estonia | ||
| 217 | EUCTR2016-001448-21-PL (EUCTR) | 09/05/2017 | 13/01/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Czech Republic;Slovakia;Spain;Poland;Ukraine;Turkey;Croatia;Russian Federation;Bulgaria;United Kingdom | ||
| 218 | EUCTR2011-005249-12-PT (EUCTR) | 24/04/2017 | 01/02/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;Italy;France;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland;Bulgaria | ||
| 219 | EUCTR2016-001448-21-BG (EUCTR) | 11/04/2017 | 14/02/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria | ||
| 220 | EUCTR2014-000253-36-GR (EUCTR) | 31/03/2017 | 30/01/2017 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 19.1;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: NA | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 221 | NCT02907177 (ClinicalTrials.gov) | March 30, 2017 | 25/8/2016 | Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) | Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) | Multiple Sclerosis | Drug: Ponesimod;Other: Placebo | Actelion | NULL | Terminated | 18 Years | 55 Years | All | 136 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;Russian Federation;Spain;Switzerland;United Kingdom;Croatia;Czech Republic;Finland;Norway |
| 222 | NCT03110315 (ClinicalTrials.gov) | March 28, 2017 | 28/3/2017 | A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia | A Double-blind, Crossover, Placebo-controlled Study to Compare the Effects of Nighttime Administration of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia | Multiple Sclerosis;Fatigue;Insomnia | Drug: Suvorexant;Drug: Placebo | Theodore R. Brown, MD MPH | Merck Sharp & Dohme Corp. | Completed | 18 Years | 75 Years | All | 34 | Phase 4 | United States |
| 223 | NCT03091400 (ClinicalTrials.gov) | March 16, 2017 | 16/3/2017 | Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS) | Phase Two Randomized Controlled Crossover Trial of Atomoxetine to Treat Memory Impairment Due to Multiple Sclerosis | Memory Disorders;Multiple Sclerosis | Drug: Atomoxetine;Drug: Placebo | Icahn School of Medicine at Mount Sinai | NULL | Completed | 21 Years | 60 Years | All | 11 | Phase 2 | United States |
| 224 | EUCTR2011-005249-12-NL (EUCTR) | 15/03/2017 | 08/11/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;Italy;France;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 225 | EUCTR2016-000700-29-DE (EUCTR) | 08/03/2017 | 16/11/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study. - SPI2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: MD1003 INN or Proposed INN: D-BIOTIN | MEDDAY PHARMACEUTICALS SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 226 | NCT02975349 (ClinicalTrials.gov) | March 7, 2017 | 23/11/2016 | A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing-remitting Multiple Sclerosis | Drug: M2951;Drug: Placebo;Drug: Tecfidera | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Active, not recruiting | 18 Years | 65 Years | All | 267 | Phase 2 | Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States |
| 227 | EUCTR2011-005249-12-IT (EUCTR) | 17/02/2017 | 02/09/2021 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | GENZYME CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Russian Federation;North Macedonia;Israel;Italy;France;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria;Portugal;Serbia;United States;Estonia;Morocco;Greece;Spain;Lebanon;Ireland | ||
| 228 | EUCTR2016-001448-21-SK (EUCTR) | 16/02/2017 | 25/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Bulgaria | ||
| 229 | EUCTR2016-000700-29-ES (EUCTR) | 10/02/2017 | 09/12/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study. - SPI2 | Multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: MD1003 INN or Proposed INN: D-BIOTIN | MEDDAY PHARMACEUTICALS SA | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy;Sweden | ||
| 230 | EUCTR2016-001448-21-CZ (EUCTR) | 06/02/2017 | 01/11/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 231 | EUCTR2016-000700-29-CZ (EUCTR) | 01/02/2017 | 10/11/2016 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study. - SPI2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: MD1003 INN or Proposed INN: D-BIOTIN | MEDDAY PHARMACEUTICALS SA | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 232 | EUCTR2016-000700-29-IT (EUCTR) | 30/01/2017 | 05/11/2020 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study - SPI2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: D-Biotin Product Code: [MD1003] INN or Proposed INN: D-BIOTINA Other descriptive name: - | MEDDAY PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 754 | Phase 3 | United States;Czechia;Spain;Turkey;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 233 | EUCTR2014-000253-36-HU (EUCTR) | 24/01/2017 | 23/11/2016 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 234 | NCT03051646 (ClinicalTrials.gov) | January 13, 2017 | 8/2/2017 | Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis | A Placebo-controlled Double Blind Crossover Trial of Acetylsalicylic Acid as a Pre-treatment for Exercise in Multiple Sclerosis | Fatigue;Overheating | Drug: Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit;Drug: Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit | Columbia University | National Multiple Sclerosis Society | Completed | 18 Years | 60 Years | All | 12 | Early Phase 1 | United States |
| 235 | EUCTR2016-001448-21-ES (EUCTR) | 05/01/2017 | 26/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 236 | NCT03172741 (ClinicalTrials.gov) | January 2017 | 25/5/2017 | The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis | The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis | Multiple Sclerosis | Drug: Medical Marijuana;Drug: Placebo | Colorado State University | NULL | Withdrawn | 21 Years | 74 Years | All | 0 | Phase 2/Phase 3 | NULL |
| 237 | EUCTR2012-000541-12-GR (EUCTR) | 21/12/2016 | 24/08/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 238 | EUCTR2015-005431-41-RO (EUCTR) | 07/12/2016 | 22/06/2016 | A late stage clinical trial to investigate the efficacy and safety of SA237 monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Sapelizumab (p-INN) Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Canada;Poland;Ukraine;Croatia;Turkey;Romania;Russian Federation;Bulgaria;Italy;Korea, Republic of | ||
| 239 | EUCTR2012-000541-12-PT (EUCTR) | 05/12/2016 | 19/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 240 | NCT02977533 (ClinicalTrials.gov) | December 1, 2016 | 28/11/2016 | A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of GZ402668 in Men and Women With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: GZ402668;Drug: Placebo;Drug: Acyclovir | Sanofi | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 1 | Germany |
| 241 | NCT02936037 (ClinicalTrials.gov) | December 2016 | 14/10/2016 | Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) | Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study | Multiple Sclerosis | Drug: MD1003 100mg capsule;Drug: PLACEBO | MedDay Pharmaceuticals SA | NULL | Terminated | 18 Years | 65 Years | All | 642 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Italy;Poland;Spain;Sweden;Turkey;United Kingdom;Czech Republic;Netherlands |
| 242 | NCT02959658 (ClinicalTrials.gov) | December 2016 | 8/11/2016 | Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis | Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: Dimethyl Fumarate;Drug: Placebo Oral Capsule | Rigshospitalet, Denmark | Biogen | Active, not recruiting | 18 Years | 65 Years | All | 54 | Phase 2 | Denmark |
| 243 | EUCTR2015-005431-41-HR (EUCTR) | 30/11/2016 | 15/12/2016 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of | ||
| 244 | EUCTR2012-000541-12-ES (EUCTR) | 21/11/2016 | 11/08/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 245 | EUCTR2012-000541-12-DE (EUCTR) | 15/11/2016 | 06/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 246 | EUCTR2012-000541-12-DK (EUCTR) | 07/11/2016 | 20/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | ||
| 247 | EUCTR2015-003471-30-NL (EUCTR) | 02/11/2016 | 26/04/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 248 | EUCTR2012-000541-12-AT (EUCTR) | 02/11/2016 | 22/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 249 | NCT02601885 (ClinicalTrials.gov) | October 18, 2016 | 5/11/2015 | A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis | An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: ABT-555;Other: Placebo | AbbVie | NULL | Completed | 18 Years | 60 Years | All | 20 | Phase 1 | United States |
| 250 | NCT02804594 (ClinicalTrials.gov) | October 1, 2016 | 3/6/2016 | A Study of Oxidative Pathways in MS Fatigue | A Phase 2 Randomized, Placebo- Controlled, Parallel Group, Double Blinded Single Center Study on Effect of N-acetyl Cysteine Compared to Placebo on Fatigue in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis;Fatigue | Drug: N-acetyl cysteine;Drug: Placebo | University of California, San Francisco | NULL | Completed | 18 Years | 75 Years | All | 15 | Phase 2 | United States |
| 251 | NCT01649050 (ClinicalTrials.gov) | October 2016 | 6/7/2012 | Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis | A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis | Muscle Spasticity Due to Multiple Sclerosis | Drug: BGG492;Drug: Placebo | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2 | Germany;Russian Federation |
| 252 | EUCTR2015-003471-30-RO (EUCTR) | 26/09/2016 | 23/02/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | United States;Portugal;Czechia;Taiwan;Turkey;Italy;Czech Republic;Canada;Malaysia;Poland;Romania;Netherlands;Korea, Republic of | ||
| 253 | EUCTR2015-003471-30-PL (EUCTR) | 23/09/2016 | 15/07/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Czech Republic;Taiwan;Canada;Malaysia;Poland;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 254 | NCT02792218 (ClinicalTrials.gov) | September 20, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 930 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Thailand;Turkey;United Kingdom |
| 255 | EUCTR2012-000541-12-HU (EUCTR) | 08/09/2016 | 21/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 256 | EUCTR2012-000541-12-CZ (EUCTR) | 29/08/2016 | 22/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 257 | NCT02792231 (ClinicalTrials.gov) | August 26, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis. | Relapsing Multiple Scelrosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 957 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Finland;France;Germany;Hungary;India;Italy;Latvia;Lithuania;Mexico;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;United Kingdom |
| 258 | EUCTR2015-004059-29-CZ (EUCTR) | 18/08/2016 | 09/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 259 | NCT02466074 (ClinicalTrials.gov) | August 17, 2016 | 3/6/2015 | Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis | Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis | Multiple Sclerosis | Drug: Acetazolamide;Drug: Placebo | The University of Texas Health Science Center, Houston | NULL | Terminated | 18 Years | 55 Years | All | 6 | Phase 2 | United States |
| 260 | EUCTR2015-004059-29-IT (EUCTR) | 09/08/2016 | 27/02/2018 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GENEURO SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | |||
| 261 | EUCTR2015-003147-19-GR (EUCTR) | 18/07/2016 | 25/05/2016 | To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS). | Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety. - Efficacy and Safety study of NEUROASPIS PLP10® versus placebo | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NEUROASPIS PLP10® INN or Proposed INN: FISH OIL,RICH IN OMEGA 3 ACIDS Other descriptive name: FISH OIL, RICH IN OMEGA-3-ACIDS INN or Proposed INN: BORAGE OIL 20% GLA Other descriptive name: BORAGE OIL INN or Proposed INN: beta-Carotene Other descriptive name: BETACAROTENE INN or Proposed INN: Gamma-tocopherol | PALUPA Medical Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Greece | ||
| 262 | EUCTR2016-001356-22-HU (EUCTR) | 13/07/2016 | 26/04/2016 | A STUDY OF THE SAFETY AND EFFECTS OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH TIGHTNESS, STIFFNESS AND PULL OF MUSCLES DUE TO MULTIPLE SCLEROSIS | A PLACEBO-CONTROLLED RANDOMIZED WITHDRAWAL EVALUATION OF THE EFFICACY AND SAFETY OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS | Spasticity due to multiple sclerosis MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 10 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Baclofen Tablets USP Product Name: Baclofen Tablets USP 10 mg INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 20 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 30mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 40mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 50 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN | Sun Pharma Advanced Research Company Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Hungary;Ukraine;Russian Federation;Germany | ||
| 263 | EUCTR2015-000507-44-LT (EUCTR) | 11/07/2016 | 16/05/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 264 | NCT02660359 (ClinicalTrials.gov) | July 8, 2016 | 14/1/2016 | Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2 | A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis | Urinary Incontinence;Overactive Bladder | Biological: Botulinum toxin type A;Drug: Placebo | Ipsen | NULL | Terminated | 18 Years | 80 Years | All | 258 | Phase 3 | Argentina;Australia;Belgium;Brazil;Chile;Colombia;France;Germany;Israel;Lithuania;Mexico;Peru;Russian Federation;Spain;Ukraine;United Kingdom;New Zealand |
| 265 | EUCTR2015-004059-29-DE (EUCTR) | 04/07/2016 | 16/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 266 | NCT02869425 (ClinicalTrials.gov) | July 2016 | 3/8/2016 | To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS | A Randomized, Double-Blind, Parallel-Group Study to Assess the Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With Multiple Sclerosis | Multiple Sclerosis;Sperm | Drug: arbaclofen ER Tablets;Drug: Placebo for arbaclofen ER tablets | RVL Pharmaceuticals, Inc. | Osmotica Pharmaceutical US LLC | Withdrawn | 18 Years | 55 Years | Male | 0 | Phase 3 | United States |
| 267 | EUCTR2015-004059-29-BG (EUCTR) | 30/06/2016 | 08/04/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 268 | EUCTR2015-000507-44-DE (EUCTR) | 29/06/2016 | 23/02/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 269 | NCT02424396 (ClinicalTrials.gov) | June 13, 2016 | 20/4/2015 | Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis | Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis. Multicentric Randomized Study | Relapsing Remitting Multiple Sclerosis | Drug: IL2;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Fondation ARSEP/AFM | Completed | 18 Years | 65 Years | All | 30 | Phase 2 | France |
| 270 | NCT03150966 (ClinicalTrials.gov) | June 8, 2016 | 6/5/2017 | The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis Patients | The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Nanocurcumin;Drug: Placebo | Tabriz University of Medical Sciences | NULL | Completed | 18 Years | 65 Years | All | 41 | Phase 2 | Iran, Islamic Republic of |
| 271 | NCT02760056 (ClinicalTrials.gov) | June 6, 2016 | 5/4/2016 | Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study | Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study | Multiple Sclerosis | Drug: Liothyronine sodium;Drug: Placebo | Oregon Health and Science University | NULL | Completed | 18 Years | 50 Years | All | 15 | Phase 1 | United States |
| 272 | NCT02609607 (ClinicalTrials.gov) | June 2016 | 16/11/2015 | Treating Anorectal Dysfunction in MS | Treating Anorectal Dysfunction Associated With Multiple Sclerosis | Constipation;Fecal Incontinence;Multiple Sclerosis | Drug: Bisacodyl;Other: Placebo | David Levinthal | Consortium of Multiple Sclerosis Centers | Terminated | 18 Years | 80 Years | All | 11 | Phase 2 | United States |
| 273 | EUCTR2015-003471-30-IT (EUCTR) | 30/05/2016 | 07/04/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;Italy;Korea, Republic of | ||
| 274 | EUCTR2015-003471-30-CZ (EUCTR) | 27/05/2016 | 16/03/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Czech Republic;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 275 | NCT02676739 (ClinicalTrials.gov) | May 20, 2016 | 3/2/2016 | Adderall XR and Cognitive Impairment in MS | A Double-blind Placebo Controlled Study of Mixed-amphetamine Salts, Extended Release (Adderall XR) for Cognitive Impairment in MS | Multiple Sclerosis | Drug: Adderall XR | Sarah Morrow | NULL | Recruiting | 18 Years | 59 Years | All | 180 | Phase 2/Phase 3 | Canada |
| 276 | EUCTR2015-004059-29-EE (EUCTR) | 16/05/2016 | 22/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Poland;Croatia;Bulgaria;Germany;Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary | ||
| 277 | NCT03237832 (ClinicalTrials.gov) | May 16, 2016 | 21/7/2017 | A Phase 1 Study of ARN-6039 | A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Oral Doses of ARN-6039 in Healthy Adult Subjects. | Multiple Sclerosis | Drug: ARN-6039;Other: Placebo | Arrien Pharmaceuticals | Worldwide Clinical Trials | Completed | 18 Years | 50 Years | All | 60 | Phase 1 | NULL |
| 278 | EUCTR2015-004059-29-PL (EUCTR) | 15/05/2016 | 21/03/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 279 | EUCTR2015-003471-30-PT (EUCTR) | 09/05/2016 | 08/03/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Portugal;Taiwan;Czech Republic;Canada;Poland;Malaysia;Turkey;Romania;Netherlands;Italy;Korea, Republic of | ||
| 280 | EUCTR2015-004059-29-HU (EUCTR) | 04/05/2016 | 08/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Czech Republic;Poland;Croatia;Bulgaria;Germany | ||
| 281 | EUCTR2015-000507-44-ES (EUCTR) | 04/05/2016 | 18/03/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 282 | NCT02428218 (ClinicalTrials.gov) | May 2016 | 23/4/2015 | Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate;Drug: Placebo | Biogen | NULL | Withdrawn | 10 Years | 17 Years | Both | 0 | Phase 3 | NULL |
| 283 | EUCTR2015-000507-44-FR (EUCTR) | 29/04/2016 | 21/03/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Spain;Ukraine;Lithuania;Chile;Israel;Russian Federation;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 284 | EUCTR2015-004059-29-HR (EUCTR) | 29/04/2016 | 06/07/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Serbia;Estonia;Spain;Ukraine;Croatia;Bulgaria;Germany | ||
| 285 | EUCTR2015-004059-29-ES (EUCTR) | 20/04/2016 | 17/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 286 | NCT02782858 (ClinicalTrials.gov) | April 2016 | 23/5/2016 | Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS | An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GNbAC1;Drug: Placebo | GeNeuro SA | Les Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical Trials | Completed | 18 Years | 55 Years | All | 270 | Phase 2 | Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 287 | EUCTR2015-000507-44-BE (EUCTR) | 31/03/2016 | 08/03/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 288 | NCT02739542 (ClinicalTrials.gov) | March 19, 2016 | 16/3/2016 | Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS) | Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE) | Multiple Sclerosis (MS) | Drug: Tecfidera;Drug: Placebo | University of Texas Southwestern Medical Center | Biogen | Completed | 18 Years | N/A | All | 87 | Phase 4 | United States |
| 289 | NCT02738775 (ClinicalTrials.gov) | March 18, 2016 | 10/4/2016 | Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis | A Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis | Biological: Ublituximab;Drug: Placebo | TG Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 48 | Phase 2 | United States |
| 290 | NCT02660138 (ClinicalTrials.gov) | March 2016 | 14/1/2016 | Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1 | A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis | Urinary Incontinence;Overactive Bladder | Biological: Botulinum toxin type A;Drug: Placebo | Ipsen | NULL | Terminated | 18 Years | 80 Years | All | 227 | Phase 3 | United States;Canada;Czechia;Italy;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Turkey;Czech Republic;Malaysia |
| 291 | NCT02641041 (ClinicalTrials.gov) | February 2016 | 23/12/2015 | Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants | A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects | Central Nervous System (CNS) Demyelinating Disease;Multiple Sclerosis | Biological: BIIB033;Other: Placebo | Biogen | NULL | Completed | 20 Years | 55 Years | Both | 24 | Phase 1 | United Kingdom |
| 292 | NCT02710214 (ClinicalTrials.gov) | February 2016 | 11/3/2016 | A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis | Effect of a Tissue Selective Estrogen Complex on Menopausal Symptoms in Women With MS: A Pilot Trial. | Menopause;Multiple Sclerosis | Drug: Tissue Selective Estrogen Complex;Drug: Placebo | University of California, San Francisco | National Multiple Sclerosis Society | Completed | 18 Years | 62 Years | Female | 24 | Phase 2 | United States |
| 293 | EUCTR2014-005624-98-AT (EUCTR) | 19/01/2016 | 17/09/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Spain;Lebanon;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Peru;South Africa;Kuwait;Netherlands;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 294 | EUCTR2013-001150-10-HR (EUCTR) | 07/12/2015 | 01/02/2016 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | neuromyelitis optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000167619;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 295 | NCT02011451 (ClinicalTrials.gov) | December 2015 | 10/12/2013 | Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis | Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis | Multiple Sclerosis | Drug: 95% Pure ECGC capsules 200mg;Drug: Placebo Comparator: | Louisiana State University Health Sciences Center in New Orleans | National Multiple Sclerosis Society | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 296 | EUCTR2011-005249-12-LT (EUCTR) | 06/11/2015 | 02/10/2015 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 297 | EUCTR2010-021219-17-BG (EUCTR) | 27/10/2015 | 13/11/2013 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Slovakia;Morocco;Greece;United States;Serbia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Brazil;Poland;Romania;South Africa;Bulgaria;Tunisia;Germany;Bosnia and Herzegovina | ||
| 298 | EUCTR2014-005624-98-IT (EUCTR) | 14/10/2015 | 23/02/2018 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety ofBG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | ||
| 299 | EUCTR2012-003056-36-FR (EUCTR) | 06/10/2015 | 19/06/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 300 | EUCTR2014-005624-98-HU (EUCTR) | 09/09/2015 | 16/07/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 172 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | |||
| 301 | NCT02542787 (ClinicalTrials.gov) | August 2015 | 4/9/2015 | Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis | A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis | Spasticity in People With Multiple Sclerosis | Drug: VSN16R;Other: Placebo | Canbex Therapeutics Ltd | NULL | Completed | 18 Years | 70 Years | All | 160 | Phase 2 | United Kingdom |
| 302 | EUCTR2014-003021-18-DE (EUCTR) | 09/07/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 303 | EUCTR2014-001643-20-SE (EUCTR) | 03/07/2015 | 19/01/2015 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Germany;Italy;Switzerland;Sweden;United States;Czech Republic;Mexico;Canada;Poland;Russian Federation | ||
| 304 | NCT02472938 (ClinicalTrials.gov) | July 2015 | 11/5/2015 | Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis | Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Other: Placebo | Biogen | GB Pharma Services & Consulting S.r.l. Unipersonale | Withdrawn | 18 Years | 50 Years | Both | 0 | Phase 4 | NULL |
| 305 | EUCTR2014-003021-18-DK (EUCTR) | 25/06/2015 | 09/04/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 306 | EUCTR2015-000303-21-IT (EUCTR) | 24/06/2015 | 01/04/2015 | Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012 | A Phase IV, interventional, multicenteR, double-blind, randomized, placebo-controlled study tO explore the onset of efficacy on Magnetic resonance disease activity of BG00012 (dimethyl fumarate) in Patients with relapsing-remitTing Multiple Sclerosis (PROMPT) - PROMPT | Relapsing-remitting Multiple Sclerosis patients MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera® Product Name: Tecfidera® Product Code: BG00012 INN or Proposed INN: Dimethyl fumarate | Biogen Idec Italia S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Italy | |||
| 307 | EUCTR2014-003021-18-CZ (EUCTR) | 22/06/2015 | 13/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Phase 3 | Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden;Slovakia;United States;Serbia | ||
| 308 | EUCTR2011-005249-12-PL (EUCTR) | 11/06/2015 | 07/07/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis with Relapsing Forms of Multiple Sclerosis Followed byan Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | United States;Estonia;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Poland;Belgium;Australia;China | |||
| 309 | EUCTR2014-003021-18-IT (EUCTR) | 05/06/2015 | 18/02/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 310 | EUCTR2014-003021-18-BE (EUCTR) | 02/06/2015 | 24/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 311 | EUCTR2014-003021-18-FI (EUCTR) | 02/06/2015 | 28/05/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 312 | EUCTR2013-001055-12-IT (EUCTR) | 28/05/2015 | 03/06/2013 | Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. | Flu-like syndrome Inhibition Giving anti-histaminic Therapy. Randomized cross-over, single-center, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine on Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. - FLU-LIGHT | Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS). MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Cetirizina Mylan Generics Product Name: Cetirizina Mylan Generics INN or Proposed INN: Cetirizina Other descriptive name: CETIRIZINE HYDROCHLORIDE | Biogen Idec Italia S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 313 | NCT02315872 (ClinicalTrials.gov) | May 22, 2015 | 9/12/2014 | ACTH for Fatigue in Multiple Sclerosis Patients | The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis. | Multiple Sclerosis, Relapsing-Remitting | Drug: ACTH;Drug: Placebo | Providence Health & Services | Mallinckrodt | Completed | 18 Years | 65 Years | All | 8 | Phase 3 | United States |
| 314 | EUCTR2014-001579-30-NL (EUCTR) | 21/05/2015 | 26/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Spain;Poland;Ukraine;Russian Federation;Germany;Netherlands;United Kingdom;Italy | ||
| 315 | EUCTR2014-003021-18-SK (EUCTR) | 19/05/2015 | 10/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 316 | EUCTR2014-003021-18-PL (EUCTR) | 17/05/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 317 | NCT02495766 (ClinicalTrials.gov) | May 11, 2015 | 3/6/2015 | Autologous Mesenchymal Stromal Cells for Multiple Sclerosis | Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Drug: XCEL-MC-ALPHA;Drug: Placebo | Banc de Sang i Teixits | Vall d'Hebron Research Institute (VHIR) | Completed | 18 Years | 60 Years | All | 8 | Phase 1/Phase 2 | Spain |
| 318 | EUCTR2013-003752-21-ES (EUCTR) | 07/05/2015 | 11/03/2015 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom | ||
| 319 | EUCTR2014-003021-18-AT (EUCTR) | 04/05/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 320 | EUCTR2013-003752-21-HU (EUCTR) | 04/05/2015 | 25/02/2015 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 18.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;France;Taiwan;Hungary;Spain;Poland;Germany;United Kingdom;Japan;Italy | ||
| 321 | EUCTR2014-003021-18-NL (EUCTR) | 01/05/2015 | 12/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 322 | NCT02430532 (ClinicalTrials.gov) | May 2015 | 27/4/2015 | BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive | Drug: dimethyl fumarate;Other: Placebo | Biogen | NULL | Terminated | 18 Years | 58 Years | All | 58 | Phase 3 | United States;Belgium;Czech Republic;Netherlands;Poland;Slovakia;Austria;Sweden |
| 323 | NCT02471222 (ClinicalTrials.gov) | May 2015 | 11/6/2015 | Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 60 | Phase 2 | United States |
| 324 | EUCTR2013-001150-10-CZ (EUCTR) | 22/04/2015 | 19/09/2014 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | Neuromyelitis optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| 325 | NCT02391961 (ClinicalTrials.gov) | April 1, 2015 | 3/3/2015 | Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis | Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis | Multiple Sclerosis;Internuclear Ophthalmoplegia;Fatigue | Drug: Dalfampridine;Drug: Placebo | VA Office of Research and Development | NULL | Completed | 18 Years | 65 Years | All | 23 | Phase 2 | United States |
| 326 | NCT02200770 (ClinicalTrials.gov) | April 1, 2015 | 16/7/2014 | N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Drug: Inebilizumab;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | All | 231 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine |
| 327 | NCT02398461 (ClinicalTrials.gov) | April 2015 | 13/3/2015 | An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse | A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse | Multiple Sclerosis, Acute Relapsing | Drug: rHIgM22;Drug: Placebo | Acorda Therapeutics | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 27 | Phase 1 | United States |
| 328 | NCT02939079 (ClinicalTrials.gov) | April 2015 | 14/10/2016 | Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients | Evaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod;Dietary Supplement: Fish Oil;Drug: Placebo (for Fish Oil) | Isfahan University of Medical Sciences | Shiraz University of Medical Sciences | Completed | 18 Years | 45 Years | All | 50 | Phase 2/Phase 3 | NULL |
| 329 | EUCTR2014-003021-18-SE (EUCTR) | 25/03/2015 | 13/02/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 330 | EUCTR2014-001579-30-DE (EUCTR) | 20/03/2015 | 11/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 331 | EUCTR2014-003145-99-GB (EUCTR) | 19/03/2015 | 19/01/2015 | A trial to determine bexarotene's safety and tolerability and it's ability to promote brain repair in patients with multiple sclerosis. | A randomised placebo-controlled study of the safety and tolerability of a retinoid-X receptor agonist's ability to promote remyelination in people with relapsing-remitting multiple sclerosis already on interferon-beta therapy: a phase 2a trial - CCMR One | Relapsing-remitting multiple sclerosis already on interferon-beta therapy MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targretin Product Name: Bexarotene INN or Proposed INN: Bexarotene | Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
| 332 | NCT02410278 (ClinicalTrials.gov) | March 12, 2015 | 2/4/2015 | Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera | A Multicenter, Double- Blind, Placebo- Controlled Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera® (Dimethyl Fumarate) Delayed Release Capsules | Multiple Sclerosis | Drug: dimethyl fumarate;Drug: montelukast;Drug: Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 102 | Phase 4 | United States |
| 333 | EUCTR2013-001150-10-DK (EUCTR) | 06/03/2015 | 11/02/2015 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | neuromyelitis optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| 334 | EUCTR2014-000253-36-DE (EUCTR) | 27/02/2015 | 30/09/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 335 | EUCTR2013-003600-40-NL (EUCTR) | 20/02/2015 | 26/11/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland | ||
| 336 | EUCTR2014-000253-36-ES (EUCTR) | 16/02/2015 | 22/12/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: NA | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2;Phase 3 | United States;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 337 | EUCTR2015-000182-31-NL (EUCTR) | 11/02/2015 | 26/01/2015 | Study to evaluate the effects of fampridine in patients with multiple sclerosis and eye movement abnormality | A randomized, double-blind, placebo-controlled, cross-over study to assess the effects of fampridine on eye movements and nerve conduction in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO) | Multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra 10 mg prolonged-release tablets INN or Proposed INN: FAMPRIDINE | CHDR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 338 | EUCTR2014-001643-20-DE (EUCTR) | 10/02/2015 | 18/08/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 339 | EUCTR2014-000253-36-BG (EUCTR) | 04/02/2015 | 05/11/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 340 | NCT02638038 (ClinicalTrials.gov) | February 2015 | 16/12/2015 | This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for = 3 Years | A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing Remitting | Drug: INT131 | InteKrin Therapeutics, Inc. | NULL | Completed | 18 Years | 50 Years | All | 228 | Phase 2 | NULL |
| 341 | EUCTR2014-001643-20-PL (EUCTR) | 23/01/2015 | 31/10/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 342 | EUCTR2014-004412-11-GB (EUCTR) | 16/01/2015 | 19/11/2014 | The purpose of this study is to examine the safety and efficacy of VSN16R and the performance in treating spasticity (tightness, stiffness or pull of muscles) in patients with Multiple Sclerosis (MS). | A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VSN16R 100mg Product Code: VSN16R INN or Proposed INN: VSN16R Other descriptive name: (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide | Canbex Therapeutics Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 343 | NCT02284568 (ClinicalTrials.gov) | January 12, 2015 | 31/10/2014 | A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo | A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: Placebo;Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 25 Years | 55 Years | All | 374 | Phase 2 | United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 344 | EUCTR2014-000253-36-PL (EUCTR) | 30/12/2014 | 14/11/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 345 | EUCTR2014-001579-30-ES (EUCTR) | 22/12/2014 | 23/10/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 346 | NCT01910259 (ClinicalTrials.gov) | December 18, 2014 | 19/7/2013 | MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial | A Multi-arm Phase IIB Randomised, Double Blind Placebo-controlled Clinical Trial Comparing the Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis. | Secondary Progressive Multiple Sclerosis | Drug: Amiloride;Drug: Riluzole;Drug: Fluoxetine;Drug: Placebo | University College, London | Medical Research Council;National Institute for Health Research, United Kingdom;MS Society;University of Edinburgh;Queen Mary University of London;Keele University;University of Sheffield;University of Leeds;University of Warwick | Completed | 25 Years | 65 Years | All | 445 | Phase 2 | United Kingdom |
| 347 | EUCTR2014-000253-36-CZ (EUCTR) | 08/12/2014 | 14/08/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 348 | EUCTR2014-001579-30-IT (EUCTR) | 04/12/2014 | 19/09/2014 | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 349 | EUCTR2013-003600-40-BG (EUCTR) | 04/12/2014 | 17/10/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland | ||
| 350 | NCT02294058 (ClinicalTrials.gov) | December 3, 2014 | 5/8/2014 | Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) | A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Ozanimod;Drug: Interferon beta-1a;Drug: Placebo to ozanimod;Drug: Placebo to interferon beta-1a | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1346 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Latvia;Lithuania;Moldova, Republic of;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Argentina;Austria;Colombia;Czech Republic;Mexico;Peru |
| 351 | NCT02317263 (ClinicalTrials.gov) | December 2014 | 3/12/2014 | A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis | Multiple Sclerosis | Drug: testosterone;Drug: placebo gel | University of California, Los Angeles | NULL | Withdrawn | 18 Years | 60 Years | Male | 0 | Phase 2 | NULL | |
| 352 | EUCTR2014-001579-30-GB (EUCTR) | 27/11/2014 | 08/09/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as compared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 353 | NCT02259361 (ClinicalTrials.gov) | November 2014 | 1/10/2014 | Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS | Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study | Multiple Sclerosis | Drug: Sustained-release oral dalfampridine;Drug: Placebo | Sheba Medical Center | NULL | Not yet recruiting | 18 Years | 70 Years | Both | 30 | Phase 4 | Israel |
| 354 | EUCTR2014-000253-36-EE (EUCTR) | 24/10/2014 | 13/10/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 355 | EUCTR2013-003600-40-CZ (EUCTR) | 22/10/2014 | 19/06/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | United States;Serbia;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;United Kingdom;Switzerland;Italy | ||
| 356 | EUCTR2012-002714-40-HR (EUCTR) | 17/10/2014 | 05/11/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1410 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Slovenia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 357 | NCT02096133 (ClinicalTrials.gov) | October 13, 2014 | 21/3/2014 | Vitamin D3 and the Stress-axis in MS | Regulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled Study | Multiple Sclerosis | Drug: Cholecalciferol;Other: Placebo comparator | Academic MS Center Limburg | NULL | Terminated | 18 Years | N/A | Female | 54 | Phase 2 | Netherlands |
| 358 | NCT02104661 (ClinicalTrials.gov) | October 2014 | 1/4/2014 | Protective Role of Oxcarbazepine in Multiple Sclerosis | OxCarbazepine as a Neuroprotective Agent in MS: A Phase 2a Trial | Multiple Sclerosis | Drug: Oxcarbazepine;Drug: Placebo | Queen Mary University of London | National Multiple Sclerosis Society;Novartis Pharmaceuticals;Barts & The London NHS Trust;University College, London;Royal Free Hospital NHS Foundation Trust;Southend University Hospital;Basildon and Thurrock University Hospitals NHS Foundation Trust;St George's Healthcare NHS Trust;Barnet and Chase Farm Hospitals NHS Trust | Completed | 18 Years | 60 Years | All | 30 | Phase 2 | United Kingdom |
| 359 | NCT02228213 (ClinicalTrials.gov) | October 2014 | 21/8/2014 | Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis | A Phase 2B Randomised, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of MIS416 in the Treatment of Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Biological: MIS416;Drug: Saline | Innate Immunotherapeutics | INC Research | Completed | 18 Years | 70 Years | All | 93 | Phase 2 | Australia;New Zealand |
| 360 | NCT02286557 (ClinicalTrials.gov) | October 2014 | 16/10/2014 | Testing the Effects of Methylphenidate on Multiple Sclerosis | Testing the Effects of Methylphenidate on Cognitive Fatigue in Multiple Sclerosis: a Double-blind, Placebo-controlled, Randomized Clinical Trial | Fatigue in Multiple Sclerosis | Drug: Methelphenidate;Drug: Placebo | Kessler Foundation | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 36 | Phase 2 | NULL |
| 361 | NCT02280096 (ClinicalTrials.gov) | October 2014 | 10/10/2014 | Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis | Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Randomized, Blinded, Placebo-controlled Clinical Trial. | Multiple Sclerosis | Drug: 4-aminopyridine;Drug: Placebo | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | 60 Years | All | 24 | Phase 2 | Mexico |
| 362 | NCT02282826 (ClinicalTrials.gov) | October 2014 | 31/10/2014 | A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: GZ402668;Drug: placebo;Drug: acyclovir | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 65 Years | Both | 48 | Phase 1 | Germany |
| 363 | EUCTR2011-005249-12-GB (EUCTR) | 29/09/2014 | 14/07/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Russian Federation;United States;Portugal;Greece;Netherlands;Morocco;China;Ireland;Poland;Slovenia;Serbia;France;Lithuania;Bulgaria;Tunisia;Ukraine;United Kingdom;Macedonia, the former Yugoslav Republic of;Spain;Lebanon;Canada;Turkey;Belgium;Italy;Israel;Australia;Estonia | ||
| 364 | EUCTR2013-001150-10-AT (EUCTR) | 16/09/2014 | 17/02/2014 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | neuromyelitis optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 365 | EUCTR2013-003600-40-GB (EUCTR) | 15/09/2014 | 08/05/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | United States;Serbia;Finland;Ukraine;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Poland;Bulgaria;Netherlands | ||
| 366 | EUCTR2013-003600-40-IT (EUCTR) | 11/09/2014 | 27/06/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;United Kingdom;Switzerland;Italy | |||
| 367 | EUCTR2013-003600-40-LT (EUCTR) | 02/09/2014 | 18/06/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland | |||
| 368 | NCT02045732 (ClinicalTrials.gov) | September 2014 | 22/1/2014 | A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS) | A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms) | Multiple Sclerosis | Biological: PF-06342674 0.25 mg/kg;Biological: Placebo;Biological: PF-06342674 1.5 mg/kg;Biological: PF-06342674 6.0 mg/kg | Pfizer | NULL | Terminated | 18 Years | 55 Years | All | 4 | Phase 1 | United States |
| 369 | NCT02222948 (ClinicalTrials.gov) | September 2014 | 20/8/2014 | Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab;Drug: Placebo (for Vatelizumab) | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | 55 Years | Both | 112 | Phase 2 | United States;Canada;Poland;Russian Federation;Sweden |
| 370 | NCT02219932 (ClinicalTrials.gov) | September 2014 | 18/8/2014 | Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE) | Multiple Sclerosis | Drug: fampridine;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 70 Years | All | 646 | Phase 3 | United States;Bulgaria;Czech Republic;Finland;Italy;Lithuania;Netherlands;Poland;Russian Federation;Serbia;United Kingdom;Argentina;Germany;Switzerland |
| 371 | NCT02273635 (ClinicalTrials.gov) | September 2014 | 3/10/2014 | Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS | Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis | Primary Progressive Multiple Sclerosis;Multiple Sclerosis, Secondary Progressive | Drug: Andrographolides;Drug: placebo | Innobioscience SpA | Pontificia Universidad Catolica de Chile;University of Chile;Universidad Austral de Chile | Recruiting | 18 Years | 70 Years | Both | 68 | Phase 1/Phase 2 | Chile |
| 372 | NCT02193217 (ClinicalTrials.gov) | September 2014 | 15/7/2014 | A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303 | Relapsing-remitting Multiple Sclerosis | Drug: MT-1303-Low;Drug: MT-1303-High;Drug: Fingolimod;Drug: Placebo | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 18 Years | 55 Years | Both | 81 | Phase 1 | United Kingdom | |
| 373 | EUCTR2013-003752-21-PL (EUCTR) | 31/08/2014 | 04/07/2014 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120mg/vial) Product Code: Satralizumab (RO5333787/Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;France;Taiwan;Hungary;Spain;Poland;Ukraine;Germany;United Kingdom;Japan;Italy | ||
| 374 | EUCTR2013-002112-27-GB (EUCTR) | 28/08/2014 | 07/08/2015 | Effect of MD1003 on visuel impairement of multiple sclerosis | Effect of MD1003 in chronic visual loss related to optic neuritis in multiplesclerosis: a pivotal randomized double masked placebo controlled study - MS-ON | chronic visual loss related to optic neuritis in multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10030942;Term: Optic neuritis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Biotin Product Code: MD1003 INN or Proposed INN: BIOTIN | MEDDAY Pharmaceuticals SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | France;United Kingdom | ||
| 375 | EUCTR2011-005249-12-EE (EUCTR) | 13/08/2014 | 27/02/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China | ||
| 376 | NCT02073279 (ClinicalTrials.gov) | August 5, 2014 | 25/2/2014 | Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD) | Drug: Satralizumab;Drug: Placebo | Hoffmann-La Roche | Chugai Pharmaceutical | Active, not recruiting | 18 Years | 74 Years | All | 95 | Phase 3 | United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Puerto Rico;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Singapore |
| 377 | EUCTR2013-003600-40-FI (EUCTR) | 05/08/2014 | 21/07/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland | |||
| 378 | EUCTR2012-000835-18-PL (EUCTR) | 22/07/2014 | 06/06/2014 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: Fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 379 | NCT02201108 (ClinicalTrials.gov) | July 16, 2014 | 17/7/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 10 Years | 17 Years | All | 166 | Phase 3 | United States;Belgium;Bulgaria;Canada;China;Estonia;France;Greece;Israel;Lebanon;Lithuania;Morocco;Netherlands;North Macedonia;Portugal;Russian Federation;Serbia;Slovenia;Spain;Tunisia;Turkey;Ukraine;United Kingdom;Australia;Macedonia, The Former Yugoslav Republic of;Poland |
| 380 | EUCTR2011-005249-12-BE (EUCTR) | 11/07/2014 | 17/03/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;Italy;France;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria;Serbia;United States | ||
| 381 | EUCTR2011-005249-12-GR (EUCTR) | 07/07/2014 | 21/05/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;Italy;France;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 382 | EUCTR2013-004533-32-PL (EUCTR) | 04/07/2014 | 05/05/2014 | A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 202 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Taiwan;Poland;Japan;Korea, Republic of | ||
| 383 | NCT02727907 (ClinicalTrials.gov) | July 2014 | 29/5/2015 | Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis | International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: BCD-033 (interferon beta 1a);Drug: Rebif (interferon beta 1a);Drug: Placebo | Biocad | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 147 | Phase 2/Phase 3 | Russian Federation |
| 384 | NCT02201849 (ClinicalTrials.gov) | July 2014 | 18/7/2014 | A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults | Multiple Sclerosis | Drug: Study Drug;Drug: Active Control;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 55 Years | All | 104 | Phase 1 | United States |
| 385 | EUCTR2012-000835-18-DK (EUCTR) | 23/06/2014 | 09/05/2014 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 386 | EUCTR2013-002324-16-CZ (EUCTR) | 13/06/2014 | 08/01/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 387 | EUCTR2013-002324-16-PL (EUCTR) | 04/06/2014 | 09/04/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 388 | EUCTR2011-005249-12-ES (EUCTR) | 03/06/2014 | 01/04/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China | ||
| 389 | EUCTR2012-002714-40-SK (EUCTR) | 02/06/2014 | 12/03/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 390 | NCT01941004 (ClinicalTrials.gov) | June 2014 | 9/9/2013 | Safety and Efficacy of Fingolimod in MS Patients in China | A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Drug: fingolimod;Drug: Placebo (6mos) + open label fingolimod (6 mos) | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 50 Years | All | 0 | Phase 3 | NULL |
| 391 | NCT02133664 (ClinicalTrials.gov) | June 2014 | 6/5/2014 | Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis | Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis | Multiple Sclerosis;Cognition | Drug: lipoic acid and omega-3 fatty acids;Drug: Placebo | Oregon Health and Science University | National Multiple Sclerosis Society | Completed | 18 Years | 65 Years | All | 54 | Phase 1/Phase 2 | United States |
| 392 | EUCTR2012-002714-40-GB (EUCTR) | 29/05/2014 | 28/02/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1265 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 393 | EUCTR2013-003752-21-DE (EUCTR) | 22/05/2014 | 20/12/2013 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;France;Taiwan;Hungary;Spain;Poland;Germany;United Kingdom;Japan;Italy | ||
| 394 | EUCTR2013-003752-21-GB (EUCTR) | 19/05/2014 | 15/10/2013 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom | ||
| 395 | EUCTR2013-001150-10-FR (EUCTR) | 13/05/2014 | 21/09/2015 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing neuromyelitis optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 93 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 396 | JPRN-UMIN000013453 | 2014/05/10 | 18/03/2014 | A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody | A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody - RIN-1 | Neuromyelitis optica | Rituximab intravenous infusion Placebo | Clinical Research Center, NHO Utano National Hospital | Zenyaku Kogyo Co., Ltd. | Complete: follow-up complete | 16years-old | 80years-old | Male and Female | 40 | Phase 2,3 | Japan |
| 397 | JPRN-JapicCTI-142447 | 01/5/2014 | 19/02/2014 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Intervention name : BAF312 INN of the intervention : Siponimod Dosage And administration of the intervention : BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching Placebo administered orally. | Novartis Pharma K.K. | NULL | complete | 18 | 60 | BOTH | 1530 | Phase 3 | NULL |
| 398 | NCT02086188 (ClinicalTrials.gov) | May 2014 | 11/3/2014 | Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis | Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis (MIRROR) | Multiple Sclerosis | Drug: Mirabegron;Drug: Placebo | Theodore R. Brown, MD MPH | Astellas Pharma Inc | Completed | 18 Years | N/A | All | 28 | Phase 4 | United States |
| 399 | NCT02090413 (ClinicalTrials.gov) | May 2014 | 14/3/2014 | Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis | A Phase 4, Randomized, Double-Blind Study With a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects With Relapsing-Remitting Multiple Sclerosis Treated With Tecfidera® (Dimethyl Fumarate) Delayed-Release Capsules | Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Drug: acetylsalicylic acid;Drug: ASA-Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 241 | Phase 4 | Ireland;United Kingdom |
| 400 | NCT02143167 (ClinicalTrials.gov) | May 2014 | 9/5/2014 | Resistance Training and Amino Pyridine in Multiple Sclerosis | RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: SR-fampridine;Drug: Placebo | University of Southern Denmark | Region of Southern Denmark;Biogen | Completed | 18 Years | 60 Years | All | 40 | Phase 4 | Denmark |
| 401 | EUCTR2013-004533-32-CZ (EUCTR) | 28/04/2014 | 08/01/2014 | A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 3 | Taiwan;Czech Republic;Poland;Japan;Korea, Republic of | ||
| 402 | NCT01892345 (ClinicalTrials.gov) | April 11, 2014 | 20/6/2013 | A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Eculizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 143 | Phase 3 | United States;Argentina;Australia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Canada;Colombia;Czech Republic;France;Singapore |
| 403 | EUCTR2012-005394-31-GB (EUCTR) | 01/04/2014 | 05/09/2014 | MS-SMART: A Trial of Efficacy (usefulness) of 3 Neuroprotective Drugs in SPMS | MS-SMART: A Multi-Arm Phase IIb Randomised, Double Blind Placebo-Controlled Clinical Trial Comparing The Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis - MS-SMART: Multiple Sclerosis Secondary Progressive Multi-Arm Randomisation Trial | Mutliple Sclerosis (Secondary Progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rilutek Product Name: Rilutek INN or Proposed INN: Riluzole Trade Name: Amiloride Product Name: Amiloride INN or Proposed INN: Amiloride Trade Name: Fluoxetine Product Name: Fluoxetine INN or Proposed INN: Fluoxetine hydrochloride | UCL | NULL | Not Recruiting | Female: yes Male: yes | 440 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 404 | EUCTR2013-003752-21-IT (EUCTR) | 28/03/2014 | 06/02/2014 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 16.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;Hungary;Taiwan;Spain;Poland;Germany;United Kingdom;Japan;Italy | ||
| 405 | NCT02208050 (ClinicalTrials.gov) | February 21, 2014 | 19/5/2014 | A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS | A Phase IV Double Blind, Randomized, Placebo Controlled, Crossover Study of the Effectiveness of Oral Fampridine in Improving Upper Limb Function in Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Fampridine;Drug: Placebo | University College Dublin | NULL | Completed | 18 Years | 70 Years | All | 64 | Phase 4 | Ireland |
| 406 | JPRN-JapicCTI-132397 | 20/2/2014 | 26/12/2013 | Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) | Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : subcutaneous administration of SA237 Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Chugai Pharmaceutical Co., Ltd. | F. Hoffmann-La Roche Ltd | complete | 12 | 74 | BOTH | 85 | Phase 3 | Japan, Asia except Japan, North America, Europe |
| 407 | NCT02028884 (ClinicalTrials.gov) | February 20, 2014 | 6/1/2014 | Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD) | Drug: Satralizumab;Drug: Placebo;Drug: Baseline Treatment | Hoffmann-La Roche | Chugai Pharmaceutical | Active, not recruiting | 12 Years | 74 Years | All | 83 | Phase 3 | United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom |
| 408 | EUCTR2013-001150-10-GB (EUCTR) | 18/02/2014 | 25/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 409 | NCT02166346 (ClinicalTrials.gov) | February 2014 | 16/6/2014 | Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch) | Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch) | Transverse Myelitis;Neuromyelitis Optica;Idiopathic Transverse Myelitis;Myelitis NOS | Drug: Dalfampridine;Drug: Placebo | Johns Hopkins University | Acorda Therapeutics | Completed | 18 Years | 70 Years | All | 24 | Phase 2 | United States |
| 410 | NCT02040298 (ClinicalTrials.gov) | January 2014 | 10/1/2014 | Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis | A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Crossover Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Clemastine;Drug: Placebo | University of California, San Francisco | NULL | Completed | 18 Years | 60 Years | Both | 50 | Phase 2 | United States |
| 411 | NCT02038049 (ClinicalTrials.gov) | December 20, 2013 | 14/1/2014 | A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis | A Randomized, Partially Blind, Placebo-controlled, Proof-of-concept Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity as Measured by Brain MRI Scans in Patients With Relapsing-remitting Multiple Sclerosis | Relapse Remitting Multiple Sclerosis | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 8 | Phase 2 | United States;Czechia;Ukraine;Czech Republic;Germany;Poland;Russian Federation |
| 412 | EUCTR2013-002558-64-IT (EUCTR) | 18/12/2013 | 16/10/2013 | improvement of cognitive performance after administration of fampridina in patients with multiple sclerosis | A randomised, placebo-controlled trial investigating the role of fampiridina in improving cognitive function of patients with multiple sclerosis. | MULTIPLE SCLEROSIS MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: fampyra Product Name: FAMPYRA INN or Proposed INN: FAMPRIDINE | dipartimento di neurologia e psichiatria | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 4 | Italy | ||
| 413 | EUCTR2013-001150-10-DE (EUCTR) | 12/12/2013 | 02/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | Neuromyelitis Optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 414 | NCT02047734 (ClinicalTrials.gov) | December 3, 2013 | 26/1/2014 | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study) | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients | Relapsing Multiple Sclerosis | Drug: Ozanimod 0.5 mg;Drug: Ozanimod 1 mg;Drug: Ozanimod placebo;Drug: Interferon ß-1a;Drug: IFN ß-1a placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1320 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Georgia;Greece;Hungary;Italy;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom |
| 415 | NCT02146534 (ClinicalTrials.gov) | December 2013 | 23/4/2014 | Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients | Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study. | Multiple Sclerosis | Drug: extended release fampridine;Drug: Placebo | Clinique Neuro-Outaouais | CogState Ltd. | Completed | 18 Years | N/A | All | 44 | Phase 4 | Canada |
| 416 | EUCTR2010-021219-17-PL (EUCTR) | 07/11/2013 | 16/07/2013 | A 96 weeks study to compare efficacy and safety of masitinib to placebo in the treatment of patients with primary progressiveor relapse free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;Czech Republic;Slovakia;Greece;Spain;Poland;Romania;Germany | ||
| 417 | NCT01982942 (ClinicalTrials.gov) | November 2013 | 29/10/2013 | Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis | A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Secondary Progressive | Drug: ibudilast;Drug: Placebo oral capsule | MediciNova | National Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS);National Multiple Sclerosis Society | Completed | 21 Years | 65 Years | All | 255 | Phase 2 | United States |
| 418 | NCT01968902 (ClinicalTrials.gov) | November 2013 | 21/10/2013 | Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients | A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Incobotulinumtoxin Type A for the Functional Improvement of Lower Extremity Spasticity in Patients With Multiple Sclerosis | Muscle Spasticity;Multiple Sclerosis | Biological: incabotulinumtoxinA;Biological: Placebo | Multiple Sclerosis Center of Northeastern New York | Merz North America, Inc. | Completed | 18 Years | 65 Years | All | 27 | Phase 4 | United States |
| 419 | NCT02048358 (ClinicalTrials.gov) | November 2013 | 17/1/2014 | Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients | Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201 | Healthy Volunteers;Multiple Sclerosis | Drug: 2B3-201;Drug: Placebo;Drug: Methylprednisolone hemisuccinate | BBB-Therapeutics B.V. | NULL | Terminated | 18 Years | 65 Years | Both | 47 | Phase 1 | Netherlands |
| 420 | EUCTR2013-001150-10-ES (EUCTR) | 17/10/2013 | 08/08/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing neuromyelitis optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 421 | EUCTR2012-004019-29-PL (EUCTR) | 07/10/2013 | 02/09/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | United States;Portugal;Finland;Spain;Turkey;Russian Federation;Colombia;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 422 | NCT02220933 (ClinicalTrials.gov) | October 2013 | 18/8/2014 | Effect of MD1003 in Spinal Progressive Multiple Sclerosis | Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study | Multiple Sclerosis | Drug: MD1003 100mg capsule;Drug: Placebo | MedDay Pharmaceuticals SA | NULL | Active, not recruiting | 18 Years | 75 Years | All | 144 | Phase 3 | France |
| 423 | NCT02753088 (ClinicalTrials.gov) | October 2013 | 19/4/2016 | Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis | International, Multicentre, Double-blind, Placebo-controlled, Comparative, Randomized Study to Compare Efficacy and Safety of the Generic Drug BCD-063 (CJSC BIOCAD, Russia) and Copaxone®-Teva (Teva Pharmaceutical Industries Limited, Israel) in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: BCD-063;Drug: Copaxone-Teva;Drug: Placebo | Biocad | NULL | Completed | 18 Years | 55 Years | All | 158 | Phase 3 | NULL |
| 424 | NCT02220244 (ClinicalTrials.gov) | October 2013 | 18/8/2014 | Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis | Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study | Multiple Sclerosis | Drug: MD1003 100mg capsule | MedDay Pharmaceuticals SA | NULL | Active, not recruiting | 18 Years | 75 Years | All | 105 | Phase 3 | France;United Kingdom |
| 425 | NCT01868048 (ClinicalTrials.gov) | October 2013 | 30/5/2013 | Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis. | A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis. | Spasticity;Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Research Ltd | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 426 | EUCTR2012-000835-18-CZ (EUCTR) | 27/09/2013 | 17/06/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 427 | EUCTR2011-006262-40-GB (EUCTR) | 24/09/2013 | 03/07/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 428 | EUCTR2012-004019-29-DE (EUCTR) | 19/09/2013 | 06/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 429 | EUCTR2013-001150-10-IT (EUCTR) | 17/09/2013 | 09/07/2013 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 | Relapsing neuromyelitis optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 430 | EUCTR2012-003647-30-AT (EUCTR) | 27/08/2013 | 07/02/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 431 | EUCTR2012-002714-40-ES (EUCTR) | 02/08/2013 | 09/04/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 432 | EUCTR2012-004019-29-PT (EUCTR) | 02/08/2013 | 03/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 433 | NCT01864148 (ClinicalTrials.gov) | August 2013 | 24/5/2013 | Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex | Multiple Sclerosis | Drug: BIIB033;Other: Placebo;Drug: Avonex | Biogen | NULL | Completed | 18 Years | 58 Years | All | 419 | Phase 2 | United States;Canada;Czech Republic;France;Hungary;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom |
| 434 | NCT01917019 (ClinicalTrials.gov) | August 2013 | 2/8/2013 | A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis | A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension | Multiple Sclerosis, Remittent Progressive;Multiple Sclerosis, Primary Progressive;Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple Sclerosis | Drug: Placebo;Drug: BIIB041 (fampridine) | Biogen | NULL | Completed | 18 Years | 70 Years | All | 101 | Phase 3 | Japan |
| 435 | NCT01892722 (ClinicalTrials.gov) | July 26, 2013 | 8/5/2013 | Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis | A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon ß-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase | Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Fingolimod;Drug: Placebo capsule;Drug: Placebo i.m. injection | Novartis Pharmaceuticals | NULL | Recruiting | 10 Years | 17 Years | All | 220 | Phase 3 | United States;Australia;Austria;Belarus;Brazil;Bulgaria;Canada;Croatia;Estonia;France;Germany;Italy;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;South Africa |
| 436 | EUCTR2012-004019-29-CZ (EUCTR) | 18/07/2013 | 13/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 437 | NCT01817166 (ClinicalTrials.gov) | July 16, 2013 | 20/3/2013 | Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome | Multicentric, Randomized, Double-blind Versus Placebo Study Evaluating the Efficacy of Treatment With Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of Multiple Sclerosis (MS) After a Clinically Isolated Syndrome (CIS). Comparison of Conversion Rates After 2 Years. | Multiple Sclerosis | Drug: Vitamin D;Drug: Placebo;Other: Imaging;Biological: Lumbar puncture;Biological: Blood sampling;Biological: Urine samples | Centre Hospitalier Universitaire de Nimes | NULL | Active, not recruiting | 18 Years | 56 Years | All | 316 | Phase 3 | France |
| 438 | EUCTR2012-002714-40-GR (EUCTR) | 10/07/2013 | 17/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 439 | EUCTR2012-004019-29-IT (EUCTR) | 10/07/2013 | 11/01/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebocontrolled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2 | United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;Canada;Argentina;Poland;Germany;Japan;Sweden | ||
| 440 | EUCTR2012-003647-30-CZ (EUCTR) | 08/07/2013 | 28/11/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 441 | EUCTR2011-006262-40-NL (EUCTR) | 03/07/2013 | 10/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: PRD806998 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 442 | NCT01896700 (ClinicalTrials.gov) | July 2013 | 8/7/2013 | Methylphenidate to Improve Balance and Walking in MS | Methylphenidate to Improve Balance and Walking in MS | Multiple Sclerosis | Drug: Methylphenidate;Drug: Placebo | Oregon Health and Science University | Portland VA Medical Center | Completed | 20 Years | 65 Years | All | 24 | Phase 2/Phase 3 | United States |
| 443 | EUCTR2011-006262-40-ES (EUCTR) | 28/06/2013 | 13/06/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: No disponible Other descriptive name: Anticuerpo monoclonal anti-LINGO-1 humano Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 444 | EUCTR2012-004019-29-SE (EUCTR) | 19/06/2013 | 12/04/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 445 | EUCTR2012-004019-29-FI (EUCTR) | 19/06/2013 | 16/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 446 | EUCTR2011-006262-40-CZ (EUCTR) | 18/06/2013 | 05/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 447 | EUCTR2012-002714-40-HU (EUCTR) | 10/06/2013 | 02/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 448 | EUCTR2011-006262-40-HU (EUCTR) | 06/06/2013 | 25/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: Not available Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Czech Republic;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 449 | EUCTR2011-006262-40-IT (EUCTR) | 01/06/2013 | 08/04/2013 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Canada;Spain;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 450 | JPRN-JapicCTI-132178 | 01/6/2013 | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching placebo will be administered intravenously. | Novartis Pharma K.K. | NULL | 18 | 55 | BOTH | 380 | Phase 2 | NULL | ||
| 451 | NCT01874340 (ClinicalTrials.gov) | June 2013 | 28/5/2013 | Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: AIN457 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 28 | Phase 2 | Belgium;Czech Republic;France;Italy;Japan;Poland;Russian Federation;Spain;Sweden;Turkey;Canada;Finland;Germany;Romania;Switzerland;United States |
| 452 | EUCTR2012-003056-36-IE (EUCTR) | 31/05/2013 | 06/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 453 | EUCTR2012-003647-30-IT (EUCTR) | 24/05/2013 | 11/01/2013 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - Concerto | Relapsing remitting multiple sclerosis (RRMS). MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 Other descriptive name: Laquinimod Sodium (USAN) | TEVA PHARMACEUTICALS INDUSTRIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 454 | EUCTR2012-004019-29-ES (EUCTR) | 24/05/2013 | 24/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 455 | EUCTR2012-002714-40-BG (EUCTR) | 17/05/2013 | 08/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;South Africa;Moldova, Republic of;Bosnia and Herzegovina | ||
| 456 | EUCTR2012-002714-40-IT (EUCTR) | 09/05/2013 | 08/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Belgium;Croatia;Georgia;Bulgaria | ||
| 457 | EUCTR2012-002714-40-BE (EUCTR) | 29/04/2013 | 14/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Sweden;Bosnia and Herzegovina | ||
| 458 | EUCTR2012-004019-29-BE (EUCTR) | 29/04/2013 | 23/10/2012 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 459 | EUCTR2012-000835-18-HU (EUCTR) | 15/04/2013 | 28/02/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 460 | EUCTR2012-003647-30-PL (EUCTR) | 11/04/2013 | 12/02/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;Estonia | ||
| 461 | EUCTR2012-003056-36-GB (EUCTR) | 08/04/2013 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 462 | EUCTR2012-005113-39-AT (EUCTR) | 08/04/2013 | 18/02/2013 | Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve. | A Randomized, Placebo-Controlled, Double-Blind, Phase IIa Study of Amiloride in the Treatment of Acute Autoimmune Optic Neuritis - Amiloride Hydrochlorothiazide in acute autoimmune optic neuritis | Optic neuritis is among the most common first symptoms of multiple sclerosis leading to significant atrophy of the optic nerve within a short period of time, thus reflecting neurodegneration.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Amilostad HCT Product Name: Amilostad HCT tablets INN or Proposed INN: AMILORIDE HYDROCHLORIDE, 2 H2O Other descriptive name: Amiloride Hydrochloride INN or Proposed INN: hydrochlorothiazide Other descriptive name: HYDROCHLOROTHIAZIDE | Universitätsklinik für Neurologie, Medizinische Universität Wien | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Austria | |||
| 463 | NCT01808885 (ClinicalTrials.gov) | April 2013 | 12/2/2013 | Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. | A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. | Relapsing Remitting Multiple Sclerosis | Drug: olesoxime (TRO19622);Drug: placebo | Hoffmann-La Roche | Hôpital de la Timone;SGS S.A.;STRAGEN Services | Completed | 18 Years | N/A | Both | 44 | Phase 1 | France |
| 464 | NCT01838668 (ClinicalTrials.gov) | March 28, 2013 | 20/4/2013 | An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: Placebo;Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 225 | Phase 3 | Czechia;Japan;Korea, Republic of;Poland;Taiwan;Czech Republic |
| 465 | EUCTR2012-003056-36-BG (EUCTR) | 20/03/2013 | 06/02/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 466 | EUCTR2010-021219-17-GR (EUCTR) | 19/03/2013 | 30/01/2013 | A clinical study to compare the efficacy and safety of masitinib 4.5 mg/kg/day vs. placebo in the treatment of patients with multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Greece;Poland;Spain;Turkey;Bulgaria;Germany | ||
| 467 | EUCTR2012-000835-18-NL (EUCTR) | 19/03/2013 | 03/01/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 468 | EUCTR2012-003056-36-PL (EUCTR) | 18/03/2013 | 20/12/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 469 | EUCTR2012-000835-18-GB (EUCTR) | 18/03/2013 | 09/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 470 | NCT01808482 (ClinicalTrials.gov) | March 13, 2013 | 7/3/2013 | A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A First Time in Human Study Exploring Preliminary Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Part A: 100 mg/mL GSK2618960;Drug: Part A: matching placebo;Drug: Part B: Dose of GSK2618960 decided from Part A;Drug: Part B: matching placebo;Drug: Part C: Dose of GSK2618960 decided from Part A and B | GlaxoSmithKline | NULL | Terminated | 18 Years | 55 Years | Male | 16 | Phase 1 | United Kingdom |
| 471 | EUCTR2011-002959-34-DK (EUCTR) | 11/03/2013 | 01/03/2013 | RETRAP - A study of the effect of combination of resistance training and prolonged-release fampridine on muscle strength in the legs, walking capacity and quality of life in multiple sclerosis patients. | RETRAP - A double blind, randomized, placebo controlled study of the effect of the combination of resistance training and prolonged release fampridine on muscle strength in the lower extremities, walking capacity and quality of life in relapsing remitting multiple sclerosis - RETRAP | Multiple sclerosis MedDRA version: 15.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Sønderjylland Hospital, department of neurology | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 4 | Denmark | ||
| 472 | EUCTR2012-002470-31-LT (EUCTR) | 06/03/2013 | 05/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 473 | EUCTR2010-020338-25-NL (EUCTR) | 02/03/2013 | 30/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 474 | NCT01768039 (ClinicalTrials.gov) | March 2013 | 11/1/2013 | Vitamine D in Multiple Sclerosis | Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis | Multiple Sclerosis | Drug: Vitamin D;Drug: Placebo | Mazandaran University of Medical Sciences | NULL | Not yet recruiting | 18 Years | 50 Years | Both | 240 | Phase 3 | Iran, Islamic Republic of |
| 475 | NCT01803867 (ClinicalTrials.gov) | March 2013 | 26/2/2013 | An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis | A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: rHIgM22 | Acorda Therapeutics | PRA Health Sciences | Completed | 18 Years | 70 Years | Both | 72 | Phase 1 | United States |
| 476 | EUCTR2012-000835-18-DE (EUCTR) | 26/02/2013 | 06/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 477 | EUCTR2012-002470-31-BE (EUCTR) | 25/02/2013 | 22/10/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 478 | NCT01707992 (ClinicalTrials.gov) | February 20, 2013 | 28/9/2012 | The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 55 Years | All | 2199 | Phase 3 | United States;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Montenegro;North Macedonia;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom;Czech Republic;Kazakhstan;Macedonia, The Former Yugoslav Republic of;Mexico;Portugal |
| 479 | NCT01848327 (ClinicalTrials.gov) | February 2013 | 16/4/2013 | Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis | A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis. | Relapsing Remitting MS;Secondary Progressive MS;Primary Progressive MS | Dietary Supplement: Caprylic Triglyceride;Dietary Supplement: Placebo | University of Miami | National Multiple Sclerosis Society;Cerecin | Completed | 18 Years | 59 Years | All | 124 | N/A | United States |
| 480 | NCT01772199 (ClinicalTrials.gov) | February 2013 | 17/1/2013 | Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK239512;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 50 Years | Both | 131 | Phase 2 | Bulgaria;Canada;Czech Republic;Germany;Spain;Sweden;Ukraine;United Kingdom |
| 481 | NCT01802489 (ClinicalTrials.gov) | February 2013 | 27/2/2013 | Amiloride Clinical Trial In Optic Neuritis | A Double Blind Randomised Control Trial on Neuroprotection of Amiloride in Optic Neuritis | Optic Neuritis;Multiple Sclerosis | Drug: Amiloride;Drug: Placebo | University of Oxford | Multiple Sclerosis Society of Great Britain and Northern Ireland | Completed | 18 Years | 55 Years | All | 46 | Phase 2 | United Kingdom |
| 482 | EUCTR2012-002470-31-BG (EUCTR) | 30/01/2013 | 03/01/2013 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 483 | EUCTR2012-004183-21-GB (EUCTR) | 25/01/2013 | 14/12/2012 | Melatonin for Nocturia in patients with Multiple Sclerosis | A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study - Melatonin for Nocturia in MS | Nocturia; Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Circadin Product Name: Circadin Product Code: N/A INN or Proposed INN: Circadin ( INN= Melatonin) | North Bristol NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 484 | EUCTR2012-000835-18-ES (EUCTR) | 23/01/2013 | 29/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GYLENIA 0,5 mg Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Farmaceutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 485 | EUCTR2012-002470-31-IT (EUCTR) | 21/01/2013 | 13/12/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebocontrolled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 Product Name: MT-1303 Product Code: MT-1303 Product Name: MT-1303 Product Code: MT-1303 | MITSUBISHI PHARMA CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Bosnia and Herzegovina | ||
| 486 | EUCTR2012-003056-36-BE (EUCTR) | 21/01/2013 | 19/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 487 | EUCTR2012-003647-30-BE (EUCTR) | 18/01/2013 | 08/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 488 | EUCTR2012-000835-18-BE (EUCTR) | 18/01/2013 | 19/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 489 | EUCTR2012-002470-31-ES (EUCTR) | 16/01/2013 | 05/02/2013 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 490 | EUCTR2012-003056-36-GR (EUCTR) | 15/01/2013 | 23/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 491 | EUCTR2012-002470-31-FI (EUCTR) | 14/01/2013 | 02/10/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 492 | EUCTR2012-000835-18-IT (EUCTR) | 12/01/2013 | 19/12/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Sweden | |||
| 493 | EUCTR2012-004602-97-ES (EUCTR) | 11/01/2013 | 12/11/2012 | ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? | ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? - VITADEM | RELAPSING-REMITING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA INN or Proposed INN: COLECALCIFEROL Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM) | Javier Olascoaga Urtaza | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain | ||
| 494 | EUCTR2012-003647-30-ES (EUCTR) | 04/01/2013 | 29/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 495 | EUCTR2012-003647-30-HU (EUCTR) | 04/01/2013 | 25/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 496 | EUCTR2012-005076-34-BE (EUCTR) | 03/01/2013 | 14/12/2012 | Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.A cross-over, double-blinded, placebo-controlled study. | Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.A cross-over, double-blinded, placebo-controlled study. | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 | Cliniques Universitaires Saint-Luc, Neurologie | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Belgium | ||
| 497 | EUCTR2012-003647-30-EE (EUCTR) | 03/01/2013 | 19/11/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 498 | NCT01606215 (ClinicalTrials.gov) | January 2013 | 21/5/2012 | Stem Cells in Rapidly Evolving Active Multiple Sclerosis | Stem Cells in Rapidly Evolving Active Multiple Sclerosis | Multiple Sclerosis | Drug: Mesenchymal stem cells;Drug: Placebo | Imperial College London | NULL | Completed | 18 Years | 50 Years | All | 21 | Phase 1/Phase 2 | United Kingdom |
| 499 | NCT01742052 (ClinicalTrials.gov) | January 2013 | 2/12/2012 | Dose-finding Study of MT-1303 | A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: MT-1303-Low;Drug: MT-1303-Middle;Drug: MT-1303-High;Drug: Placebo | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 18 Years | 60 Years | Both | 415 | Phase 2 | Belgium;Bulgaria;Canada;Croatia;Czech Republic;Finland;Germany;Hungary;Italy;Lithuania;Poland;Russian Federation;Serbia;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 500 | NCT01779934 (ClinicalTrials.gov) | January 2013 | 26/10/2012 | OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: FTY720 | Novartis Pharmaceuticals | NULL | Completed | 28 Years | N/A | Both | 579 | Phase 3 | United States;Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 501 | NCT01753375 (ClinicalTrials.gov) | January 2013 | 17/12/2012 | Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis | Role of Vitamin D on the Relapse Rate of Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Vitamin D3;Dietary Supplement: Placebo | AlJohara M AlQuaiz, M.D. | NULL | Not yet recruiting | 18 Years | 55 Years | Both | 200 | Phase 2 | Saudi Arabia |
| 502 | EUCTR2012-003056-36-LT (EUCTR) | 21/12/2012 | 29/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 503 | EUCTR2012-003647-30-GB (EUCTR) | 20/12/2012 | 23/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) consisting of two parts: First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 504 | EUCTR2012-000835-18-FR (EUCTR) | 20/12/2012 | 19/06/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 505 | NCT01665144 (ClinicalTrials.gov) | December 20, 2012 | 3/8/2012 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312. | Secondary Progressive Multiple Sclerosis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 60 Years | All | 1652 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;China;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Latvia;Lithuania;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Egypt |
| 506 | EUCTR2012-003056-36-LV (EUCTR) | 18/12/2012 | 18/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 507 | EUCTR2012-002470-31-PL (EUCTR) | 17/12/2012 | 21/12/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 508 | EUCTR2012-003056-36-DE (EUCTR) | 14/12/2012 | 11/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 509 | EUCTR2012-003647-30-LV (EUCTR) | 13/12/2012 | 25/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 510 | EUCTR2012-003056-36-EE (EUCTR) | 13/12/2012 | 09/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 511 | EUCTR2012-003056-36-SE (EUCTR) | 12/12/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 512 | EUCTR2012-003056-36-PT (EUCTR) | 11/12/2012 | 11/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 513 | EUCTR2012-003647-30-GR (EUCTR) | 11/12/2012 | 14/11/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Albania;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 514 | EUCTR2012-003056-36-SK (EUCTR) | 10/12/2012 | 13/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 515 | EUCTR2012-002470-31-CZ (EUCTR) | 04/12/2012 | 11/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 516 | EUCTR2012-003056-36-ES (EUCTR) | 04/12/2012 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Farmacéutica S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Sweden | |||
| 517 | EUCTR2012-003647-30-SK (EUCTR) | 04/12/2012 | 20/02/2014 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2100 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 518 | NCT01879202 (ClinicalTrials.gov) | December 2012 | 7/11/2012 | Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis | Methylphenidate Modified-release as Treatment of MS-associated Fatigue. A Single-center Randomized Double-blind Placebo-controlled Study. | Multiple Sclerosis;Fatigue | Drug: Methylphenidate modified release;Drug: Maltodextrin | Medical University of Vienna | NULL | Recruiting | 18 Years | N/A | Both | 96 | Phase 2 | Austria |
| 519 | NCT01764737 (ClinicalTrials.gov) | December 2012 | 3/1/2013 | Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS | A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of Intravenous VX15/2503 In Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: VX15/2503;Drug: Placebo | Vaccinex Inc. | PRA Health Sciences | Completed | 18 Years | 60 Years | Both | 50 | Phase 1 | United States |
| 520 | EUCTR2012-003056-36-AT (EUCTR) | 28/11/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 521 | EUCTR2012-000835-18-FI (EUCTR) | 28/11/2012 | 08/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 522 | EUCTR2012-003056-36-IT (EUCTR) | 21/11/2012 | 15/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate | NOVARTIS FARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Portugal;United States;Estonia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Australia;Bulgaria;Latvia;Germany;Sweden | |||
| 523 | EUCTR2012-002470-31-HU (EUCTR) | 08/11/2012 | 25/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 524 | EUCTR2012-003056-36-CZ (EUCTR) | 08/11/2012 | 12/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 525 | EUCTR2012-000835-18-SE (EUCTR) | 07/11/2012 | 01/10/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 526 | NCT01728922 (ClinicalTrials.gov) | November 6, 2012 | 8/11/2012 | Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome | Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome and Healthy Control Participants. An Exploratory Double Blind Placebo Randomised Controlled Study. | Clinically Isolated Syndrome;Multiple Sclerosis | Dietary Supplement: 5000IU vitamin D;Dietary Supplement: 10000IU vitamin D;Other: Placebo | University College Dublin | University of Dublin, Trinity College;St Vincent's University Hospital, Ireland | Completed | 18 Years | 55 Years | All | 64 | Phase 1/Phase 2 | Ireland |
| 527 | NCT01743651 (ClinicalTrials.gov) | November 2012 | 28/11/2012 | Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis | A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis | Spasticity;Multiple Sclerosis | Drug: arbaclofen;Drug: baclofen;Drug: Placebo | RVL Pharmaceuticals, Inc. | Osmotica Pharmaceutical US LLC | Completed | 18 Years | 65 Years | All | 353 | Phase 3 | United States;Russian Federation;Ukraine |
| 528 | EUCTR2012-003056-36-HU (EUCTR) | 31/10/2012 | 03/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 529 | EUCTR2012-002470-31-GB (EUCTR) | 29/10/2012 | 03/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 530 | EUCTR2012-003418-15-AT (EUCTR) | 23/10/2012 | 09/11/2012 | Methylphenidate modified release as treatment of MS-associated fatigue. | Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. | Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ritalin LA 20mg capsules Product Name: Methylphenidate modified release 20 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 30mg capsules Product Name: Methylphenidate modified release 30 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 40mg capsules Product Name: Methylphenidate modified release 40 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE | Medizinische Universität Wien | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Austria | ||
| 531 | EUCTR2012-000368-90-NL (EUCTR) | 02/10/2012 | 06/08/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Belgium;Netherlands;United Kingdom;Italy;Sweden | |||
| 532 | EUCTR2012-000635-68-IE (EUCTR) | 19/09/2012 | 09/02/2012 | An initial, short-duration study of vitamin D versus an inactive therapy on the ability of the human immune system to counteract the effects of Multiple Sclerosis on the brain and the effects of vitamin D on the immune system in healthy individuals. | Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome or early multiple sclerosis and healthy control participants. An exploratory randomised double blind placebo controlled study - N/A | Multiple Sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Product Name: N/A Product Code: N/A | University College Dublin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Ireland | |||
| 533 | NCT01628393 (ClinicalTrials.gov) | September 18, 2012 | 22/6/2012 | Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study) | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients | Relapsing Multiple Sclerosis | Drug: RPC1063;Drug: placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 258 | Phase 2/Phase 3 | United States;Belgium;Bulgaria;Georgia;Greece;Hungary;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine |
| 534 | EUCTR2010-023210-31-LT (EUCTR) | 12/09/2012 | 29/05/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 535 | EUCTR2010-023210-31-CZ (EUCTR) | 06/09/2012 | 13/06/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 536 | NCT01667497 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? A Cross Over Study | Cognitive Fatigue | Drug: Fampridine SR;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 64 Years | Both | 60 | Phase 2/Phase 3 | Canada |
| 537 | NCT01413243 (ClinicalTrials.gov) | September 2012 | 8/8/2011 | Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome | Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome - A Monocentric, Prospective, Randomized, Double-blind and Placebo-controlled Phase 2 Trial | Multiple Sclerosis | Drug: Trichuris suis ova | Charite University, Berlin, Germany | NULL | Terminated | 18 Years | 65 Years | Both | 50 | Phase 2 | Germany |
| 538 | NCT02442570 (ClinicalTrials.gov) | September 2012 | 1/5/2015 | A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple Sclerosis | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: recombinant human alpha B-crystallin;Other: Placebo comparator | Delta Crystallon BV | NULL | Completed | 18 Years | 55 Years | Both | 32 | Phase 2 | Bulgaria |
| 539 | NCT01667484 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Adderall XR and Processing Speed in Multiple Sclerosis (MS) | Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients? | Impaired Processing Speed;Cognitive Impairment;Multiple Sclerosis | Drug: Adderall XR 5mg;Drug: Adderall XR 10 mg;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 59 Years | Both | 70 | Phase 2/Phase 3 | Canada |
| 540 | EUCTR2012-000368-90-BE (EUCTR) | 08/08/2012 | 11/06/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Canada;Belgium;Netherlands;Italy;United Kingdom;Sweden | ||
| 541 | NCT01597297 (ClinicalTrials.gov) | August 2012 | 10/5/2012 | Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: BIIB041 (PR Fampridine);Other: Placebo | Biogen | NULL | Completed | 18 Years | 70 Years | All | 132 | Phase 2 | Belgium;Canada;Italy;Netherlands;Sweden;United Kingdom |
| 542 | NCT01684761 (ClinicalTrials.gov) | August 2012 | 11/9/2012 | Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis | A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis | Autoimmune Diseases of the Nervous System;Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Disease Progression;Brain Atrophy | Biological: Tcelna;Biological: Placebo | Opexa Therapeutics, Inc. | NULL | Completed | 18 Years | 60 Years | All | 183 | Phase 2 | United States;Canada |
| 543 | EUCTR2012-000368-90-IT (EUCTR) | 30/07/2012 | 12/09/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra INN or Proposed INN: FAMPRIDINE | BIOGEN IDEC RESEARCH LTD | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Belgium;Netherlands;United Kingdom;Switzerland;Italy | |||
| 544 | EUCTR2010-021978-11-IE (EUCTR) | 06/07/2012 | 14/05/2012 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 545 | NCT01639300 (ClinicalTrials.gov) | July 2012 | 10/7/2012 | Safety Study of GNbAC1 in Multiple Sclerosis Patients | Randomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1 | Multiple Sclerosis | Biological: GNbAC1;Biological: GNbAC1 placebo | GeNeuro Innovation SAS | NULL | Completed | 18 Years | 65 Years | All | 10 | Phase 2 | Switzerland |
| 546 | EUCTR2012-000368-90-GB (EUCTR) | 27/06/2012 | 10/07/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Belgium;Netherlands;Italy;United Kingdom;Sweden | |||
| 547 | EUCTR2012-000518-13-DK (EUCTR) | 21/06/2012 | 21/06/2012 | Own mesenchymal stem cells for multiple sclerosis patients | Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study - COMSCIMS | Multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mesenchymal stem/stromal cells Product Name: Mesenchymal stem cells (MSCs) | Prof. Per Soelberg Sørensen | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 548 | NCT01600716 (ClinicalTrials.gov) | June 13, 2012 | 15/5/2012 | Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS) | Urinary Incontinence;Multiple Sclerosis;Neurogenic Bladder | Biological: OnabotulinumtoxinA;Drug: Placebo (Normal Saline) | Allergan | NULL | Completed | 18 Years | N/A | All | 144 | Phase 3 | United States;Belgium;Canada;Czechia;France;Poland;Portugal;Russian Federation;Czech Republic | |
| 549 | EUCTR2010-023172-12-LT (EUCTR) | 12/06/2012 | 13/04/2012 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 550 | EUCTR2011-005550-57-GR (EUCTR) | 05/06/2012 | 09/05/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Serbia;Ukraine;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 551 | EUCTR2011-005550-57-EE (EUCTR) | 21/05/2012 | 14/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | |||
| 552 | EUCTR2011-004475-36-BG (EUCTR) | 19/05/2012 | 10/04/2012 | A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis | A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DC-TAB Product Code: DC-TAB Other descriptive name: recombinant human alpha B-crystallin | Delta Crystallon B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Bulgaria | |||
| 553 | EUCTR2011-005550-57-LV (EUCTR) | 15/05/2012 | 09/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | |||
| 554 | EUCTR2011-005550-57-BG (EUCTR) | 14/05/2012 | 07/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Germany;Moldova, Republic of;Bosnia and Herzegovina;Latvia;Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Bulgaria;Albania | |||
| 555 | NCT01718678 (ClinicalTrials.gov) | May 2012 | 28/10/2012 | Effect of Melatonin on Multiple Sclerosis Related Fatigue | Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis | Fatigue | Drug: Melatonin;Drug: Placebo | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 55 Years | Both | 44 | Phase 2 | Iran, Islamic Republic of |
| 556 | NCT01514370 (ClinicalTrials.gov) | April 30, 2012 | 17/1/2012 | Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a | ProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW) | Multiple Sclerosis | Drug: IFN beta 1a 44 mcg TIW;Drug: Curcumin;Drug: Placebo | Merck KGaA, Darmstadt, Germany | Merck Serono S.P.A., Italy | Completed | 18 Years | 60 Years | All | 80 | Phase 2 | Italy |
| 557 | EUCTR2010-023210-31-IT (EUCTR) | 27/04/2012 | 12/03/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: DYSPORT*SC IM 2FL 500U INN or Proposed INN: BOTULINUM TOXIN TYPE A | IPSEN INNOVATION | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 558 | EUCTR2011-002178-22-GB (EUCTR) | 27/04/2012 | 29/03/2012 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 559 | NCT01585766 (ClinicalTrials.gov) | April 24, 2012 | 9/4/2012 | Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis | A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing Forms | Drug: MEDI-551 30 MG-IV;Drug: MEDI-551 60 MG-SC;Drug: PLACEBO-IV-SC;Drug: MEDI-551 100 MG-IV;Drug: MEDI-551 300 MG-SC;Drug: MEDI-551 600 MG-IV | MedImmune LLC | NULL | Completed | 18 Years | 65 Years | All | 56 | Phase 1 | United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom |
| 560 | EUCTR2011-002683-24-BG (EUCTR) | 17/04/2012 | 10/01/2012 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Betaferon Product Name: Betaferon INN or Proposed INN: n/a Other descriptive name: INTERFERON BETA-1B | Nuron Biotech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Belarus;Hungary;Spain;Poland;Ukraine;Lebanon;Croatia;Georgia;Russian Federation;Bulgaria;Italy | ||
| 561 | EUCTR2011-005550-57-PL (EUCTR) | 04/04/2012 | 09/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Hungary;Germany;Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Czech Republic;Ukraine;Serbia;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 562 | NCT01627938 (ClinicalTrials.gov) | April 2012 | 30/5/2012 | Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in Combination | A Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro) | Multiple Sclerosis | Drug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX) | PD Dr. Andrew Chan | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 50 | Phase 2 | Germany |
| 563 | NCT01538225 (ClinicalTrials.gov) | April 2012 | 20/2/2012 | Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity | Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | Almirall, S.A. | NULL | Completed | 18 Years | N/A | Both | 45 | Phase 3 | Italy |
| 564 | EUCTR2011-002561-38-IE (EUCTR) | 30/03/2012 | 09/02/2012 | Trial on the effectiveness of Fampridine medication for upper limb function in people with MS. | A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis. | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10053395;Term: Progressive multiple sclerosis;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra Product Code: SUB0750MIG INN or Proposed INN: FAMPRIDINE | St. Vincent's University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | Ireland | ||
| 565 | EUCTR2011-002178-22-PL (EUCTR) | 20/03/2012 | 25/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 15.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 566 | EUCTR2011-002333-19-IT (EUCTR) | 19/03/2012 | 14/03/2012 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS). MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra INN or Proposed INN: OFATUMUMAB Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy | |||
| 567 | EUCTR2011-002683-24-HU (EUCTR) | 02/03/2012 | 15/12/2011 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Betaferon Product Name: Betaferon INN or Proposed INN: n/a Other descriptive name: INTERFERON BETA-1B | Nuron Biotech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Belarus;Hungary;Spain;Poland;Ukraine;Lebanon;Croatia;Bulgaria;Georgia;Russian Federation;Italy | ||
| 568 | NCT01578785 (ClinicalTrials.gov) | March 2012 | 13/3/2012 | An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Placebo | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 55 Years | All | 178 | Phase 3 | United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Greece;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Montenegro;Poland;Romania;Russian Federation;Serbia;Ukraine;Lithuania |
| 569 | NCT01404117 (ClinicalTrials.gov) | March 2012 | 26/7/2011 | A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability | Relapsing Multiple Sclerosis | Drug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ Placebo | Teva Pharmaceutical Industries | NULL | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 2 | NULL | |
| 570 | NCT01576354 (ClinicalTrials.gov) | March 2012 | 22/3/2012 | Characterization of the Effects of Prolonged-release Fampridine on Ambulatory Function in Patients With Multiple Sclerosis | A Phase IIb, Double-blind, Randomized, Mono-center, Placebo-controlled Study With Crossover Design Characterizing the Effects of Prolonged-release Fampridine Treatment on Ambulatory Function in Patients With Multiple Sclerosis Using Detailed Gait Analysis Based on Kinematic and Kinetic Parameters | Multiple Sclerosis | Drug: Prolonged-release Fampridine;Drug: Placebo | University of Zurich | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 70 | Phase 2 | Switzerland |
| 571 | EUCTR2011-002333-19-CZ (EUCTR) | 27/02/2012 | 31/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Norway;Italy | |||
| 572 | EUCTR2010-023210-31-DE (EUCTR) | 24/02/2012 | 09/11/2011 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 15.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 573 | EUCTR2010-023210-31-AT (EUCTR) | 23/02/2012 | 18/01/2012 | The aim of the study is to assess the efficacy and safety of intra -detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 15.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 574 | EUCTR2011-002683-24-IT (EUCTR) | 14/02/2012 | 23/12/2011 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 Trade Name: Betaferon Other descriptive name: INTERFERON BETA-1B | NURON BIOTECH INC. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Belarus;Hungary;Spain;Bulgaria;Russian Federation;Italy | ||
| 575 | EUCTR2011-002178-22-CZ (EUCTR) | 08/02/2012 | 02/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 576 | EUCTR2010-021978-11-BE (EUCTR) | 03/02/2012 | 20/09/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden | |||
| 577 | EUCTR2010-021219-17-SK (EUCTR) | 01/02/2012 | 06/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Tunisia;Germany;Bosnia and Herzegovina | ||
| 578 | NCT01516554 (ClinicalTrials.gov) | February 2012 | 19/1/2012 | Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients | A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients | Multiple Sclerosis;Fatigue | Drug: Testosterone undecanoate;Drug: placebo | Health Sciences Centre, Winnipeg, Manitoba | University of Manitoba;Consortium of Multiple Sclerosis Centers;Manitoba Medical Service Foundation | Terminated | 18 Years | 65 Years | Male | 3 | Phase 2 | Canada |
| 579 | NCT01569451 (ClinicalTrials.gov) | February 2012 | 30/3/2012 | Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate | A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Rituximab;Drug: Glatiramer Acetate;Other: Placebo | University of Colorado, Denver | Rocky Mountain MS Research Group, LLC | Completed | 18 Years | 55 Years | All | 53 | Phase 2 | United States |
| 580 | EUCTR2011-002683-24-ES (EUCTR) | 30/01/2012 | 14/11/2011 | A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis | A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis | Relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NU100 Trade Name: Betaferon Product Name: Betaferon Other descriptive name: INTERFERON BETA-1B | Nuron Biotech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Hungary;Russian Federation;Ukraine;Belarus;Georgia;Bulgaria;Spain;Italy;Croatia;Poland | ||
| 581 | EUCTR2011-000888-27-DE (EUCTR) | 24/01/2012 | 19/08/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 582 | EUCTR2011-000888-27-GR (EUCTR) | 09/01/2012 | 13/12/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 583 | EUCTR2010-020328-23-PT (EUCTR) | 06/01/2012 | 17/11/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 584 | NCT01517282 (ClinicalTrials.gov) | January 2012 | 10/1/2012 | Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety and Pharmacokinetics of MOR103, a Human Antibody to GM-CSF, in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: MOR103;Other: Placebo | MorphoSys AG | NULL | Completed | 18 Years | 60 Years | All | 32 | Phase 1/Phase 2 | Germany;Poland;United Kingdom |
| 585 | NCT01964547 (ClinicalTrials.gov) | January 2012 | 15/10/2013 | A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients | A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple Sclerosis | Multiple Sclerosis;Spasticity | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 121 | Phase 4 | Czech Republic |
| 586 | EUCTR2011-002178-22-ES (EUCTR) | 26/12/2011 | 31/10/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HiDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Poland;Spain;Bulgaria;United Kingdom | ||
| 587 | EUCTR2010-021978-11-IT (EUCTR) | 14/12/2011 | 02/03/2012 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326 | Multiple Sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI*IV 1FL 300MG 15ML INN or Proposed INN: NA Other descriptive name: NA | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | |||
| 588 | EUCTR2010-021978-11-PL (EUCTR) | 07/12/2011 | 28/10/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 589 | EUCTR2010-021978-11-CZ (EUCTR) | 02/12/2011 | 22/08/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 590 | NCT02006160 (ClinicalTrials.gov) | December 2011 | 6/6/2012 | Effects of Dalfampridine on Cognition in Multiple Sclerosis | Effects of Dalfampridine on Cognition in Multiple Sclerosis | Multiple Sclerosis | Drug: dalfampridine;Drug: placebo | State University of New York at Buffalo | NULL | Completed | 18 Years | 60 Years | All | 61 | Phase 2/Phase 3 | United States |
| 591 | NCT01470521 (ClinicalTrials.gov) | December 2011 | 9/11/2011 | Worms for Immune Regulation of Multiple Sclerosis | Worms for Immune Regulation of Multiple Sclerosis (WIRMS) | Multiple Sclerosis, Relapsing-Remitting | Biological: Hookworm larvae;Biological: Placebo | University of Nottingham | National Multiple Sclerosis Society | Completed | 18 Years | 65 Years | Both | 72 | Phase 2 | United Kingdom |
| 592 | EUCTR2011-002333-19-DE (EUCTR) | 29/11/2011 | 09/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 15.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy | |||
| 593 | EUCTR2011-002333-19-DK (EUCTR) | 25/11/2011 | 18/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 594 | EUCTR2010-020328-23-AT (EUCTR) | 23/11/2011 | 28/10/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 595 | EUCTR2011-002333-19-NL (EUCTR) | 23/11/2011 | 05/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Germany;Norway;Netherlands;Italy | |||
| 596 | EUCTR2010-021978-11-ES (EUCTR) | 21/11/2011 | 26/09/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 597 | EUCTR2011-000888-27-RO (EUCTR) | 18/11/2011 | 09/10/2012 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | ||
| 598 | NCT01457924 (ClinicalTrials.gov) | November 1, 2011 | 20/10/2011 | Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Ofatumumab 3mg;Drug: Ofatumumab 30mg;Drug: Ofatumumab 60mg;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 232 | Phase 2 | United States;Bulgaria;Canada;Czechia;Denmark;Germany;Italy;Netherlands;Norway;Russian Federation;Spain;Czech Republic |
| 599 | NCT01451593 (ClinicalTrials.gov) | November 2011 | 11/10/2011 | Neuroprotection With Phenytoin in Optic Neuritis | A Phase II Double Blind, Randomized, Placebo Controlled Trial of Neuroprotection With Phenytoin in Acute Optic Neuritis | Optic Neuritis;Multiple Sclerosis | Drug: Phenytoin;Drug: Placebo | University College, London | National Multiple Sclerosis Society;Multiple Sclerosis Society of Great Britain and Northern Ireland | Completed | 18 Years | 60 Years | Both | 92 | Phase 2 | United Kingdom |
| 600 | EUCTR2010-021219-17-DE (EUCTR) | 31/10/2011 | 05/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina | ||
| 601 | EUCTR2011-000888-27-GB (EUCTR) | 24/10/2011 | 01/08/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 602 | EUCTR2011-002333-19-ES (EUCTR) | 21/10/2011 | 28/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months? administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline SA | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 603 | EUCTR2011-000888-27-IT (EUCTR) | 13/10/2011 | 24/01/2012 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: glatiramer acetate | SYNTHON BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Estonia;Czech Republic;Greece;Ukraine;Romania;Croatia;Bulgaria;Russian Federation;Germany;United Kingdom;Italy | |||
| 604 | NCT01464905 (ClinicalTrials.gov) | October 2011 | 31/10/2011 | Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A Phase 3, Multicenter, Double-blind,Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of NU100 in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Biological: NU100;Biological: Placebo;Biological: rhIFN beta-1b | Nuron Biotech Inc. | NULL | Active, not recruiting | 18 Years | 60 Years | Both | 500 | Phase 3 | Belarus;Bulgaria;Croatia;Georgia;Hungary;Italy;Lebanon;Poland;Russian Federation;Serbia;Spain;Ukraine;India |
| 605 | NCT01489254 (ClinicalTrials.gov) | October 2011 | 8/12/2011 | Efficacy and Safety of GTR in Comparison to Copaxone® | Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects | Multiple Sclerosis | Drug: Glatiramer Acetate (GTR);Drug: Glatiramer Acetate (Copaxone®);Drug: Placebo | Synthon BV | NULL | Completed | 18 Years | 55 Years | All | 794 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Ukraine;United Kingdom;Greece;Kazakhstan |
| 606 | NCT01466114 (ClinicalTrials.gov) | October 2011 | 31/10/2011 | Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition | A Double-Blind, Placebo Controlled Trial of Estriol Treatment in Women With Multiple Sclerosis: Effect on Cognition. | Relapsing-remitting Multiple Sclerosis;Secondary-progressive Multiple Sclerosis;Primary-progressive Multiple Sclerosis | Drug: estriol;Other: Placebo;Drug: Norethindrone;Other: Progestin Placebo | University of California, Los Angeles | NULL | Recruiting | 18 Years | 55 Years | Female | 64 | Phase 2 | United States |
| 607 | EUCTR2010-021978-11-FI (EUCTR) | 28/09/2011 | 15/08/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 608 | EUCTR2011-000888-27-CZ (EUCTR) | 21/09/2011 | 17/06/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 609 | EUCTR2011-000888-27-EE (EUCTR) | 21/09/2011 | 01/09/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 610 | NCT01412333 (ClinicalTrials.gov) | September 20, 2011 | 8/8/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 55 Years | All | 835 | Phase 3 | United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco |
| 611 | EUCTR2010-021978-11-DK (EUCTR) | 19/09/2011 | 23/08/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 612 | NCT01416181 (ClinicalTrials.gov) | September 13, 2011 | 21/7/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis | Drug: natalizumab;Drug: Placebo | Biogen | NULL | Terminated | 18 Years | 58 Years | All | 889 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic |
| 613 | EUCTR2010-021219-17-ES (EUCTR) | 12/09/2011 | 01/07/2011 | Evaluación de masitinib en esclerosis múltiple | Estudio prospectivo Fase III, multicéntrico, randomizado, doble ciego, de dos grupos paralelos, controlado con placebo y de 96 semanas de duración, para comparar la eficacia y seguridad de masitinib a la dosis de 6 mg/kg/día con placebo en el tratamiento de pacientes con esclerosis múltiple primaria progresiva o esclerosis múltiple secundaria progresiva sin recidiva | Pacientes con esclerosis múltiple primaria progresiva o secundaria progresiva sin recidiva MedDRA version: 14.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Slovakia;Greece;Poland;Spain;Romania;Bulgaria;Germany | ||
| 614 | NCT01435993 (ClinicalTrials.gov) | September 8, 2011 | 25/8/2011 | Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis | A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK1223249;Other: Saline placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 60 Years | All | 3 | Phase 1 | Italy;Norway;Germany |
| 615 | NCT01499667 (ClinicalTrials.gov) | September 2011 | 18/8/2011 | Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod | A 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720) | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: Fingolimod;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 142 | Phase 3 | Australia;Austria;Czech Republic;Finland;Germany;Greece;Hungary;Israel;Italy;Spain;Switzerland |
| 616 | NCT01324232 (ClinicalTrials.gov) | September 2011 | 23/3/2011 | Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis | Central Neuropathic Pain;Multiple Sclerosis | Drug: AVP-923;Drug: Placebo | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 200 | Phase 2 | United States;Argentina;Czechia;Poland;Spain;Czech Republic;Germany;United Kingdom |
| 617 | NCT01444300 (ClinicalTrials.gov) | September 2011 | 20/9/2011 | Dalfampridine for Imbalance in Multiple Sclerosis | Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study | Multiple Sclerosis;Fatigue | Drug: Dalfampridine;Drug: Placebo | Oregon Health and Science University | Acorda Therapeutics | Completed | 20 Years | 59 Years | All | 24 | Phase 2 | United States |
| 618 | NCT01247324 (ClinicalTrials.gov) | August 31, 2011 | 23/11/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 55 Years | All | 821 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;Czech Republic;Morocco;New Zealand |
| 619 | EUCTR2010-021978-11-DE (EUCTR) | 19/08/2011 | 04/04/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, with Optional Open-LabelExtension | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Israel;United Kingdom;Iraq;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 620 | EUCTR2011-000888-27-BG (EUCTR) | 18/08/2011 | 11/07/2011 | A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment. | Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: glatiramer acetate Product Code: GTR INN or Proposed INN: glatiramer acetate Other descriptive name: GTR.ace Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Synthon BV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 621 | NCT01433497 (ClinicalTrials.gov) | August 2011 | 12/9/2011 | Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis | A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Relapse Free | Drug: Masitinib;Drug: Placebo | AB Science | NULL | Completed | 18 Years | 75 Years | All | 656 | Phase 3 | Bulgaria;France;Germany;Greece;Poland;Romania;Spain;United States |
| 622 | NCT01405820 (ClinicalTrials.gov) | August 2011 | 14/7/2011 | Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS) | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: natalizumab IV;Drug: natalizumab SC;Drug: IV Placebo;Drug: SC Placebo | Biogen | NULL | Completed | 18 Years | 55 Years | All | 290 | Phase 2 | Belgium;France;Germany;Italy;Spain |
| 623 | NCT01411514 (ClinicalTrials.gov) | August 2011 | 26/5/2011 | Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis | Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort | Multiple Sclerosis | Drug: Prednisone;Drug: Placebo | Claudio Gobbi | Ente Ospedaliero Cantonale, Ticino, Switzerland | Terminated | 18 Years | 80 Years | Both | 27 | Phase 4 | Switzerland |
| 624 | EUCTR2010-021978-11-GB (EUCTR) | 26/07/2011 | 04/04/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 625 | EUCTR2010-020328-23-LV (EUCTR) | 19/07/2011 | 16/05/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Latvia;Norway;Germany;Netherlands | ||
| 626 | NCT01103583 (ClinicalTrials.gov) | July 2011 | 13/4/2010 | Hydroxyurea in Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Hydroxyurea;Other: placebo | S. Andrea Hospital | NULL | Terminated | 18 Years | 60 Years | Both | 33 | Phase 2/Phase 3 | Italy | |
| 627 | NCT01699555 (ClinicalTrials.gov) | July 2011 | 27/9/2012 | First-in-Human Study With GNbAC1 in Healthy Volunteers | Randomized Placebo-Controlled First-in-Human Study With GNbAC1 | Multiple Sclerosis | Biological: GNbAC1;Biological: GNbAC1 placebo | GeNeuro Innovation SAS | NULL | Completed | 18 Years | 55 Years | Male | 33 | Phase 1 | NULL |
| 628 | NCT01417312 (ClinicalTrials.gov) | July 2011 | 15/8/2011 | Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients | Multiple Sclerosis, Relapsing-Remitting | Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG);Dietary Supplement: Placebo | Charite University, Berlin, Germany | NULL | Completed | 20 Years | 60 Years | All | 20 | N/A | Germany | |
| 629 | NCT01451723 (ClinicalTrials.gov) | July 2011 | 11/10/2011 | Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II | Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS | Multiple Sclerosis | Drug: Polyphenon E;Other: Placebo | Louisiana State University Health Sciences Center in New Orleans | National Center for Complementary and Integrative Health (NCCIH) | Terminated | 18 Years | 60 Years | All | 11 | Phase 2 | United States |
| 630 | EUCTR2011-000926-31-CZ (EUCTR) | 29/06/2011 | 25/05/2011 | A long term, 50 week, Phase IV multi-centre study to determine if Sativex has an effect on cognition (thinking ability) when prescribed to patients with spasticity due to MS | A Multicentre, Double-blind, Randomised Parallel Group, Placebo- controlled Study of the Effect of long-term treatment with Sativex onCognitive Function and Mood of Patients with Spasticity due toMultiple Sclerosis | Spasticity in multiple sclerosis (MS). MedDRA version: 14.1;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray INN or Proposed INN: N/A Other descriptive name: delta-9-tetrahydrocannabinol INN or Proposed INN: N/A Other descriptive name: cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Czech Republic | ||
| 631 | EUCTR2010-020338-25-DE (EUCTR) | 08/06/2011 | 06/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10 ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10 ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 632 | EUCTR2010-020338-25-PL (EUCTR) | 04/06/2011 | 14/05/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 633 | EUCTR2010-020338-25-BE (EUCTR) | 26/05/2011 | 22/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 634 | EUCTR2010-023172-12-AT (EUCTR) | 26/05/2011 | 06/04/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 635 | EUCTR2010-020338-25-BG (EUCTR) | 11/05/2011 | 19/01/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: Ro 496-4913/F03 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 636 | EUCTR2010-020328-23-LT (EUCTR) | 09/05/2011 | 02/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oil Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 637 | EUCTR2010-021978-11-SE (EUCTR) | 04/05/2011 | 30/03/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 638 | NCT01357980 (ClinicalTrials.gov) | May 2011 | 17/5/2011 | Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis | A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis. | Detrusor Muscle Hyperactivity | Biological: Botulinum toxin type A;Drug: Placebo | Ipsen | NULL | Completed | 18 Years | 70 Years | All | 47 | Phase 2 | Czechia;France;Germany;Italy;Poland;Austria;Czech Republic |
| 639 | NCT01337986 (ClinicalTrials.gov) | May 2011 | 13/4/2011 | Ampyra for Optic Neuritis in Multiple Sclerosis | Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis | Multiple Sclerosis;Optic Neuritis | Drug: Dalfampridine/Placebo;Drug: Placebo/Dalfampridine | Washington University School of Medicine | Acorda Therapeutics | Completed | 18 Years | 55 Years | All | 53 | Phase 2/Phase 3 | United States |
| 640 | NCT01359566 (ClinicalTrials.gov) | May 2011 | 22/5/2011 | Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis | A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis | Multiple Sclerosis | Drug: Arbaclofen placarbil 15 mg BID;Drug: Placebo;Drug: Arbaclofen placarbil 30 mg BID;Drug: Arbaclofen placarbil 45 mg BID | XenoPort, Inc. | NULL | Completed | 18 Years | 70 Years | All | 228 | Phase 3 | United States |
| 641 | EUCTR2010-020328-23-EE (EUCTR) | 26/04/2011 | 21/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 642 | EUCTR2010-020328-23-BE (EUCTR) | 01/04/2011 | 18/11/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA-Geneva an affiliate of Merck KgaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 643 | EUCTR2010-023172-12-PT (EUCTR) | 30/03/2011 | 01/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 644 | EUCTR2010-023172-12-DK (EUCTR) | 23/03/2011 | 26/04/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 645 | EUCTR2010-023172-12-GR (EUCTR) | 15/03/2011 | 27/01/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Other descriptive name: NA Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis group | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 646 | EUCTR2010-023172-12-GB (EUCTR) | 14/03/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 647 | EUCTR2010-020328-23-IT (EUCTR) | 10/03/2011 | 07/02/2011 | A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR | A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR | RELAPSING REMITTING MULTIPLE SCLEROSIS MedDRA version: 9.1;Level: PT;Classification code 10063399 | Trade Name: VIGANTOL OIL INN or Proposed INN: Colecalciferol | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 648 | NCT01194570 (ClinicalTrials.gov) | March 2, 2011 | 28/8/2010 | A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis | A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Other: Placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 732 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czechia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Uruguay;Czech Republic;Denmark;Turkey |
| 649 | EUCTR2010-023172-12-FI (EUCTR) | 02/03/2011 | 10/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 650 | EUCTR2010-020338-25-DK (EUCTR) | 02/03/2011 | 07/02/2011 | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Netherlands;Germany | ||
| 651 | NCT01328379 (ClinicalTrials.gov) | March 2011 | 29/3/2011 | Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10 mg Twice Daily) in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Dalfampridine-ER 5mg;Drug: Dalfampridine-ER 10mg;Other: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 430 | Phase 3 | United States |
| 652 | EUCTR2010-023172-12-DE (EUCTR) | 25/02/2011 | 05/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 653 | EUCTR2010-023172-12-SE (EUCTR) | 18/02/2011 | 07/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 654 | EUCTR2010-023172-12-NL (EUCTR) | 15/02/2011 | 17/11/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 655 | EUCTR2010-023172-12-ES (EUCTR) | 14/02/2011 | 23/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Esclerosis múltiple_______Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 656 | EUCTR2010-023172-12-BE (EUCTR) | 08/02/2011 | 29/11/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 657 | NCT01285401 (ClinicalTrials.gov) | February 2011 | 26/1/2011 | Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment | A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif® | Relapsing-Remitting Multiple Sclerosis | Drug: VigantOL oil plus interferon beta-1a (Rebif);Drug: Placebo plus interferon beta-1a (Rebif);Biological: Interferon beta-1a (Rebif®) alone | Merck KGaA | NULL | Completed | 18 Years | 55 Years | All | 260 | Phase 2 | Austria;Denmark;Estonia;Finland;Germany;Italy;Latvia;Lithuania;Netherlands;Norway;Portugal;Switzerland;Belgium;Hungary |
| 658 | EUCTR2010-020328-23-DE (EUCTR) | 31/01/2011 | 27/10/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Italy;Switzerland;Belgium;Denmark;Germany;Latvia;Netherlands;Norway | ||
| 659 | EUCTR2010-020338-25-AT (EUCTR) | 26/01/2011 | 18/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 660 | EUCTR2010-023172-12-SK (EUCTR) | 26/01/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 661 | EUCTR2010-023172-12-NO (EUCTR) | 25/01/2011 | 03/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Norway;Germany;Sweden | |||
| 662 | EUCTR2010-020338-25-GR (EUCTR) | 21/01/2011 | 17/01/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 663 | EUCTR2010-020338-25-CZ (EUCTR) | 20/01/2011 | 05/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 664 | EUCTR2010-023172-12-IT (EUCTR) | 13/01/2011 | 08/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245 | Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 665 | EUCTR2010-020338-25-PT (EUCTR) | 12/01/2011 | 14/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: OCREVUS Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand | ||
| 666 | EUCTR2010-023172-12-EE (EUCTR) | 12/01/2011 | 14/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden;United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation | |||
| 667 | EUCTR2010-023172-12-HU (EUCTR) | 11/01/2011 | 23/11/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | ||
| 668 | EUCTR2010-022033-28-NL (EUCTR) | 10/01/2011 | 26/10/2010 | A study investigating safety, tolerability and efficacy of ECP002A (?9-THC) in Multiple Sclerosis patients suffering from spasticity and pain. | A two-phased, randomized, double blind, placebo-controlled study of ECP002A (?9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain. - ECP002A (?9-THC) in MS patients | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Namisol Product Code: ECP002A INN or Proposed INN: dronabinol Other descriptive name: Namisol | Echo Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 669 | EUCTR2010-020328-23-NL (EUCTR) | 06/01/2011 | 16/09/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono The Netherlands - a division of Merck B.V. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 670 | NCT01252355 (ClinicalTrials.gov) | January 2011 | 30/11/2010 | Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta | A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta | Multiple Sclerosis Relapse | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-beta (IFN-beta) | Sanofi | NULL | Terminated | 18 Years | 55 Years | All | 534 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Lithuania;Netherlands;Norway;Portugal;Russian Federation;Slovakia;Spain;Sweden;Tunisia;United Kingdom;Turkey |
| 671 | NCT01454791 (ClinicalTrials.gov) | January 2011 | 9/8/2011 | Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate | Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial | Multiple Sclerosis | Drug: diclofenac sodium topical gel;Other: Placebo | Brown, Theodore R., M.D., MPH | Teva Neuroscience, Inc. | Completed | 18 Years | N/A | All | 40 | Phase 4 | United States |
| 672 | EUCTR2010-020338-25-GB (EUCTR) | 29/12/2010 | 05/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 673 | EUCTR2010-020338-25-ES (EUCTR) | 20/12/2010 | 17/09/2010 | Estudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Estudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Esclerosis múltiple progresiva primaria (EMPP) MedDRA version: 12.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: - | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria | ||
| 674 | EUCTR2009-017939-18-GB (EUCTR) | 15/12/2010 | 27/08/2010 | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | Chronic urinary tract infection. MedDRA version: 16.1;Level: LLT;Classification code 10059617;Term: Overactive bladder;System Organ Class: 100000004857 | Trade Name: Nitrofurantoin Product Name: Nitrofurantoin Product Code: PL 12762/0049 INN or Proposed INN: Nitrofurantoin Other descriptive name: Nitrofurantoin | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 675 | EUCTR2010-020338-25-FI (EUCTR) | 15/12/2010 | 15/12/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 676 | EUCTR2010-020328-23-DK (EUCTR) | 09/12/2010 | 08/11/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 677 | EUCTR2010-020338-25-IT (EUCTR) | 07/12/2010 | 24/12/2010 | A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIO | A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIO | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 9.1;Level: LLT;Classification code 10063401 | Product Name: ocrelizumab | F. Hoffmann - La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | Portugal;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria | ||
| 678 | NCT01712373 (ClinicalTrials.gov) | December 2010 | 19/10/2012 | Ginseng in Treatment of Fatigue in Multiple Sclerosis | Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis | Fatigue | Drug: Ginseng;Drug: Placebo | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 50 Years | Both | 60 | Phase 2 | Iran, Islamic Republic of |
| 679 | NCT01228266 (ClinicalTrials.gov) | December 2010 | 25/10/2010 | Mesenchymal Stem Cell Transplantation in MS | Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study | Multiple Sclerosis | Biological: autologous mesenchymal stem cells | Albert Saiz | Instituto de Salud Carlos III | Terminated | 18 Years | 50 Years | Both | 9 | Phase 2 | Spain |
| 680 | EUCTR2007-002627-32-DK (EUCTR) | 29/11/2010 | 20/10/2010 | A study to evaluate how safe and effective 0.5 mg fingolimod is in delaying disability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | |||
| 681 | EUCTR2010-020338-25-HU (EUCTR) | 17/11/2010 | 29/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: Ro 496-4913/F03 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 682 | EUCTR2010-020338-25-LT (EUCTR) | 02/11/2010 | 02/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 683 | NCT01236534 (ClinicalTrials.gov) | November 2010 | 4/11/2010 | Lubiprostone in Patients With Multiple Sclerosis Associated Constipation | Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation | Multiple Sclerosis;Constipation | Drug: Lubiprostone;Drug: Placebo | University of Rochester | Takeda | Completed | 18 Years | N/A | All | 21 | Phase 4 | United States |
| 684 | NCT01440101 (ClinicalTrials.gov) | November 2010 | 14/4/2011 | Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B) | Multiple Sclerosis | Drug: Natalizumab (BG00002);Drug: Placebo | Biogen | NULL | Completed | 18 Years | 65 Years | All | 106 | Phase 2/Phase 3 | Japan;China |
| 685 | NCT01356940 (ClinicalTrials.gov) | November 2010 | 18/5/2011 | A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis | A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis | Multiple Sclerosis | Drug: dalfampridine ER;Drug: placebo | Brown, Theodore R., M.D., MPH | Acorda Therapeutics | Completed | 18 Years | 75 Years | All | 43 | Phase 4 | United States |
| 686 | EUCTR2010-020328-23-FI (EUCTR) | 21/10/2010 | 27/08/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 687 | NCT01431937 (ClinicalTrials.gov) | October 10, 2010 | 11/8/2011 | Assessment of Repeat Ascending Doses of GSK2018682 in Healthy Volunteers | A Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Ascending Doses of GSK2018682 (S1P1 Agonist) in Healthy Volunteers | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK2018682;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 40 | Phase 1 | Australia |
| 688 | EUCTR2010-019028-30-BE (EUCTR) | 08/10/2010 | 17/08/2010 | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | France;Finland;Spain;Belgium;United Kingdom | |||
| 689 | NCT01166178 (ClinicalTrials.gov) | October 2010 | 19/7/2010 | Zoledronic Acid in MS-patients With Osteoporosis | A 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment Phase | Osteoporosis;Multiple Sclerosis | Drug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combination | Novartis | NULL | Terminated | 18 Years | 75 Years | All | 29 | Phase 3 | Germany |
| 690 | NCT01244139 (ClinicalTrials.gov) | October 2010 | 18/11/2010 | Safety Study of BIIB033 in Subjects With Multiple Sclerosis | A Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: BIIB033;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 60 Years | All | 47 | Phase 1 | United States |
| 691 | NCT01188811 (ClinicalTrials.gov) | October 2010 | 25/8/2010 | Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS) | Lipoic Acid for Neuroprotection in Secondary Progressive MS | Multiple Sclerosis, Chronic Progressive | Drug: lipoic acid;Drug: Placebo | VA Office of Research and Development | Oregon Health and Science University | Completed | 40 Years | 70 Years | All | 54 | Phase 2/Phase 3 | United States |
| 692 | EUCTR2010-019028-30-FR (EUCTR) | 03/09/2010 | 09/07/2010 | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | France;Finland;Belgium;Spain;United Kingdom | |||
| 693 | NCT01212094 (ClinicalTrials.gov) | September 2010 | 29/9/2010 | Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe) | Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe) | Multiple Sclerosis | Drug: Rituximab;Other: normal saline | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Terminated | 18 Years | 65 Years | All | 44 | Phase 1/Phase 2 | United States |
| 694 | NCT01181089 (ClinicalTrials.gov) | September 2010 | 5/8/2010 | Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS) | A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Biological: Placebo;Biological: Baminercept | Biogen Idec | NULL | Withdrawn | 18 Years | 57 Years | Both | 0 | Phase 1/Phase 2 | Canada;United Kingdom |
| 695 | NCT01116427 (ClinicalTrials.gov) | September 2010 | 3/5/2010 | A Cooperative Clinical Study of Abatacept in Multiple Sclerosis | A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: abatacept;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 65 Years | All | 65 | Phase 2 | United States;Canada |
| 696 | NCT01199861 (ClinicalTrials.gov) | August 2010 | 9/9/2010 | Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS) | A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS) | Relapsing Multiple Sclerosis | Drug: Fingolimod;Drug: Placebo;Biological: Seasonal influenza vaccine;Biological: Tetanus toxoid vaccine | Novartis | NULL | Completed | 18 Years | 55 Years | All | 138 | Phase 3 | Belgium;Canada;Finland;France;Guatemala;Poland;Spain;Switzerland;United Kingdom;Austria |
| 697 | NCT01337427 (ClinicalTrials.gov) | August 2010 | 7/4/2011 | Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis | Optical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BIIB017 | Johns Hopkins University | Biogen Idec | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 3 | United States |
| 698 | EUCTR2010-019028-30-GB (EUCTR) | 30/07/2010 | 02/08/2010 | A 3-month blinded, randomized, multicenter, placebo controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebo controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Finland;United Kingdom;France;Spain | |||
| 699 | EUCTR2009-018084-27-GB (EUCTR) | 29/07/2010 | 08/06/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Poland;Croatia;Romania;South Africa;Georgia;Bulgaria;Germany;United States;Estonia;Ukraine;Lithuania;Israel | ||
| 700 | EUCTR2009-014339-19-DE (EUCTR) | 29/07/2010 | 29/01/2010 | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ONO-4641 Product Code: ONO-4641 Product Name: ONO-4641 Product Code: ONO-4641 Product Name: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | United States;Czech Republic;Greece;Canada;Spain;Ukraine;Russian Federation;Germany;Japan | |||
| 701 | EUCTR2009-011888-37-DE (EUCTR) | 23/07/2010 | 26/03/2010 | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | osteoporosis in patients with multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10049088;Term: Osteopenia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10031282;Term: Osteoporosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Aclasta 5 mg Infusionslösung Product Name: Aclasta Product Code: ZOL446H Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 702 | EUCTR2008-006333-27-CZ (EUCTR) | 22/07/2010 | 03/07/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom | |||
| 703 | EUCTR2009-018084-27-BG (EUCTR) | 19/07/2010 | 30/04/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;South Africa;Georgia;Germany | ||
| 704 | EUCTR2009-014339-19-GR (EUCTR) | 13/07/2010 | 04/02/2010 | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | Germany;Czech Republic;Spain;Greece | |||
| 705 | EUCTR2010-019028-30-FI (EUCTR) | 07/07/2010 | 27/05/2010 | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | A 3-month blinded, randomized, multicenter, placebocontrolled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis. | Relapsing forms of multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Finland;United Kingdom;France;Spain | |||
| 706 | EUCTR2009-012716-40-PL (EUCTR) | 06/07/2010 | 11/01/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 707 | NCT01067521 (ClinicalTrials.gov) | June 22, 2010 | 10/2/2010 | A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design | A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer acetate (GA);Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 55 Years | All | 1404 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Poland;Romania;Russian Federation;South Africa;Ukraine;United Kingdom;Czech Republic;Turkey |
| 708 | EUCTR2009-018084-27-DE (EUCTR) | 16/06/2010 | 09/03/2010 | A clincial study to find out whether Copaxone (glatiramer acetate 40mg/1ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 709 | EUCTR2009-018084-27-CZ (EUCTR) | 01/06/2010 | 29/03/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 710 | NCT01149525 (ClinicalTrials.gov) | June 2010 | 21/6/2010 | Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis | A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis | Multiple Sclerosis | Drug: L-Carnitine;Drug: Placebo | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | All | 59 | Phase 3 | France |
| 711 | EUCTR2009-018084-27-LT (EUCTR) | 28/05/2010 | 01/04/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 712 | EUCTR2009-012716-40-DE (EUCTR) | 28/05/2010 | 16/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany | ||
| 713 | EUCTR2008-006786-92-FR (EUCTR) | 27/05/2010 | 06/04/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden | ||
| 714 | NCT01387217 (ClinicalTrials.gov) | May 21, 2010 | 14/4/2011 | GSK2018682 FTIH in Healthy Volunteers | A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers | Multiple Sclerosis | Drug: GSK2018682;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 27 | Phase 1 | Australia |
| 715 | EUCTR2009-018084-27-IT (EUCTR) | 19/05/2010 | 07/06/2010 | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALA | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALA | Subject with Relapse-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: 40 mg Glatiramer Acetate Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Czech Republic;Estonia;Hungary;Lithuania;Bulgaria;Germany;United Kingdom;Italy | ||
| 716 | EUCTR2009-018084-27-EE (EUCTR) | 07/05/2010 | 16/03/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Croatia;Romania;Georgia;South Africa;Bulgaria;Germany | ||
| 717 | EUCTR2007-004452-36-SK (EUCTR) | 06/05/2010 | 11/04/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 718 | NCT01064401 (ClinicalTrials.gov) | May 2010 | 26/1/2010 | Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon ß 1a) in Patients With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Interferon beta-1a Placebo;Biological: Interferon beta-1a;Drug: Daclizumab High Yield Process Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 1841 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Bulgaria;Egypt;Slovenia |
| 719 | NCT01842191 (ClinicalTrials.gov) | May 2010 | 25/4/2013 | Efficacy of Fish Oil in Multiple Sclerosis | Efficacy of Fish Oil on Serum TNFa, IL-1ß, IL-6, Oxidative Stress Markers in Multiple Sclerosis Treated With Interferon Beta 1-b | Relapsing- Remitting Multiple Sclerosis | Dietary Supplement: Fish Oil;Dietary Supplement: Placebo | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | 55 Years | Both | 50 | Phase 4 | Mexico |
| 720 | EUCTR2009-012716-40-BG (EUCTR) | 01/04/2010 | 08/04/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;France;Estonia;Bulgaria;Poland | ||
| 721 | EUCTR2007-002627-32-HU (EUCTR) | 31/03/2010 | 05/02/2010 | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 940 | France;Czech Republic;Hungary;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 722 | EUCTR2009-018084-27-HU (EUCTR) | 30/03/2010 | 01/03/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 723 | EUCTR2009-014339-19-CZ (EUCTR) | 26/03/2010 | 11/01/2010 | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | Germany;Czech Republic;Spain;Greece | |||
| 724 | EUCTR2009-014339-19-ES (EUCTR) | 18/03/2010 | 20/01/2010 | ESTUDIO DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | ESTUDIO DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Esclerosis múltiple remitente-recurrente.Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | Phase 2 | Czech Republic;Greece;Spain;Germany | ||
| 725 | EUCTR2008-003706-33-GR (EUCTR) | 10/03/2010 | 12/03/2009 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 642 | Phase 3 | Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece | ||
| 726 | EUCTR2009-012716-40-CZ (EUCTR) | 10/03/2010 | 08/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 727 | EUCTR2008-006333-27-GR (EUCTR) | 10/03/2010 | 23/10/2009 | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Czech Republic;Estonia;Greece;Spain;Belgium;Bulgaria;Netherlands;Germany;Latvia;United Kingdom | |||
| 728 | EUCTR2009-012716-40-FR (EUCTR) | 03/03/2010 | 28/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;Estonia;France;Poland | ||
| 729 | NCT01081782 (ClinicalTrials.gov) | March 2010 | 4/3/2010 | A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis | A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ONO-4641;Drug: ONO-4641 placebo | Ono Pharma USA Inc | NULL | Completed | 18 Years | 55 Years | Both | 407 | Phase 2 | United States;Belgium;Canada;Czech Republic;Germany;Greece;Japan;Poland;Russian Federation;Spain;Ukraine |
| 730 | NCT01144351 (ClinicalTrials.gov) | March 2010 | 9/6/2010 | A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: ELND002;Drug: Placebo | Elan Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | Both | 32 | Phase 1 | United States;Canada |
| 731 | NCT01071083 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | Treatment Interruption of Natalizumab | Randomized Treatment Interruption of Natalizumab | Relapsing Remitting Multiple Sclerosis | Drug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetate | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 60 Years | All | 175 | Phase 2 | United States;Germany;Spain |
| 732 | NCT01424423 (ClinicalTrials.gov) | February 11, 2010 | 9/6/2011 | NOGO-A in Multiple Sclerosis FTIH | A Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy | Multiple Sclerosis | Drug: Placebo;Drug: GSK1223249 | GlaxoSmithKline | NULL | Terminated | 18 Years | 55 Years | All | 3 | Phase 1 | Australia |
| 733 | EUCTR2009-012716-40-SK (EUCTR) | 03/02/2010 | 19/01/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany | ||
| 734 | EUCTR2009-015934-30-FR (EUCTR) | 02/02/2010 | 19/01/2010 | étude randomisée en double insu et crossover comparant l’efficacité de la L-carnitine à un placebo dans le traitement de la fatigue dans la sclérose en plaques - FACTSEP | étude randomisée en double insu et crossover comparant l’efficacité de la L-carnitine à un placebo dans le traitement de la fatigue dans la sclérose en plaques - FACTSEP | sclérose en plaquefatigue MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: levocarnil Product Name: Levocarnil Product Code: na INN or Proposed INN: L-carnitine | CHU de Bordeaux | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 735 | NCT01417273 (ClinicalTrials.gov) | February 2010 | 17/11/2010 | Impact of Vitamin A on Multiple Sclerosis (MS) | Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: vitamin A;Drug: Drug: placebo | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 100 | Phase 4 | Iran, Islamic Republic of |
| 736 | NCT01705457 (ClinicalTrials.gov) | February 2010 | 9/10/2012 | Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis | Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients | Relapsing Remitting Multiple Sclerosis | Drug: Dietary Supplement: vitamin A;Drug: placebo | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 20 | Phase 4 | Iran, Islamic Republic of |
| 737 | NCT00988988 (ClinicalTrials.gov) | February 2010 | 30/9/2009 | The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections | The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate | Multiple Sclerosis | Drug: AGEE cream;Drug: 1% Steroid Cream;Drug: topical placebo cream with no active ingredients | University of Nebraska | Teva Pharmaceutical Industries | Withdrawn | 19 Years | 65 Years | Both | 0 | Phase 4 | United States |
| 738 | EUCTR2009-012716-40-EE (EUCTR) | 31/12/2009 | 07/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 739 | EUCTR2008-006786-92-PL (EUCTR) | 08/12/2009 | 28/07/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 740 | EUCTR2008-006333-27-GB (EUCTR) | 03/12/2009 | 18/10/2010 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand | ||
| 741 | NCT01051817 (ClinicalTrials.gov) | December 2009 | 19/1/2010 | POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler | A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis;RRMS | Drug: AIN457;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 73 | Phase 2 | Czech Republic;Russian Federation;Ukraine;Serbia;Sweden |
| 742 | NCT02442557 (ClinicalTrials.gov) | December 2009 | 1/5/2015 | Safety and Dose-finding Study of DC-TAB in Healthy Subjects | A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and T-cell Tolerizing Effect of DC-TAB in Healthy Volunteers | Multiple Sclerosis | Biological: recombinant human alpha B-crystallin;Other: placebo comparator | Delta Crystallon BV | NULL | Completed | 18 Years | 55 Years | Both | 76 | Phase 1 | Netherlands |
| 743 | NCT00986960 (ClinicalTrials.gov) | December 2009 | 29/9/2009 | Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS) | Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study | Multiple Sclerosis | Drug: repository corticotropin injection;Drug: Saline | University at Buffalo | NULL | Terminated | 18 Years | 65 Years | All | 3 | Phase 2 | United States |
| 744 | EUCTR2008-006786-92-BG (EUCTR) | 20/11/2009 | 18/11/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | United Kingdom;Sweden;France;Hungary;Czech Republic;Finland;Poland;Spain;Austria;Bulgaria;Netherlands;Italy | |||
| 745 | EUCTR2008-006786-92-AT (EUCTR) | 19/11/2009 | 16/09/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Poland;Austria;Sweden | |||
| 746 | EUCTR2008-006333-27-BE (EUCTR) | 09/11/2009 | 27/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Latvia;Netherlands;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand | |||
| 747 | EUCTR2008-006786-92-NL (EUCTR) | 03/11/2009 | 18/06/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 748 | NCT00950248 (ClinicalTrials.gov) | November 1, 2009 | 30/7/2009 | Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS) | Double Blind Placebo-Controlled Phase I/II Clinical Trial of Idebenone in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: Idebenone;Other: placebo | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 65 Years | All | 85 | Phase 1/Phase 2 | United States |
| 749 | NCT01615887 (ClinicalTrials.gov) | November 2009 | 23/3/2011 | Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis | Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis | Multiple Sclerosis | Drug: lisdexamfetamine sulfate;Drug: placebo | State University of New York at Buffalo | NULL | Completed | 18 Years | 55 Years | Both | 63 | Phase 2 | United States |
| 750 | NCT01144117 (ClinicalTrials.gov) | November 2009 | 7/6/2010 | The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis | Double Blind, Placebo-controlled Study to Assess the Effects of Erythropoietin on Clinical Disability and Brain Pathology as Shown by Magnetic Resonance Imaging in Patients With Progressive Multiple Sclerosis | Multiple Sclerosis (Primary or Secondary Progressive Phase). | Drug: Erythropoietin | Rigshospitalet, Denmark | Danish Research Centre for Magnetic Resonance | Recruiting | 19 Years | 60 Years | Both | 56 | Phase 2 | Denmark |
| 751 | NCT01037907 (ClinicalTrials.gov) | November 2009 | 21/12/2009 | A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS | Relapsing Remitting Multiple Sclerosis | Drug: Pleneva TM BGC20-0134;Drug: Placebo | Boston Scientific Corporation | NULL | Terminated | 18 Years | 65 Years | All | 173 | Phase 2 | Belgium;France;Germany;Poland;Russian Federation;Spain;Italy |
| 752 | NCT01198132 (ClinicalTrials.gov) | November 2009 | 8/9/2010 | A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly | A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly | Multiple Sclerosis | Dietary Supplement: Cholecalciferol (Vitamin D3);Dietary Supplement: Placebo;Drug: Rebif | Merck KGaA | Merck Serono S.A.S, France | Completed | 18 Years | 65 Years | All | 129 | Phase 2 | France |
| 753 | EUCTR2009-011585-28-ES (EUCTR) | 30/10/2009 | 24/08/2009 | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)? | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)? | Esclerosis Múltiple Recurrente-RemitenteRelapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BGC20-0134 Product Code: BGC20-0134 Other descriptive name: Glicerol-1,3-didecanoato-2-octadeca-(6Z,9Z,12Z)-trienoato | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 166 | Phase 2 | Germany;Belgium;France;Spain | ||
| 754 | EUCTR2009-011626-34-SE (EUCTR) | 28/10/2009 | 20/07/2009 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | Czech Republic;Sweden | ||
| 755 | EUCTR2009-013695-46-FR (EUCTR) | 22/10/2009 | 07/09/2009 | ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline | ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline | Sclérose en plaques récurrente (SEP-R) MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: UVEDOSE 100 000 UI, solution buvable en ampoule Product Name: UVEDOSE 100 000 UI INN or Proposed INN: COLECALCIFEROL | MERCK SERONO s.a.s | NULL | Not Recruiting | Female: yes Male: yes | France | ||||
| 756 | EUCTR2008-006333-27-NL (EUCTR) | 22/10/2009 | 29/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand | |||
| 757 | EUCTR2008-006786-92-BE (EUCTR) | 22/10/2009 | 24/09/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Sweden | ||
| 758 | EUCTR2009-011585-28-FR (EUCTR) | 21/10/2009 | 05/08/2009 | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | Germany;Belgium;France;Spain | ||
| 759 | EUCTR2006-003361-14-CZ (EUCTR) | 12/10/2009 | 05/05/2009 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 760 | EUCTR2009-011585-28-DE (EUCTR) | 08/10/2009 | 07/07/2009 | Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosis | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 2 | France;European Union;Spain;Belgium;Russian Federation;Germany | ||
| 761 | NCT01006265 (ClinicalTrials.gov) | October 1, 2009 | 30/10/2009 | Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ACT-128800 Dose 1;Drug: Placebo;Drug: ACT-128800 Dose 2;Drug: ACT-128800 Dose 3 | Actelion | NULL | Completed | 18 Years | 55 Years | All | 464 | Phase 2 | Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Austria;Belgium;United States;Czech Republic |
| 762 | NCT01225289 (ClinicalTrials.gov) | October 2009 | 6/9/2010 | Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients | The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: Vitamin A;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 20 Years | 45 Years | All | 36 | Phase 4 | Iran, Islamic Republic of |
| 763 | NCT00947895 (ClinicalTrials.gov) | October 2009 | 2/7/2009 | Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone | Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study | Multiple Sclerosis | Drug: Methylprednisolone;Drug: ACTH;Other: IV placebo;Other: IM placebo | Neurologique Foundation, Inc. | Mallinckrodt | Terminated | 18 Years | N/A | Both | 30 | Phase 2/Phase 3 | United States |
| 764 | EUCTR2008-006786-92-IT (EUCTR) | 29/09/2009 | 10/08/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - ND | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - ND | Multiple Sclerosis Relapsing Remitting MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 765 | EUCTR2009-011585-28-BE (EUCTR) | 28/09/2009 | 13/07/2009 | Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosis | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 2 | France;European Union;Spain;Belgium;Russian Federation;Germany | ||
| 766 | EUCTR2008-006333-27-BG (EUCTR) | 26/09/2009 | 16/09/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand | |||
| 767 | EUCTR2006-003361-14-EE (EUCTR) | 25/09/2009 | 19/08/2009 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;Estonia;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 768 | EUCTR2009-011626-34-CZ (EUCTR) | 21/09/2009 | 27/07/2009 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | Relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Russian Federation;Czech Republic;Ukraine;Serbia;Sweden | |||
| 769 | EUCTR2008-006786-92-HU (EUCTR) | 18/09/2009 | 02/06/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Finland;Hungary;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 770 | EUCTR2006-001152-12-DE (EUCTR) | 14/09/2009 | 04/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 771 | EUCTR2008-006333-27-ES (EUCTR) | 11/09/2009 | 02/07/2009 | Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis. - ADVANCE | Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis. - ADVANCE | Esclerosis múltiple recidivanteRelapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Interferón Beta-1a pegilado Product Code: BIIB017 Other descriptive name: Interferón Beta-1a pegilado Product Name: Interferón Beta-1a pegilado Product Code: BIIB017 Other descriptive name: Interferón Beta-1a pegilado Product Name: Interferón Beta-1a pegilado Product Code: BIIB017 Other descriptive name: Interferón Beta-1a pegilado | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Phase 3 | Czech Republic;Estonia;Greece;Belgium;Spain;Bulgaria;Netherlands;Germany;Latvia;United Kingdom | ||
| 772 | EUCTR2007-004452-36-SE (EUCTR) | 20/08/2009 | 24/06/2009 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | ||
| 773 | EUCTR2008-008719-25-FI (EUCTR) | 13/08/2009 | 19/02/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | ||
| 774 | EUCTR2008-006786-92-GB (EUCTR) | 17/07/2009 | 27/04/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 775 | EUCTR2008-006786-92-SE (EUCTR) | 16/07/2009 | 08/05/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | France;Hungary;Czech Republic;Finland;Poland;Spain;Austria;Bulgaria;Netherlands;Italy;United Kingdom;Sweden | |||
| 776 | EUCTR2008-006786-92-FI (EUCTR) | 06/07/2009 | 01/04/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden | |||
| 777 | EUCTR2008-006786-92-ES (EUCTR) | 04/07/2009 | 06/05/2009 | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente | Esclerosis Múltiple Recurrente-Remitente MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden | ||
| 778 | EUCTR2008-003706-33-FR (EUCTR) | 02/07/2009 | 12/03/2009 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 642 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden | ||
| 779 | EUCTR2009-011234-99-DE (EUCTR) | 23/06/2009 | 21/04/2009 | A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administereddaily in subjects with relapsing remitting multiple sclerosis (RRMS) | A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administereddaily in subjects with relapsing remitting multiple sclerosis (RRMS) - MS-LAQ-101 | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS).This study is planned to assess the tolerability and safety of escalating doses of orallaquinimod administered daily in subjects with RRMS. MedDRA version: 15.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt Product Name: Laquinimod Capsules 0.3 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 1 | Germany | ||
| 780 | EUCTR2006-001152-12-LT (EUCTR) | 22/06/2009 | 31/03/2009 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 781 | EUCTR2008-006333-27-LV (EUCTR) | 19/06/2009 | 14/04/2009 | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec LTD | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Czech Republic;Estonia;Greece;Spain;Belgium;Bulgaria;Netherlands;Germany;Latvia;United Kingdom | |||
| 782 | EUCTR2008-006786-92-CZ (EUCTR) | 18/06/2009 | 26/03/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden | ||
| 783 | EUCTR2008-006333-27-EE (EUCTR) | 16/06/2009 | 11/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Latvia;Netherlands;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand | |||
| 784 | EUCTR2008-003706-33-GB (EUCTR) | 09/06/2009 | 27/11/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 785 | EUCTR2008-003706-33-SE (EUCTR) | 04/06/2009 | 09/04/2009 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 786 | NCT00906399 (ClinicalTrials.gov) | June 2009 | 20/5/2009 | Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: BIIB017 (peginterferon beta-1a);Drug: Placebo | Biogen | NULL | Completed | 18 Years | 65 Years | All | 1516 | Phase 3 | United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom |
| 787 | NCT00917839 (ClinicalTrials.gov) | June 2009 | 9/6/2009 | The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis | Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis. | Relapsing-Remitting Multiple Sclerosis | Drug: lamotrigine | Cantonal Hospital of St. Gallen | NULL | Recruiting | 18 Years | 50 Years | Both | 88 | Phase 2 | Switzerland |
| 788 | EUCTR2009-011516-37-DK (EUCTR) | 29/05/2009 | 15/05/2009 | Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS | Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS | Multiple Sclerosis, with primary and secondary progressive courses. MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: NeoRecormon INN or Proposed INN: Solu-Medrol Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Danish Multiple Sclerosis Research Centre | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 789 | EUCTR2008-003706-33-BG (EUCTR) | 28/05/2009 | 09/07/2009 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway | ||
| 790 | EUCTR2007-004122-24-EE (EUCTR) | 25/05/2009 | 23/04/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720 INN or Proposed INN: fingolimod Product Name: FTY720 Product Code: FTY720 INN or Proposed INN: fingolimod | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 791 | EUCTR2007-004122-24-IE (EUCTR) | 22/05/2009 | 04/03/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod INN or Proposed INN: fingolimod | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 792 | EUCTR2008-008719-25-HU (EUCTR) | 12/05/2009 | 11/03/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Finland;Hungary;Germany;Spain;Italy | ||
| 793 | EUCTR2007-002627-32-GB (EUCTR) | 05/05/2009 | 18/04/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - Efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 794 | NCT00799890 (ClinicalTrials.gov) | May 2009 | 28/11/2008 | Sunphenon in Progressive Forms of Multiple Sclerosis | Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Sunphenon EGCG;Drug: Placebo | Friedemann Paul | TAIYO EUROPE | Completed | 18 Years | 65 Years | All | 61 | Phase 2/Phase 3 | Germany |
| 795 | NCT01228396 (ClinicalTrials.gov) | May 2009 | 26/9/2010 | AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled Study of AIMSPRO in Treating Bladder Dysfunction in Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: Hyperimmune caprine serum against HIV lysate | Daval International Limited | NULL | Active, not recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United Kingdom |
| 796 | EUCTR2008-001999-67-DE (EUCTR) | 23/04/2009 | 16/03/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | France;Finland;Spain;Germany | |||
| 797 | EUCTR2007-004122-24-HU (EUCTR) | 23/04/2009 | 16/02/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Sweden | |||
| 798 | EUCTR2008-008719-25-ES (EUCTR) | 21/04/2009 | 06/03/2009 | Estudio fase II, a doble ciego, aleatorizado y multicéntrico, con esquema adaptativo de dosis, controlado con placebo y de grupos paralelos, para evaluar la eficacia, tolerabilidad y seguridad en base a parámetros de lesión observados mediante resonancia magnética, así como determinar la curva dosis - respuesta de BAF312 administrado oralmente en dosis única diaria en pacientes con Esclerosis Múltiple remitente recurrente. | Estudio fase II, a doble ciego, aleatorizado y multicéntrico, con esquema adaptativo de dosis, controlado con placebo y de grupos paralelos, para evaluar la eficacia, tolerabilidad y seguridad en base a parámetros de lesión observados mediante resonancia magnética, así como determinar la curva dosis - respuesta de BAF312 administrado oralmente en dosis única diaria en pacientes con Esclerosis Múltiple remitente recurrente. | Esclerosis Múltiple remitente recurrente MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | Novartis Farmacéutica, S.A | NULL | Not Recruiting | Female: yes Male: yes | 275 | Hungary;Finland;Germany;Spain;Italy | |||
| 799 | EUCTR2007-004452-36-AT (EUCTR) | 14/04/2009 | 14/04/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Tunisia;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 800 | EUCTR2008-008719-25-IT (EUCTR) | 08/04/2009 | 06/03/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - ND | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | ||
| 801 | EUCTR2007-004122-24-FI (EUCTR) | 08/04/2009 | 04/06/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 802 | EUCTR2008-003706-33-AT (EUCTR) | 02/04/2009 | 24/11/2008 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece | ||
| 803 | NCT00881205 (ClinicalTrials.gov) | April 2009 | 14/4/2009 | Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment | A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment Phase | Multiple Sclerosis;Cognitive Impairment | Drug: Rivastigmine transdermal patch;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 86 | Phase 4 | Germany |
| 804 | NCT00882999 (ClinicalTrials.gov) | April 2009 | 16/4/2009 | A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: LY2127399;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 64 Years | All | 245 | Phase 2 | United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland |
| 805 | NCT00914290 (ClinicalTrials.gov) | April 2009 | 2/6/2009 | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | Spasticity;Multiple Sclerosis | Drug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IR | Impax Laboratories, LLC | NULL | Completed | 18 Years | N/A | All | 23 | Phase 2 | United States |
| 806 | EUCTR2008-003706-33-DE (EUCTR) | 31/03/2009 | 09/12/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain | ||
| 807 | NCT00879658 (ClinicalTrials.gov) | March 30, 2009 | 9/4/2009 | Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis | A Phase II, Double-blind, Randomized, Multi-center, Adaptive Dose-ranging, Placebo-controlled, Parallel-group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis. | Relapsing-remitting Multiple Sclerosis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 297 | Phase 2 | United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey |
| 808 | EUCTR2007-004452-36-GB (EUCTR) | 24/03/2009 | 01/02/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | Belarus;United States;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Germany;Sweden | ||
| 809 | EUCTR2008-003706-33-CZ (EUCTR) | 24/03/2009 | 22/10/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon | ||
| 810 | EUCTR2008-002096-27-AT (EUCTR) | 19/03/2009 | 09/07/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Poland;Austria;Lithuania | |||
| 811 | EUCTR2008-001999-67-FI (EUCTR) | 19/03/2009 | 28/01/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Finland;Germany;France;Spain | |||
| 812 | EUCTR2008-003706-33-NO (EUCTR) | 18/03/2009 | 09/12/2008 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece | ||
| 813 | EUCTR2008-001999-67-FR (EUCTR) | 16/03/2009 | 03/02/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Phase 2 | France;Finland;Spain;Germany | ||
| 814 | EUCTR2008-003706-33-BE (EUCTR) | 16/03/2009 | 09/12/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine Product Code: L01BB04 INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 815 | EUCTR2008-003706-33-PT (EUCTR) | 06/03/2009 | 17/12/2008 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden | ||
| 816 | EUCTR2006-001827-21-DK (EUCTR) | 06/03/2009 | 15/01/2009 | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Simvastatin Trade Name: Copaxone Product Name: Glatiramer acetate | Glostrup Hospital, Dep. of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Denmark | ||||
| 817 | EUCTR2008-003706-33-IT (EUCTR) | 02/03/2009 | 23/02/2009 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORACLE Cladribine in Early MS (ORACLE MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORACLE Cladribine in Early MS (ORACLE MS) | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: CLADRIBINE INN or Proposed INN: Cladribine Trade Name: REBIF*SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta-1a | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 642 | Phase 3 | Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece | ||
| 818 | EUCTR2007-004452-36-GR (EUCTR) | 17/02/2009 | 18/02/2009 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | ||
| 819 | EUCTR2007-002627-32-CZ (EUCTR) | 04/02/2009 | 09/04/2008 | efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;South Africa;Netherlands;Germany;Sweden | |||
| 820 | NCT00835770 (ClinicalTrials.gov) | February 3, 2009 | 2/2/2009 | BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Drug: Placebo | Biogen | NULL | Completed | 19 Years | 58 Years | All | 1736 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Greece;India;Ireland;Israel;Italy;Latvia;Mexico;Moldova, Republic of;Netherlands;New Zealand;North Macedonia;Poland;Puerto Rico;Romania;Serbia;Slovakia;South Africa;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Guatemala;Macedonia, The Former Yugoslav Republic of |
| 821 | NCT00870740 (ClinicalTrials.gov) | February 2009 | 26/3/2009 | Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 517 | Phase 2 | Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom |
| 822 | EUCTR2008-001999-67-ES (EUCTR) | 30/01/2009 | 17/11/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Esclerosis Múltiple______________Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Phase 2 | France;Finland;Spain;Germany | ||
| 823 | EUCTR2008-003706-33-ES (EUCTR) | 29/01/2009 | 09/12/2008 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS).Sujetos con un primer episodio de desmielinización clínica (Síndrome aislado desde el punto de vista clínico (CIS)) de alto riesgo de conversión a Esclerosis Múltiple (EM). MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2?-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 642 | Phase 3 | Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece | ||
| 824 | EUCTR2007-004122-24-GR (EUCTR) | 13/01/2009 | 30/01/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 825 | EUCTR2006-003696-12-BG (EUCTR) | 06/01/2009 | 11/11/2008 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - DEFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 826 | EUCTR2007-004223-38-GB (EUCTR) | 05/01/2009 | 26/11/2007 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline UK | NULL | Not Recruiting | Female: yes Male: yes | 57 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 827 | NCT00666887 (ClinicalTrials.gov) | January 2009 | 23/4/2008 | Minocycline in Clinically Isolated Syndromes (CIS) | A Phase III Double-blind, Randomized, Placebo-controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS) | Clinically Isolated Syndromes;Early Single Relapse of Multiple Sclerosis | Drug: Minocycline;Drug: Placebo | Dr. Luanne Metz | Multiple Sclerosis Society of Canada | Completed | 18 Years | 60 Years | All | 142 | Phase 3 | Canada |
| 828 | NCT00841321 (ClinicalTrials.gov) | January 2009 | 9/2/2009 | Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis | Ginkgo Biloba for Cognitive Impairment in Multiple Sclerosis | Multiple Sclerosis;Cognitive Ability, General | Drug: Ginkgo biloba;Drug: Placebo | VA Office of Research and Development | NULL | Completed | 18 Years | 65 Years | All | 120 | Phase 2 | United States |
| 829 | EUCTR2008-003706-33-EE (EUCTR) | 31/12/2008 | 20/11/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Romania;Estonia;Thailand;Spain;Bosnia and Herzegovina;Lebanon | ||
| 830 | NCT00725985 (ClinicalTrials.gov) | December 31, 2008 | 30/7/2008 | Oral Cladribine in Early Multiple Sclerosis (MS) | A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS | Multiple Sclerosis | Drug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF) | EMD Serono | NULL | Completed | 18 Years | 55 Years | All | 617 | Phase 3 | United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Saudi Arabia |
| 831 | EUCTR2007-005450-23-DE (EUCTR) | 29/12/2008 | 28/10/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection INN or Proposed INN: INTERFERON BETA-1A | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy | |||
| 832 | EUCTR2008-002096-27-LT (EUCTR) | 22/12/2008 | 16/07/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 833 | EUCTR2008-005125-11-GB (EUCTR) | 19/12/2008 | 07/01/2009 | A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis. | A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis. | Primary progressive multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Trade Name: Neorecormon Product Name: Recombinant Human Erythropoietin Product Code: rhEPO INN or Proposed INN: epoetin beta | Walton Centre for Neurology and Neurosurgery | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 834 | EUCTR2008-003706-33-FI (EUCTR) | 18/12/2008 | 10/11/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon | ||
| 835 | EUCTR2007-004452-36-ES (EUCTR) | 04/12/2008 | 23/09/2008 | Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Esclerosis múltiple_____________Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 836 | EUCTR2007-004452-36-FR (EUCTR) | 02/12/2008 | 21/10/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 837 | NCT00813709 (ClinicalTrials.gov) | December 2008 | 22/12/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind Extension of the Study 27025 (REFLEX) to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION) | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: RNF;Drug: Placebo | Merck KGaA | NULL | Completed | 18 Years | N/A | All | 402 | Phase 3 | Argentina;Austria;Belgium;Bulgaria;Canada;Croatia;Czech Republic;Estonia;Finland;France;Germany;Greece;Israel;Italy;Latvia;Lebanon;Morocco;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Saudi Arabia;Turkey |
| 838 | NCT00811902 (ClinicalTrials.gov) | December 2008 | 18/12/2008 | Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis. | Multiple Sclerosis | Drug: Nerispirdine (HP184);Drug: placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 405 | Phase 2 | United States;Canada;Finland;France;Germany;Norway;Spain |
| 839 | EUCTR2008-002096-27-GB (EUCTR) | 28/11/2008 | 14/10/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 840 | EUCTR2006-003696-12-IT (EUCTR) | 18/11/2008 | 10/10/2008 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - ND | Relapsing-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Dimethyl Fumarate Product Code: BG00012 | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 841 | EUCTR2006-001152-12-SK (EUCTR) | 11/11/2008 | 16/04/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 842 | EUCTR2007-007759-15-HU (EUCTR) | 10/11/2008 | 18/08/2008 | The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple SclerosisA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial | The Effect of the Dose of PI-2301 on Safety, Tolerability, and Pharmacokinetics in Subjects with the Secondary Progressive Form of Multiple SclerosisA double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) trial | Patients with current diagnosis of SP-MS MedDRA version: 9.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: PI-2301 Product Code: CO-14 Other descriptive name: CO-14 | PEPTIMMUNE Inc | NULL | Not Recruiting | Female: yes Male: yes | 53 | Hungary | |||
| 843 | NCT00753792 (ClinicalTrials.gov) | November 2008 | 16/9/2008 | Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse | Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse | Multiple Sclerosis | Drug: methylprednisolone;Drug: Placebo | Germans Trias i Pujol Hospital | NULL | Completed | 18 Years | 59 Years | Both | 49 | Phase 4 | Spain |
| 844 | EUCTR2007-002627-32-NL (EUCTR) | 31/10/2008 | 11/07/2008 | A clinical study in which the efficacy and safety of 0.5 mg FTY720 versus placebo is evaluated vluated in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 845 | EUCTR2006-003366-33-IT (EUCTR) | 30/10/2008 | 08/01/2008 | A phase II, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif New Formulation in Multiple Scleroris Subjects with Active Disease - Phase II Cladribine add-on to Rebif New Formulation in MS subjects with active disease | A phase II, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif New Formulation in Multiple Scleroris Subjects with Active Disease - Phase II Cladribine add-on to Rebif New Formulation in MS subjects with active disease | MULTIPLE SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: REBIF*SC 12SIR 12000000UI44MCG INN or Proposed INN: Cladribine | MERCK SERONO INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Spain;Italy | ||
| 846 | EUCTR2007-000381-20-BG (EUCTR) | 28/10/2008 | 20/10/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 847 | EUCTR2007-004122-24-GB (EUCTR) | 14/10/2008 | 16/05/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 848 | EUCTR2007-004452-36-CZ (EUCTR) | 13/10/2008 | 07/04/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 849 | EUCTR2007-006338-32-FI (EUCTR) | 08/10/2008 | 30/06/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 850 | EUCTR2007-006338-32-BG (EUCTR) | 07/10/2008 | 31/07/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Multiple sclerosis is a disabling disease of brain and spinal cord thatdisrupts flow of information within brain, characterized by flare-ups withperiods of remission in between (relapsing remitting) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: oclelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 851 | NCT00755807 (ClinicalTrials.gov) | October 2008 | 17/9/2008 | Duloxetine for Multiple Sclerosis Pain | Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis. | Multiple Sclerosis | Drug: Duloxetine Hydrochloride (HCI);Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 239 | Phase 3 | United States;Belgium;Canada;Poland |
| 852 | EUCTR2007-004452-36-BE (EUCTR) | 30/09/2008 | 11/03/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | ||
| 853 | EUCTR2006-006299-39-FR (EUCTR) | 24/09/2008 | 06/08/2007 | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment. MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum toxin type A Other descriptive name: Botulinum toxin type A | Allergan | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 3 | France;Netherlands | ||
| 854 | EUCTR2006-001152-12-BG (EUCTR) | 17/09/2008 | 05/09/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 855 | EUCTR2007-006338-32-BE (EUCTR) | 15/09/2008 | 17/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 856 | EUCTR2007-006338-32-IT (EUCTR) | 11/09/2008 | 02/10/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI. | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS. | Relapsing-Remitting Multiple Sclerosis (RRMS). MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Denmark;Bulgaria;Netherlands;Germany | ||
| 857 | EUCTR2008-002096-27-PL (EUCTR) | 10/09/2008 | 25/06/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 858 | EUCTR2007-000381-20-GR (EUCTR) | 09/09/2008 | 01/04/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Czech Republic;Denmark;Estonia;Greece;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom | |||
| 859 | EUCTR2008-002560-34-BE (EUCTR) | 02/09/2008 | 29/07/2008 | A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR | A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis - HMFR | Central neuropathic pain due to Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Trade Name: Cymbalta Product Name: Duloxetine Product Code: LY248686 INN or Proposed INN: DULOXETINE | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 238 | Belgium | |||
| 860 | NCT00772525 (ClinicalTrials.gov) | September 2008 | 13/10/2008 | Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis | A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis | Multiple Sclerosis;Optic Nerve;Neuritis | Drug: Nerispirdine (HP184);Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 31 | Phase 2 | United States |
| 861 | EUCTR2007-000381-20-NL (EUCTR) | 29/08/2008 | 01/02/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece | |||
| 862 | EUCTR2006-003361-14-DK (EUCTR) | 29/08/2008 | 22/07/2008 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 863 | EUCTR2007-005450-23-LT (EUCTR) | 27/08/2008 | 07/05/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A (Avonex®) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 864 | EUCTR2006-003696-12-DE (EUCTR) | 27/08/2008 | 13/02/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Greece;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 865 | EUCTR2007-004122-24-FR (EUCTR) | 21/08/2008 | 03/06/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 866 | EUCTR2007-004122-24-SK (EUCTR) | 18/08/2008 | 23/04/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 867 | EUCTR2006-003697-10-BG (EUCTR) | 14/08/2008 | 14/06/2008 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Estonia;Bulgaria;Ireland;Spain;Greece;Latvia | |||
| 868 | EUCTR2007-003936-50-GB (EUCTR) | 11/08/2008 | 13/01/2009 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: atacicept Product Code: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | Netherlands;France;Austria;Lithuania;Australia;Sweden;United Kingdom;Russian Federation;Czech Republic;Canada;Ukraine;Spain;Lebanon;United States | ||
| 869 | EUCTR2007-002627-32-BE (EUCTR) | 08/08/2008 | 20/08/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 870 | EUCTR2007-002627-32-FR (EUCTR) | 05/08/2008 | 09/05/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 871 | NCT00751881 (ClinicalTrials.gov) | August 2008 | 7/5/2008 | An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis | A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 1169 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Czech Republic;Estonia;France;Germany;Greece;Mexico;Netherlands;Philippines;Poland;Romania;Slovakia;Spain;Sweden;Thailand;Tunisia;Turkey;Ukraine;United Kingdom;South Africa |
| 872 | EUCTR2007-006338-32-GB (EUCTR) | 28/07/2008 | 07/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 873 | NCT00731692 (ClinicalTrials.gov) | July 28, 2008 | 7/8/2008 | This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. | A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 25 Years | 65 Years | All | 970 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic |
| 874 | EUCTR2007-004452-36-DE (EUCTR) | 23/07/2008 | 07/05/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 875 | EUCTR2007-004122-24-DE (EUCTR) | 22/07/2008 | 19/05/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | |||
| 876 | NCT00676715 (ClinicalTrials.gov) | July 17, 2008 | 9/5/2008 | A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Drug: Placebo;Drug: Ocrelizumab;Drug: Avonex | Genentech, Inc. | Roche Pharma AG | Active, not recruiting | 18 Years | 55 Years | All | 220 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands |
| 877 | EUCTR2007-002627-32-ES (EUCTR) | 17/07/2008 | 08/05/2008 | Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos, para comparar la eficacia y seguridad de 1,25 mg FTY720 administrado por vía oral una vez al día versus placebo en pacientes con esclerosis múltiple primaria progresiva | Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos, para comparar la eficacia y seguridad de 1,25 mg FTY720 administrado por vía oral una vez al día versus placebo en pacientes con esclerosis múltiple primaria progresiva | Esclerosis múltiple primaria progresiva. MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Farmacéutica S.A | NULL | Not Recruiting | Female: yes Male: yes | 650 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 878 | EUCTR2007-006338-32-ES (EUCTR) | 16/07/2008 | 28/03/2008 | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom | ||
| 879 | EUCTR2007-003936-50-LT (EUCTR) | 15/07/2008 | 20/05/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept Product Code: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA-Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Sweden;Lithuania | ||
| 880 | EUCTR2007-000381-20-LT (EUCTR) | 15/07/2008 | 06/06/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 881 | EUCTR2007-006338-32-NL (EUCTR) | 09/07/2008 | 29/05/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 882 | EUCTR2007-006338-32-DE (EUCTR) | 09/07/2008 | 17/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F. Hoffman-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 883 | EUCTR2007-006338-32-DK (EUCTR) | 09/07/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 884 | EUCTR2007-003997-24-GB (EUCTR) | 08/07/2008 | 20/08/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 885 | EUCTR2007-003936-50-AT (EUCTR) | 02/07/2008 | 10/03/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 886 | NCT00726648 (ClinicalTrials.gov) | July 2008 | 29/7/2008 | CDP323 Biomarker Study | Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability. | Relapsing Multiple Sclerosis | Drug: CDP323;Drug: Placebo | UCB Pharma | Biogen Idec | Completed | 18 Years | 65 Years | Both | 71 | Phase 1/Phase 2 | United Kingdom |
| 887 | EUCTR2007-003936-50-CZ (EUCTR) | 23/06/2008 | 07/04/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 888 | EUCTR2007-006338-32-SK (EUCTR) | 16/06/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 889 | EUCTR2006-003696-12-NL (EUCTR) | 16/06/2008 | 19/03/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Product Code: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 890 | EUCTR2007-002627-32-SE (EUCTR) | 12/06/2008 | 28/04/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - Efficacy and safety of 0.5 mg fingolimod in patients with PPMS | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Services Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 891 | EUCTR2007-002627-32-IT (EUCTR) | 11/06/2008 | 16/05/2008 | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - ND | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - ND | primary progressive multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: fingolimod Product Code: FTY720D | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 650 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 892 | EUCTR2007-004452-36-NL (EUCTR) | 09/06/2008 | 28/02/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Tunisia;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 893 | EUCTR2007-003997-24-IT (EUCTR) | 05/06/2008 | 13/06/2008 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-Aventis recherche & de'veloppement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 894 | EUCTR2007-002627-32-FI (EUCTR) | 05/06/2008 | 22/04/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 940 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 895 | EUCTR2007-004223-38-DE (EUCTR) | 02/06/2008 | 24/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 2 | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 896 | EUCTR2007-000381-20-LV (EUCTR) | 29/05/2008 | 12/05/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 897 | EUCTR2007-005450-23-BG (EUCTR) | 29/05/2008 | 27/05/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Estonia;Bulgaria;Spain;Italy;Lithuania | |||
| 898 | EUCTR2007-006338-32-CZ (EUCTR) | 28/05/2008 | 01/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 899 | EUCTR2007-004452-36-EE (EUCTR) | 22/05/2008 | 09/04/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Czech Republic;Estonia;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 900 | EUCTR2007-003226-19-BG (EUCTR) | 22/05/2008 | 22/03/2008 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1419 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 901 | EUCTR2006-001161-42-HU (EUCTR) | 21/05/2008 | 18/08/2006 | Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis. - SELECT | Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis. - SELECT | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Germany;United Kingdom;Sweden | |||
| 902 | EUCTR2007-000381-20-EE (EUCTR) | 19/05/2008 | 28/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 903 | EUCTR2007-003936-50-NL (EUCTR) | 17/05/2008 | 22/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 332 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 904 | EUCTR2006-005910-11-DE (EUCTR) | 08/05/2008 | 08/02/2008 | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | Spasticity in multiple sclerosis (MS) | Trade Name: Sativex Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 488 | Phase 3 | United Kingdom;Germany;Spain;Italy | ||
| 905 | EUCTR2006-001161-42-DE (EUCTR) | 08/05/2008 | 31/05/2006 | A study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Sweden;India | |||
| 906 | EUCTR2007-006338-32-FR (EUCTR) | 06/05/2008 | 26/02/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom | ||
| 907 | EUCTR2007-004223-38-SE (EUCTR) | 05/05/2008 | 13/03/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline AB | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;Czech Republic;United Kingdom;Denmark;Sweden | |||
| 908 | NCT00640328 (ClinicalTrials.gov) | May 2008 | 18/3/2008 | Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | Multiple Sclerosis | Drug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 38 | Phase 2 | Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom |
| 909 | EUCTR2007-004122-24-CZ (EUCTR) | 30/04/2008 | 03/01/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 910 | EUCTR2007-000381-20-PT (EUCTR) | 28/04/2008 | 15/01/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece | |||
| 911 | NCT00605215 (ClinicalTrials.gov) | April 24, 2008 | 8/1/2008 | BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®) | A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded Design | Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo;Drug: Avonex® | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 55 Years | All | 1331 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Latvia;Macedonia, The Former Yugoslav Republic of;Montenegro;Turkey |
| 912 | EUCTR2006-006299-39-NL (EUCTR) | 23/04/2008 | 13/06/2007 | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment | Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment. MedDRA version: 8.1;Level: LLT;Classification code 10046543;Term: Urinary incontinence | Trade Name: BOTOX® Product Name: BOTOX® Product Code: 9060X INN or Proposed INN: Botulinum toxin type A Other descriptive name: Botulinum toxin type A | Allergan | NULL | Not Recruiting | Female: yes Male: yes | 135 | Netherlands;France | |||
| 913 | EUCTR2007-000381-20-CZ (EUCTR) | 23/04/2008 | 14/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 914 | EUCTR2007-004223-38-BE (EUCTR) | 16/04/2008 | 06/05/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 324 | Sweden;Czech Republic;Belgium;Denmark;Germany;United Kingdom | |||
| 915 | EUCTR2006-005910-11-IT (EUCTR) | 16/04/2008 | 23/04/2008 | A two-phase, Phase 3 study of the safety and efficacy of Sativex, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A - single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. - Study of Sativex in subjects with spasticity due to MS | A two-phase, Phase 3 study of the safety and efficacy of Sativex, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A - single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. - Study of Sativex in subjects with spasticity due to MS | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex INN or Proposed INN: Other analgesics and antipyretics | GW PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 488 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 916 | EUCTR2007-000381-20-DK (EUCTR) | 15/04/2008 | 05/03/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Australia;United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 917 | EUCTR2007-005450-23-CZ (EUCTR) | 14/04/2008 | 12/02/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 918 | EUCTR2007-005450-23-SK (EUCTR) | 10/04/2008 | 30/04/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Estonia;Slovakia;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 919 | EUCTR2007-004223-38-DK (EUCTR) | 04/04/2008 | 23/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 57 | Czech Republic;Denmark;Germany;United Kingdom;Sweden | |||
| 920 | EUCTR2007-003936-50-SE (EUCTR) | 02/04/2008 | 03/03/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono Geneva- an affiliate of Merck KGaA, Darmstadt Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 921 | NCT00642902 (ClinicalTrials.gov) | April 2008 | 21/3/2008 | A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) | A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course | Relapsing Multiple Sclerosis | Drug: Atacicept;Drug: Placebo matched to atacicept | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 255 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 922 | NCT00670449 (ClinicalTrials.gov) | April 2008 | 28/4/2008 | An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis | An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 143 | Phase 2 | Japan |
| 923 | EUCTR2007-005450-23-EE (EUCTR) | 28/03/2008 | 11/02/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection Product Name: - Product Code: - INN or Proposed INN: interferon beta-1a | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy | |||
| 924 | EUCTR2007-004122-24-NL (EUCTR) | 26/03/2008 | 28/02/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 925 | EUCTR2007-004122-24-BE (EUCTR) | 21/03/2008 | 13/02/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 926 | EUCTR2007-003936-50-BE (EUCTR) | 17/03/2008 | 23/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | France;Czech Republic;Spain;Belgium;Lithuania;Austria;Netherlands;United Kingdom;Sweden | ||
| 927 | EUCTR2007-000381-20-DE (EUCTR) | 17/03/2008 | 28/02/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 928 | EUCTR2007-005450-23-ES (EUCTR) | 17/03/2008 | 29/01/2008 | Estudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVO | Estudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVO | Esclerosis Múltiple Remitente Recurrente (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Cápsulas de Laquinimod 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgramos/0.5 ml Solución para inyección | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 929 | NCT00629642 (ClinicalTrials.gov) | March 14, 2008 | 26/2/2008 | Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis | A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity | Multiple Sclerosis;Neurogenic Bladder;Spinal Cord Diseases | Drug: Solifenacin Succinate;Drug: Oxybutynin Hydrochloride;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 18 Years | 65 Years | All | 249 | Phase 4 | Australia;Belgium;Czechia;France;Germany;Hungary;Italy;Netherlands;Russian Federation;Spain;United Kingdom;Czech Republic;Portugal |
| 930 | EUCTR2007-003936-50-ES (EUCTR) | 10/03/2008 | 02/01/2008 | Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Esclerosis múltiple recidivante Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 332 | Phase 2 | France;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;United Kingdom;Sweden | ||
| 931 | EUCTR2007-000192-42-IT (EUCTR) | 10/03/2008 | 31/07/2007 | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND | urinary incontinence caused by neurogenic detrusor overactivity (spinal lesion or multiple sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10029279;Term: Neurogenic bladder | Trade Name: BOTOX INN or Proposed INN: Botulinum toxin | ALLERGAN | NULL | Not Recruiting | Female: yes Male: yes | 260 | Portugal;United Kingdom;Germany;Netherlands;France;Spain;Italy | |||
| 932 | EUCTR2006-003361-14-PT (EUCTR) | 07/03/2008 | 07/01/2008 | Multiple Sclerosis study to document the safety of two doses of teriflunomide | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 933 | EUCTR2007-000381-20-GB (EUCTR) | 04/03/2008 | 26/11/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 934 | EUCTR2007-005450-23-IT (EUCTR) | 04/03/2008 | 13/03/2008 | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon β-1a (Avonex) in a rater-blinded design - Bravo | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon β-1a (Avonex) in a rater-blinded design - Bravo | Multiple sclerosis with relapse MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: laquinimod Product Code: TV-5600 INN or Proposed INN: laquinimod Trade Name: AVONEX*IM 4SIR 30MCG/0,5ML+4AG INN or Proposed INN: Interferon beta-1a | TEVA ITALIA srl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 935 | EUCTR2007-003936-50-FR (EUCTR) | 03/03/2008 | 17/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 332 | Phase 2 | France;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;United Kingdom;Sweden | ||
| 936 | NCT00638196 (ClinicalTrials.gov) | March 2008 | 10/3/2008 | Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS | Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Linoleic Acid/Oleic Acid | University of Rochester | NULL | Terminated | 18 Years | 70 Years | Both | 9 | Phase 1 | United States |
| 937 | NCT01339676 (ClinicalTrials.gov) | March 2008 | 19/4/2011 | Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: Colecalciferol;Drug: Placebo capsules | University of Turku | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 70 | Phase 4 | Finland |
| 938 | NCT00429442 (ClinicalTrials.gov) | March 2008 | 30/1/2007 | Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in Patients Treated With Copaxone for at Least 3 Months | Relapsing Remitting Multiple Sclerosis | Drug: Simvastatin;Drug: placebo | Anna Tsakiri | Sanofi | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 3 | Denmark |
| 939 | NCT00641537 (ClinicalTrials.gov) | February 29, 2008 | 13/3/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY) | Relapsing-Remitting Multiple Sclerosis | Drug: Cladribine;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | NULL | Completed | 18 Years | 65 Years | All | 867 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Italy;Latvia;Lebanon;Lithuania;Morocco;Netherlands;Poland;Portugal;Russian Federation;Saudi Arabia;Serbia;Switzerland;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Former Serbia and Montenegro |
| 940 | EUCTR2007-004223-38-CZ (EUCTR) | 27/02/2008 | 02/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline s.r.o. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;United Kingdom;Czech Republic;Denmark;Sweden | |||
| 941 | EUCTR2008-000490-37-IT (EUCTR) | 26/02/2008 | 20/03/2008 | Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND | Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028053;Term: MS | Trade Name: EBIXA INN or Proposed INN: Memantine | OSPEDALE S. RAFFAELE | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Italy | ||
| 942 | EUCTR2005-000365-19-GB (EUCTR) | 19/02/2008 | 11/11/2005 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Hungary;Czech Republic;Slovakia;Greece;Finland;Ireland;Lithuania;Germany;United Kingdom;Sweden | ||
| 943 | EUCTR2006-003361-14-NL (EUCTR) | 12/02/2008 | 07/01/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 944 | EUCTR2006-001152-12-EE (EUCTR) | 08/02/2008 | 21/11/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 945 | EUCTR2004-000555-42-GB (EUCTR) | 05/02/2008 | 03/03/2005 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;Italy;United Kingdom;Sweden | ||
| 946 | EUCTR2007-003226-19-PT (EUCTR) | 01/02/2008 | 24/10/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 947 | NCT00390221 (ClinicalTrials.gov) | February 2008 | 17/10/2006 | Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 621 | Phase 2 | Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Australia;Former Serbia and Montenegro;Sweden;Turkey |
| 948 | NCT00662649 (ClinicalTrials.gov) | February 2008 | 17/4/2008 | Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod 0.5 mg;Drug: Fingolimod 1.25 mg | Novartis | NULL | Completed | 20 Years | 58 Years | All | 920 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom |
| 949 | NCT00622700 (ClinicalTrials.gov) | February 2008 | 14/2/2008 | Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis | An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 618 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Turkey;Ukraine;United Kingdom;Brazil;Italy;Slovakia |
| 950 | EUCTR2007-004122-24-SE (EUCTR) | 23/01/2008 | 19/12/2007 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 951 | EUCTR2007-000381-20-BE (EUCTR) | 21/01/2008 | 20/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 952 | EUCTR2007-003226-19-LT (EUCTR) | 11/01/2008 | 25/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 953 | EUCTR2006-001152-12-HU (EUCTR) | 09/01/2008 | 09/10/2007 | Not applicable | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 954 | EUCTR2006-005910-11-GB (EUCTR) | 09/01/2008 | 14/08/2007 | A two-phase, Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | A two-phase, Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | Spasticity in multiple sclerosis (MS) | Trade Name: Sativex Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 955 | EUCTR2006-001152-12-FR (EUCTR) | 08/01/2008 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 956 | EUCTR2006-006872-39-GB (EUCTR) | 04/01/2008 | 19/06/2007 | A randomised, double-blind, placebo controlled study of AIMSPRO in Multiple Sclerosis - AIMSPRO in MS bladder function | A randomised, double-blind, placebo controlled study of AIMSPRO in Multiple Sclerosis - AIMSPRO in MS bladder function | Overactive Bladder in Secondary Progressive Multiple Sclerosis and the other neurological symptoms associated with Secondary Progressive Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10059617;Term: Overactive bladder MedDRA version: 9.1;Classification code 10012547;Term: Detrusor hyperreflexia | Product Name: AIMSPRO | Daval International Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 957 | NCT00785473 (ClinicalTrials.gov) | January 2008 | 4/11/2008 | Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis | Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study | Multiple Sclerosis, Osteoporosis | Dietary Supplement: cholecalciferol;Dietary Supplement: calcium carbonate | University Hospital of North Norway | NULL | Completed | 18 Years | 50 Years | Both | 80 | Phase 4 | Norway |
| 958 | NCT00681538 (ClinicalTrials.gov) | January 2008 | 19/5/2008 | A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS) | A Two-phase, Phase 3 Study of the Safety and Efficacy of Sativex, in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis: Phase A - Single-blind Response Assessment; Phase B - Double-blind, Randomised, Placebo Controlled, Parallel Group Study. | Spasticity;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 572 | Phase 3 | United Kingdom |
| 959 | NCT00647348 (ClinicalTrials.gov) | January 2008 | 26/3/2008 | Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis | A Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis. | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin;Drug: Placebo | Imperial College London | NULL | Completed | 18 Years | 65 Years | All | 140 | Phase 2 | United Kingdom |
| 960 | EUCTR2007-000381-20-AT (EUCTR) | 30/12/2007 | 03/01/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 961 | EUCTR2007-003226-19-SE (EUCTR) | 27/12/2007 | 29/10/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Sweden;Lithuania;United Kingdom;Czech Republic;Estonia;Spain | |||
| 962 | EUCTR2007-005414-40-IT (EUCTR) | 21/12/2007 | 28/11/2007 | Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND | Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND | Patients with an established and stable Multiple Sclerosis (according to Poser criteria). MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: KEPPRA INN or Proposed INN: Levetiracetam | AZIENDA SANITARIA N. 3 GENOVESE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 963 | EUCTR2007-001958-99-FI (EUCTR) | 18/12/2007 | 07/12/2007 | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Dekristol 20000 IE Product Name: Dekristol INN or Proposed INN: INN COLECALCIFEROL Product Name: Placebo Dekristol SGC 20000 | Merja Soilu Häninen | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 964 | EUCTR2007-000381-20-FR (EUCTR) | 14/12/2007 | 17/10/2007 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Estonia;Greece;Finland;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Germany | ||
| 965 | EUCTR2007-003226-19-IT (EUCTR) | 06/12/2007 | 10/03/2008 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: laquinimod Product Code: TV-5600 INN or Proposed INN: laquinimod | TEVA ITALIA srl | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 966 | EUCTR2006-001152-12-DK (EUCTR) | 05/12/2007 | 30/10/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 967 | EUCTR2007-003226-19-EE (EUCTR) | 04/12/2007 | 10/10/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 968 | NCT00509145 (ClinicalTrials.gov) | December 2007 | 27/7/2007 | Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Laquinimod;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | Both | 1106 | Phase 3 | United States;Austria;Bulgaria;Canada;Czech Republic;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Former Serbia and Montenegro;Spain;Sweden;Turkey;Ukraine;United Kingdom;Portugal |
| 969 | NCT00623415 (ClinicalTrials.gov) | December 2007 | 15/2/2008 | Flupirtine as Oral Treatment in Multiple Sclerosis | Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-ß1b on Neurodegeneration in Patients With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Flupirtine;Drug: Placebo | Charite University, Berlin, Germany | Bayer | Terminated | 18 Years | 60 Years | All | 30 | Phase 2 | Germany |
| 970 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
| 971 | EUCTR2006-002982-38-LT (EUCTR) | 30/11/2007 | 01/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 972 | EUCTR2007-003997-24-ES (EUCTR) | 26/11/2007 | 15/10/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Multiple Sclerosis.-----------------------Esclerosis Múltiple. | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 973 | EUCTR2007-003226-19-ES (EUCTR) | 22/11/2007 | 04/10/2007 | Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - Allegro | Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - Allegro | Esclerosis Múltiple Remitente Recurrente (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | ||
| 974 | EUCTR2007-000381-20-FI (EUCTR) | 16/11/2007 | 15/10/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 975 | EUCTR2007-003226-19-LV (EUCTR) | 06/11/2007 | 12/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 976 | NCT00702468 (ClinicalTrials.gov) | November 2007 | 19/6/2008 | Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis | A Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-term Sativex®. | Spasticity;Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 36 | Phase 3 | United Kingdom |
| 977 | EUCTR2006-003697-10-GR (EUCTR) | 30/10/2007 | 31/05/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 978 | EUCTR2006-002204-33-HU (EUCTR) | 29/10/2007 | 22/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Finland;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 979 | EUCTR2007-003226-19-CZ (EUCTR) | 25/10/2007 | 10/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;Czech Republic;United Kingdom;Estonia;Spain | |||
| 980 | EUCTR2007-003226-19-GB (EUCTR) | 24/10/2007 | 01/08/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 981 | EUCTR2006-001152-12-GB (EUCTR) | 24/10/2007 | 14/10/2010 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | ||
| 982 | EUCTR2007-003226-19-DE (EUCTR) | 23/10/2007 | 15/07/2008 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | |||
| 983 | EUCTR2006-003696-12-GR (EUCTR) | 16/10/2007 | 14/05/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 984 | EUCTR2006-001152-12-CZ (EUCTR) | 15/10/2007 | 07/08/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | ||
| 985 | EUCTR2006-001152-12-FI (EUCTR) | 15/10/2007 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 986 | EUCTR2007-003997-24-AT (EUCTR) | 14/10/2007 | 21/09/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 987 | EUCTR2007-003226-19-HU (EUCTR) | 09/10/2007 | 13/07/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 988 | EUCTR2006-003697-10-DE (EUCTR) | 04/10/2007 | 06/04/2009 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Czech Republic;Germany;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 989 | EUCTR2006-001152-12-AT (EUCTR) | 04/10/2007 | 20/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 990 | NCT00811395 (ClinicalTrials.gov) | October 2007 | 18/12/2008 | Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA] | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 182 | Phase 2 | United States;Austria;Canada;Germany;Italy;Spain;United Kingdom |
| 991 | NCT00104143 (ClinicalTrials.gov) | October 2007 | 23/2/2005 | A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis. | Multiple Sclerosis | Drug: A4I Antagonist | Hoffmann-La Roche | NULL | Withdrawn | 18 Years | 59 Years | Both | 0 | Phase 2 | Bulgaria;Canada;Czech Republic;Germany;Poland;Russian Federation;Slovakia;Spain;United Kingdom;Finland;United States |
| 992 | EUCTR2007-003226-19-AT (EUCTR) | 30/09/2007 | 19/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 993 | EUCTR2006-004893-29-IT (EUCTR) | 24/09/2007 | 24/07/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - ND | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;United Kingdom;Italy;Austria | |||
| 994 | EUCTR2006-003134-14-IT (EUCTR) | 24/09/2007 | 24/07/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - ND | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Spain;Italy | |||
| 995 | EUCTR2007-003226-19-FR (EUCTR) | 21/09/2007 | 06/08/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | ||
| 996 | EUCTR2007-001031-63-CZ (EUCTR) | 20/09/2007 | 10/08/2007 | AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis. | AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis. | Spasticity associated with multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028335;Term: Muscle spasticity | Trade Name: Tolposan Product Code: AV605 INN or Proposed INN: Tolperisone HC1 Other descriptive name: Tolpersan | Avigen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Czech Republic;Germany | ||
| 997 | EUCTR2006-003697-10-EE (EUCTR) | 18/09/2007 | 12/06/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 998 | EUCTR2007-002138-13-GB (EUCTR) | 13/09/2007 | 14/06/2007 | A placebo controlled, parallel group, randomised withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term GW-1000-02 (Sativex®). | A placebo controlled, parallel group, randomised withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term GW-1000-02 (Sativex®). | Symptoms of spasticity in multiple sclerosis. | Trade Name: Sativex Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 999 | EUCTR2006-002633-20-LT (EUCTR) | 07/09/2007 | 05/07/2007 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 1000 | EUCTR2006-006347-31-GB (EUCTR) | 06/09/2007 | 07/08/2007 | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | Multiple Sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Product Name: Encapsulated Simvastatin tablets Product Code: MSTC-001 (MS-STAT) | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1001 | EUCTR2007-003226-19-NL (EUCTR) | 05/09/2007 | 12/07/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1419 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 1002 | NCT00638833 (ClinicalTrials.gov) | September 2007 | 12/3/2008 | Memantine Therapy for Multiple Sclerosis | Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Memantine;Drug: Placebo | Clinica Universidad de Navarra, Universidad de Navarra | H. Lundbeck A/S | Terminated | 18 Years | 65 Years | Both | 20 | Phase 2 | Spain |
| 1003 | NCT00532532 (ClinicalTrials.gov) | September 2007 | 18/9/2007 | Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis | AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis | Muscle Spasticity | Drug: tolperisone HCl | Avigen | NULL | Terminated | 18 Years | 70 Years | Both | 150 | Phase 2 | Czech Republic;Germany;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro |
| 1004 | NCT00525668 (ClinicalTrials.gov) | September 2007 | 4/9/2007 | Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study) | Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study) | Relapsing-remitting Multiple Sclerosis | Drug: epigallocatechin-gallate (Sunphenon);Drug: placebo | Charite University, Berlin, Germany | NULL | Completed | 18 Years | 60 Years | All | 120 | Phase 1/Phase 2 | Germany |
| 1005 | NCT00537082 (ClinicalTrials.gov) | September 2007 | 26/9/2007 | Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS) | A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 171 | Phase 2 | Japan |
| 1006 | EUCTR2006-003697-10-ES (EUCTR) | 29/08/2007 | 28/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A | Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: glatiramer acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Phase 3 | Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Latvia | ||
| 1007 | EUCTR2006-002204-33-DE (EUCTR) | 29/08/2007 | 12/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 1008 | EUCTR2006-005910-11-CZ (EUCTR) | 29/08/2007 | 10/07/2007 | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | Spacticity in multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 488 | Phase 3 | Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 1009 | EUCTR2006-003696-12-AT (EUCTR) | 28/08/2007 | 12/03/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 1010 | EUCTR2006-003697-10-LV (EUCTR) | 22/08/2007 | 26/07/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 1011 | EUCTR2007-001031-63-DE (EUCTR) | 15/08/2007 | 19/01/2009 | AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis. | AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis. | Spasticity associated with multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028335;Term: Muscle spasticity | Trade Name: Tolposan Product Code: AV605 INN or Proposed INN: Tolperisone HC1 Other descriptive name: Tolpersan | Avigen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Germany | |||
| 1012 | EUCTR2006-003696-12-GB (EUCTR) | 06/08/2007 | 22/01/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Phase 3 | Czech Republic;Slovakia;Greece;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1013 | EUCTR2006-004893-29-GB (EUCTR) | 25/07/2007 | 17/12/2006 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria;Germany;Italy;United Kingdom | ||
| 1014 | EUCTR2006-003361-14-SE (EUCTR) | 24/07/2007 | 27/06/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1015 | EUCTR2006-002204-33-FR (EUCTR) | 18/07/2007 | 26/03/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 1016 | EUCTR2006-003697-10-BE (EUCTR) | 13/07/2007 | 23/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Phase 3 | Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;Latvia | ||
| 1017 | EUCTR2006-003696-12-SE (EUCTR) | 06/07/2007 | 16/03/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 1018 | EUCTR2004-000555-42-EE (EUCTR) | 06/07/2007 | 18/04/2007 | A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses. | A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses. | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis U.S. Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Norway;Estonia;Italy;Sweden | |||
| 1019 | EUCTR2007-000236-16-LV (EUCTR) | 04/07/2007 | 02/04/2007 | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | Established Spasticity Resulting from Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity | Product Code: IPX056-40 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-35 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-30 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-25 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-20 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-10 mg INN or Proposed INN: BACLOFEN Trade Name: baclofen Product Name: baclofen Product Code: baclofen 20 mg INN or Proposed INN: BACLOFEN | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Estonia;Latvia | |||
| 1020 | EUCTR2006-003697-10-IE (EUCTR) | 04/07/2007 | 20/03/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Ireland;Greece;Latvia | |||
| 1021 | EUCTR2006-002633-20-FR (EUCTR) | 04/07/2007 | 11/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 1022 | NCT00467584 (ClinicalTrials.gov) | July 2007 | 26/4/2007 | Aspirin for Treatment of Multiple Sclerosis-Related Fatigue | Aspirin for Treatment of Multiple Sclerosis-Related Fatigue | Multiple Sclerosis;Fatigue | Drug: High Dose Aspirin (1300 mg/day);Drug: Low Dose Aspirin (162 mg/day);Drug: Placebo | Mayo Clinic | National Multiple Sclerosis Society | Terminated | 18 Years | 65 Years | All | 62 | Phase 3 | United States |
| 1023 | EUCTR2004-002571-16-GB (EUCTR) | 29/06/2007 | 22/02/2005 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | Secondary progressive multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Dirucotide acetate Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Estonia;Finland;Spain;Lithuania;Denmark;Latvia;Netherlands;United Kingdom;Sweden | |||
| 1024 | EUCTR2006-002204-33-GB (EUCTR) | 18/06/2007 | 26/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 1025 | EUCTR2006-003134-14-DE (EUCTR) | 04/06/2007 | 08/02/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Spain;Italy | |||
| 1026 | NCT00451451 (ClinicalTrials.gov) | June 2007 | 21/3/2007 | Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: BG00012;Drug: Placebo;Drug: Glatiramer Acetate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 1417 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Costa Rica;Croatia;Czech Republic;Estonia;France;Germany;Greece;India;Ireland;Israel;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;New Zealand;Poland;Puerto Rico;Romania;Serbia;Slovakia;Spain;Ukraine;Australia;Italy;Kazakhstan;Lithuania;Russian Federation |
| 1027 | NCT00480181 (ClinicalTrials.gov) | June 2007 | 28/5/2007 | Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis | A Comparative, Single Center, Randomized, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Nabilone (Cesamet) as Adjunctive Therapy to Gabapentin (Neurontin) in the Management of Neuropathic Pain (NPP) Symptoms in Subjects With Multiple Sclerosis (MS) | Neuropathic Pain;Multiple Sclerosis | Drug: nabilone;Other: placebo | University of Manitoba | Valeant Pharmaceuticals International, Inc. | Completed | 18 Years | 65 Years | Both | 50 | Phase 4 | Canada |
| 1028 | NCT00468611 (ClinicalTrials.gov) | June 2007 | 1/5/2007 | Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis | A Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive | Drug: MBP8298 | BioMS Technology Corp. | NULL | Terminated | 18 Years | 65 Years | Both | 510 | Phase 3 | United States |
| 1029 | NCT00488839 (ClinicalTrials.gov) | June 2007 | 18/6/2007 | IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis | Multiple Sclerosis | Drug: IPX056 20 mg;Drug: IPX056 40 mg;Drug: Encapsulated Baclofen 20 mg;Drug: Placebo Baclofen Tablet;Drug: IPX056 10 mg;Drug: IPX056 30 mg;Drug: IPX056 35 mg;Drug: Placebo IPX056 20 mg;Drug: Placebo IPX056 40 mg | Impax Laboratories, LLC | NULL | Completed | 18 Years | N/A | All | 173 | Phase 3 | United States;Canada;Estonia;Latvia;Ukraine |
| 1030 | NCT00959218 (ClinicalTrials.gov) | June 2007 | 13/8/2009 | Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis | Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain | Central Neuropathic Pain in Multiple Sclerosis | Drug: Dronabinol;Drug: Placebo | Bionorica Research GmbH | NULL | Completed | 18 Years | 70 Years | Both | 240 | Phase 3 | Germany |
| 1031 | EUCTR2006-002982-38-PT (EUCTR) | 29/05/2007 | 22/02/2007 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 1032 | EUCTR2004-004519-43-DE (EUCTR) | 29/05/2007 | 09/02/2007 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United Kingdom;Czech Republic;Germany;Spain | ||
| 1033 | EUCTR2007-000236-16-EE (EUCTR) | 28/05/2007 | 16/03/2007 | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | Established Spasticity Resulting from Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity | Product Code: IPX056-40 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-35 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-30 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-20 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-10 mg INN or Proposed INN: BACLOFEN Trade Name: baclofen Product Name: baclofen Product Code: baclofen 20 mg INN or Proposed INN: BACLOFEN | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Estonia;Latvia | |||
| 1034 | EUCTR2006-003361-14-IT (EUCTR) | 23/05/2007 | 07/03/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D Product Name: teriflunomide Product Code: HMR1726D | sanofi-aventis recherche de veloppement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 1035 | EUCTR2004-000555-42-CZ (EUCTR) | 14/05/2007 | 09/03/2007 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis U.S Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United Kingdom;Czech Republic;Denmark;Estonia;Norway;Italy;Sweden | |||
| 1036 | EUCTR2005-000365-19-LT (EUCTR) | 11/05/2007 | 27/03/2007 | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720 Product Name: FTY720 Product Code: FTY720 | NovartisPharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Sweden;Lithuania | |||
| 1037 | EUCTR2006-002982-38-GR (EUCTR) | 08/05/2007 | 29/12/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 1038 | EUCTR2006-002204-33-ES (EUCTR) | 04/05/2007 | 05/03/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas. | Relapsing forms of multiple slerosisEsclerosis multiple (EM) con recaidas MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | France;Hungary;Finland;Belgium;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 1039 | NCT00489489 (ClinicalTrials.gov) | May 2007 | 20/6/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-beta in Subjects With Multiple Sclerosis. | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for Teriflunomide);Drug: Interferon-ß | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 118 | Phase 2 | United States;Canada;Germany;Italy;Spain;Poland |
| 1040 | NCT00483652 (ClinicalTrials.gov) | May 2007 | 6/6/2007 | Study of Fampridine-SR Tablets in Multiple Sclerosis Patients | Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 240 | Phase 3 | United States;Canada |
| 1041 | NCT00484536 (ClinicalTrials.gov) | May 2007 | 8/6/2007 | Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323 | Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323. | Multiple Sclerosis | Drug: CDP323;Drug: placebo | UCB Pharma | Biogen Idec | Terminated | 18 Years | 55 Years | Both | 232 | Phase 2 | United States;Belgium;Canada;Finland;France;Germany;Hungary;Netherlands;Spain;Sweden;United Kingdom |
| 1042 | EUCTR2005-000365-19-EE (EUCTR) | 26/04/2007 | 01/03/2007 | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | Remitting-relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720 Product Name: FTY720 Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1043 | EUCTR2006-002204-33-SE (EUCTR) | 20/04/2007 | 26/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 1044 | EUCTR2006-002204-33-NL (EUCTR) | 16/04/2007 | 31/10/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 1045 | EUCTR2006-003697-10-CZ (EUCTR) | 13/04/2007 | 23/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 1046 | EUCTR2006-003696-12-CZ (EUCTR) | 13/04/2007 | 23/02/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Germany;United Kingdom;Czech Republic;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 1047 | EUCTR2006-002204-33-FI (EUCTR) | 05/04/2007 | 20/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 1048 | NCT00475865 (ClinicalTrials.gov) | April 2007 | 18/5/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 123 | Phase 2 | United States;Austria;Canada;Germany;Italy;United Kingdom |
| 1049 | EUCTR2005-000365-19-IE (EUCTR) | 30/03/2007 | 18/01/2007 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1050 | EUCTR2006-002633-20-IT (EUCTR) | 26/03/2007 | 05/02/2007 | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | |||
| 1051 | EUCTR2004-004519-43-SK (EUCTR) | 20/03/2007 | 13/02/2007 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Slovakia;Spain;Germany;United Kingdom | ||
| 1052 | EUCTR2006-004893-29-AT (EUCTR) | 19/03/2007 | 08/03/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;United Kingdom;Italy;Austria | |||
| 1053 | EUCTR2006-002982-38-DE (EUCTR) | 16/03/2007 | 10/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 1054 | EUCTR2006-002982-38-EE (EUCTR) | 15/03/2007 | 31/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 1055 | EUCTR2005-000365-19-GR (EUCTR) | 13/03/2007 | 02/10/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1056 | EUCTR2004-004519-43-GB (EUCTR) | 07/03/2007 | 08/07/2005 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Germany;Czech Republic;United Kingdom;Spain | ||
| 1057 | EUCTR2006-004736-79-CZ (EUCTR) | 06/03/2007 | 17/10/2006 | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo. | Product Name: ATL1102 Product Code: ATL1102 | Antisense Therapeutics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Czech Republic | |||
| 1058 | EUCTR2006-003696-12-BE (EUCTR) | 02/03/2007 | 05/12/2006 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 1059 | EUCTR2006-002204-33-BE (EUCTR) | 02/03/2007 | 08/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 1060 | EUCTR2006-003361-14-DE (EUCTR) | 01/03/2007 | 28/12/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 1061 | NCT00451204 (ClinicalTrials.gov) | March 2007 | 22/3/2007 | A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) | A Combination Trial of Copaxone Plus Estriol in RRMS | Relapsing Remitting Multiple Sclerosis | Drug: Estriol;Drug: Placebo;Drug: Copaxone | University of California, Los Angeles | Washington University School of Medicine;University of Texas Southwestern Medical Center;Ohio State University;University of Medicine and Dentistry of New Jersey;University of Chicago;University of Utah;Johns Hopkins University;University of Kansas Medical Center;University of Minnesota, MN;Mayo Clinic;University of Colorado, Aurora;University of New Mexico;University of Pennsylvania;Dartmouth-Hitchcock Medical Center;National Multiple Sclerosis Society;National Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 50 Years | Female | 158 | Phase 2 | United States;Canada |
| 1062 | EUCTR2006-003134-14-ES (EUCTR) | 23/02/2007 | 26/10/2009 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | Multiple sclerosis.Esclerosis Múltiple. | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Spain;Germany;Italy | ||
| 1063 | EUCTR2006-002856-14-DE (EUCTR) | 21/02/2007 | 07/11/2006 | Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis. | Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis. | Secondary progressive or progressive relapsing multiple sclerosis with signs of disease activity in terms of inflammation MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Trade Name: Ovastat 1000 INN or Proposed INN: TREOSULFAN Trade Name: Ovastat 5000 INN or Proposed INN: TREOSULFAN | medac Gesellschaft für klinische Spezialpräparate mbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 1064 | EUCTR2006-003366-33-ES (EUCTR) | 13/02/2007 | 03/03/2010 | Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa | Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa | Pacientes con esclerosis múltiple activa MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: not applicable Product Name: Interferon beta-1a FBS-free/HSA free, RNF Product Code: Not applicable Trade Name: not applicable Product Name: cladribina oral Product Code: not applicable INN or Proposed INN: cladribine | Serono International, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Spain;Italy | ||
| 1065 | NCT00501696 (ClinicalTrials.gov) | February 2007 | 12/7/2007 | A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone | A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone on Quality of Life as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI54) | Multiple Sclerosis | Drug: 4.5 mg Naltrexone;Drug: Naltrexone | University of California, San Francisco | NULL | Completed | 18 Years | 86 Years | Both | 80 | Phase 3 | United States |
| 1066 | EUCTR2006-002633-20-GB (EUCTR) | 25/01/2007 | 10/02/2012 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 1067 | EUCTR2005-000365-19-HU (EUCTR) | 25/01/2007 | 22/09/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Finland;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1068 | EUCTR2006-003361-14-GB (EUCTR) | 23/01/2007 | 29/09/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 1069 | EUCTR2006-004736-79-SK (EUCTR) | 19/01/2007 | 17/10/2006 | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo. | Product Name: ATL1102 Product Code: ATL1102 | Antisense Therapeutics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Slovakia | ||
| 1070 | EUCTR2006-004255-38-DE (EUCTR) | 17/01/2007 | 20/02/2007 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Austria;Germany | |||
| 1071 | EUCTR2006-004255-38-DK (EUCTR) | 15/01/2007 | 18/12/2006 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Austria;Denmark;Germany | ||
| 1072 | EUCTR2006-002982-38-SK (EUCTR) | 12/01/2007 | 06/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 1073 | EUCTR2006-004255-38-AT (EUCTR) | 05/01/2007 | 06/11/2006 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 16.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852 | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Austria;Germany | |||
| 1074 | EUCTR2006-002982-38-FR (EUCTR) | 05/01/2007 | 24/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 1075 | NCT00423527 (ClinicalTrials.gov) | January 2007 | 16/1/2007 | Levetiracetam in Central Pain in Multiple Sclerosis(MS) | Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis | Multiple Sclerosis | Drug: levetiracetam | Odense University Hospital | NULL | Completed | 18 Years | N/A | Both | 30 | Phase 4 | Denmark |
| 1076 | NCT00420212 (ClinicalTrials.gov) | January 2007 | 8/1/2007 | Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: BG00012;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 55 Years | All | 1234 | Phase 3 | United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czech Republic;France;Germany;Greece;Guatemala;India;Israel;Italy;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Serbia;Slovakia;South Africa;Switzerland;Ukraine;United Kingdom;Virgin Islands (U.S.);Belarus;Bulgaria;Kazakhstan;Russian Federation;Sweden;Turkey |
| 1077 | NCT00457730 (ClinicalTrials.gov) | January 2007 | 4/4/2007 | A Study to Test the Use of Duloxetine for Pain in MS | A Randomized Placebo Controlled Trial of Duloxetine for Central Pain in Multiple Sclerosis | Multiple Sclerosis | Drug: Duloxetine;Drug: Placebo | Brown, Theodore R., M.D., MPH | Eli Lilly and Company | Completed | 18 Years | N/A | All | 38 | Phase 2/Phase 3 | United States |
| 1078 | NCT00414453 (ClinicalTrials.gov) | January 2007 | 19/12/2006 | Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis | Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS) | Neuropathic Pain;Chronic Pain;Multiple Sclerosis | Drug: Lidocaine patch 5%;Drug: Extended-release oxycodone;Drug: Placebo extended-release oxycodone pills;Drug: Placebo lidocaine patches | University of Rochester | Endo Pharmaceuticals | Terminated | 18 Years | N/A | All | 19 | Phase 4 | United States |
| 1079 | EUCTR2006-002982-38-DK (EUCTR) | 20/12/2006 | 30/11/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece | ||
| 1080 | EUCTR2006-003361-14-FI (EUCTR) | 19/12/2006 | 10/11/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1081 | EUCTR2006-002982-38-FI (EUCTR) | 19/12/2006 | 19/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 1082 | EUCTR2005-005265-11-FR (EUCTR) | 14/12/2006 | 27/10/2006 | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. | Relief of central neuropathic pain in subjects with multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 3 | France;Czech Republic;United Kingdom | ||
| 1083 | EUCTR2006-002982-38-ES (EUCTR) | 13/12/2006 | 10/03/2010 | Ensayo clínico multicéntrico en Fase III, randomizado, doble-ciego, controlado con placebo, de Rebif New Formulation (44 mcg tres veces por semana y 44 mcg una vez por semana) en pacientes con alto riesgo de conversión a esclerosis múltiple.A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Ensayo clínico multicéntrico en Fase III, randomizado, doble-ciego, controlado con placebo, de Rebif New Formulation (44 mcg tres veces por semana y 44 mcg una vez por semana) en pacientes con alto riesgo de conversión a esclerosis múltiple.A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: REBIF 44 microgramos solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 1084 | EUCTR2006-002633-20-FI (EUCTR) | 05/12/2006 | 04/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 1085 | EUCTR2006-002982-38-AT (EUCTR) | 04/12/2006 | 29/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 1086 | EUCTR2006-002633-20-ES (EUCTR) | 01/12/2006 | 13/04/2012 | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Esclerosis múltiple remitente-recurrente MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline S.A | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand | ||
| 1087 | NCT00411723 (ClinicalTrials.gov) | December 2006 | 12/12/2006 | Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis | Phase 1 Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis | Multiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Relapsing-Remitting | Drug: RTL1000 (recombinant T cell receptor ligand);Drug: RTL1000 Placebo | Artielle ImmunoTherapeutics | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 34 | Phase 1 | United States |
| 1088 | NCT00441103 (ClinicalTrials.gov) | December 2006 | 26/2/2007 | A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis | A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif® New Formulation (IFN-beta-1a, RNF);Drug: Placebo | Merck KGaA | NULL | Completed | 18 Years | 60 Years | All | 180 | Phase 3 | Canada;Germany;Italy;Russian Federation;Spain;Switzerland |
| 1089 | NCT00594087 (ClinicalTrials.gov) | December 2006 | 3/1/2008 | Eszopiclone for Improving Sleep in Multiple Sclerosis (MS) | Eszopiclone for Improving Sleep Continuity in MS Patients With Sleep Disturbances and Its Impact on Daytime Fatigue | Relapsing Remitting Multiple Sclerosis;Sleep Initiation and Maintenance Disorders;Fatigue | Drug: eszopiclone;Other: placebo | University of Vermont | NULL | Completed | 18 Years | 64 Years | Both | 30 | N/A | United States |
| 1090 | NCT00395317 (ClinicalTrials.gov) | December 2006 | 1/11/2006 | Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS) | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Other: Placebo;Drug: Firategrast 150 mg;Drug: Firategrast 300 mg | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 343 | Phase 2 | Australia;Austria;Canada;Finland;France;Germany;Italy;Netherlands;New Zealand;Norway;Poland;Russian Federation;Spain;United Kingdom;Lithuania |
| 1091 | EUCTR2006-001161-42-CZ (EUCTR) | 30/11/2006 | 25/08/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Germany;United Kingdom;Sweden | |||
| 1092 | NCT00436826 (ClinicalTrials.gov) | November 30, 2006 | 15/2/2007 | A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD) | A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-ß) Treatment in Multiple Sclerosis Subjects With Active Disease | Multiple Sclerosis | Drug: Cladribine;Drug: Placebo;Drug: Interferon-beta (IFN-beta) | EMD Serono Research & Development Institute, Inc. | NULL | Completed | 18 Years | 65 Years | All | 172 | Phase 2 | United States;Italy;Russian Federation;Spain |
| 1093 | EUCTR2006-002982-38-BE (EUCTR) | 29/11/2006 | 14/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 1094 | EUCTR2006-003361-14-AT (EUCTR) | 21/11/2006 | 10/10/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 1095 | EUCTR2006-002633-20-NL (EUCTR) | 17/11/2006 | 10/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 1096 | EUCTR2006-002982-38-IT (EUCTR) | 09/11/2006 | 04/12/2006 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation 44 mcg tiw and 44 mcg ow in subjects at high risk of converting to Multiple Sclerosis - REFLEX | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation 44 mcg tiw and 44 mcg ow in subjects at high risk of converting to Multiple Sclerosis - REFLEX | clinically isolated syndrome suggestive of multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Interferon beta-1a FBS-free/HSA-free, RNF INN or Proposed INN: Interferon beta-1a | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 1097 | EUCTR2006-002982-38-CZ (EUCTR) | 03/11/2006 | 15/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 1098 | NCT00404352 (ClinicalTrials.gov) | November 2006 | 27/11/2006 | REbif FLEXible Dosing in Early Multiple Sclerosis (MS) | A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Microgram [Mcg] Three Times Weekly [Tiw] and 44 Mcg Once Weekly [ow]) in Subjects at High Risk of Converting to Multiple Sclerosis (REFLEX) | Multiple Sclerosis | Drug: RNF;Drug: Placebo | Merck KGaA | NULL | Completed | 18 Years | 50 Years | All | 517 | Phase 3 | Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czech Republic;Estonia;Finland;France;Germany;Greece;Israel;Italy;Latvia;Lebanon;Morocco;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Turkey;Denmark;Switzerland |
| 1099 | NCT00869986 (ClinicalTrials.gov) | November 2006 | 24/3/2009 | A Study for Patients With Relapsing Remitting Multiple Sclerosis | A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: dirucotide;Drug: placebo | Eli Lilly and Company | BioMS Technology Corp. | Completed | 18 Years | 50 Years | Both | 218 | Phase 2/Phase 3 | Bulgaria;Poland;Russian Federation;Serbia;Slovakia;Ukraine |
| 1100 | NCT00529581 (ClinicalTrials.gov) | November 2006 | 12/9/2007 | A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of C105 in Persons With Multiple Sclerosis With Cognitive Impairment | Cognition Disorders;Multiple Sclerosis | Drug: C105 | Cognition Pharmaceuticals, LLC | NULL | Completed | 18 Years | 65 Years | Both | 150 | Phase 2 | United States |
| 1101 | EUCTR2006-002633-20-DE (EUCTR) | 25/10/2006 | 23/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy | |||
| 1102 | EUCTR2005-005265-11-CZ (EUCTR) | 17/10/2006 | 24/08/2006 | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects. | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects. | Relief of central neuropathic pain in subjects with multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 312 | United Kingdom;Czech Republic;France | |||
| 1103 | EUCTR2006-001161-42-SE (EUCTR) | 17/10/2006 | 29/05/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable | Multiple sclerosis (MS) | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 232 | Hungary;Germany;United Kingdom;Sweden | |||
| 1104 | EUCTR2006-002633-20-AT (EUCTR) | 05/10/2006 | 14/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 1105 | NCT00803049 (ClinicalTrials.gov) | October 2006 | 1/12/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide (HMR1726) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 742 | Phase 3 | United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 1106 | EUCTR2004-002571-16-EE (EUCTR) | 28/09/2006 | 09/06/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | Secondary progressive multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Dirucotide acetate Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Lithuania;Sweden | |||
| 1107 | EUCTR2004-002571-16-LT (EUCTR) | 27/09/2006 | 01/08/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/A | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/A | Secondary progressive multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Not Known Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Sweden;Lithuania | |||
| 1108 | EUCTR2005-005985-35-CZ (EUCTR) | 22/09/2006 | 02/08/2006 | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | Relapsing forms of Multiple Sclerosis MedDRA version: 8.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BIRT 2584 XX Product Code: BIRT 2584 XX | Boehringer Ingelheim Ltd | NULL | Not Recruiting | Female: yes Male: yes | 320 | Czech Republic;Netherlands;Italy | |||
| 1109 | EUCTR2006-001947-70-SK (EUCTR) | 14/09/2006 | 08/08/2006 | A Double Blind, Placebo Controlled Multi-Center Pilot Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis | A Double Blind, Placebo Controlled Multi-Center Pilot Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp. | NULL | Not Recruiting | Female: yes Male: yes | 215 | Phase 2 | Slovakia | ||
| 1110 | EUCTR2005-005985-35-IT (EUCTR) | 05/09/2006 | 15/01/2007 | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. - ND | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. - ND | relapsing forms of multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Code: BIRT 2584XX Product Code: BIRT 2584 XX | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Czech Republic;Netherlands;Italy | |||
| 1111 | NCT00391079 (ClinicalTrials.gov) | September 2006 | 20/10/2006 | Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS | A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex When Added to the Existing Treatment Regimen, in the Relief of Central Neuropathic Pain in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 339 | Phase 3 | Canada |
| 1112 | NCT00261326 (ClinicalTrials.gov) | September 2006 | 2/12/2005 | Simvastatin Treatment of Patients With Acute Optic Neuritis | Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial | Optic Neuritis;Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Glostrup University Hospital, Copenhagen | Alpharma ApS | Active, not recruiting | 18 Years | 59 Years | Both | 64 | Phase 3 | Denmark |
| 1113 | EUCTR2006-001161-42-GB (EUCTR) | 29/08/2006 | 15/05/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 2 | Czech Republic;Hungary;Germany;United Kingdom;Sweden | ||
| 1114 | EUCTR2005-005985-35-NL (EUCTR) | 29/08/2006 | 05/07/2006 | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | Relapsing forms of Multiple Sclerosis MedDRA version: 8.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BIRT 2584 XX Product Code: BIRT 2584 XX | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Czech Republic;Netherlands | ||
| 1115 | EUCTR2005-005592-14-DE (EUCTR) | 27/07/2006 | 12/05/2006 | Double blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision Protect | Double blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision Protect | Multiple sclerosis (MS) is a chronic disease of the central nervous system.Optic neuritis represents one of the most common and frequently the first clinical manifestation of MS. Optic neuritis is mainly characterized by a subacute loss of vision. | Trade Name: Erypo/Erypo FS Product Name: Erypo/Erypo FS INN or Proposed INN: Epoetin alfa Other descriptive name: Epo Trade Name: Urbason solubile forte 1000mg Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolon-21-hydrogensuccinat, Natriumsalz | IFSgGmbH, Institute for clinical research | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 1116 | EUCTR2004-002571-16-LV (EUCTR) | 21/07/2006 | 24/08/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/A | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/A | Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Not known Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Lithuania;Sweden | |||
| 1117 | EUCTR2004-002571-16-ES (EUCTR) | 20/07/2006 | 09/06/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. | Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Phase 2;Phase 3 | Estonia;Finland;Spain;Lithuania;Denmark;Latvia;Netherlands;United Kingdom;Sweden | ||
| 1118 | EUCTR2004-005148-28-LT (EUCTR) | 18/07/2006 | 02/05/2006 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 1119 | EUCTR2005-000365-19-FI (EUCTR) | 14/07/2006 | 16/06/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1120 | NCT00501943 (ClinicalTrials.gov) | July 2006 | 12/7/2007 | Neuroprotection With Riluzole Patients With Early Multiple Sclerosis | Neuroprotection With Riluzole in Patients With Early Multiple Sclerosis | Multiple Sclerosis | Drug: Avonex (Interferon beta 1a);Drug: Riluzole;Drug: Placebo | University of California, San Francisco | National Multiple Sclerosis Society;Oregon Health and Science University | Completed | 18 Years | 55 Years | All | 43 | Phase 2 | United States |
| 1121 | NCT00638027 (ClinicalTrials.gov) | July 2006 | 10/3/2008 | Memantine for Spasticity in MS Patients | Memantine for Spasticity in MS Patients | Multiple Sclerosis | Drug: placebo;Drug: memantine | University of Rochester | Forest Laboratories | Completed | 18 Years | 70 Years | All | 21 | Phase 4 | United States |
| 1122 | EUCTR2005-001567-55-DE (EUCTR) | 23/06/2006 | 29/07/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United Kingdom;Germany;Spain | ||
| 1123 | EUCTR2005-000365-19-SK (EUCTR) | 23/06/2006 | 05/05/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | Estonia;Hungary;Czech Republic;Slovakia;Greece;Finland;Ireland;Lithuania;Germany;United Kingdom;Sweden | ||
| 1124 | EUCTR2004-002571-16-NL (EUCTR) | 12/06/2006 | 05/07/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/A | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/A | Secondary progressive multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Not known Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Lithuania;Sweden | |||
| 1125 | EUCTR2004-005148-28-LV (EUCTR) | 05/06/2006 | 11/01/2007 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 1126 | EUCTR2004-005148-28-SK (EUCTR) | 01/06/2006 | 25/04/2006 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom | ||
| 1127 | NCT00342381 (ClinicalTrials.gov) | June 2006 | 20/6/2006 | Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation | Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation | Multiple Sclerosis;Fatigue | Drug: 3,4-diaminopyridine;Drug: Placebo | University of Aarhus | The Danish Multiple Sclerosis Society | Completed | 18 Years | 55 Years | Both | 120 | Phase 2 | Denmark |
| 1128 | NCT00355134 (ClinicalTrials.gov) | June 2006 | 19/7/2006 | Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase | Multiple Sclerosis | Drug: Fingolimod;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1083 | Phase 3 | United States;Australia;Austria;Canada;Poland;Romania;Turkey;United Kingdom;Lithuania |
| 1129 | NCT00552604 (ClinicalTrials.gov) | June 2006 | 1/11/2007 | MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study | Randomised, Double-blind, Placebo-controlled Phase III Trial to Determine the Efficacy and Safety of a Standardised Oral Extract of Cannabis Sativa for the Symptomatic Relief of Muscle Stiffness and Pain in Multiple Sclerosis. | Muscle Spasticity | Drug: standardized cannabis extract;Drug: Placebo | Institut fur Klinische Forschung, Germany | Weleda AG | Terminated | 18 Years | 64 Years | Both | 279 | Phase 3 | United Kingdom |
| 1130 | EUCTR2004-002571-16-DK (EUCTR) | 31/05/2006 | 18/04/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | Secondary progressive multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Dirucotide acetate Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Lithuania;Sweden | |||
| 1131 | EUCTR2006-000397-71-DK (EUCTR) | 16/05/2006 | 02/05/2006 | Double-blind, randomised, placebo-controlled trial of levetiracetam for central neuropathic pain in patients with multiple sclerosis - levetiracetam for central neuropathic pain in patients with multiple sclerosis | Double-blind, randomised, placebo-controlled trial of levetiracetam for central neuropathic pain in patients with multiple sclerosis - levetiracetam for central neuropathic pain in patients with multiple sclerosis | Trade Name: Keppra Product Name: Levetiracetam Product Code: ucb L059 | Søren H. Sindrup, Department of Neurology, Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 30 | Denmark | ||||
| 1132 | EUCTR2005-000365-19-DE (EUCTR) | 03/05/2006 | 25/01/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Hungary;Finland;Czech Republic;United Kingdom;Germany;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1133 | NCT00245622 (ClinicalTrials.gov) | May 2006 | 20/10/2005 | Autologous T Cell Vaccine (TCV) for Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS | Relapsing-Remitting Multiple Sclerosis | Biological: Tovaxin Autologous T cell vaccine;Biological: Placebo | Opexa Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 150 | Phase 2 | United States |
| 1134 | EUCTR2004-002571-16-FI (EUCTR) | 19/04/2006 | 27/02/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | Secondary progressive multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Dirucotide acetate Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Lithuania;Sweden | |||
| 1135 | EUCTR2005-005265-11-GB (EUCTR) | 03/04/2006 | 24/02/2006 | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects | Relief of central neuropathic pain in subjects with multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;United Kingdom | ||
| 1136 | EUCTR2005-000365-19-CZ (EUCTR) | 02/02/2006 | 11/01/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;United Kingdom;Czech Republic;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1137 | NCT01134627 (ClinicalTrials.gov) | February 2006 | 28/5/2010 | Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS] | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Minocycline;Drug: Placebo | Merck KGaA | NULL | Terminated | 18 Years | 55 Years | All | 305 | Phase 2 | Denmark |
| 1138 | NCT00382629 (ClinicalTrials.gov) | February 2006 | 27/9/2006 | BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis | BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BHT-3009 0.5 mg;Drug: BHT-3009 1.5 mg;Drug: Placebo | Bayhill Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 252 | Phase 2 | NULL |
| 1139 | NCT00492765 (ClinicalTrials.gov) | February 2006 | 25/6/2007 | Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment IM Administered Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: Simvastatin;Drug: Placebo | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 380 | Phase 4 | Denmark |
| 1140 | EUCTR2005-005263-29-GB (EUCTR) | 31/01/2006 | 09/12/2005 | Multiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. - MUSEC study | Multiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. - MUSEC study | Multiple Sclerosis | Product Name: Cannador | Gesellschaft fuer klinische Forschung e.V. (Society for Clinical Research) | WELEDA AG | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 1141 | EUCTR2005-004289-18-FI (EUCTR) | 26/01/2006 | 07/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 1142 | EUCTR2004-000555-42-PT (EUCTR) | 26/01/2006 | 04/11/2005 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Aventis Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 870 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 1143 | EUCTR2005-003930-16-SE (EUCTR) | 19/01/2006 | 21/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 1144 | EUCTR2005-003930-16-FI (EUCTR) | 05/01/2006 | 29/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who have been prescribed treatment with Avonex. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Trade Name: Simvastatin Alternova Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 1145 | EUCTR2005-004289-18-SE (EUCTR) | 04/01/2006 | 10/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 1146 | NCT00289978 (ClinicalTrials.gov) | January 2006 | 9/2/2006 | Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1272 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Finland;France;Germany;Greece;Israel;Lithuania;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom;Italy |
| 1147 | NCT00280592 (ClinicalTrials.gov) | January 2006 | 20/1/2006 | Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients | Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients. | Multiple Sclerosis;Urinary Tract Infections;Bladder Dysfunction | Drug: Cranberry;Drug: Placebo | Rennes University Hospital | Pierre Fabre Laboratories;Ministry of Health, France | Completed | 18 Years | 70 Years | Both | 171 | Phase 3 | France |
| 1148 | EUCTR2005-004289-18-DK (EUCTR) | 19/12/2005 | 28/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | E. Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Denmark;Sweden | |||
| 1149 | EUCTR2005-000365-19-SE (EUCTR) | 19/12/2005 | 02/11/2005 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 1150 | EUCTR2005-001567-55-GB (EUCTR) | 14/12/2005 | 24/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 1151 | EUCTR2004-000555-42-DK (EUCTR) | 12/12/2005 | 23/01/2008 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 1152 | EUCTR2005-003930-16-DK (EUCTR) | 09/12/2005 | 05/12/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Denmark;Sweden | |||
| 1153 | NCT00745615 (ClinicalTrials.gov) | December 7, 2005 | 2/9/2008 | An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease | An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL) | Relapsing Remitting Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo | Teva Pharmaceutical Industries, Ltd. | NULL | Terminated | 18 Years | 50 Years | All | 257 | Phase 2 | Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic |
| 1154 | EUCTR2004-005148-28-AT (EUCTR) | 22/11/2005 | 18/10/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Czech Republic;Estonia;Finland;Lithuania;Denmark;Austria;Latvia;Germany;Italy;United Kingdom | ||
| 1155 | EUCTR2005-003410-15-SE (EUCTR) | 21/11/2005 | 29/09/2005 | A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MS | A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MS | Multiple sclerosis is a devastating inflammation in the central nervous system and it can often give cognitive dysfunction, affecting memory, mental concentration. Lately it has been shown that the cognitive dysfunction has a big impact on life quality. Immunomodulatory medication can only partially limit the bouts but there is no effective cure at the moment. There is little options to treat the effects on higher functions for the moment. | Trade Name: Aricept 5 mg filmdragerade tabletter Product Name: Aricept 5 mg INN or Proposed INN: Donepezil Trade Name: Aricept 10 mg filmdragerade tabletter Product Name: Aricept 10 mg INN or Proposed INN: Donepezil | Neurology Unit | NULL | Not Recruiting | Female: yes Male: yes | 20 | Sweden | |||
| 1156 | EUCTR2004-005148-28-DE (EUCTR) | 17/11/2005 | 16/05/2006 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International, a branch of Laboratories Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 1157 | EUCTR2004-005148-28-GB (EUCTR) | 28/10/2005 | 20/04/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International, a branch of Laboratoires Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom | ||
| 1158 | EUCTR2005-001567-55-ES (EUCTR) | 18/10/2005 | 05/09/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 1159 | EUCTR2005-001567-55-AT (EUCTR) | 27/09/2005 | 23/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 1160 | EUCTR2004-005148-28-EE (EUCTR) | 09/09/2005 | 31/05/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 1161 | EUCTR2004-005148-28-IT (EUCTR) | 08/09/2005 | 21/07/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral cladribine in subjects with relapsing remitting multiple sclerosis | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral cladribine in subjects with relapsing remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: cladribine Product Code: NA INN or Proposed INN: Cladribine | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Czech Republic;Estonia;Finland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Italy | ||
| 1162 | NCT01074619 (ClinicalTrials.gov) | September 2005 | 12/9/2005 | Study on Cognitive Disorders of Multiple Sclerosis | Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Memantine;Drug: Placebo | University Hospital, Caen | Ministry of Health, France;H. Lundbeck A/S | Completed | 18 Years | 60 Years | Both | 90 | Phase 3 | France |
| 1163 | NCT00754832 (ClinicalTrials.gov) | September 2005 | 16/9/2008 | American Ginseng Treatment for Multiple Sclerosis Related Fatigue | A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue | Multiple Sclerosis | Drug: American ginseng extract HT-1001;Drug: placebo | Oregon Health and Science University | National Multiple Sclerosis Society | Completed | 18 Years | 70 Years | All | 56 | Phase 2 | United States |
| 1164 | EUCTR2004-002571-16-SE (EUCTR) | 15/08/2005 | 21/06/2005 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01 | Secondary progressive multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 INN or Proposed INN: Dirucotide acetate Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Lithuania;Sweden | |||
| 1165 | EUCTR2004-005148-28-CZ (EUCTR) | 14/07/2005 | 15/06/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;United Kingdom;Czech Republic;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 1166 | NCT00122954 (ClinicalTrials.gov) | July 2005 | 20/7/2005 | Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis | Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis | Multiple Sclerosis;Depression | Drug: Fish oil concentrate;Drug: Placebo | Oregon Health and Science University | National Center for Complementary and Integrative Health (NCCIH) | Completed | 18 Years | 85 Years | All | 39 | Phase 1/Phase 2 | United States |
| 1167 | EUCTR2004-005148-28-BE (EUCTR) | 14/06/2005 | 05/07/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Czech Republic;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom | ||
| 1168 | EUCTR2004-005148-28-DK (EUCTR) | 02/06/2005 | 09/05/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 1169 | NCT00127075 (ClinicalTrials.gov) | June 2005 | 4/8/2005 | POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis | POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis | Multiple Sclerosis | Drug: nomegestrol acetate;Drug: estradiol;Drug: placebo | Hospices Civils de Lyon | NULL | Active, not recruiting | 18 Years | 50 Years | Female | 300 | Phase 3 | France |
| 1170 | NCT00202397 (ClinicalTrials.gov) | June 2005 | 12/9/2005 | Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia | Phase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar Ataxia | Hereditary Ataxia;Multiple Sclerosis;Cerebellar Ataxia | Drug: Riluzole;Other: placebo | S. Andrea Hospital | NULL | Completed | 18 Years | 80 Years | Both | 40 | Phase 2 | Italy |
| 1171 | NCT01450488 (ClinicalTrials.gov) | June 2005 | 6/10/2011 | Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis | A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: masitinib | AB Science | NULL | Completed | 18 Years | 60 Years | All | 35 | Phase 2 | NULL |
| 1172 | EUCTR2004-005148-28-FI (EUCTR) | 26/05/2005 | 18/04/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 1173 | NCT00127530 (ClinicalTrials.gov) | May 2005 | 4/8/2005 | Study of Oral Fampridine-SR in Multiple Sclerosis | Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 300 | Phase 3 | United States;Canada |
| 1174 | NCT00094172 (ClinicalTrials.gov) | May 2005 | 14/10/2004 | Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin in Patients With Clinically Isolated Syndrome and High Risk of Conversion to Multiple Sclerosis (ITN020AI) | Multiple Sclerosis | Drug: Atorvastatin;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 55 Years | All | 82 | Phase 2 | United States;Canada |
| 1175 | EUCTR2004-003943-28-DE (EUCTR) | 06/04/2005 | 14/09/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
| 1176 | NCT00213135 (ClinicalTrials.gov) | April 2005 | 13/9/2005 | A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Cladribine 5.25 mg/kg;Drug: Cladribine 3.5 mg/kg;Other: Placebo | EMD Serono | NULL | Completed | 18 Years | 65 Years | All | 1326 | Phase 3 | Canada;Switzerland |
| 1177 | NCT00109161 (ClinicalTrials.gov) | April 2005 | 22/4/2005 | Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) | PDL BioPharma, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 270 | Phase 2 | United States;Canada |
| 1178 | NCT00668343 (ClinicalTrials.gov) | April 2005 | 27/4/2008 | Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo | Relapsing Remitting Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Tehran University of Medical Sciences | NULL | Completed | 15 Years | 60 Years | Both | 80 | Phase 3 | Iran, Islamic Republic of | |
| 1179 | EUCTR2004-003943-28-CZ (EUCTR) | 21/03/2005 | 09/02/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy | |||
| 1180 | EUCTR2004-002509-63-CZ (EUCTR) | 11/03/2005 | 04/02/2005 | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | Spasticity due to Multiple Sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Czech Republic | |||
| 1181 | NCT01599234 (ClinicalTrials.gov) | March 2005 | 10/5/2012 | A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis | A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis. | Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 337 | Phase 3 | United Kingdom |
| 1182 | NCT00349193 (ClinicalTrials.gov) | March 2005 | 26/6/2006 | A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod | A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects | Relapsing Remitting Multiple Sclerosis | Drug: laquinimod 0.3;Drug: laquinimod 0.6;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 306 | Phase 2 | Italy |
| 1183 | EUCTR2004-002509-63-GB (EUCTR) | 21/02/2005 | 23/02/2005 | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | Spasticity due to Multiple Sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 3 | Czech Republic;United Kingdom | ||
| 1184 | EUCTR2004-003943-28-GB (EUCTR) | 18/02/2005 | 22/02/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 1185 | EUCTR2004-003943-28-ES (EUCTR) | 17/02/2005 | 09/12/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy | ||
| 1186 | EUCTR2004-003761-33-ES (EUCTR) | 17/02/2005 | 25/01/2006 | Unicenter double-blind, cross-over, randomised, placebo controlled clinical trial to evaluate efficacy of vardenafil in subjects with E.D. and multiple sclerosis (M.S.) - EMDE | Unicenter double-blind, cross-over, randomised, placebo controlled clinical trial to evaluate efficacy of vardenafil in subjects with E.D. and multiple sclerosis (M.S.) - EMDE | Erectile Dysfunction | Trade Name: Levitra Product Name: Vardenafil (hidrocloride) INN or Proposed INN: VARDENAFILO HIDROCLORURO Trade Name: Levitra Product Name: Vardenafil (hidrocloride) INN or Proposed INN: VARDENAFILO HIDROCLORURO Trade Name: Levitra Product Name: Vardenafil (hidrocloride) INN or Proposed INN: VARDENAFILO HIDROCLORURO | Unidad de Neuroinmunología | NULL | Not Recruiting | Female: Male: yes | 28 | Phase 4 | Spain | ||
| 1187 | EUCTR2004-003943-28-HU (EUCTR) | 14/02/2005 | 13/12/2004 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 265 | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy | |||
| 1188 | NCT00190268 (ClinicalTrials.gov) | February 2005 | 13/9/2005 | Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis | Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis | Multiple Sclerosis | Drug: 3,4-diaminopyridine | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | 60 Years | Both | 126 | Phase 3 | France |
| 1189 | EUCTR2004-003943-28-IT (EUCTR) | 19/01/2005 | 02/02/2005 | A multinational,multicenter,randomized,double-blind,parallel-group,placebo-controlled study,to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R)multiple sclerosis (MS) subjects. | A multinational,multicenter,randomized,double-blind,parallel-group,placebo-controlled study,to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R)multiple sclerosis (MS) subjects. | relapsing remitting multiple sclerosis subjects with an active lesion on MRI MedDRA version: 6.1;Level: PT;Classification code 10048393 | Trade Name: CITOCHINE ED IMMUNOMODULATORI Product Name: LAQUINIMOD Product Code: ABR-215062 INN or Proposed INN: LAQUINIMOD | TEVA | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy | ||||
| 1190 | EUCTR2004-004519-43-CZ (EUCTR) | 12/01/2005 | 04/02/2005 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Germany;United Kingdom;Czech Republic;Spain | ||
| 1191 | EUCTR2004-000145-38-GB (EUCTR) | 11/01/2005 | 22/02/2005 | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | Relapse-remitting Multiple Sclerosis (RRMS) Classification code 10048393 | Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40 Product Code: CNTO 1275 Other descriptive name: Anti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Hungary;Czech Republic;United Kingdom | ||
| 1192 | NCT00211887 (ClinicalTrials.gov) | January 2005 | 13/9/2005 | Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx | A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) | Relapsing Remitting Multiple Sclerosis | Drug: Interferon beta 1-a;Drug: glatiramer acetate;Other: placebo | Fred Lublin | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 60 Years | All | 1008 | Phase 3 | United States;Canada |
| 1193 | NCT00203047 (ClinicalTrials.gov) | January 2005 | 13/9/2005 | Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate | A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA) | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Placebo;Drug: Prednisone | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 55 Years | All | 414 | Phase 4 | Canada;United States |
| 1194 | EUCTR2004-000555-42-IT (EUCTR) | 30/12/2004 | 23/11/2004 | A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | Multiple sclerosis with relapses MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: TERIFLUNOMIDE Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | sanofi-aventis Recherche & De`veloppement | NULL | Not Recruiting | Female: yes Male: yes | 870 | Portugal;Estonia;Czech Republic;Denmark;Norway;United Kingdom;Italy;Sweden | |||
| 1195 | EUCTR2004-000145-38-HU (EUCTR) | 14/12/2004 | 28/09/2004 | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | Relapse-remitting Multiple Sclerosis (RRMS) Classification code 10048393 | Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40 Product Code: CNTO 1275 Other descriptive name: Anti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Hungary;United Kingdom;Czech Republic | ||
| 1196 | EUCTR2004-000555-42-AT (EUCTR) | 02/12/2004 | 28/10/2004 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-Aventis US, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;United Kingdom;Italy;Sweden | |||
| 1197 | NCT00097188 (ClinicalTrials.gov) | December 2004 | 18/11/2004 | A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: rituximab | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 104 | Phase 2 | United States |
| 1198 | NCT00869726 (ClinicalTrials.gov) | December 2004 | 24/3/2009 | A Study for Patients With Secondary Progressive Multiple Sclerosis | A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: dirucotide;Drug: Placebo | Eli Lilly and Company | BioMS Technology Corp. | Completed | 18 Years | 65 Years | Both | 596 | Phase 2/Phase 3 | Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom |
| 1199 | NCT00200655 (ClinicalTrials.gov) | December 2004 | 12/9/2005 | Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis | Safety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled Study | Relapsing-remitting Multiple Sclerosis | Drug: Pravastatin;Drug: Placebo | Nantes University Hospital | NULL | Completed | 18 Years | 45 Years | Both | 40 | Phase 3 | France |
| 1200 | EUCTR2004-000555-42-NO (EUCTR) | 22/11/2004 | 27/09/2004 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 1201 | EUCTR2004-000555-42-SE (EUCTR) | 17/11/2004 | 29/09/2004 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 1202 | EUCTR2004-000145-38-CZ (EUCTR) | 16/11/2004 | 24/09/2004 | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | Relapse-remitting Multiple Sclerosis (RRMS) Classification code 10048393 | Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40 Product Code: CNTO 1275 Other descriptive name: Anti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Hungary;Czech Republic;United Kingdom | ||
| 1203 | EUCTR2004-000663-99-HU (EUCTR) | 08/11/2004 | 08/09/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 1204 | NCT00151294 (ClinicalTrials.gov) | November 2004 | 6/9/2005 | The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis | A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis | Depression;Multiple Sclerosis | Drug: escitalopram oxalate antidepressant | Weill Medical College of Cornell University | Forest Laboratories | Terminated | 18 Years | N/A | Both | 20 | Phase 4 | United States |
| 1205 | EUCTR2004-000663-99-CZ (EUCTR) | 12/10/2004 | 22/10/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Czech Republic;Sweden | |||
| 1206 | NCT00240032 (ClinicalTrials.gov) | October 2004 | 13/10/2005 | A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®. | A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe. | Multiple Sclerosis | Drug: glatiramer acetate injection with oral cetirizine hydrochloride;Drug: glatiramer acetate with placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | Both | 80 | Phase 4 | United States |
| 1207 | NCT00168701 (ClinicalTrials.gov) | October 2004 | 9/9/2005 | Efficacy and Safety of BG00012 in MS | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: BG00012 | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 260 | Phase 2 | Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Sweden;Switzerland;Turkey;United Kingdom |
| 1208 | EUCTR2005-000393-47-IT (EUCTR) | 22/09/2004 | 05/03/2007 | Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study. | Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study. | Treatment of spasticity in patients with Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Cannabis Based Medicine Extract (Sativex) | AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1209 | EUCTR2004-000663-99-SE (EUCTR) | 10/09/2004 | 03/08/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 1210 | EUCTR2004-000073-64-FI (EUCTR) | 03/09/2004 | 14/07/2004 | A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - - | A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - - | Aaltomainen MS-tauti | Product Code: L-000124467 | Merck & Co., Inc./Suomen MSD Oy | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Finland | ||
| 1211 | NCT00134563 (ClinicalTrials.gov) | September 2004 | 23/8/2005 | Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 1088 | Phase 3 | United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 1212 | NCT00097331 (ClinicalTrials.gov) | September 2004 | 22/11/2004 | Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: SB683699 | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 261 | Phase 2 | Belgium;Germany;Poland;Russian Federation;Spain;United States;Canada;France;Italy;Romania |
| 1213 | NCT00239655 (ClinicalTrials.gov) | August 2004 | 13/10/2005 | A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED) | A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRI | Relapsing-Remitting Multiple Sclerosis | Drug: MK0812 | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 55 Years | Both | 120 | Phase 2 | Canada;Finland;Germany;United Kingdom;United States |
| 1214 | NCT00207727 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis | A Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: CNTO 1275 | Centocor, Inc. | Centocor BV | Completed | 18 Years | 65 Years | All | 249 | Phase 2 | Australia;Canada;Czech Republic;Hungary;Poland;United Kingdom;United States |
| 1215 | NCT00223301 (ClinicalTrials.gov) | July 2004 | 19/9/2005 | Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis | A One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (cellcept) | University of Texas Southwestern Medical Center | Roche Pharma AG;Biogen Idec | Completed | 21 Years | 45 Years | Both | 24 | Phase 2/Phase 3 | United States |
| 1216 | EUCTR2004-000374-31-IT (EUCTR) | 09/06/2004 | 26/08/2004 | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Trade Name: ALTRI FARMACI DEL SISTEMA NERVOSO Product Name: NA Product Code: aSB-683699 | GLAXO SMITHKLINE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1217 | NCT00203112 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline | A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA). | Relapse Remitting Multiple Sclerosis | Drug: glatiramer acetate with minocycline;Drug: Glatiramer acetate with placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 44 | Phase 2 | Canada |
| 1218 | NCT00087529 (ClinicalTrials.gov) | June 2004 | 9/7/2004 | A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis | A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: placebo;Drug: rituximab | Genentech, Inc. | NULL | Completed | 18 Years | 65 Years | All | 439 | Phase 2/Phase 3 | Canada;United States |
| 1219 | NCT00682929 (ClinicalTrials.gov) | April 14, 2004 | 19/5/2008 | Cannabis for Spasticity in Multiple Sclerosis | Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study | Multiple Sclerosis | Drug: Inhaled Cannabis;Drug: Oral THC;Drug: Oral Placebo;Drug: Inhaled placebo | University of California, Davis | National Multiple Sclerosis Society | Terminated | 21 Years | N/A | All | 41 | Phase 1/Phase 2 | United States |
| 1220 | NCT00217295 (ClinicalTrials.gov) | April 2004 | 14/9/2005 | A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis | A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis. | Multiple Sclerosis | Drug: Avonex and Topamax | Multiple Sclerosis Institute | NULL | Recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | United States |
| 1221 | NCT00300716 (ClinicalTrials.gov) | April 2004 | 8/3/2006 | Trial of Memantine for Cognitive Impairment in Multiple Sclerosis | Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis | Multiple Sclerosis;Cognition Disorders | Drug: Memantine | Oregon Health and Science University | Forest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub Seattle | Completed | 18 Years | 65 Years | All | 82 | Phase 2/Phase 3 | United States |
| 1222 | NCT00086671 (ClinicalTrials.gov) | April 2004 | 7/7/2004 | Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS) | A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis With a 24-Week Double-Blind, Active Extension Phase | Multiple Sclerosis | Drug: ABT-874/Human monoclonal antibody against IL-12;Drug: Placebo | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 60 Years | Both | 215 | Phase 2 | United States;Canada;Germany;Netherlands;United Kingdom |
| 1223 | NCT00666224 (ClinicalTrials.gov) | January 2004 | 22/4/2008 | Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome | A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS) | Multiple Sclerosis | Drug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL) | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 45 Years | All | 481 | Phase 3 | Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States |
| 1224 | NCT00276341 (ClinicalTrials.gov) | August 2003 | 12/1/2006 | Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis | Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study. | Multiple Sclerosis, Relapsing-Remitting | Drug: EGb 761® (Tanakan®) | Ipsen | NULL | Completed | 18 Years | N/A | All | 240 | Phase 3 | France |
| 1225 | NCT00079495 (ClinicalTrials.gov) | July 2003 | 8/3/2004 | Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: NBI-5788 | Neurocrine Biosciences | Immune Tolerance Network (ITN) | Completed | 18 Years | 55 Years | Both | 150 | Phase 2 | NULL |
| 1226 | NCT00097760 (ClinicalTrials.gov) | June 2003 | 30/11/2004 | Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis | Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA) | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab;Drug: Placebo | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 110 | Phase 2 | NULL |
| 1227 | NCT00333138 (ClinicalTrials.gov) | May 2003 | 1/6/2006 | Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis | Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase | Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 60 Years | All | 281 | Phase 2 | Canada;Denmark;Finland;France;Germany;Italy;Poland;Portugal;Spain;Switzerland;United Kingdom |
| 1228 | NCT00260741 (ClinicalTrials.gov) | March 2003 | 30/11/2005 | Cannabis for Spasticity in Multiple Sclerosis | Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study | Multiple Sclerosis | Drug: Smoked Cannabis | Center for Medicinal Cannabis Research | NULL | Terminated | 21 Years | N/A | Both | 60 | Phase 1/Phase 2 | United States |
| 1229 | NCT00053417 (ClinicalTrials.gov) | February 2003 | 29/1/2003 | Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 206 | Phase 2 | United States;Canada |
| 1230 | NCT00168766 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 345 | Phase 4 | Belgium;Denmark;Finland;Netherlands;Norway;Sweden;Switzerland;United Kingdom |
| 1231 | NCT00220779 (ClinicalTrials.gov) | December 2002 | 13/9/2005 | Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis | Randomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | 55 Years | All | 128 | Phase 2 | United States;Austria;Canada;Czech Republic;Germany;Greece;Hungary;Israel;Poland;Slovakia;Sweden;United Kingdom |
| 1232 | NCT00185211 (ClinicalTrials.gov) | August 2002 | 9/9/2005 | BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study | Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months. | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 48 Years | All | 468 | Phase 3 | Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom |
| 1233 | NCT00678795 (ClinicalTrials.gov) | August 2002 | 14/5/2008 | A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis | A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis. | Detrusor Overactivity;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 135 | Phase 3 | United Kingdom |
| 1234 | NCT00711646 (ClinicalTrials.gov) | June 2002 | 8/7/2008 | A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis. | A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis. | Spasticity;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 189 | Phase 3 | United Kingdom |
| 1235 | NCT01604265 (ClinicalTrials.gov) | March 2002 | 21/5/2012 | A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis | A Double Blind, Randomised, Parallel Group, Placebo Controlled Study of Sativex in the Treatment of Central Neuropathic Pain in Multiple Sclerosis. | Multiple Sclerosis;Neuropathic Pain | Drug: Placebo;Drug: Sativex | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 66 | Phase 3 | United Kingdom |
| 1236 | NCT01606176 (ClinicalTrials.gov) | March 2002 | 21/5/2012 | A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin | A Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function. | Pain;Multiple Sclerosis | Drug: GW-1000-02;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United Kingdom |
| 1237 | NCT00030966 (ClinicalTrials.gov) | January 2002 | 15/2/2002 | Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab;Drug: Placebo | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 1200 | Phase 3 | United States;Austria;Belgium;France;Germany;Israel;Italy |
| 1238 | NCT00202410 (ClinicalTrials.gov) | November 2001 | 12/9/2005 | Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis | Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study. | Multiple Sclerosis | Biological: Bacille of Calmette-Guerin;Other: placebo | S. Andrea Hospital | Multiple Sclerosis Italian Foundation (FISM);Istituto Superiore di Sanità | Completed | 18 Years | N/A | Both | 80 | Phase 2/Phase 3 | Italy |
| 1239 | NCT00035529 (ClinicalTrials.gov) | November 2001 | 3/5/2002 | A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis | A Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: BMS 188667 (Abatacept) | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 55 Years | Both | Phase 2 | United States | |
| 1240 | NCT00039988 (ClinicalTrials.gov) | November 2001 | 18/6/2002 | Treatment of Multiple Sclerosis With Copaxone and Albuterol | Treatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and Albuterol | Autoimmune Diseases;Multiple Sclerosis | Drug: Glatiramer acetate;Drug: Albuterol;Drug: Albuterol placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Completed | 18 Years | 55 Years | Both | 40 | N/A | United States |
| 1241 | NCT00027300 (ClinicalTrials.gov) | November 2001 | 30/11/2001 | Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab;Drug: Placebo | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 50 Years | All | 900 | Phase 3 | United States;Belgium;Canada;Czech Republic;France;Germany;Netherlands;United Kingdom |
| 1242 | NCT01610687 (ClinicalTrials.gov) | July 2001 | 31/5/2012 | A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | A Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis;Spasticity | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 137 | Phase 3 | United Kingdom |
| 1243 | NCT01610713 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 154 | Phase 3 | United Kingdom |
| 1244 | NCT01610700 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients | Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis | Drug: GW-1000-02;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | United Kingdom |
| 1245 | NCT01487096 (ClinicalTrials.gov) | April 2001 | 5/12/2011 | Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (placebo for teriflunomide) | Sanofi | NULL | Completed | 18 Years | 65 Years | Both | 179 | Phase 2 | Canada;France |
| 1246 | NCT00004744 (ClinicalTrials.gov) | February 1993 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis | Multiple Sclerosis | Drug: immune globulin | National Institute of Neurological Disorders and Stroke (NINDS) | Mayo Clinic | Completed | 18 Years | 60 Years | Both | 76 | Phase 3 | NULL | |
| 1247 | NCT00004814 (ClinicalTrials.gov) | October 1991 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: copolymer 1 | National Center for Research Resources (NCRR) | University of Maryland | Completed | 18 Years | 45 Years | Both | 250 | Phase 3 | NULL | |
| 1248 | EUCTR2014-000728-97-NL (EUCTR) | 08/05/2014 | Regulation of the stress-axis by vitamin D in subjects with multiple sclerosis. | Regulation of the stress-axis by vitamin D3 in subjects with multiple sclerosis; a double-blinded, randomized, placebo-controlled study - Vitamin D3 and the stress-axis in MS | Relapsing remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol® Oil Product Name: Vigantol® Oil Product Code: EMD 28162 | Academic MS Center Limburg | NULL | Not Recruiting | Female: yes Male: no | Phase 2 | Netherlands | ||||
| 1249 | EUCTR2009-016442-74-ES (EUCTR) | 22/12/2009 | Trasplante autólogo de células madre mesenquimales en esclerosis múltiple: ensayo clínico fase II aleatorizado, enmascarado y cruzado con placebo. | Trasplante autólogo de células madre mesenquimales en esclerosis múltiple: ensayo clínico fase II aleatorizado, enmascarado y cruzado con placebo. | Esclerosis Múltiple MedDRA version: 9;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Product Name: Células madre mesenquimales INN or Proposed INN: Células madre mesenquimales | Fundació Clínic per a la Recerca Biomèdica | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | |||||
| 1250 | EUCTR2006-004893-29-DE (EUCTR) | 06/02/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Austria;Germany;Italy;United Kingdom | ||||
| 1251 | EUCTR2008-008719-25-DE (EUCTR) | 16/02/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | |||
| 1252 | EUCTR2013-002113-35-FR (EUCTR) | 29/05/2015 | Effect of MD1003 in progressive multiple sclerosis with walking impairment | Effect of MD1003 in spinal progressive multiple sclerosis: a pivotal randomized double blind placebo controlled study - MS-SPI | Progressive spinal multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: biotin Product Code: MD1003 INN or Proposed INN: BIOTIN | MEDDAY SAS | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | France | |||
| 1253 | EUCTR2007-002627-32-DE (EUCTR) | 26/05/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Gilenya 0,5 mg Hartkapseln Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden | ||||
| 1254 | EUCTR2013-002112-27-FR (EUCTR) | 29/05/2015 | Effect of MD1003 on visuel impairement of multiple sclerosis | Effect of MD1003 in chronic visual loss related to optic neuritis in multiple sclerosis: a pivotal randomized double masked placebo controlled study - MS-ON | chronic visual loss related to optic neuritis in multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Classification code 10030942;Term: Optic neuritis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: biotin Product Code: MD1003 INN or Proposed INN: BIOTIN | MEDDAY SAS | NULL | Not Recruiting | Female: yes Male: yes | 0 | Phase 3 | France;United Kingdom | |||
| 1255 | EUCTR2011-005249-12-FR (EUCTR) | 17/06/2015 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;China | |||
| 1256 | EUCTR2015-000137-78-AT (EUCTR) | 17/09/2015 | Mesenchymal stem cells therapy for patients with multiple sclerosis | Randomised, double-blind, cross-over phase II study with intravenous autologous mesenchymal stem cells vs. placebo for multiple sclerosis patients in Austria (MESEMS Austria) | multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Human autologous mesenchymal stem cells INN or Proposed INN: MSC2015 Other descriptive name: UNDIFFERENTIATED AUTOLOGOUS MESENCHYMAL STEM CELLS | SALK - Gemeinnützige Salzburger Landeskliniken Betriebsges. m.b.H., Christian-Doppler-Klinik, UK für Neurologie der PMU | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Austria | ||||
| 1257 | EUCTR2008-006333-27-DE (EUCTR) | 18/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Latvia;Netherlands;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand | ||||
| 1258 | EUCTR2008-007015-32-DE (EUCTR) | 03/03/2009 | A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase | A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase | cognitive impairment in Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin Trade Name: Exelon transdermales Pflaster Product Name: Exelon Product Code: ENA713 INN or Proposed INN: Rivastigmin | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | |||||
| 1259 | EUCTR2011-005249-12-BG (EUCTR) | 13/01/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;Italy;France;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | |||
| 1260 | EUCTR2012-003056-36-NL (EUCTR) | 21/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Latvia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 1261 | EUCTR2011-005249-12-Outside-EU/EEA (EUCTR) | 10/05/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | Tunisia;Turkey;United States;Australia;Bosnia and Herzegovina;Canada;China;Israel;Lebanon;Morocco;Russian Federation | |||
| 1262 | EUCTR2014-005624-98-EE (EUCTR) | 14/09/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | |||
| 1263 | EUCTR2011-005249-12-IE (EUCTR) | 21/06/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Portugal;Estonia;Morocco;Greece;Spain;Lebanon;Ireland;Russian Federation;Israel;Italy;France;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05405361 (ClinicalTrials.gov) | January 18, 2023 | 17/5/2022 | A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy | A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy | Multifocal Motor Neuropathy (MMN) | Biological: ARGX-117;Other: Placebo | argenx | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States |
| 2 | NCT05581199 (ClinicalTrials.gov) | December 15, 2022 | 12/10/2022 | To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP | A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly;Drug: Batoclimab 340 mg SC weekly;Drug: Placebo | Immunovant Sciences GmbH | NULL | Recruiting | 18 Years | N/A | All | 240 | Phase 2 | United States |
| 3 | NCT05327114 (ClinicalTrials.gov) | September 23, 2022 | 7/4/2022 | Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Nipocalimab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Slovakia;Spain;Taiwan;United Kingdom;Romania;South Africa |
| 4 | JPRN-jRCT2041220037 | 10/09/2022 | 23/06/2022 | Efficacy and Safety Study of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Nipocalimab : Nipocalimab will be administered intravenously. Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant s local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. Placebo : Placebo will be administered intravenously. Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant s local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. | Nakano Masayoshi | NULL | Pending | >= 18age old | Not applicable | Both | 300 | Phase 2-3 | Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;UnitedKingdomOf GreatBritainAndNorthernIreland;Greece;Italy;Korea,RepublicOf;Mexico;Poland;Portugal;Slovakia;Taiwan,ProvinceOf China;UnitedStates OfAmerica;Japan |
| 5 | EUCTR2021-003302-50-AT (EUCTR) | 22/04/2022 | 20/12/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Belgium;Spain;Poland;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 6 | NCT05225675 (ClinicalTrials.gov) | March 31, 2022 | 5/11/2021 | A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Biological: ARGX-117;Other: Placebo | argenx | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States;Austria;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 7 | EUCTR2021-003302-50-ES (EUCTR) | 08/03/2022 | 02/11/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2021-003302-50-IT (EUCTR) | 17/02/2022 | 26/11/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy,Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: [ARGX-117 IV] Trade Name: Act-HiB Product Name: Haemophilus type b vaccine (conjugated) Product Code: [.] Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) Trade Name: Intratect Product Name: Human normal immunoglobulin (IVIg) Product Code: [-] INN or Proposed INN: Human normal immunoglobulin (IVIg) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Menjugate Product Name: Group C meningococcal conjugate vaccine Product Code: [J07AH07] INN or Proposed INN: Group C meningococcal conjugate vaccine Other descriptive name: N. MENINGITIDIS GROUP C POLYSACCHARIDE Trade Name: Prevenar 13 sospensione per iniezione Product Name: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) Product Code: [NA] INN or Proposed INN: VACCINO PNEUMOCOCCICO SACCARIDICO | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2021-003302-50-NL (EUCTR) | 14/02/2022 | 27/12/2021 | A study for adult patients with Multifocal Motor Neuropathy comparing 2 doses of ARGX-117 | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 10 | NCT04281472 (ClinicalTrials.gov) | April 15, 2020 | 20/2/2020 | A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) | A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Biological: efgartigimod PH20 SC in stage B;Other: placebo in stage B | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 360 | Phase 2 | United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 11 | EUCTR2016-002411-17-GB (EUCTR) | 23/07/2019 | 14/08/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2016-002411-17-FR (EUCTR) | 02/07/2019 | 19/07/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom | ||
| 13 | EUCTR2016-002411-17-NL (EUCTR) | 13/06/2019 | 02/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 14 | EUCTR2016-002411-17-DE (EUCTR) | 23/05/2019 | 04/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 15 | EUCTR2016-002411-17-ES (EUCTR) | 09/05/2019 | 11/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom | ||
| 16 | EUCTR2016-002411-17-BE (EUCTR) | 29/04/2019 | 08/02/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 17 | EUCTR2016-002411-17-DK (EUCTR) | 11/04/2019 | 20/02/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 18 | JPRN-UMIN000035753 | 2019/03/28 | 02/02/2019 | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial | Chronic Inflammatory Demyelinating Polyneuropathy | CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. | Nagoya University Hospital | Zenyaku Kogyo Co., Ltd. | Complete: follow-up complete | 12years-old | Not applicable | Male and Female | 25 | Phase 2 | Japan |
| 19 | NCT03864185 (ClinicalTrials.gov) | March 28, 2019 | 19/2/2019 | The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients With Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Biological: Rituximab (genetical recombination);Other: Placebo | Nagoya University | Japan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd. | Completed | 12 Years | N/A | All | 25 | Phase 2 | Japan |
| 20 | JPRN-jRCT2041180037 | 28/03/2019 | 31/01/2019 | RECIPE Trial | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial | Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy | CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) or placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. | Iijima Masahiro | NULL | Complete | >= 12age old | Not applicable | Both | 25 | Phase 2 | Japan |
| 21 | NCT03861481 (ClinicalTrials.gov) | March 26, 2019 | 1/3/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | United States;Belgium;Denmark;France;Germany;Netherlands;Spain;United Kingdom;Canada |
| 22 | EUCTR2011-003448-28-PL (EUCTR) | 07/07/2015 | 06/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 23 | EUCTR2011-003448-28-EE (EUCTR) | 11/06/2015 | 14/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 24 | EUCTR2011-003448-28-LT (EUCTR) | 09/06/2015 | 21/04/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 25 | EUCTR2011-005280-24-CZ (EUCTR) | 19/05/2015 | 24/11/2014 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | Serbia;United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 26 | NCT02372149 (ClinicalTrials.gov) | February 2015 | 12/2/2015 | IVIg for Demyelination in Diabetes Mellitus | Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study | Peripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chloride | University of Toronto | University Health Network, Toronto | Recruiting | 18 Years | N/A | Both | 25 | Phase 4 | Canada |
| 27 | EUCTR2011-005280-24-NL (EUCTR) | 30/01/2013 | 19/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 28 | EUCTR2011-005280-24-PL (EUCTR) | 11/01/2013 | 11/12/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 29 | EUCTR2011-005280-24-GR (EUCTR) | 17/10/2012 | 24/09/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 15.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Norway;Japan | ||
| 30 | EUCTR2011-005280-24-BE (EUCTR) | 08/10/2012 | 04/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 31 | EUCTR2011-003448-28-BE (EUCTR) | 27/09/2012 | 02/04/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 32 | EUCTR2011-005280-24-GB (EUCTR) | 25/09/2012 | 09/08/2012 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 33 | EUCTR2011-005280-24-ES (EUCTR) | 19/09/2012 | 07/08/2012 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GILENYA 0,5 mg cápsulas duras Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: HIDROCLORURO DE FINGOLIMOD | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Norway;Germany;Japan | ||
| 34 | EUCTR2011-005280-24-IT (EUCTR) | 17/09/2012 | 13/09/2012 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy. | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720I INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan | ||
| 35 | JPRN-JapicCTI-121961 | 01/9/2012 | A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Intervention name : FTY720 INN of the intervention : fingolimod Dosage And administration of the intervention : oral daily, 0.5 mg Control intervention name : placebo Dosage And administration of the control intervention : oral daily | Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K. | NULL | 18 | BOTH | 156 | Phase 3 | NULL | |||
| 36 | EUCTR2011-005280-24-DE (EUCTR) | 29/08/2012 | 30/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 37 | EUCTR2011-003448-28-IT (EUCTR) | 23/08/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN | CSL BEHRING GMBH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of | ||
| 38 | EUCTR2011-003448-28-GB (EUCTR) | 23/05/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 39 | EUCTR2011-003448-28-AT (EUCTR) | 18/05/2012 | 16/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 40 | EUCTR2011-003448-28-NL (EUCTR) | 11/05/2012 | 14/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 41 | EUCTR2011-003448-28-CZ (EUCTR) | 09/05/2012 | 23/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 42 | EUCTR2011-003448-28-ES (EUCTR) | 24/04/2012 | 29/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 43 | EUCTR2011-003448-28-DE (EUCTR) | 20/04/2012 | 31/01/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 44 | EUCTR2011-003448-28-FI (EUCTR) | 05/04/2012 | 05/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 45 | NCT01545076 (ClinicalTrials.gov) | March 2012 | 1/3/2012 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) | Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study | Chronic Inflammatory Demyelinating Polyneuropathy;Polyradiculoneuropathy | Biological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose) | CSL Behring | ICON Clinical Research | Completed | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic |
| 46 | EUCTR2009-017805-13-CZ (EUCTR) | 14/07/2011 | 22/04/2010 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Bulgaria | ||
| 47 | EUCTR2009-017805-13-BG (EUCTR) | 27/01/2011 | 13/12/2010 | Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy. | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2/3 | India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria | ||
| 48 | EUCTR2009-017805-13-RO (EUCTR) | 08/09/2010 | 15/07/2010 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 12.1;Level: LLT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Romania;Bulgaria | ||
| 49 | EUCTR2009-013841-27-DK (EUCTR) | 17/12/2009 | 27/10/2009 | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | Multifocal motor neuropathy MedDRA version: 12.0;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy | Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: IGIV, 10% Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Denmark | |||
| 50 | NCT00962429 (ClinicalTrials.gov) | February 2009 | 19/8/2009 | Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy | Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study | CIDP;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: lipoic acid | Oregon Health and Science University | Collins Medical Trust | Completed | 18 Years | 80 Years | All | 7 | Phase 2 | United States |
| 51 | NCT00666263 (ClinicalTrials.gov) | August 2008 | 23/4/2008 | Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Biological: Immune Globulin Intravenous (human), 10%;Biological: 0.25% human albumin solution (Placebo) | Baxalta now part of Shire | NULL | Completed | 18 Years | N/A | All | 50 | Phase 3 | United States;Canada;Denmark;Netherlands;Poland |
| 52 | NCT00220740 (ClinicalTrials.gov) | April 2004 | 13/9/2005 | Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | N/A | All | 117 | Phase 3 | United States;Argentina;Canada;Czech Republic;Germany;Israel;Italy;Mexico;Poland;Serbia;Former Serbia and Montenegro |
| 53 | NCT00004772 (ClinicalTrials.gov) | September 1992 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Immune globulin | National Center for Research Resources (NCRR) | Ohio State University | Completed | 15 Years | N/A | Both | 90 | Phase 3 | NULL |
37. 膿疱性乾癬（汎発型）
臨床試験数 : 79 / 薬物数 : 57 - (DrugBank : 21) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05366855 (ClinicalTrials.gov) | April 21, 2022 | 25/4/2022 | Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis | A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis | Generalized Pustular Psoriasis | Biological: Imsidolimab;Other: Placebo | AnaptysBio, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 45 | Phase 3 | United States;Australia;France;Georgia;Germany;Korea, Republic of;Malaysia;Morocco;Poland;Romania;Spain;Taiwan;Thailand;Tunisia;Turkey |
| 2 | NCT05352893 (ClinicalTrials.gov) | April 14, 2022 | 25/4/2022 | Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis | Generalized Pustular Psoriasis | Drug: Imsidolimab high dose;Drug: Imsidolimab low dose;Other: Placebo | AnaptysBio, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 45 | Phase 3 | United States;Australia;Georgia;Germany;Korea, Republic of;Malaysia;Morocco;Poland;Romania;Slovakia;Spain;Taiwan;Thailand;Tunisia;Turkey |
| 3 | EUCTR2021-001447-27-ES (EUCTR) | 07/02/2022 | 12/11/2021 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Efficacy and Safety of Imsidolimab in Subjects with Generalized Pustular Psoriasis | Subjects with generalized pustular psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: ANB019 INN or Proposed INN: anti-IL-36R monoclonal antibody | AnaptysBio Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 3 | Taiwan;Thailand;Malaysia;Spain;Australia;Georgia;Germany;Korea, Republic of | ||
| 4 | EUCTR2021-001447-27-DE (EUCTR) | 08/12/2021 | 08/09/2021 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis - Efficacy and Safety of Imsidolimab in Subjects with Generalized Pustular Psoriasis | Subjects with generalized pustular psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: ANB019 INN or Proposed INN: anti-IL-36R monoclonal antibody Product Code: ANB019 INN or Proposed INN: anti-IL-36R monoclonal antibody | AnaptysBio Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 3 | Georgia;Germany;United States;Taiwan;Spain;Thailand;United Kingdom;France;Malaysia;Poland;Romania;Australia;Korea, Republic of | ||
| 5 | EUCTR2018-003081-14-HR (EUCTR) | 26/08/2021 | 03/12/2021 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 6 | EUCTR2018-003081-14-BG (EUCTR) | 17/05/2021 | 14/04/2021 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 7 | ChiCTR2100044690 | 2021-04-01 | 2021-03-25 | A randomized, double-blind, placebo-controlled clinical trial of melatonin combined with acitretin in the treatment of children with generalized pustular psoriasis | A randomized, double-blind, placebo-controlled clinical trial of melatonin combined with acitretin in the treatment of children with generalized pustular psoriasis | Generalized pustular psoriasis | Experimental group:Acitretin combined with melatonin;Control group:Acitretin combined with cooked flour; | Department of Dermatology, Children's Hospital of Chongqing Medical University | NULL | Recruiting | 0 | 18 | Both | Experimental group:15;Control group:15; | China | |
| 8 | EUCTR2018-003081-14-PL (EUCTR) | 24/09/2020 | 01/06/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 9 | JPRN-JapicCTI-205387 | 03/8/2020 | 23/07/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil(TM) 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis (GPP) | Intervention name : spesolimab INN of the intervention : spesolimab Dosage And administration of the intervention : s.c. and i.v. single dose Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Boehringer Ingelheim | NULL | complete | 12 | 75 | BOTH | 120 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa |
| 10 | NCT04399837 (ClinicalTrials.gov) | June 4, 2020 | 20/5/2020 | A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP | Generalized Pustular Psoriasis | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 12 Years | 75 Years | All | 123 | Phase 2 | United States;Argentina;Belgium;Chile;China;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Philippines;Russian Federation;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;Vietnam;Australia;Bulgaria;Colombia;Croatia;Czechia;Georgia;Poland;Singapore |
| 11 | EUCTR2018-003081-14-DE (EUCTR) | 16/04/2020 | 16/12/2019 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Viet Nam;Australia;South Africa;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Belgium;Poland;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 12 | EUCTR2018-003081-14-IT (EUCTR) | 16/03/2020 | 15/06/2021 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups inpatients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP - Effisayil™ 2 | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Spesolimab Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | United States;Taiwan;Greece;Spain;Thailand;Russian Federation;Chile;Italy;Vietnam;France;Malaysia;Australia;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;New Zealand;Japan | ||
| 13 | EUCTR2018-003081-14-GR (EUCTR) | 04/03/2020 | 14/01/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 14 | EUCTR2018-003081-14-NL (EUCTR) | 25/02/2020 | 07/01/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Netherlands BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 15 | EUCTR2018-003081-14-FR (EUCTR) | 17/02/2020 | 11/02/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | United States;Taiwan;Greece;Spain;Thailand;Chile;Russian Federation;Italy;Vietnam;France;Malaysia;Australia;Netherlands;Tunisia;China;Korea, Republic of;Turkey;Egypt;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand | ||
| 16 | EUCTR2018-003081-14-ES (EUCTR) | 24/01/2020 | 20/12/2019 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Thailand;Spain;Russian Federation;Chile;Italy;Vietnam;France;Malaysia;Australia;Tunisia;Netherlands;China;Korea, Republic of;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Japan;New Zealand | ||
| 17 | NCT03998683 (ClinicalTrials.gov) | September 3, 2019 | 25/6/2019 | A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis | A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis | Psoriasis | Drug: Guselkumab 100 mg;Drug: Placebo | Janssen-Cilag Ltd. | NULL | Completed | 18 Years | N/A | All | 117 | Phase 3 | France;Germany;Italy;Spain;United Kingdom |
| 18 | EUCTR2018-003206-58-GB (EUCTR) | 29/07/2019 | 28/05/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | France;Spain;Germany;United Kingdom | ||
| 19 | EUCTR2018-003206-58-IT (EUCTR) | 11/07/2019 | 15/06/2021 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: TREMFYA Product Name: GUSELKUMAB Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB | JANSSEN CILAG INTERNATIONAL NV | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | France;Spain;Germany;United Kingdom;Italy | ||
| 20 | EUCTR2018-003206-58-DE (EUCTR) | 02/07/2019 | 25/04/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | France;Spain;Germany;Italy;United Kingdom | ||
| 21 | EUCTR2018-003206-58-FR (EUCTR) | 29/06/2019 | 11/04/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Germany;United Kingdom | ||
| 22 | EUCTR2018-003206-58-ES (EUCTR) | 20/06/2019 | 08/05/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Germany;United Kingdom | ||
| 23 | EUCTR2017-004231-37-DE (EUCTR) | 23/05/2019 | 17/12/2018 | A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular Psoriasis | Effisayil™ 1:Multi-center, double-blind, randomised, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. - Flare Treatment Phase II Trial in GPP | Generalized Pustular Psoriasis (GPP) MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 2 | United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan;China;Korea, Republic of | |||
| 24 | NCT03782792 (ClinicalTrials.gov) | January 31, 2019 | 19/12/2018 | A Study to Test BI 655130 in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis | Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of BI 655130 in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity. | Generalized Pustular Psoriasis | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 53 | Phase 2 | United States;China;France;Germany;Japan;Korea, Republic of;Malaysia;Singapore;Switzerland;Taiwan;Thailand;Tunisia |
| 25 | EUCTR2017-004231-37-FR (EUCTR) | 22/01/2019 | 26/11/2018 | A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular Psoriasis | Multi-center, double-blind, randomised, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. - Flare Treatment Phase II Trial in GPP | Generalized Pustular Psoriasis (GPP) MedDRA version: 20.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 27 | Phase 2 | United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan | ||
| 26 | JPRN-JapicCTI-184065 | 22/8/2018 | 15/08/2018 | I6T-MC-AMAJ | A Multicenter Randomized Double-Blind Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-2 | Psoriasis valgaris, Generalized pustular psoriasis, Erythrodermic psoriasis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Administered subcutaneous injection Control intervention name : Secukinumab INN of the control intervention : secukinumab Dosage And administration of the control intervention : Administered subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Administered subcutaneous injection | Eli Lilly Japan K.K. | NULL | complete | 20 | BOTH | 120 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
| 27 | NCT03051217 (ClinicalTrials.gov) | February 21, 2017 | 9/2/2017 | A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis | Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis | Moderate to Severe Psoriasis;Generalized Pustular Psoriasis and Erythrodermic Psoriasis | Other: Placebo;Drug: Certolizumab Pegol | UCB Biopharma S.P.R.L. | NULL | Completed | 20 Years | N/A | All | 127 | Phase 2/Phase 3 | Japan |
| 28 | EUCTR2015-003600-23-GB (EUCTR) | 01/04/2016 | 28/01/2016 | Comparing Anakinra versus placebo in the treatment of pustular psoriasis | Treatment of Pustular Psoriasis with the IL-1 receptor antagonist anakinra: a randomised, placebo controlled trial and associated mechanistic studies | Acral Pustular Psoriasis, specifically but not limited to Palmo-Plantar Pustulosis will be the target population for therapeutic intervention with Anakinra in this study. MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Anakinra Product Name: Anakinra INN or Proposed INN: ANAKINRA | Guy's and St Thomas NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 4 | United Kingdom | ||
| 29 | EUCTR2013-003086-34-PL (EUCTR) | 18/04/2014 | 10/03/2014 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 17.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 30 | EUCTR2013-003086-34-IT (EUCTR) | 04/03/2014 | 12/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 14.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Spain;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden | ||
| 31 | EUCTR2013-003086-34-BE (EUCTR) | 10/02/2014 | 09/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlledstudy of subcutaneous secukinumab to demonstrate efficacy as assessedby palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at16 weeks of treatment, compared to placebo, and to assess long-termsafety, tolerability, and efficacy in subjects with moderate to severechronic palmoplantar pustular psoriasis - amended with an optionalextension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 100000018190;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab 150 mg/1 mL Solution for injection Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Spain;Belgium;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 32 | EUCTR2013-003086-34-DE (EUCTR) | 27/12/2013 | 05/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 19.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 19.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457, 150mg INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 33 | NCT02008890 (ClinicalTrials.gov) | December 26, 2013 | 8/12/2013 | Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab | A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks | Palmoplantar Pustular Psoriasis | Biological: Secukinumab 300mg;Biological: Secukinumab 150mg;Biological: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 237 | Phase 3 | Austria;Belgium;France;Germany;Italy;Poland;Russian Federation;Spain;Sweden;United Kingdom |
| 34 | EUCTR2013-003086-34-AT (EUCTR) | 17/12/2013 | 28/11/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 18.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 35 | EUCTR2013-003086-34-GB (EUCTR) | 12/12/2013 | 28/11/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks. | moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 17.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 36 | EUCTR2013-003086-34-ES (EUCTR) | 09/12/2013 | 05/12/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis. | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis. | Moderate to severe chronic palmoplantar pustular psoriasis. MedDRA version: 14.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Belgium;Poland;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden | ||
| 37 | EUCTR2013-003086-34-SE (EUCTR) | 04/12/2013 | 22/11/2013 | Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis | A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis | Moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 16.1;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 16.1;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;Spain;Belgium;Poland;Austria;Russian Federation;Germany;United Kingdom;Italy;Sweden | ||
| 38 | ChiCTR-TRC-12003542 | 2011-08-01 | 2012-12-18 | A Multi-center, randomized, double-blinded, double-dummy, parallel-controlled clinical trial to determine the efficacy and safety of Tripterygium Glycosides and Acitretin in patients with generalized pustular psoriasis | Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases | Generalized pustular psoriasis | TG treatment group:Take TG tablet 2 slices every time, thrice a day, the placebo of Acitretin Capsules 2 pills every time, twice a day;Acitretin treatment group:Take the placebo of TG tablet 2 slices every time, thrice a day, Acitretin Capsules 2 pills every time, twice a day; | Institute of dermatology, Chinese Academy of Medical Sciences | NULL | Completed | 16 | 75 | Both | TG treatment group:180;Acitretin treatment group:180; | China | |
| 39 | NCT01091051 (ClinicalTrials.gov) | March 2010 | 18/3/2010 | Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis | Safety and Efficacy of Ustekinumab in the Treatment of Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis | Palmo-Plantar Pustular Psoriasis;Palmo-Plantar Pustulosis | Drug: Ustekinumab;Drug: Placebo (Soduim Chloride) | Innovaderm Research Inc. | Janssen-Ortho LLC | Terminated | 18 Years | N/A | Both | 33 | Phase 3 | Canada |
| 40 | EUCTR2006-005344-83-DE (EUCTR) | 09/02/2007 | 07/11/2006 | A Randomized, Double-blind, Placebo and Active Treatment-Controlled Study in Psoriatic Patients to Assess the Tolerability, Pharmacokinetics and Efficacy of a Cream Formulation Containing 3% of P32/98 | A Randomized, Double-blind, Placebo and Active Treatment-Controlled Study in Psoriatic Patients to Assess the Tolerability, Pharmacokinetics and Efficacy of a Cream Formulation Containing 3% of P32/98 | Psoriasis is a common inherited autoimmune disease that affects 2-3% of the world-wide population. There are several recognized forms of psoriasis, such as plaque psoriasis, which is also known as psoriasis vulgaris and guttate, inverse, erythrodermic and pustular psoriasis, which can coexist within the same patient. The most common form is the plaque psoriasis. MedDRA version: 8.1;Level: LLT;Classification code 10037153;Term: Psoriasis | Product Name: P32/98 3% Product Code: P32/98 Trade Name: Silikis 3µg/g Salbe INN or Proposed INN: Calcitriol | Probiodrug AG | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 41 | EUCTR2018-003081-14-BE (EUCTR) | 19/12/2019 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | NA | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 42 | EUCTR2018-003081-14-CZ (EUCTR) | 28/04/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan |
40. 高安動脈炎
臨床試験数 : 24 / 薬物数 : 40 - (DrugBank : 18) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 110
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2061210007 | 13/10/2021 | 28/05/2021 | A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Takayasu Arteritis | Takayasu Arteritis | Ustekinumab Participants will receive IV infusion and SC injection of ustekinumab. Placebo Participants will receive IV infusion and SC injection of matching placebo. Glucorticoid Taper Regimen Glucocorticoid will be administered orally. | Nishikawa Kazuko | NULL | Recruiting | >= 18age old | <= 75age old | Both | 50 | Phase 3 | Japan |
| 2 | NCT04882072 (ClinicalTrials.gov) | September 15, 2021 | 10/5/2021 | A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Takayasu Arteritis | Takayasu Arteritis | Drug: Ustekinumab;Other: Placebo;Drug: Glucorticoid Taper Regimen | Janssen Pharmaceutical K.K. | NULL | Active, not recruiting | 15 Years | 75 Years | All | 14 | Phase 3 | Japan |
| 3 | NCT05168475 (ClinicalTrials.gov) | July 14, 2021 | 9/12/2021 | Biologics in Refractory Vasculitis | Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children | Giant Cell Arteritis;Takayasu Arteritis;Cogan Syndrome;Relapsing Polychondritis;Cryoglobulinemic Vasculitis;IgA Vasculitis;Polyarteritis Nodosa;Cutaneous Polyarteritis Nodosa;Primary Angiitis of Central Nervous System | Biological: Rituximab;Biological: Infliximab;Biological: Tocilizumab | Cambridge University Hospitals NHS Foundation Trust | NULL | Recruiting | 5 Years | N/A | All | 140 | Phase 2 | United Kingdom |
| 4 | NCT04161898 (ClinicalTrials.gov) | February 4, 2020 | 12/11/2019 | A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-Takayasu) | Takayasu Arteritis (TAK) | Drug: Upadacitinib;Drug: Placebo for Upadacitinib;Drug: Prednisolone | AbbVie | NULL | Recruiting | 15 Years | N/A | All | 56 | Phase 3 | Argentina;Brazil;China;Japan;Korea, Republic of;Turkey |
| 5 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
| 6 | JPRN-JapicCTI-142616 | 02/10/2014 | 23/07/2014 | Phase III Study of MRA-SC in Patients with Takayasu Arteritis | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Study of MRA-SC in Patients with Takayasu Arteritis | Takayasu Arteritis | Intervention name : tocilizumab (MRA-SC) INN of the intervention : tocilizumab Dosage And administration of the intervention : 162mg/W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo/W, SC | Chugai Pharmaceutical Co., Ltd. | NULL | complete | 12 | BOTH | 34 | Phase 3 | Japan |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05306353 (ClinicalTrials.gov) | May 15, 2023 | 23/3/2022 | CD40L Antagonism in Rheumatoid Arthritis (RA) | Combining a CD40L-Binding Protein (VIB4920) With a TNF-alpha Inhibitor for the Treatment of Inadequately Controlled Rheumatoid Arthritis (ITN092AI) | Rheumatoid Arthritis | Drug: Placebo for VIB4920;Drug: VIB4920 with TNFi;Drug: VIB4920 without TNFi | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Not yet recruiting | 18 Years | 70 Years | All | 104 | Phase 2 | United States |
| 2 | EUCTR2021-005771-39-CZ (EUCTR) | 20/12/2022 | 08/07/2022 | A clinical trial to investigate IRL201805 in patients with rheumatoid arthritis | A Phase 2, randomised, double-blind, placebo-controlled, dose escalation study to investigate the effects of IRL201805 in participants with moderately to severely active rheumatoid arthritis - RVLO 221-02 IRL201805 in rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: IRL201805 INN or Proposed INN: IRL201805 Other descriptive name: Modified BiP | Revolo Biotherapeutics Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 2 | Czechia;Hungary;Czech Republic;Spain;Poland;Georgia;Bulgaria;Germany;Latvia;United Kingdom | ||
| 3 | NCT05480878 (ClinicalTrials.gov) | December 2, 2022 | 23/7/2022 | Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis | Clinical Study Evaluating the Efficacy of Nitazoxanide and Escitalopram as Adjuvant Therapies in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Escitalopram 10mg | Tanta University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 90 | Phase 3 | NULL |
| 4 | NCT05604885 (ClinicalTrials.gov) | November 30, 2022 | 31/10/2022 | A Dose-range Study of the Safety and Efficacy of Treatment in Adult Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Two-part, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Dose-range, Safety and Efficacy of 4 and 12 Weeks of Treatment With AP1189 in Adult Rheumatoid Arthritis (RA) Patients With an Inadequate Response to Methotrexate (MTX) Alone - (RESOLVE) | Rheumatoid Arthritis | Drug: AP1189, 60 mg;Drug: AP1189, 80 mg;Drug: AP1189, 100 mg;Drug: Placebo | SynAct Pharma Aps | NBCD A/S | Recruiting | 18 Years | 85 Years | All | 420 | Phase 2 | Moldova, Republic of |
| 5 | NCT05594680 (ClinicalTrials.gov) | November 1, 2022 | 18/10/2022 | Cilostazol and Methotrexate in Rheumatoid Arthritis | The Phosphodiesterase 3 Inhibitor Cilostazol as Adjunct to Methotrexate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Cilostazol;Drug: Methotrexate;Drug: Placebo | Tanta University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 70 | Phase 3 | NULL |
| 6 | NCT05576012 (ClinicalTrials.gov) | October 13, 2022 | 3/10/2022 | First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase) | A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of SOL-116 in Healthy Subjects and Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: SOL-116;Biological: Placebo | Lipum AB | QPS Netherlands B.V. | Recruiting | 18 Years | 65 Years | All | 56 | Phase 1 | Netherlands |
| 7 | NCT05533372 (ClinicalTrials.gov) | October 10, 2022 | 5/9/2022 | MAD Study of IA-14069 | Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IA-14069 in Healthy Subjects, With an Extension to Explore Any Drug-Drug Interaction Potential With Methotrexate (Part 1), and in Patients With Rheumatoid Arthritis, With Preliminary Assessment of Efficacy in Patients (Part 2) | Healthy;Rheumatoid Arthritis | Drug: IA-14069;Drug: Placebo;Drug: Methotrexate | ILAb Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | All | 75 | Phase 1 | United States |
| 8 | NCT05516979 (ClinicalTrials.gov) | September 26, 2022 | 24/8/2022 | A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment | A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment | Rheumatoid Arthritis | Drug: 100 mg AP1189;Drug: Placebo | SynAct Pharma Aps | NBCD A/S | Recruiting | 18 Years | 85 Years | All | 120 | Phase 2 | Moldova, Republic of |
| 9 | NCT05516758 (ClinicalTrials.gov) | August 31, 2022 | 24/8/2022 | A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis | A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis;Arthritis;Joint Diseases;Musculoskeletal Diseases;Rheumatic Diseases;Connective Tissue Diseases;Autoimmune Diseases;Immune System Diseases | Drug: Peresolimab;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 18 Years | N/A | All | 420 | Phase 2 | United States;Argentina;Canada;China;Greece;Hungary;Italy;Japan;Mexico;Poland;Puerto Rico;Spain |
| 10 | NCT05460832 (ClinicalTrials.gov) | August 29, 2022 | 12/7/2022 | Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA | A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy & Safety of MBS2320 in Participants With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response to Methotrexate Alone | Rheumatoid Arthritis | Drug: MBS2320 5 mg;Drug: MBS2320 20 mg;Drug: MBS2320 40 mg;Drug: Placebo | Modern Biosciences Ltd | NULL | Recruiting | 18 Years | 75 Years | All | 224 | Phase 2 | Bosnia and Herzegovina;Bulgaria;Chile;Czechia;Guatemala;Mexico;Poland;Serbia |
| 11 | NCT05437419 (ClinicalTrials.gov) | August 10, 2022 | 23/6/2022 | A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis | A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: TCK-276;Drug: TCK-276 Placebo | Teijin America, Inc. | Parexel | Recruiting | 18 Years | 64 Years | All | 32 | Phase 1 | United States |
| 12 | NCT05274243 (ClinicalTrials.gov) | August 9, 2022 | 1/3/2022 | 2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis | 2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 2-HOBA;Other: Placebo | Vanderbilt University Medical Center | NULL | Recruiting | 18 Years | N/A | All | 32 | Phase 2 | United States |
| 13 | EUCTR2022-000169-42-CZ (EUCTR) | 18/07/2022 | 18/07/2022 | Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects with Moderate to Severe, Active Rheumatoid Arthritis with Inadequate Response or Intolerance to at Least One Biologic Disease modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor | Rheumatoid arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: KPL-404 Other descriptive name: Human IgG4 monoclonal antibody against CD40 | Kiniksa Pharmaceuticals, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 99 | Phase 2 | Serbia;United States;Czechia;Hungary;Czech Republic;Poland;Lithuania;Georgia;Bulgaria;South Africa;Germany;United Kingdom | ||
| 14 | NCT05447520 (ClinicalTrials.gov) | July 15, 2022 | 1/7/2022 | Montelukast Use in Rheumatoid Arthritis | Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Montelukast;Drug: Placebo;Drug: Conventional DMARDs | Noha Mansour | NULL | Recruiting | 18 Years | 80 Years | All | 50 | Phase 2 | Egypt |
| 15 | NCT05165771 (ClinicalTrials.gov) | July 2022 | 8/12/2021 | Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Rheumatoid Arthritis | Drug: GS-5718;Drug: Placebo to match GS-5718;Drug: Tofacitinib 5 mg;Drug: Placebo to match Tofacitinib | Gilead Sciences | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 16 | NCT05092984 (ClinicalTrials.gov) | June 22, 2022 | 28/9/2021 | Evaluation of Spironolactone Efficacy in Patient With Rheumatoid Arthritis (RA) | Evaluation of Spironolactone Efficacy in Patient With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Spironolactone;Drug: Placebo | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | N/A | All | 154 | Phase 3 | France |
| 17 | NCT05363891 (ClinicalTrials.gov) | June 15, 2022 | 2/5/2022 | Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis | Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Natrunix;Drug: Placebo | XBiotech, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 150 | Phase 2 | NULL |
| 18 | NCT05363917 (ClinicalTrials.gov) | June 15, 2022 | 2/5/2022 | Natrunix Versus Methotrexate in Rheumatoid Arthritis | Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix Versus Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Natrunix with MTX placebo (+folate);Drug: Natrunix placebo with MTX (+folate) | XBiotech, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 150 | Phase 2 | NULL |
| 19 | NCT05264025 (ClinicalTrials.gov) | June 1, 2022 | 10/1/2022 | Fexofenadine in Patients With Active Rheumatoid Arthritis | Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid | Rheumatoid Arthritis | Drug: Fexofenadine;Drug: Placebo | October 6 University | NULL | Recruiting | 18 Years | 60 Years | All | 80 | Phase 1/Phase 2 | Egypt |
| 20 | NCT04269993 (ClinicalTrials.gov) | May 18, 2022 | 12/2/2020 | Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis | Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Cannabis: placebo and medium THC/medium CBD | Brown University | NULL | Recruiting | 18 Years | 65 Years | All | 76 | Phase 2 | United States |
| 21 | NCT05374785 (ClinicalTrials.gov) | May 1, 2022 | 4/5/2022 | Efficacy and Safety Study Comparing CPL409116 to Placebo in Participants With Active Rheumatoid Arthritis | A 12-week, Phase II, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing CPL409116 to Placebo, in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to MTX | Rheumatoid Arthritis | Drug: CPL409116;Other: Placebo | Celon Pharma SA | National Center for Research and Development, Poland | Recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | Poland |
| 22 | NCT05380934 (ClinicalTrials.gov) | May 2022 | 16/5/2022 | A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects | A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of TQH3821 in Adult Healthy Subjects | Rheumatoid Arthritis | Drug: TQH3821 tablets;Drug: TQH3821 tablets (Placebo);Drug: Methotrexate tablets | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | NULL | Recruiting | 18 Years | 55 Years | All | 62 | Phase 1 | China |
| 23 | NCT05166304 (ClinicalTrials.gov) | April 2022 | 8/12/2021 | Rebamipide in Patients With Active Rheumatoid Arthritis | Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rebamipide;Drug: Placebo | October 6 University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 100 | Phase 1/Phase 2 | NULL |
| 24 | NCT05245448 (ClinicalTrials.gov) | February 22, 2022 | 22/1/2022 | Tetrandrine in the Treatment of Rheumatoid Arthritis | Comparing the Efficacy of Tetrandrine Combined With Methotrexate and Methotrexate Alone in the Treatment of Rheumatoid arthritis---a Randomized, Double-blinded, Placebo-controlled, Multicenter Study | Rheumatoid Arthritis | Drug: Tetrandrine;Drug: Placebo | Peking University People's Hospital | NULL | Not yet recruiting | 18 Years | 65 Years | All | 240 | N/A | China |
| 25 | NCT05279417 (ClinicalTrials.gov) | February 2, 2022 | 18/2/2022 | ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA | ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Alone | Rheumatoid Arthritis | Drug: ATI-450 50mg oral tablet BID;Drug: Placebo oral tablet;Drug: Methotrexate;Drug: ATI-450 20mg oral tablet BID | Aclaris Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 2 | United States;Czechia;Poland |
| 26 | NCT05053165 (ClinicalTrials.gov) | January 4, 2022 | 16/9/2021 | A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants | A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of LB-P6 or LB-P8 in Healthy Participants | Rheumatoid Arthritis;Non-Alcoholic Steatohepatitis | Drug: LB-P6;Drug: LB-P8;Drug: Placebo | LISCure Biosciences | NULL | Completed | 18 Years | 65 Years | All | 31 | Phase 1 | Australia |
| 27 | NCT05090124 (ClinicalTrials.gov) | January 1, 2022 | 20/7/2021 | Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis | Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Adalimumab;Drug: Placebo | NHS Greater Glasgow and Clyde | University of Glasgow | Not yet recruiting | 18 Years | 74 Years | All | 50 | N/A | NULL |
| 28 | NCT04924270 (ClinicalTrials.gov) | January 2022 | 7/6/2021 | Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases | Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial | Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis | Biological: Faecal microbiota transplantation;Other: Placebo | Torkell Ellingsen | Region of Southern Denmark;University of Southern Denmark | Not yet recruiting | 18 Years | 70 Years | All | 200 | Phase 2 | NULL |
| 29 | NCT05198310 (ClinicalTrials.gov) | December 14, 2021 | 3/1/2022 | Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor | A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor | Arthritis, Rheumatoid | Drug: KPL-404;Drug: Placebo | Kiniksa Pharmaceuticals, Ltd. | NULL | Recruiting | 18 Years | 80 Years | All | 91 | Phase 2 | United States;Czechia |
| 30 | EUCTR2020-005303-39-IT (EUCTR) | 01/12/2021 | 12/10/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/orTargeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: [ABBV-154] INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: [ABBV-154] INN or Proposed INN: ABBV-154 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 31 | EUCTR2020-005303-39-NL (EUCTR) | 11/11/2021 | 28/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 32 | EUCTR2020-005303-39-SK (EUCTR) | 04/11/2021 | 16/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 33 | EUCTR2020-005303-39-PL (EUCTR) | 02/11/2021 | 26/08/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 34 | NCT04834557 (ClinicalTrials.gov) | November 1, 2021 | 2/4/2021 | Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis | Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt | Rheumatoid Arthritis | Drug: Placebo;Drug: Digoxin 0.25 mg;Drug: Ursodeoxycholic acid (UDCA) 500 mg | Tanta University | NULL | Recruiting | 18 Years | 80 Years | All | 90 | Phase 2 | Egypt |
| 35 | EUCTR2020-005303-39-DE (EUCTR) | 26/10/2021 | 07/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 473 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 36 | EUCTR2020-005303-39-GR (EUCTR) | 21/10/2021 | 13/09/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 37 | NCT04985812 (ClinicalTrials.gov) | October 18, 2021 | 6/7/2021 | A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis | A Multicenter, Double-blind, Placebo-controlled, Randomized, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of JNJ-67484703 in Participants With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: JNJ-67484703;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 47 | Phase 1 | United States;Georgia;Hungary;Moldova, Republic of;Spain;Ukraine |
| 38 | NCT04991753 (ClinicalTrials.gov) | October 14, 2021 | 2/8/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy | Arthritis, Rheumatoid | Other: Placebo;Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 75 Years | All | 53 | Phase 2 | United States;Germany;Poland;Spain;United Kingdom |
| 39 | NCT04911127 (ClinicalTrials.gov) | October 5, 2021 | 14/5/2021 | Therapeutic Response of Cannabidiol in Rheumatoid Arthritis | Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis;Cannabis | Drug: 200mg Cannabidiol by capsules twice daily;Drug: 400mg Cannabidiol by capsules twice daily;Drug: Placebo capsules | University of California, Los Angeles | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 1/Phase 2 | United States |
| 40 | EUCTR2021-000510-42-DE (EUCTR) | 05/10/2021 | 16/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Spain;Poland;Germany;United Kingdom | ||
| 41 | ChiCTR2100048769 | 2021-09-29 | 2021-07-16 | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | rheumatoid arthritis | Test group:Methotrexate tablets+Qufengzhitong capsule;control group:Methotrexate tablets+Qufeng Zhitong Capsule Placebo; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 75 | Both | Test group:102;control group:102; | Phase 4 | china |
| 42 | ITMCTR2100005057 | 2021-09-29 | 2021-07-16 | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis | rheumatoid arthritis | control group:Methotrexate tablets+Qufeng Zhitong Capsule Placebo;Test group:Methotrexate tablets+Qufengzhitong capsule; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 75 | Both | control group:102;Test group:102; | Phase 4 | china |
| 43 | EUCTR2021-000510-42-ES (EUCTR) | 17/09/2021 | 09/07/2021 | A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis. | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. - IRIS | Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;Poland;Spain;Germany;United Kingdom | ||
| 44 | EUCTR2020-005303-39-ES (EUCTR) | 31/08/2021 | 02/07/2021 | This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) - Moderate to Severe RA: A Phase 2b, Dose-Ranging, Safety and Efficacy Study of ABBV-154 | Moderate to Severe Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;Hungary;Canada;Puerto Rico;Poland;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 45 | NCT04870203 (ClinicalTrials.gov) | July 15, 2021 | 26/4/2021 | Combination of Baricitinib and Adalimumab in Rheumatoid Arthritis | Combination of Baricitinib and Adalimumab vs. Baricitinib in Patients With Rheumatoid Arthritis: a Randomized Placebo-controlled Phase III Trial | Rheumatoid Arthritis | Drug: baricitinib treatment;Drug: adalimumab;Drug: Placebo | University Hospital, Bordeaux | Eli Lilly and Company;Biogen;Ministry for Health and Solidarity, France | Recruiting | 18 Years | 75 Years | All | 178 | Phase 3 | France;Monaco |
| 46 | NCT05117593 (ClinicalTrials.gov) | June 28, 2021 | 23/9/2021 | Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX | Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single-Ascending Doses of FBL-MTX in Healthy Subjects | Rheumatoid Arthritis | Drug: FBL-MTX;Drug: Placebo | SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | Portugal |
| 47 | NCT04909931 (ClinicalTrials.gov) | June 15, 2021 | 11/5/2021 | Vitamin D Supplementation on Outcome and Disease Activity. | Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients at Rajavithi Hospital : A Randomized Clinical Trial | Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR | Drug: Vitamin D 2;Drug: Placebo | Rajavithi Hospital | NULL | Recruiting | 18 Years | N/A | All | 60 | N/A | Thailand |
| 48 | EUCTR2019-002205-22-NL (EUCTR) | 15/06/2021 | 11/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom | ||
| 49 | NCT04888585 (ClinicalTrials.gov) | June 2, 2021 | 13/5/2021 | Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | Rheumatoid Arthritis (RA) | Drug: ABBV-154;Drug: Placebo | AbbVie | NULL | Active, not recruiting | 18 Years | 75 Years | All | 473 | Phase 2 | United States;Australia;Canada;Czechia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;France;United Kingdom |
| 50 | NCT05078502 (ClinicalTrials.gov) | June 1, 2021 | 4/10/2021 | Role of Vitamin D3 Supplementation With Conventional Synthetic Disease Modifying Antirheumatic Drugs(csDMARD) in Rheumatoid Arthritis Patients | Role of Vitamin D3 Supplementation With Conventional Synthetic Disease Modifying Antirheumatic Drugs (csDMARD) in Rheumatoid Arthritis Patients: Randomized Double-blind Placebo Controlled Trial | Rheumatoid Arthritis | Dietary Supplement: Vitamin D3 | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | NULL | Completed | 18 Years | 70 Years | All | 58 | N/A | Bangladesh |
| 51 | NCT04884880 (ClinicalTrials.gov) | May 14, 2021 | 30/4/2021 | Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis | Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Luo-Fu-Shan Plaster;Drug: The placebo 10g | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Not yet recruiting | 18 Years | 75 Years | All | 180 | N/A | China |
| 52 | NCT05247216 (ClinicalTrials.gov) | March 26, 2021 | 31/5/2021 | A Phase 2 Study of Hemay007 in Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Hemay007 in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Hemay007 800 mg QD group;Drug: Hemay007 1200 mg QD group;Drug: Hemay007 600 mg QD group;Drug: Hemay007 placebo group | Tianjin Hemay Pharmaceutical Co.,Ltd | NULL | Recruiting | 18 Years | 75 Years | All | 140 | Phase 2 | China |
| 53 | NCT04757571 (ClinicalTrials.gov) | February 1, 2021 | 12/2/2021 | The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients | The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients. A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. | Rheumatoid Arthritis | Drug: Paroxetine;Drug: Placebo | Sadat City University | NULL | Recruiting | 18 Years | 60 Years | All | 120 | Phase 1/Phase 2 | Egypt |
| 54 | NCT04535427 (ClinicalTrials.gov) | January 1, 2021 | 22/8/2020 | Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis | Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: L-arginine;Drug: Placebo | RenJi Hospital | NULL | Not yet recruiting | 18 Years | 45 Years | All | 144 | Phase 2 | China |
| 55 | ChiCTR2000036094 | 2021-01-01 | 2020-08-21 | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | Rheumatoid Arthritis | Experimental group:Duhuo Jisheng Tang, MTX as base treatment.;Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.; | Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 70 | Both | Experimental group:60;Control group:60; | China | |
| 56 | ITMCTR2000003610 | 2021-01-01 | 2020-08-21 | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage | Rheumatoid Arthritis | Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.;Experimental group:Duhuo Jisheng Tang, MTX as base treatment.; | Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 70 | Both | Control group:60;Experimental group:60; | China | |
| 57 | EUCTR2020-003955-14-DE (EUCTR) | 21/12/2020 | 04/11/2020 | A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy. | Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AMT-101 Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Germany | ||
| 58 | NCT04586933 (ClinicalTrials.gov) | December 10, 2020 | 22/9/2020 | Nutrition in Rheumatic Diseases | Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance | Spondyloarthritis;Rheumatoid Arthritis;Polyarthritis | Dietary Supplement: Omega-3;Dietary Supplement: Placebo (soya);Behavioral: Dietary guidance | Haukeland University Hospital | GC Rieber Oils AS | Recruiting | 18 Years | 75 Years | All | 120 | N/A | Norway |
| 59 | NCT04196868 (ClinicalTrials.gov) | December 3, 2020 | 5/12/2019 | Methotrexate and Metformin in Rheumatoid Arthritis Patients | Randomized Placebo-controlled Trial Comparing Methotrexate vs. Methotrexate/Metformin Association in Rheumatoid Arthritis Patients | Arthritis, Rheumatoid | Drug: Metformin treatment;Other: Placebo;Drug: Methotrexate treatment | University Hospital, Bordeaux | Ministry for Health and Solidarity, France | Recruiting | 18 Years | N/A | All | 128 | Phase 2 | France |
| 60 | ChiCTR2000034924 | 2020-10-30 | 2020-07-24 | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Rheumatoid arthritis, Sjogren's syndrome | Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets; | The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | NULL | Pending | Both | Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler | Phase 1 | China | ||
| 61 | EUCTR2020-000658-83-BG (EUCTR) | 21/10/2020 | 07/10/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | Poland;Ukraine;Georgia;Bulgaria | ||
| 62 | NCT04577781 (ClinicalTrials.gov) | October 12, 2020 | 30/9/2020 | A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: GLPG3970;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 64 Years | All | 28 | Phase 2 | Bulgaria;Georgia;Poland;Ukraine |
| 63 | ChiCTR2000036141 | 2020-10-01 | 2020-08-21 | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | Rheumatoid arthritis | 1:Guizhi Decoction+MTX;2:Placebo+MTX; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 75 | Both | 1:76;2:76; | China | |
| 64 | ChiCTR2000037008 | 2020-10-01 | 2020-08-26 | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | rheumatoid arthritis | experimental group:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day;control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day; | Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | 18 | 80 | Both | experimental group:53;control group:53; | China | |
| 65 | ITMCTR2000003729 | 2020-10-01 | 2020-08-26 | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study | rheumatoid arthritis | experimental group:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day;control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day; | Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | 18 | 80 | Both | experimental group:53;control group:53; | China | |
| 66 | EUCTR2019-002205-22-FR (EUCTR) | 01/10/2020 | 13/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 67 | ITMCTR2000003615 | 2020-10-01 | 2020-08-21 | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation | Rheumatoid arthritis | 2:Placebo+MTX;1:Guizhi Decoction+MTX; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 75 | Both | 2:76;1:76; | China | |
| 68 | NCT04638426 (ClinicalTrials.gov) | September 10, 2020 | 13/11/2020 | Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis | For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa) | Rheumatoid Arthritis | Drug: HL237 tablet;Drug: Placebo of HL237 tablet | Hanlim Pharm. Co., Ltd. | NULL | Enrolling by invitation | 19 Years | N/A | All | 196 | Phase 2 | Korea, Republic of |
| 69 | EUCTR2019-002205-22-DE (EUCTR) | 12/08/2020 | 07/07/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 70 | NCT04333771 (ClinicalTrials.gov) | July 31, 2020 | 2/4/2020 | A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs. | Rheumatoid Arthritis | Drug: SHR0302;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | China |
| 71 | EUCTR2019-001185-15-BG (EUCTR) | 29/05/2020 | 15/05/2020 | A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 72 | EUCTR2019-002205-22-BE (EUCTR) | 05/05/2020 | 21/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 73 | EUCTR2019-002205-22-GB (EUCTR) | 01/05/2020 | 07/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 74 | EUCTR2019-000867-26-DE (EUCTR) | 08/04/2020 | 04/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 75 | EUCTR2019-002205-22-ES (EUCTR) | 06/04/2020 | 23/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 76 | EUCTR2019-002205-22-PL (EUCTR) | 29/03/2020 | 07/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Belgium;Spain;Poland;Germany;Netherlands;United Kingdom | ||
| 77 | NCT04247815 (ClinicalTrials.gov) | March 16, 2020 | 16/1/2020 | Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA | A Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ATI-450;Drug: Placebo oral tablet;Drug: Methotrexate | Aclaris Therapeutics, Inc. | NULL | Completed | 18 Years | 70 Years | All | 19 | Phase 2 | United States |
| 78 | EUCTR2019-000868-18-DE (EUCTR) | 13/03/2020 | 08/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan | ||
| 79 | EUCTR2019-001185-15-NO (EUCTR) | 19/02/2020 | 07/11/2019 | A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 80 | NCT04186871 (ClinicalTrials.gov) | January 7, 2020 | 28/11/2019 | Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis | Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome | Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia |
| 81 | JPRN-UMIN000042632 | 2020/01/01 | 03/12/2020 | THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS | THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis | Rheumatoid arthritis | low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses. The laser apparatuses used for therapy in this study were the following, 1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW. 2.GaAIAs diode laser (830 nm, maximum output power 300 mW). 12 patients placebo laser and naproxen Naproxen is given as tablet 500mg twice per day. 12 patients naproxen Naproxen is given as tablet 500mg twice per day. 10 patients | Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 34 | Not applicable | Asia(except Japan) |
| 82 | NCT04115397 (ClinicalTrials.gov) | January 2020 | 2/10/2019 | Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints | Towards Efficient Prediction and Prevention of Rheumatoid Arthritis | Seropositive Muskuloskeletal Complaints | Drug: Zoledronic Acid;Drug: Placebo | Karolinska Institutet | NULL | Not yet recruiting | 18 Years | N/A | All | 80 | Phase 4 | NULL |
| 83 | EUCTR2019-000797-39-IT (EUCTR) | 20/12/2019 | 24/05/2021 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severelyactive rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Xeljanz Product Name: Tofacitinib Product Code: [Tofacitinib] INN or Proposed INN: Tofacitinib citrate Product Name: GSK3196165 Product Code: [GSK3196165] INN or Proposed INN: Otilimab | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;Sweden | ||
| 84 | EUCTR2019-000868-18-IT (EUCTR) | 18/12/2019 | 17/06/2021 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 20.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: N/A Product Name: Otilimab Product Code: [GSK3196165] INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab Product Code: [N/A] INN or Proposed INN: Sarilumab Trade Name: NA Product Name: Otilimab Product Code: [GSK3196165] Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: NA Product Name: Otilimab Product Code: [GSK3196165] Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 85 | EUCTR2019-000867-26-GB (EUCTR) | 10/12/2019 | 12/06/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of | ||
| 86 | NCT04163991 (ClinicalTrials.gov) | December 9, 2019 | 12/11/2019 | A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: VIB4920;Drug: Placebo | Viela Bio | NULL | Completed | 18 Years | 99 Years | All | 78 | Phase 2 | United States;Poland |
| 87 | EUCTR2019-000868-18-GB (EUCTR) | 02/12/2019 | 11/06/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Kevzara INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colo | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 88 | EUCTR2019-000797-39-GB (EUCTR) | 22/11/2019 | 10/06/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation | ||
| 89 | EUCTR2018-004287-56-FR (EUCTR) | 21/11/2019 | 31/01/2020 | Methotrexate and Metformin in rheumatoid arthritis patients | Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2 | rheumatoid arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: METFORMINE ARROW 500mg Product Name: Metformin Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Acide folique Product Name: Acide folique Product Code: B03BB01 Trade Name: Prednisone Product Name: Prednisone Product Code: H02AB07 | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 90 | NCT04227366 (ClinicalTrials.gov) | November 19, 2019 | 25/12/2019 | Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: BCD-089;Biological: Placebo;Drug: Methotrexat | Biocad | NULL | Completed | 18 Years | N/A | All | 154 | Phase 3 | Russian Federation |
| 91 | EUCTR2019-000797-39-PL (EUCTR) | 18/11/2019 | 15/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anit human granulocyt-macrophage colony-stimulating factor (GM-CSF)monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF)monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 92 | EUCTR2019-000868-18-PL (EUCTR) | 15/11/2019 | 11/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Antihuman granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 93 | EUCTR2019-000867-26-PL (EUCTR) | 15/11/2019 | 15/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of | ||
| 94 | EUCTR2019-000868-18-ES (EUCTR) | 14/11/2019 | 26/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 95 | EUCTR2019-000797-39-ES (EUCTR) | 14/11/2019 | 09/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 96 | EUCTR2019-000867-26-ES (EUCTR) | 14/11/2019 | 09/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 97 | NCT04038970 (ClinicalTrials.gov) | November 8, 2019 | 29/7/2019 | Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate | Rheumatoid Arthritis | Biological: KN019, 5mg/kg;Biological: KN019, 10 mg/kg;Biological: Placebo;Combination Product: Methotrexate | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | NULL | Completed | 18 Years | N/A | All | 145 | Phase 2 | China |
| 98 | EUCTR2019-001185-15-SE (EUCTR) | 06/11/2019 | 01/07/2019 | A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 99 | EUCTR2019-000867-26-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 100 | EUCTR2019-000797-39-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China | ||
| 101 | EUCTR2019-000868-18-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan | ||
| 102 | EUCTR2019-000867-26-BG (EUCTR) | 11/10/2019 | 30/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 103 | EUCTR2019-000797-39-LT (EUCTR) | 11/10/2019 | 19/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 104 | EUCTR2019-000868-18-LT (EUCTR) | 11/10/2019 | 19/07/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Czechia;Spain;Lithuania;Italy;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan | ||
| 105 | EUCTR2019-000867-26-EE (EUCTR) | 10/10/2019 | 01/08/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 106 | ITMCTR1900002626 | 2019-09-28 | 2019-09-28 | A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue | Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial | Rheumatoid arthritis (RA);FA20 | High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ; | Zhejiang Provincal Hospital of TCM | NULL | Pending | 18 | 70 | Both | High-dose experimental group :30;Low-dose experimental group:30;Control group :30; | Phase 2 | China |
| 107 | ChiCTR1900026257 | 2019-09-28 | 2019-09-28 | A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue | Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial | Rheumatoid arthritis (RA) | High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ; | Zhejiang Provincal Hospital of TCM | NULL | Pending | 18 | 70 | Both | High-dose experimental group :30;Low-dose experimental group:30;Control group :30; | Phase 2 | China |
| 108 | EUCTR2019-000868-18-CZ (EUCTR) | 20/09/2019 | 20/08/2019 | Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. | A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Argentina;Hungary;United States;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Belgium;China;Korea, Republic of;Poland;Italy;South Africa;Lithuania;Germany | ||
| 109 | EUCTR2019-000797-39-CZ (EUCTR) | 19/09/2019 | 18/09/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 110 | EUCTR2018-004677-27-BE (EUCTR) | 16/09/2019 | 25/03/2019 | Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. | Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Belgium | ||
| 111 | EUCTR2019-000797-39-LV (EUCTR) | 13/09/2019 | 25/06/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 112 | NCT04004429 (ClinicalTrials.gov) | August 26, 2019 | 26/6/2019 | A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease | A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease | Rheumatoid Arthritis | Drug: 50 mg AP1189;Drug: AP1189;Drug: Placebo | SynAct Pharma Aps | NULL | Completed | 18 Years | 85 Years | All | 105 | Phase 2 | Denmark;Norway |
| 113 | JPRN-JapicCTI-194928 | 26/8/2019 | 22/08/2019 | -An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101 | An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101 | Rheumatoid Arthritis | Intervention name : methotrexate INN of the intervention : methotrexate Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg. Control intervention name : methotrexate INN of the control intervention : methotrexate Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval. | medac GmbH | NULL | complete | 20 | 75 | BOTH | 100 | Phase 3 | Japan |
| 114 | NCT04068246 (ClinicalTrials.gov) | August 1, 2019 | 21/8/2019 | The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients | The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. | Rheumatoid Arthritis | Drug: Metformin;Drug: Placebo | Sadat City University | NULL | Completed | 18 Years | N/A | All | 120 | Phase 1/Phase 2 | Egypt |
| 115 | EUCTR2018-004677-27-HU (EUCTR) | 25/07/2019 | 25/07/2019 | Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients. | Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy. | Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Belgium | ||
| 116 | EUCTR2018-003933-14-BE (EUCTR) | 19/07/2019 | 24/04/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 117 | EUCTR2018-003330-32-PL (EUCTR) | 19/07/2019 | 06/05/2019 | Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies | Rheumatoid Arthritis Despite Treatment With Conventional Therapies MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cevidoplenib Product Code: SKI-O-703 INN or Proposed INN: Cevidoplenib | Oscotec Inc. | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 2 | United States;Serbia;Czech Republic;Poland;Ukraine;Russian Federation;Korea, Republic of | ||
| 118 | ChiCTR1900024261 | 2019-07-15 | 2019-07-03 | Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China | Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China | rheumatoid arthritis | A:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d);B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week); | The Second Hospital of Shanxi Medical University | NULL | Pending | 18 | 65 | Both | A:30;B:30; | Phase 4 | China |
| 119 | EUCTR2016-003682-26-PL (EUCTR) | 11/07/2019 | 17/05/2018 | Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid Arthritis | A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis | Early Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: METHOTREXATE Product Code: METHOTREXATE INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Can-Fite BioPharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 120 | NCT03813199 (ClinicalTrials.gov) | July 4, 2019 | 15/1/2019 | Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis | Phase IIa Randomized, Double Blind, Placebo Controlled, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to Anti-Tnfa, or Intolerance to Anti-Tnfa | Rheumatoid Arthritis | Drug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: Methotrexate | Abivax S.A. | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | Belgium;Czechia;France;Hungary;Poland |
| 121 | EUCTR2018-003933-14-BG (EUCTR) | 21/06/2019 | 27/03/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Czechia;Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 122 | EUCTR2019-001185-15-DK (EUCTR) | 06/06/2019 | 12/04/2019 | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 | rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 123 | NCT03970837 (ClinicalTrials.gov) | June 5, 2019 | 16/5/2019 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs) | A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs | Arthritis, Rheumatoid | Biological: GSK3196165 (Otilimab);Drug: Tofacitinib;Drug: Placebo to GSK3196165 (Otilimab);Drug: Placebo to Tofacitinib;Drug: csDMARDs | GlaxoSmithKline | Iqvia Pty Ltd | Terminated | 18 Years | N/A | All | 1764 | Phase 3 | United States;Argentina;Australia;Bulgaria;China;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Thailand;United Kingdom;Brazil |
| 124 | EUCTR2018-003933-14-CZ (EUCTR) | 28/05/2019 | 29/04/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of | ||
| 125 | EUCTR2018-003933-14-LV (EUCTR) | 27/05/2019 | 07/03/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of | ||
| 126 | NCT03980483 (ClinicalTrials.gov) | May 16, 2019 | 15/5/2019 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Arthritis, Rheumatoid | Biological: GSK3196165 (Otilimab);Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acid | GlaxoSmithKline | Iqvia Pty Ltd | Completed | 18 Years | N/A | All | 1537 | Phase 3 | United States;Argentina;Canada;China;Czechia;Hungary;India;Italy;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom |
| 127 | NCT03823378 (ClinicalTrials.gov) | May 13, 2019 | 8/1/2019 | A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib. | A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599) | Rheumatoid Arthritis (RA) | Drug: Upadacitinib;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo;Drug: ABBV-105 | AbbVie | NULL | Completed | 18 Years | N/A | All | 97 | Phase 2 | Belgium;Canada;Czechia;Hungary;Poland;Spain;United Kingdom |
| 128 | EUCTR2018-003933-14-ES (EUCTR) | 30/04/2019 | 21/05/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 129 | EUCTR2018-003933-14-EE (EUCTR) | 09/04/2019 | 14/03/2019 | A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia | ||
| 130 | NCT03823391 (ClinicalTrials.gov) | March 27, 2019 | 29/1/2019 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis (RA) | Drug: ABBV-3373;Drug: Placebo for ABBV-3373;Drug: Adalimumab;Drug: Placebo for adalimumab | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 48 | Phase 2 | United States;Germany;Hungary;Israel;Netherlands;Poland;Puerto Rico |
| 131 | NCT04057118 (ClinicalTrials.gov) | March 20, 2019 | 13/8/2019 | A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies. | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies | Rheumatoid Arthritis | Drug: SKI-O-703;Drug: Placebo | Oscotec Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 148 | Phase 2 | United States;Czechia;Poland;Russian Federation;Ukraine |
| 132 | NCT03890302 (ClinicalTrials.gov) | March 14, 2019 | 25/3/2019 | Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A | A Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704A | Rheumatoid Arthritis | Drug: FB704A;Drug: Placebo | Fountain Biopharma Inc. | Oneness Biotech Co., Ltd. | Completed | 18 Years | 55 Years | All | 31 | Phase 1 | United States |
| 133 | NCT03863405 (ClinicalTrials.gov) | January 9, 2019 | 4/3/2019 | Metformin Use in Rheumatoid Arthritis | The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Metformin;Drug: Conventional DMARDs;Drug: Placebo Oral Tablet | Ain Shams University | Future University in Egypt | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Egypt |
| 134 | NCT03896594 (ClinicalTrials.gov) | December 24, 2018 | 28/3/2019 | A Multiple Dose of HL237 in Healthy Male Subject | A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject | Rheumatoid Arthritis | Drug: HL237;Drug: Placebo Oral Tablet | Hanlim Pharm. Co., Ltd. | NULL | Recruiting | 20 Years | 45 Years | Male | 36 | Phase 1 | Korea, Republic of |
| 135 | NCT04204603 (ClinicalTrials.gov) | November 30, 2018 | 17/12/2019 | A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: CKD-506;Drug: Placebo | Chong Kun Dang Pharmaceutical | NULL | Completed | 18 Years | 65 Years | All | 122 | Phase 2 | Czechia;Georgia;Poland;Russian Federation;Ukraine |
| 136 | EUCTR2017-004226-15-DK (EUCTR) | 26/10/2018 | 05/01/2018 | Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. | CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art | Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Cannabidiol tablet 10 mg Other descriptive name: CANNABIDIOL Product Name: Dronabinol capsule 2.5. mg INN or Proposed INN: DRONABINOL | King Christian 10th Hospital for Rheumatology | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Denmark | ||
| 137 | EUCTR2018-001377-24-CZ (EUCTR) | 09/10/2018 | 14/10/2019 | Not available. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CKD-506 INN or Proposed INN: Not yet assigned | Chong Kun Dang Pharmaceutical Corporation (CKD) | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Poland;Ukraine;Russian Federation;Georgia | ||
| 138 | NCT03682705 (ClinicalTrials.gov) | October 8, 2018 | 21/9/2018 | A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis. | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs | Rheumatoid Arthritis (RA) | Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 242 | Phase 2 | United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland |
| 139 | NCT03593837 (ClinicalTrials.gov) | October 1, 2018 | 10/7/2018 | Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid Arthritis | Huang Qi Gui Zhi Wu Wu Granule;Rheumatoid Arthritis | Drug: Huang qi gui zhi wu wu granule;Drug: Huang qi gui zhi wu wu granule placebo | Cui xuejun | NULL | Unknown status | 18 Years | 80 Years | All | 100 | Phase 2/Phase 3 | NULL |
| 140 | NCT03660059 (ClinicalTrials.gov) | September 27, 2018 | 26/8/2018 | A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX) | A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX | Rheumatoid Arthritis (RA) | Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs) | Astellas Pharma China, Inc. | NULL | Completed | 18 Years | N/A | All | 385 | Phase 3 | China;Korea, Republic of;Taiwan |
| 141 | JPRN-JapicCTI-184029 | 04/9/2018 | 09/07/2018 | A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy | A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy | Rheumatoid Arthritis (RA) | Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain | Taisho Pharmaceutical co., LTD | NULL | complete | 20 | 75 | BOTH | 370 | Phase 2-3 | Japan |
| 142 | NCT02927522 (ClinicalTrials.gov) | September 1, 2018 | 5/10/2016 | Donepezil Attenuate Postoperative Cognitive Dysfunction | Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail | Osteoarthritis;Femoral Head Necrosis;Rheumatoid Arthritis | Drug: Donepezil;Drug: Placebo | RenJi Hospital | Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | Recruiting | 60 Years | N/A | All | 550 | Phase 3 | China |
| 143 | NCT03605251 (ClinicalTrials.gov) | August 30, 2018 | 3/7/2018 | Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis. | An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: TAS5315 low dose;Drug: TAS5315 high dose;Drug: Placebos | Taiho Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | 64 Years | All | 91 | Phase 2 | Japan |
| 144 | NCT03618784 (ClinicalTrials.gov) | July 11, 2018 | 24/7/2018 | Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: FURESTEM-RA Inj;Other: sterile saline | Kang Stem Biotech Co., Ltd. | NULL | Completed | 19 Years | 80 Years | All | 33 | Phase 1/Phase 2 | Korea, Republic of |
| 145 | NCT02885597 (ClinicalTrials.gov) | July 2018 | 18/8/2016 | Juanbi Pill for Rheumatoid Arthritis | Juanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical Trials | Juanbi Pill;Rheumatoid Arthritis | Drug: Juanbi pill;Drug: Juanbi pill placebo;Drug: Methotrexate | Cui xuejun | Shanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | Unknown status | 18 Years | 80 Years | All | 120 | Phase 2/Phase 3 | China |
| 146 | NCT03173040 (ClinicalTrials.gov) | July 2018 | 30/5/2017 | The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis | The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis: a Study Protocol for a Multicenter, Randomized, Controlled Clinical Trial | Niu Bang Zi Pill;Rheumatoid Arthritis | Drug: NiuBangZi pill or NiuBangZi pill placebo | Cui xuejun | Shanghai Yueyang Integrated Medicine Hospital;Longhua Hospital;Shanghai Seventh People's Hospital | Unknown status | 18 Years | 80 Years | All | 100 | Phase 2/Phase 3 | China |
| 147 | NCT03522415 (ClinicalTrials.gov) | May 28, 2018 | 29/4/2018 | Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Moderately to Severely Active Rheumatoid Arthritis | Drug: HLX01;Drug: Methotrexate(MTX) | Shanghai Henlius Biotech | NULL | Completed | 18 Years | 75 Years | All | 275 | Phase 3 | China |
| 148 | NCT03410056 (ClinicalTrials.gov) | May 22, 2018 | 3/1/2018 | Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy | Rheumatoid Arthritis RA | Drug: AMG 592;Drug: Placebo | Amgen | NULL | Terminated | 18 Years | 70 Years | All | 36 | Phase 1/Phase 2 | United States;Bulgaria;Germany;Poland;Spain |
| 149 | NCT03435601 (ClinicalTrials.gov) | April 18, 2018 | 31/1/2018 | A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA) | A Randomised, Double-blind, Placebo-controlled Phase II Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA) | Rheumatoid Arthritis | Drug: Anifrolumab;Drug: Placebos | Josef Smolen, Univ. Prof. Dr. | NULL | Recruiting | 18 Years | 70 Years | All | 24 | Phase 2 | Austria |
| 150 | NCT03455842 (ClinicalTrials.gov) | February 1, 2018 | 22/2/2018 | The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis | International Multicenter Comparative Randomized Double-blind Placebo-controlled Clinical Study of Efficacy and Safety of BCD-089 in Different Dosing Regimens in Patients With Active Rheumatoid Arthritis | Seropositive RA | Biological: BCD-089, 162 mg, s/c, qw;Biological: BCD-089, 162 mg, s/c, q2w;Drug: placebo | Biocad | NULL | Completed | 18 Years | 80 Years | All | 105 | Phase 2 | Belarus;Russian Federation |
| 151 | EUCTR2016-004038-24-RO (EUCTR) | 12/01/2018 | 26/05/2022 | A 12-week study of a new treatment, MBS2320, in Patients with Rheumatoid Arthritis Taking Methotrexate | A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients with Active Rheumatoid Arthritis receiving Methotrexate | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: MBS2320 INN or Proposed INN: 4'-chloro-2'-cyano-N-(trans-4-hydroxy-4-methylcyclohexyl)-biphenyl-4-sulphonamide | Modern Biosciences plc | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Romania;Georgia;Moldova, Republic of | ||
| 152 | NCT02955212 (ClinicalTrials.gov) | January 3, 2018 | 2/11/2016 | A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) | Rheumatoid Arthritis (RA) | Drug: Upadacitinib;Drug: Placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 338 | Phase 3 | Brazil;China;Korea, Republic of |
| 153 | JPRN-UMIN000030237 | 2018/01/01 | 03/12/2017 | Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial | Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial - Additional postoperative intravenous tranexamic acid administration versus placebo in total knee arthroplasty | Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis | Additional postoperative intravenous tranexamic acid group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. In addition, patients received 1000mg/100mL of tranexamic acid administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery. Placebo group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. Patients received 100 mL of normal saline administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery. | Hokusuikai Kinen Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not selected | Japan |
| 154 | NCT02795299 (ClinicalTrials.gov) | January 2018 | 2/5/2016 | Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid Arthritis | Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa Antagonist | Rheumatoid Arthritis | Drug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Placebo | Bird Rock Bio, Inc. | Techtrials Pesquisa e Tecnologia Ltda;Pharmagenix | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 155 | NCT04312815 (ClinicalTrials.gov) | December 28, 2017 | 16/3/2020 | A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX | A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis(RA) | Drug: SM03;Drug: Placebo;Drug: MTX | SinoMab Pty Ltd | NULL | Recruiting | 18 Years | 70 Years | All | 510 | Phase 3 | China |
| 156 | NCT03186417 (ClinicalTrials.gov) | December 15, 2017 | 12/6/2017 | Mesenchymal Stem Cells in Early Rheumatoid Arthritis | Cell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 Trial | Rheumatoid Arthritis | Biological: 2 million hMSC/kg;Biological: 4 million hMSC/kg;Biological: 6 million hMSC/kg;Biological: placebo | MetroHealth Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | 18 Years | 80 Years | All | 20 | Phase 1 | United States |
| 157 | EUCTR2017-001717-92-AT (EUCTR) | 11/12/2017 | 17/08/2017 | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA) | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA | High IFN siganture in patients with rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab (MEDI-546) INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | Medical University of Vienna | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Austria;Switzerland;Italy | ||
| 158 | NCT03254966 (ClinicalTrials.gov) | November 24, 2017 | 15/8/2017 | Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SHR0302;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 70 Years | All | 194 | Phase 2 | China |
| 159 | NCT03334851 (ClinicalTrials.gov) | November 17, 2017 | 3/11/2017 | Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis | A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: PF-06835375;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 74 | Phase 1 | United States;Puerto Rico |
| 160 | NCT04178070 (ClinicalTrials.gov) | November 6, 2017 | 24/11/2019 | Phase ? Clinical Trial of Gerilimzumab Injection in Healthy Subjects | A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase ? Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects. | Rheumatoid Arthritis | Biological: GB224 2mg;Biological: GB224 5mg;Biological: GB224 10mg;Biological: GB224 15mg;Biological: GB224 20mg;Biological: GB224 30mg;Other: Placebo, 2mg;Other: Placebo, 5mg;Other: Placebo, 10mg;Other: Placebo, 15mg;Other: Placebo, 20mg;Other: Placebo, 30mg | Genor Biopharma Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 58 | Phase 1 | China |
| 161 | NCT03329885 (ClinicalTrials.gov) | November 2, 2017 | 31/10/2017 | A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis | A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis | Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis | Drug: BMS-986251;Other: Placebo | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 70 Years | All | 38 | Phase 1/Phase 2 | Netherlands |
| 162 | EUCTR2017-000384-32-BG (EUCTR) | 02/11/2017 | 12/07/2017 | Phase IIb in Rheumatoid Arthritis | A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 363 | Phase 2 | United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan | ||
| 163 | NCT02647762 (ClinicalTrials.gov) | October 30, 2017 | 16/12/2015 | CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis | A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTX | Can-Fite BioPharma | NULL | Active, not recruiting | 18 Years | 75 Years | All | 525 | Phase 3 | Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia |
| 164 | NCT03337815 (ClinicalTrials.gov) | October 28, 2017 | 22/10/2017 | A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis | A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model | Rheumatoid Arthritis | Drug: Treatment of MTX and TwHF placebo;Drug: Treatment of TwHF and MTX placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Recruiting | 45 Years | 70 Years | All | 264 | Phase 2/Phase 3 | China |
| 165 | EUCTR2016-002126-36-IT (EUCTR) | 26/10/2017 | 31/01/2018 | A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 | F. Hoffmann - Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Spain;Poland;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy | ||
| 166 | EUCTR2017-000149-30-GB (EUCTR) | 25/10/2017 | 05/09/2017 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1 | Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet INN or Proposed INN: Pirfenidone | University Hospitals of Leicester NHS Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Australia;United Kingdom | ||
| 167 | EUCTR2016-004834-11-GB (EUCTR) | 23/10/2017 | 16/08/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis - CR6086-2-02 | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR0686 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR6086 Trade Name: Methotrexate ® 2.5mg Tablets Product Name: Methotrexate ® 2.5mg Tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 168 | NCT03163966 (ClinicalTrials.gov) | October 5, 2017 | 8/5/2017 | A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis, DMARD-naive and Early Disease Patients | Drug: CR6086;Drug: Methotrexate;Drug: Placebo | Rottapharm Biotech | NULL | Completed | 18 Years | N/A | All | 248 | Phase 2 | Czechia |
| 169 | NCT03257852 (ClinicalTrials.gov) | September 29, 2017 | 20/8/2017 | A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate | A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate | Rheumatoid Arthritis (RA) | Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapy | Astellas Pharma Inc | NULL | Completed | 20 Years | N/A | All | 66 | Phase 2 | Japan |
| 170 | EUCTR2016-005017-45-PL (EUCTR) | 27/09/2017 | 19/06/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 171 | EUCTR2017-000384-32-CZ (EUCTR) | 26/09/2017 | 26/07/2017 | Phase IIb in Rheumatoid Arthritis | A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 363 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 172 | NCT03233230 (ClinicalTrials.gov) | September 18, 2017 | 25/7/2017 | Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis | A Phase IIb, Randomized, Double-blind Study in Subjects With Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared With Placebo in Subjects With an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: M2591 25 mg QD;Drug: M2951 75 mg QD;Drug: M2951 50 mg BID;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Completed | 18 Years | 75 Years | All | 390 | Phase 2 | United States;Argentina;Bulgaria;Chile;Colombia;Czechia;Mexico;Poland;Russian Federation;Serbia;South Africa;Ukraine;Brazil;Germany;Hungary;Romania;Slovakia;Spain |
| 173 | EUCTR2016-004834-11-PL (EUCTR) | 05/09/2017 | 17/07/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of | ||
| 174 | EUCTR2016-004834-11-BG (EUCTR) | 04/09/2017 | 01/06/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of | ||
| 175 | EUCTR2016-004834-11-CZ (EUCTR) | 16/08/2017 | 02/08/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 176 | NCT03160001 (ClinicalTrials.gov) | August 15, 2017 | 11/5/2017 | Niclosamide With Etanercept in Rheumatoid Arthritis | Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study | Rheumatoid Arthritis (RA) | Drug: Placebo;Drug: Niclosamide;Drug: Etanercept | Faiq Gorial | NULL | Completed | 18 Years | N/A | All | 110 | Phase 1/Phase 2 | Iraq |
| 177 | NCT03156023 (ClinicalTrials.gov) | August 14, 2017 | 15/5/2017 | Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis | A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 570;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 75 Years | All | 34 | Phase 1 | United States;Germany |
| 178 | NCT03155347 (ClinicalTrials.gov) | August 2, 2017 | 15/5/2017 | An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy | A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | 70 Years | All | 340 | Phase 3 | China |
| 179 | EUCTR2016-002126-36-ES (EUCTR) | 31/07/2017 | 02/06/2017 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy | ||
| 180 | EUCTR2016-000569-21-NL (EUCTR) | 18/07/2017 | 29/06/2017 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 181 | EUCTR2016-000568-41-NL (EUCTR) | 18/07/2017 | 29/06/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 182 | EUCTR2016-004834-11-DK (EUCTR) | 06/07/2017 | 11/05/2017 | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets | Rottapharm Biotech S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 183 | NCT03189017 (ClinicalTrials.gov) | July 3, 2017 | 12/6/2017 | A Phase I Study of ICP-022 in Healthy Subjects | A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: ICP-022;Drug: Placebos | Innocare Pharma Australia Pty Ltd | NULL | Completed | 18 Years | 55 Years | Male | 64 | Phase 1 | Australia |
| 184 | EUCTR2016-001825-15-IT (EUCTR) | 28/06/2017 | 16/02/2018 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinb Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 580 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy | ||
| 185 | NCT03278470 (ClinicalTrials.gov) | June 26, 2017 | 7/9/2017 | A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject | A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject | Rheumatoid Arthritis | Drug: HL237;Drug: Placebo Oral Tablet | Hanlim Pharm. Co., Ltd. | NULL | Completed | 20 Years | 45 Years | Male | 57 | Phase 1 | Korea, Republic of |
| 186 | EUCTR2016-001825-15-DE (EUCTR) | 26/06/2017 | 01/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 187 | EUCTR2015-002887-17-FR (EUCTR) | 19/06/2017 | 16/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 188 | NCT03239080 (ClinicalTrials.gov) | June 19, 2017 | 1/8/2017 | Effect of Denosumab in Erosion Healing in RA | Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT | Rheumatoid Arthritis | Drug: Denosumab;Other: Placebo | Chinese University of Hong Kong | NULL | Completed | 18 Years | N/A | All | 110 | Phase 2 | China |
| 189 | EUCTR2016-005017-45-GB (EUCTR) | 15/06/2017 | 27/10/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 190 | EUCTR2016-000569-21-FR (EUCTR) | 08/06/2017 | 04/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 191 | EUCTR2016-002337-30-HR (EUCTR) | 05/06/2017 | 12/09/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 192 | NCT03139136 (ClinicalTrials.gov) | May 30, 2017 | 26/4/2017 | Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis | A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate | Rheumatoid Arthritis | Drug: MBS2320;Drug: Placebo | Modern Biosciences plc | NULL | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | Georgia;Moldova, Republic of;Romania |
| 193 | EUCTR2016-002337-30-DE (EUCTR) | 24/05/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 269 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 194 | EUCTR2016-005017-45-HU (EUCTR) | 12/05/2017 | 13/03/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 195 | EUCTR2016-005017-45-BG (EUCTR) | 11/05/2017 | 06/04/2017 | A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina | ||
| 196 | NCT03241108 (ClinicalTrials.gov) | May 10, 2017 | 26/6/2017 | Study of an Anti-TLR4 mAb in Rheumatoid Arthritis | Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: NI-0101;Other: Placebo | NovImmune SA | NULL | Completed | 18 Years | N/A | All | 90 | Phase 2 | Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia |
| 197 | EUCTR2016-001825-15-BE (EUCTR) | 08/05/2017 | 28/02/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 198 | EUCTR2016-002337-30-CZ (EUCTR) | 03/05/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 199 | EUCTR2016-000569-21-DE (EUCTR) | 02/05/2017 | 04/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 200 | EUCTR2016-001825-15-HU (EUCTR) | 01/05/2017 | 22/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 201 | EUCTR2016-000570-37-DE (EUCTR) | 19/04/2017 | 24/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 202 | EUCTR2016-000568-41-DE (EUCTR) | 19/04/2017 | 24/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 203 | EUCTR2016-002126-36-DE (EUCTR) | 18/04/2017 | 23/11/2016 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom | ||
| 204 | EUCTR2016-002337-30-BG (EUCTR) | 11/04/2017 | 30/01/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 205 | EUCTR2016-001825-15-BG (EUCTR) | 11/04/2017 | 07/02/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 206 | EUCTR2016-002337-30-SK (EUCTR) | 10/04/2017 | 08/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | ,NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 207 | NCT02808871 (ClinicalTrials.gov) | April 7, 2017 | 20/3/2016 | Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1) | Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1) | Rheumatoid Arthritis Interstitial Lung Disease | Drug: Pirfenidone;Drug: Placebo | Brigham and Women's Hospital | NULL | Completed | 18 Years | 85 Years | All | 123 | Phase 2 | United States;Australia;Canada;United Kingdom |
| 208 | EUCTR2016-001825-15-GB (EUCTR) | 03/04/2017 | 01/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | Korea, Republic of;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany | ||
| 209 | NCT03275025 (ClinicalTrials.gov) | April 1, 2017 | 28/8/2017 | A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Rheumatoid Arthritis | Drug: YRA-1909 low dose;Drug: YRA-1909 mid dose;Drug: YRA-1909 high dose;Drug: Placebo | Yungjin Pharm. Co., Ltd. | NULL | Completed | 19 Years | 80 Years | All | 116 | Phase 2 | Korea, Republic of |
| 210 | NCT02908490 (ClinicalTrials.gov) | April 1, 2017 | 8/7/2016 | Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis? | Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis? | Arthritis, Rheumatoid;Atherosclerosis | Drug: Sildenafil;Other: Placebo | Kimberly Liang | NULL | Completed | 18 Years | N/A | All | 26 | Phase 2 | United States |
| 211 | EUCTR2016-001825-15-PL (EUCTR) | 29/03/2017 | 08/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 212 | EUCTR2016-002862-30-PL (EUCTR) | 28/03/2017 | 03/04/2017 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 213 | EUCTR2015-005307-83-RO (EUCTR) | 28/03/2017 | 22/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Phase 3 | United States;Czechia;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 214 | EUCTR2016-002337-30-ES (EUCTR) | 27/03/2017 | 10/03/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 215 | EUCTR2016-002862-30-CZ (EUCTR) | 22/03/2017 | 14/12/2016 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 216 | EUCTR2016-001825-15-CZ (EUCTR) | 21/03/2017 | 21/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 217 | EUCTR2016-000568-41-BG (EUCTR) | 21/03/2017 | 24/01/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 218 | EUCTR2016-000570-37-BG (EUCTR) | 21/03/2017 | 13/02/2017 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 219 | EUCTR2016-002337-30-HU (EUCTR) | 16/03/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 220 | NCT03755258 (ClinicalTrials.gov) | March 16, 2017 | 21/11/2018 | Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis | A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients | Early Rheumatoid Arthritis | Drug: GCK 100 mg + Placebo 200 mg;Drug: GCK 200 mg + Placebo 100 mg;Drug: GCK 300 mg;Drug: Placebo 300mg | Zhejiang Hisun Pharmaceutical Co. Ltd. | NULL | Unknown status | 18 Years | 65 Years | All | 128 | Phase 1 | China |
| 221 | EUCTR2016-002862-30-DE (EUCTR) | 15/03/2017 | 26/01/2017 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 222 | EUCTR2015-003289-97-DE (EUCTR) | 09/03/2017 | 30/11/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 223 | EUCTR2016-001825-15-ES (EUCTR) | 09/03/2017 | 10/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 224 | EUCTR2015-005307-83-LV (EUCTR) | 03/03/2017 | 16/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 225 | EUCTR2016-002126-36-AT (EUCTR) | 01/03/2017 | 11/11/2016 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany | ||
| 226 | NCT03025308 (ClinicalTrials.gov) | February 28, 2017 | 17/1/2017 | Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib | Galapagos NV | Gilead Sciences | Active, not recruiting | 18 Years | N/A | All | 2731 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Netherlands |
| 227 | EUCTR2015-003289-97-ES (EUCTR) | 20/02/2017 | 21/02/2017 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 228 | EUCTR2016-001825-15-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 229 | EUCTR2016-002862-30-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 230 | EUCTR2016-002862-30-BG (EUCTR) | 16/02/2017 | 10/01/2017 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 231 | EUCTR2016-000570-37-PL (EUCTR) | 15/02/2017 | 13/02/2017 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Russian Federation;Hong Kong;United States;Malaysia;Thailand;Ireland;Poland;Brazil;Korea, Republic of;Slovakia;Chile;France;Serbia;Bulgaria;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Italy;Mexico;South Africa;Israel;Australia;Peru;Germany | ||
| 232 | EUCTR2016-000568-41-PL (EUCTR) | 15/02/2017 | 14/02/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4ml s.c.injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 233 | EUCTR2016-000569-21-PL (EUCTR) | 15/02/2017 | 14/02/2017 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 234 | NCT03667131 (ClinicalTrials.gov) | February 13, 2017 | 10/9/2018 | Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis. | Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients. | Rheumatoid Arthritis | Drug: Enalapril Maleate;Drug: Placebo | University of Guadalajara | NULL | Completed | 18 Years | 80 Years | Female | 59 | Phase 2 | Mexico |
| 235 | EUCTR2016-000568-41-IT (EUCTR) | 08/02/2017 | 17/06/2021 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response toMethotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administeredfor 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate - NA | Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: Filgotinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: Filgotinib Trade Name: Methotrexate INN or Proposed INN: METOTRESSATO SALE SODICO Trade Name: Humira INN or Proposed INN: ADALIMUMAB | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico | ||
| 236 | EUCTR2016-002862-30-HU (EUCTR) | 31/01/2017 | 23/11/2016 | A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE | RHEUMATOID ARTHRITIS MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-06651600 INN or Proposed INN: not yet assigned | Pfizer Inc 235 East 42nd Street, New York, NY10017 US | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 237 | EUCTR2016-000569-21-BE (EUCTR) | 30/01/2017 | 28/10/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 238 | EUCTR2016-000570-37-BE (EUCTR) | 30/01/2017 | 17/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 239 | NCT03028467 (ClinicalTrials.gov) | January 24, 2017 | 10/1/2017 | Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis | A Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate | Arthritis, Rheumatoid | Drug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acid | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 15 | Phase 1/Phase 2 | Japan |
| 240 | NCT03085940 (ClinicalTrials.gov) | January 20, 2017 | 7/2/2017 | Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis | Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Hydroxychloroquine;Drug: Placebo | Indonesia University | NULL | Completed | 18 Years | N/A | All | 37 | N/A | Indonesia |
| 241 | EUCTR2016-000569-21-ES (EUCTR) | 13/01/2017 | 13/01/2017 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 242 | EUCTR2016-000568-41-ES (EUCTR) | 13/01/2017 | 13/01/2017 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 243 | EUCTR2016-000570-37-ES (EUCTR) | 13/01/2017 | 13/01/2017 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 244 | EUCTR2015-003140-39-PL (EUCTR) | 09/01/2017 | 11/01/2017 | A Study to EValuate the Efficacy and Safety of JTE-051 on Subjects with Active Rheumatoid Arthritis (MOVE-RA) | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA | Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JTE-051 Product Code: JTE-051 INN or Proposed INN: No proposed INN available Other descriptive name: JTE-051 | Akros Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia | ||
| 245 | NCT02760433 (ClinicalTrials.gov) | January 9, 2017 | 29/4/2016 | Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease | A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | Rheumatoid Arthritis | Drug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2w | R-Pharm | Quintiles, Inc.;OCT Clinical Trials;Mene Research | Active, not recruiting | 18 Years | N/A | All | 350 | Phase 3 | United States;Argentina;Brazil;Colombia;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Russian Federation;Czech Republic;Turkey |
| 246 | EUCTR2016-000570-37-CZ (EUCTR) | 05/01/2017 | 22/11/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 247 | EUCTR2016-000568-41-CZ (EUCTR) | 05/01/2017 | 21/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 248 | EUCTR2016-000568-41-BE (EUCTR) | 04/01/2017 | 17/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 249 | NCT02965599 (ClinicalTrials.gov) | December 27, 2016 | 14/11/2016 | Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis | A Randomised, Multi-center, Double Blind (Sponsor Open), Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Severe, Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: GSK3117391;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 2 | Poland;Romania;Mexico |
| 250 | EUCTR2016-000569-21-GB (EUCTR) | 23/12/2016 | 01/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 251 | EUCTR2016-000568-41-GB (EUCTR) | 23/12/2016 | 13/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Phase 3 | Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 252 | NCT03001219 (ClinicalTrials.gov) | December 22, 2016 | 20/12/2016 | A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors | Rheumatoid Arthritis | Drug: Anti-TNF-alpha;Drug: Methotrexate;Drug: Placebo;Drug: RO7123520 | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 109 | Phase 2 | United States;Argentina;Austria;Colombia;Germany;Guatemala;Italy;Mexico;Peru;Spain;United Kingdom;Czech Republic;Czechia;Poland |
| 253 | EUCTR2016-001496-75-CZ (EUCTR) | 20/12/2016 | 30/09/2016 | A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 INN or Proposed INN: GS-9876 Product Name: filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria | ||
| 254 | NCT02969044 (ClinicalTrials.gov) | December 20, 2016 | 17/11/2016 | Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate | A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate | Rheumatoid Arthritis | Drug: Placebo;Drug: PF-06651600 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 70 | Phase 2 | United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia |
| 255 | NCT02862574 (ClinicalTrials.gov) | December 15, 2016 | 8/8/2016 | Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis | Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF Inhibitor | Gilead Sciences | NULL | Terminated | 18 Years | 80 Years | All | 15 | Phase 2 | United States;Australia;Hungary;Taiwan |
| 256 | EUCTR2016-001496-75-PL (EUCTR) | 13/12/2016 | 03/11/2016 | A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 INN or Proposed INN: GS-9876 Product Name: filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria | ||
| 257 | EUCTR2016-000569-21-HU (EUCTR) | 12/12/2016 | 07/11/2016 | Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment. | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 258 | EUCTR2015-003289-97-SK (EUCTR) | 12/12/2016 | 11/08/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 259 | EUCTR2015-003140-39-BG (EUCTR) | 05/12/2016 | 23/11/2016 | A Study to EValuate the Efficacy and Safety of JTE-051 in Subjects with Active Rheumatoid Arthritis (MOVE-RA) | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA | Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JTE-051 Product Code: JTE-051 INN or Proposed INN: No proposed INN available Other descriptive name: JTE-051 | Akros Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia | ||
| 260 | EUCTR2016-000570-37-HU (EUCTR) | 02/12/2016 | 19/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 261 | EUCTR2016-000568-41-HU (EUCTR) | 02/12/2016 | 19/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 262 | NCT02982083 (ClinicalTrials.gov) | December 2016 | 1/12/2016 | Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis | Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Raloxifene hydrochloride;Drug: Placebo Oral Tablet | Sara Saeidi Shahri | NULL | Not yet recruiting | 50 Years | N/A | Female | 40 | N/A | NULL |
| 263 | EUCTR2016-000570-37-SK (EUCTR) | 29/11/2016 | 04/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 264 | NCT02960490 (ClinicalTrials.gov) | November 26, 2016 | 3/11/2016 | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | Rheumatoid Arthritis | Drug: E6011;Drug: Placebo | Eisai Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 64 | Phase 2 | Japan |
| 265 | EUCTR2016-000570-37-GB (EUCTR) | 14/11/2016 | 17/10/2016 | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 266 | NCT02996500 (ClinicalTrials.gov) | November 10, 2016 | 13/10/2016 | Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 269 | Phase 2 | United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine |
| 267 | EUCTR2015-005307-83-DE (EUCTR) | 10/11/2016 | 24/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 268 | EUCTR2015-005800-27-PL (EUCTR) | 08/11/2016 | 03/10/2016 | Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs | A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis | Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK3117391 Product Code: GSK3117391 INN or Proposed INN: Not applicable Other descriptive name: GSK3117391 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Poland;Romania;Russian Federation | ||
| 269 | EUCTR2015-005308-27-DE (EUCTR) | 08/11/2016 | 09/05/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Turkey;Russian Federation;Colombia;Germany;Korea, Republic of | ||
| 270 | NCT02919761 (ClinicalTrials.gov) | November 7, 2016 | 26/9/2016 | Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis | A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment | Arthritis, Rheumatoid | Drug: Acthar Gel;Drug: Placebo | Mallinckrodt | NULL | Completed | 18 Years | N/A | All | 259 | Phase 4 | United States;Argentina;Mexico;Peru;Puerto Rico;Colombia |
| 271 | NCT02960438 (ClinicalTrials.gov) | November 2, 2016 | 3/11/2016 | A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate | A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate | Rheumatoid Arthritis | Drug: E6011;Drug: Placebo | Eisai Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 190 | Phase 2 | Japan |
| 272 | EUCTR2015-003289-97-PL (EUCTR) | 25/10/2016 | 17/08/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 273 | EUCTR2015-003289-97-AT (EUCTR) | 20/10/2016 | 12/08/2016 | A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis | Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of | ||
| 274 | NCT02858492 (ClinicalTrials.gov) | October 17, 2016 | 20/7/2016 | Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | A Multicenter, Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled Study to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: GSK2982772 60 mg;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 52 | Phase 2 | Germany;Italy;Poland;Russian Federation;Spain;United Kingdom |
| 275 | EUCTR2016-000568-41-SK (EUCTR) | 11/10/2016 | 04/10/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1650 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 276 | EUCTR2016-000912-13-PL (EUCTR) | 04/10/2016 | 26/07/2016 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Spain;Poland;Romania;Germany;Italy;United Kingdom | ||
| 277 | NCT02805010 (ClinicalTrials.gov) | October 2016 | 12/6/2016 | Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously | A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects | Rheumatoid Arthritis (RA) | Drug: Abatacept;Other: Placebo | Jiangsu Simcere Pharmaceutical Co., Ltd. | Bristol-Myers Squibb | Active, not recruiting | 18 Years | 45 Years | Both | 22 | Phase 1 | NULL |
| 278 | NCT02885181 (ClinicalTrials.gov) | September 21, 2016 | 26/8/2016 | Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate | Rheumatoid Arthritis | Drug: GS-9876;Drug: Filgotinib;Drug: GS-9876 placebo;Drug: Filgotinib placebo;Drug: Methotrexate | Gilead Sciences | NULL | Completed | 18 Years | 75 Years | All | 83 | Phase 2 | United States;Bulgaria;Czechia;Georgia;Moldova, Republic of;Poland;Ukraine;Czech Republic;Hungary |
| 279 | NCT02884635 (ClinicalTrials.gov) | September 16, 2016 | 26/8/2016 | A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate | Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX) | Rheumatoid Arthritis | Drug: ASP1707;Drug: Placebo;Drug: Methotrexate | Astellas Pharma Inc | NULL | Completed | N/A | N/A | Female | 72 | Phase 2 | Japan |
| 280 | NCT02919475 (ClinicalTrials.gov) | September 14, 2016 | 27/9/2016 | Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA) | Rheumatoid Arthritis | Drug: JTE-051;Drug: Placebo | Akros Pharma Inc. | NULL | Completed | 18 Years | 75 Years | All | 260 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Mexico;Peru;Poland;Romania;Russian Federation;Ukraine |
| 281 | EUCTR2015-003335-35-SI (EUCTR) | 12/09/2016 | 28/09/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 282 | NCT02833350 (ClinicalTrials.gov) | September 9, 2016 | 12/7/2016 | Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) | A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2) | Rheumatoid Arthritis | Drug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: Placebo | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 578 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile |
| 283 | EUCTR2016-000912-13-GB (EUCTR) | 05/09/2016 | 12/06/2017 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Poland;Spain;Romania;Germany;Italy;United Kingdom | ||
| 284 | NCT02831855 (ClinicalTrials.gov) | September 1, 2016 | 11/7/2016 | Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis | Drug: CP-690,550;Drug: Methotrexate;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 694 | Phase 4 | United States;Australia;Belgium;Bulgaria;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Philippines;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom |
| 285 | NCT03016013 (ClinicalTrials.gov) | September 2016 | 8/1/2017 | A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. | A Phase III Study of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Poor Efficacy of MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. | Moderate and Severe RheumatoId Arthritis | Biological: Placebo plus MTX;Biological: RC18 160 mg plus MTX | RemeGen | NULL | Recruiting | 18 Years | 65 Years | All | 480 | Phase 3 | China |
| 286 | EUCTR2016-000912-13-DE (EUCTR) | 30/08/2016 | 29/06/2016 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis. | subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Poland;Spain;Romania;Germany;Italy;United Kingdom | ||
| 287 | NCT02889796 (ClinicalTrials.gov) | August 30, 2016 | 31/8/2016 | Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: Adalimumab;Drug: Placebo to match adalimumab;Drug: MTX | Gilead Sciences | Galapagos NV | Completed | 18 Years | N/A | All | 1759 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic;France |
| 288 | EUCTR2015-003335-35-BG (EUCTR) | 29/08/2016 | 01/08/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 289 | EUCTR2016-000335-40-BG (EUCTR) | 23/08/2016 | 08/07/2016 | A Study examining the treatment effect and Safety of GDC-0853 when compared With Placebo and a biologic therapy (Adalimumab) in Rheumatoid Arthritis Patients who have not responded or intolerance to Previous therapies. | A TWO-COHORT RANDOMIZED PHASE II, DOUBLEBLIND, PARALLEL GROUP STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS EVALUATING THE EFFICACY AND SAFETY OF GDC-0853 COMPARED WITH PLACEBO AND ADALIMUMAB IN PATIENTS WITH AN INADEQUATE RESPONSE TO PREVIOUS METHOTREXATE THERAPY (COHORT 1) AND COMPARED WITH PLACEBO IN PATIENTS WITH AN INADEQUATE RESPONSE OR INTOLERANCE TO PREVIOUS TNF THERAPY (COHORT 2) | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939 INN or Proposed INN: not available Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of | ||
| 290 | NCT02628028 (ClinicalTrials.gov) | August 22, 2016 | 9/12/2015 | A Study of LY3337641 in Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study | Rheumatoid Arthritis | Drug: LY3337641;Drug: Placebo | Eli Lilly and Company | NULL | Terminated | 18 Years | 65 Years | All | 286 | Phase 2 | United States;Argentina;Australia;Austria;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;South Africa;Spain;Germany |
| 291 | ChiCTR-IIR-16008693 | 2016-08-20 | 2016-06-20 | Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously | A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects | Rheumatoid Arthritis | Abatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo; | The First Hospital, Jilin University | NULL | Pending | 18 | 45 | Both | Abatacept Group:20;Placebo Group:2; | I (Phase 1 study) | China |
| 292 | EUCTR2015-003335-35-HU (EUCTR) | 18/08/2016 | 18/03/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 293 | NCT02705989 (ClinicalTrials.gov) | August 18, 2016 | 7/3/2016 | Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects | A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects | Rheumatoid Arthritis | Drug: BMS-986195;Other: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 439 | Phase 1 | Australia |
| 294 | EUCTR2016-000064-42-BG (EUCTR) | 11/08/2016 | 28/06/2016 | Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria | ||
| 295 | EUCTR2015-003335-35-FI (EUCTR) | 10/08/2016 | 22/04/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 296 | EUCTR2015-003333-95-FI (EUCTR) | 10/08/2016 | 19/04/2016 | A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 297 | NCT02886728 (ClinicalTrials.gov) | August 8, 2016 | 29/8/2016 | Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy | A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy | Rheumatoid Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTX | Gilead Sciences | Galapagos NV | Completed | 18 Years | N/A | All | 1252 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic |
| 298 | EUCTR2016-000393-37-BG (EUCTR) | 08/08/2016 | 17/06/2016 | A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma Sprl | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom | ||
| 299 | EUCTR2016-000064-42-HU (EUCTR) | 05/08/2016 | 06/06/2016 | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria | ||
| 300 | EUCTR2015-005307-83-BG (EUCTR) | 04/08/2016 | 17/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 301 | NCT02722694 (ClinicalTrials.gov) | August 2016 | 10/3/2016 | A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept 125mg Administered Subcutaneously in Chinese Subjects With Active Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate | Rheumatoid Arthritis (RA) | Drug: Subcutaneous(SC) Abatacept;Other: Placebo;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | Both | 360 | Phase 3 | China |
| 302 | NCT02784106 (ClinicalTrials.gov) | July 31, 2016 | 24/5/2016 | Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects With Rheumatoid Arthritis on Stable Methotrexate Therapy | Rheumatoid Arthritis | Drug: Placebo;Drug: M2951 | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Completed | 18 Years | 75 Years | All | 65 | Phase 2 | United States;Germany |
| 303 | JPRN-JapicCTI-163317 | 28/7/2016 | 13/07/2016 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors | Rheumatoid Arthritis | Intervention name : BMS-986142 INN of the intervention : - Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified | Bristol-Myers Squibb K.K. | NULL | complete | 18 | 120 | BOTH | 408 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Oceania |
| 304 | EUCTR2016-000064-42-SK (EUCTR) | 27/07/2016 | 03/05/2016 | Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria | ||
| 305 | NCT02873936 (ClinicalTrials.gov) | July 27, 2016 | 17/8/2016 | Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment | Rheumatoid Arthritis | Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDs | Gilead Sciences | Galapagos NV | Completed | 18 Years | N/A | All | 449 | Phase 3 | United States;Argentina;Australia;Belgium;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Spain;Switzerland;United Kingdom;Italy;Netherlands |
| 306 | EUCTR2015-003333-95-LT (EUCTR) | 21/07/2016 | 09/05/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Stroke (ischaemic stroke or intracerebral hemorrhage) MedDRA version: 22.1;Level: PT;Classification code 10061256;Term: Ischaemic stroke;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10022754;Term: Intracerebral hemorrhage;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1;Classification code 10042244;Term: Stroke;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Paracetamol Product Name: Paracetamol INN or Proposed INN: Paracetamol Other descriptive name: PARACETAMOL Trade Name: Ceftriaxone Product Name: Ceftriaxone INN or Proposed INN: CEFTRIAXONE Trade Name: Metoclopramide Product Name: Metoclopramide INN or Proposed INN: METOCLOPRAMIDE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Greece;Netherlands;Hungary;Norway;Poland;Italy;United Kingdom;Germany;Estonia | ||
| 307 | EUCTR2015-003335-35-IT (EUCTR) | 18/07/2016 | 28/02/2018 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) - SELECT-BEYOND | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 308 | EUCTR2015-003333-95-BG (EUCTR) | 13/07/2016 | 25/03/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand | ||
| 309 | EUCTR2015-005307-83-PL (EUCTR) | 06/07/2016 | 01/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira) Product Code: LO4AB04 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 310 | EUCTR2015-003335-35-GB (EUCTR) | 05/07/2016 | 17/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 499 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 311 | EUCTR2015-003335-35-GR (EUCTR) | 05/07/2016 | 26/04/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 312 | NCT02585258 (ClinicalTrials.gov) | June 30, 2016 | 20/10/2015 | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis | RheumatoId Arthritis | Drug: Prednisolone;Other: Placebo | VU University Medical Center | European Commission | Completed | 65 Years | N/A | All | 451 | Phase 4 | Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia;Finland |
| 313 | EUCTR2015-003335-35-NO (EUCTR) | 27/06/2016 | 18/03/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 314 | EUCTR2016-000064-42-CZ (EUCTR) | 21/06/2016 | 08/06/2016 | Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis | Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria | ||
| 315 | EUCTR2015-003332-13-BG (EUCTR) | 15/06/2016 | 25/03/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 316 | NCT02799472 (ClinicalTrials.gov) | June 15, 2016 | 26/5/2016 | Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis | A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination With Methotrexate Therapy in Subjects With Active Rheumatoid Arthritis Despite Treatment With DMARDs | Arthritis, Rheumatoid | Drug: GSK3196165;Drug: Placebo;Drug: MTX;Drug: Folic (or folinic) acid | GlaxoSmithKline | Parexel | Completed | 18 Years | N/A | All | 39 | Phase 2 | United States;Germany;Poland |
| 317 | EUCTR2015-003332-13-LT (EUCTR) | 10/06/2016 | 29/04/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 318 | EUCTR2015-005307-83-HU (EUCTR) | 09/06/2016 | 28/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 319 | EUCTR2015-005308-27-HU (EUCTR) | 09/06/2016 | 28/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Colombia;Argentina;Czech Republic;Hungary;United States;Brazil;Korea, Republic of;Poland;Mexico;Germany | ||
| 320 | EUCTR2015-005307-83-CZ (EUCTR) | 07/06/2016 | 18/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm International LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 321 | EUCTR2015-005308-27-CZ (EUCTR) | 07/06/2016 | 15/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Colombia;Czech Republic;Argentina;Hungary;United States;Brazil;Korea, Republic of;Poland;Mexico;Germany | ||
| 322 | EUCTR2015-002887-17-BE (EUCTR) | 07/06/2016 | 16/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Germany;Netherlands;Japan;Korea, Republic of | ||
| 323 | EUCTR2015-003332-13-GR (EUCTR) | 06/06/2016 | 24/05/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand | ||
| 324 | EUCTR2015-003335-35-LV (EUCTR) | 03/06/2016 | 13/04/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 325 | EUCTR2015-003335-35-PT (EUCTR) | 31/05/2016 | 30/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 326 | NCT02760407 (ClinicalTrials.gov) | May 24, 2016 | 29/4/2016 | Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | Rheumatoid Arthritis | Drug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2w | R-Pharm | Quintiles, Inc.;OCT Clinical Trials | Active, not recruiting | 18 Years | N/A | All | 1575 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic |
| 327 | EUCTR2015-003335-35-FR (EUCTR) | 24/05/2016 | 17/06/2016 | A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 328 | EUCTR2015-003335-35-SK (EUCTR) | 19/05/2016 | 22/03/2016 | A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 329 | EUCTR2015-003333-95-HU (EUCTR) | 18/05/2016 | 07/04/2016 | A Study Comparing ABT-494 to |