LA ( DrugBank: - )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 660 |
| 13 | 多発性硬化症／視神経脊髄炎 | 1410 |
| 75 | クッシング病 | 114 |
| 76 | 下垂体性ゴナドトロピン分泌亢進症 | 13 |
| 222 | 一次性ネフローゼ症候群 | 82 |
6. パーキンソン病
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
| 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 | NCT05094011 (ClinicalTrials.gov) | May 1, 2022 | 20/7/2021 | Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease | A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Biological: Aadipose-Derived Mesenchymal Stem Cells | Taiwan Mitochondrion Applied Technology Co., Ltd. | NULL | Not yet recruiting | 45 Years | 70 Years | All | 9 | Phase 1 | NULL |
| 2 | NCT05258071 (ClinicalTrials.gov) | March 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 | Not yet recruiting | 55 Years | 85 Years | All | 165 | Phase 2 | NULL |
| 3 | EUCTR2020-002754-24-DE (EUCTR) | 19/01/2022 | 14/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2019-004235-23-SE (EUCTR) | 13/11/2021 | 24/08/2021 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 5 | NCT04990284 (ClinicalTrials.gov) | November 2021 | 27/7/2021 | eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. | A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Opicapone;Drug: L-DOPA/DDCI | Bial - Portela C S.A. | NULL | Not yet recruiting | 30 Years | N/A | All | 100 | Phase 4 | NULL |
| 6 | NCT05128175 (ClinicalTrials.gov) | October 29, 2021 | 27/10/2021 | Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions | An Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed Conditions | Parkinson Disease | Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets | Shanghai WD Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 15 | Phase 1 | India |
| 7 | NCT05116813 (ClinicalTrials.gov) | October 25, 2021 | 1/11/2021 | Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy | An Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications | Parkinson Disease;Dyskinesia, Drug-Induced;Dyskinesias | Drug: Dipraglurant | Addex Pharma S.A. | NULL | Recruiting | 30 Years | 85 Years | All | 140 | Phase 2/Phase 3 | United States |
| 8 | EUCTR2020-002754-24-IT (EUCTR) | 09/09/2021 | 30/08/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson's Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson's paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg tablets Product Name: SINEMET 100 mg + 25 mg compresse Product Code: [023145028] INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: Carbidopa Trade Name: Madopar 125 mg T, tablets Product Name: Madopar® 125 mg T Tablets Levodopa 100 mg Benserazide 25 mg (as benserazide hydrochloride) Product Code: [6036937.00.01] INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: Levodopa Other descriptive name: Levodopa Trade Name: Ongentys 50 mg hard capsules Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone Other descriptive name: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 9 | 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 | ||
| 10 | NCT04871464 (ClinicalTrials.gov) | September 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 | 80 Years | All | 240 | Phase 4 | China |
| 11 | NCT04879134 (ClinicalTrials.gov) | September 2021 | 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. | Not yet recruiting | 18 Years | 70 Years | All | 40 | Phase 2/Phase 3 | Canada |
| 12 | NCT05220072 (ClinicalTrials.gov) | August 28, 2021 | 18/11/2021 | Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156 | An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of Carbon-14 BIA 28-6156 in Healthy Male Subjects | Parkinson Disease | Drug: Carbon-14 BIA 28-6156 | Bial R&D Investments, S.A. | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 13 | EUCTR2020-000148-76-SE (EUCTR) | 04/08/2021 | 25/02/2020 | Effects of the Montelukast drug on brain inflammation in Parkinson's disease. | Effects of Montelukast on neuroinflammation in Parkinson's Disease. An open-label single-center trial. | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Montelukast Product Name: Montelukast Krka | Stockholm Health Care Services | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2 | Sweden | ||
| 14 | 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 | ||
| 15 | EUCTR2020-002754-24-ES (EUCTR) | 06/07/2021 | 09/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 16 | NCT04468919 (ClinicalTrials.gov) | July 1, 2021 | 8/7/2020 | Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit | Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit | Amyotrophic Lateral Sclerosis;Brainstem Stroke;Muscular Dystrophies;Parkinson's Disease and Parkinsonism;Multiple System Atrophy;Brain Tumor Adult;Spinal Cord Injuries;Locked-in Syndrome | Behavioral: BCI-FIT multi-modal access;Behavioral: BCI-FIT adaptive signal modeling;Behavioral: BCI-FIT active querying;Behavioral: BCI-FIT language modeling | Oregon Health and Science University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 60 | N/A | United States |
| 17 | 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 | ||
| 18 | NCT04821687 (ClinicalTrials.gov) | June 17, 2021 | 25/3/2021 | A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD | A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease | Parkinson Disease | Drug: Ongentys 50mg;Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg | SK Chemicals Co., Ltd. | NULL | Recruiting | 30 Years | N/A | All | 200 | Phase 4 | Korea, Republic of |
| 19 | NCT04986995 (ClinicalTrials.gov) | June 9, 2021 | 27/7/2021 | OpicApone Sleep dISorder | Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders | Parkinson Disease | Drug: Opicapone | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 30 | Phase 4 | Portugal |
| 20 | NCT04863118 (ClinicalTrials.gov) | June 1, 2021 | 11/4/2021 | Acute Effects of Strength Training and High Intensity Training on Functional and Biochemical Measurements of Individuals With Parkinson's Disease in Different Environments and Depths | Acute Effects of Strength Training in Shallow Water and Dry Land and High-intensity Training in Shallow and Deep Water, on Functional Measures and Biochemistries of Individuals With Parkinson's Disease | Parkinson Disease and Hydrotherapy | Other: Strength training in shallow water and dry land;Other: High-intensity training in shallow and deep water | Federal University of Health Science of Porto Alegre | NULL | Not yet recruiting | 50 Years | 70 Years | All | 60 | N/A | NULL |
| 21 | 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 |
| 22 | EUCTR2019-002952-17-BG (EUCTR) | 31/05/2021 | 21/05/2021 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | 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 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 | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 23 | 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 | ||
| 24 | 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 | France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy | ||
| 25 | 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 | ||
| 26 | EUCTR2019-004235-23-DE (EUCTR) | 19/05/2021 | 25/02/2021 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | EUCTR2020-001176-15-DE (EUCTR) | 07/05/2021 | 17/12/2020 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep 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: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Portugal;Germany | ||
| 31 | 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;Poland;Spain;United Kingdom;Germany |
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | EUCTR2019-002952-17-DE (EUCTR) | 30/03/2021 | 18/09/2020 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | 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 | 854 | Phase 3 | Serbia;Germany;Bulgaria;Australia;Poland;Canada;Hungary;Czech Republic;France;Italy;Israel;Ukraine;Spain;Czechia;United States | ||
| 35 | EUCTR2020-001176-15-PT (EUCTR) | 19/03/2021 | 04/01/2021 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep 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: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Portugal;Germany | ||
| 36 | NCT04787965 (ClinicalTrials.gov) | March 1, 2021 | 4/3/2021 | Opicapone Treatment Initiation Open-Label Study | Opicapone Treatment Initiation Open-Label Study | Parkinson Disease | Drug: Opicapone | Neurocrine Biosciences | NULL | Recruiting | 18 Years | N/A | All | 250 | United States | |
| 37 | NCT04764669 (ClinicalTrials.gov) | February 25, 2021 | 19/2/2021 | A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology | An Open-Label Study To Evaluate the Pharmacodynamic Effects, Efficacy, Safety, and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies or Parkinson's Disease Dementia With or Without Amyloid Copathology | Lewy Body Disease;Parkinson Disease | Drug: E2027 | Eisai Inc. | NULL | Completed | 50 Years | 85 Years | All | 34 | Phase 2 | United States;Canada |
| 38 | NCT04760769 (ClinicalTrials.gov) | February 24, 2021 | 12/2/2021 | Open-label Trial in Parkinson's Disease (PD) | 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial) | Parkinson Disease | Drug: Tavapadon | Cerevel Therapeutics, LLC | NULL | Recruiting | 40 Years | 80 Years | All | 531 | Phase 3 | United States;Australia;Czechia;France;Germany;Italy;Poland;Spain |
| 39 | EUCTR2019-002952-17-IT (EUCTR) | 19/02/2021 | 25/01/2021 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4Trial) - TEMPO-4 | 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 5 mg 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 0.25 mg 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 | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 40 | NCT04750226 (ClinicalTrials.gov) | February 18, 2021 | 10/2/2021 | Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease | An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Enrolling by invitation | 30 Years | N/A | All | 130 | Phase 3 | United States;Australia |
| 41 | NCT04593511 (ClinicalTrials.gov) | February 2, 2021 | 21/9/2020 | to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers | An Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular Injection | Parkinson's Disease | Drug: LY03009 F1;Drug: LY03009 F2;Drug: LY03009 F3;Drug: LY03009 F4 | Luye Pharma Group Ltd. | NULL | Enrolling by invitation | 18 Years | 65 Years | All | 40 | Phase 1 | Australia |
| 42 | 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 | ||
| 43 | 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 |
| 44 | EUCTR2019-002952-17-HU (EUCTR) | 30/12/2020 | 19/10/2020 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | 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 | 854 | Phase 3 | Bulgaria;Germany;Australia;Poland;Canada;Czech Republic;Hungary;France;Italy;Israel;Ukraine;Spain;Serbia;United States | ||
| 45 | 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 | ||
| 46 | EUCTR2019-004235-23-DK (EUCTR) | 18/11/2020 | 22/06/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Denmark;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 47 | EUCTR2019-004235-23-NL (EUCTR) | 09/11/2020 | 26/05/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 48 | EUCTR2019-002952-17-CZ (EUCTR) | 04/11/2020 | 12/10/2020 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | 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 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 | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 49 | 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 | Recruiting | 30 Years | 79 Years | All | 140 | Phase 2 | United States;France;Israel;Italy;Poland;Serbia |
| 50 | NCT04722198 (ClinicalTrials.gov) | October 27, 2020 | 15/1/2021 | Effects of Lactobacillus Plantarum PS128 on Symptoms of Early-onset Parkinson's Disease: a Pilot Study | Effects of Lactobacillus Plantarum PS128 on Symptoms of Early-onset Parkinson's Disease: a Pilot Study | Early Onset Parkinson Disease | Dietary Supplement: PS128 | Professor Lu Neurological Clinic | NULL | Recruiting | 20 Years | 80 Years | All | 20 | N/A | Taiwan |
| 51 | EUCTR2020-003796-17-GB (EUCTR) | 22/10/2020 | 01/09/2020 | A study to look at the effect of CST-103 or CST-139 on blood flow in the brain and on memory. | An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139 | Patients with Mild Cognitive Impairment or Parkinson’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10009846;Term: Cognitive impairment;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: Spiropent Product Name: Clenbuterol HCl Product Code: CST-103 INN or Proposed INN: CLENBUTEROL HYDROCHLORIDE Trade Name: Berachin Product Name: Tulobuterol Product Code: CST-139 INN or Proposed INN: Tolubuterol Hydrochloride Other descriptive name: TULOBUTEROL HYDROCHLORIDE | CuraSen Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United Kingdom | ||
| 52 | NCT04338997 (ClinicalTrials.gov) | October 2020 | 3/4/2020 | PK Study in Patients With Parkinson's Disease With IZD174 | An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's Disease | Parkinson Disease | Drug: IZD174 | Inflazome UK Ltd | NULL | Withdrawn | 45 Years | 75 Years | All | 0 | Phase 1 | NULL |
| 53 | NCT04591535 (ClinicalTrials.gov) | September 28, 2020 | 11/9/2020 | PK Study of WD-1603 in Healthy Subjects | An Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed Conditions | Parkinson Disease | Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
| 54 | NCT04553978 (ClinicalTrials.gov) | September 18, 2020 | 13/9/2020 | A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting Conditions | An Open Label, Balanced, Randomised, 2-treatment, 2-period, 2-sequence, Single Oral Dose, Corssover Comparative PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fasting Conditions | Parkinson Disease | Drug: WD-1603 | Hong Kong WD Pharmaceutical Co., Limited | NULL | Not yet recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | NULL |
| 55 | EUCTR2019-004235-23-GB (EUCTR) | 15/09/2020 | 28/05/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Russian Federation;Japan;United Kingdom | ||
| 56 | NCT04476017 (ClinicalTrials.gov) | September 11, 2020 | 15/7/2020 | A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI) | An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment | Parkinson Disease;Cognitive Dysfunction | Drug: SAGE-718 | Sage Therapeutics | NULL | Active, not recruiting | 50 Years | 75 Years | All | 18 | Phase 2 | United States |
| 57 | EUCTR2019-004235-23-IT (EUCTR) | 26/08/2020 | 22/10/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. - na | Parkinson's Disease MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Foscarbidopa and Foslevodopa Product Code: [ABBV-951] INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Russian Federation;Netherlands;United Kingdom;Japan;Italy | ||
| 58 | NCT04513340 (ClinicalTrials.gov) | August 13, 2020 | 12/8/2020 | WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects | AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS | Parkinson Disease | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
| 59 | NCT04483479 (ClinicalTrials.gov) | July 30, 2020 | 20/7/2020 | Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover) | A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period | Parkinson Disease;Constipation | Drug: Active Investigational Treatment ENT-01 | Enterin Inc. | NULL | Recruiting | 30 Years | 90 Years | All | 50 | Phase 2 | United States |
| 60 | NCT04630860 (ClinicalTrials.gov) | July 7, 2020 | 5/11/2020 | A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD | A Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 1 | China |
| 61 | 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 |
| 62 | NCT04379050 (ClinicalTrials.gov) | June 8, 2020 | 1/5/2020 | Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease | An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Enrolling by invitation | 30 Years | N/A | All | 121 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom |
| 63 | NCT04384666 (ClinicalTrials.gov) | June 2, 2020 | 8/5/2020 | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 56 | Phase 1 | United States |
| 64 | EUCTR2018-002144-85-DE (EUCTR) | 07/05/2020 | 06/06/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | 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: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Japan | ||
| 65 | EUCTR2018-002233-37-PL (EUCTR) | 23/04/2020 | 24/01/2020 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s 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 MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy | ||
| 66 | NCT04167540 (ClinicalTrials.gov) | April 1, 2020 | 7/11/2019 | GDNF Gene Therapy for Parkinson's Disease | Open-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's Disease | Parkinson's Disease | Biological: AAV2-GDNF | Brain Neurotherapy Bio, Inc. | NULL | Recruiting | 35 Years | 75 Years | All | 12 | Phase 1 | United States |
| 67 | NCT04870372 (ClinicalTrials.gov) | March 1, 2020 | 15/1/2020 | Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease | A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease | Parkinson Disease | Drug: Selegiline | Second Affiliated Hospital of Soochow University | NULL | Completed | 30 Years | 80 Years | All | 141 | Phase 4 | China |
| 68 | NCT04291859 (ClinicalTrials.gov) | February 28, 2020 | 28/2/2020 | Lu AF28996 in Participants With Parkinson's Disease (PD) | Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's Disease | Parkinson Disease | Drug: Lu AF28996 | H. Lundbeck A/S | NULL | Recruiting | 45 Years | 75 Years | All | 17 | Phase 1 | United States;Netherlands |
| 69 | NCT04292223 (ClinicalTrials.gov) | February 10, 2020 | 28/2/2020 | Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis | A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis | Parkinson Disease Psychosis | Drug: Pimavanserin | ACADIA Pharmaceuticals Inc. | NULL | Active, not recruiting | 40 Years | N/A | All | 53 | Phase 4 | United States |
| 70 | EUCTR2018-002234-21-GB (EUCTR) | 05/02/2020 | 04/07/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 71 | NCT04295642 (ClinicalTrials.gov) | January 8, 2020 | 24/1/2020 | A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease | A 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: CVL-751 | Cerevel Therapeutics, LLC | NULL | Completed | 45 Years | 75 Years | All | 24 | Phase 1 | United States |
| 72 | NCT04127578 (ClinicalTrials.gov) | January 3, 2020 | 14/10/2019 | A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation | A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation | Parkinson Disease | Biological: PR001;Drug: Methylprednisolone;Drug: Sirolimus;Drug: Prednisone;Drug: Rituximab | Prevail Therapeutics | Eli Lilly and Company | Recruiting | 35 Years | 80 Years | All | 12 | Phase 1/Phase 2 | United States;Israel |
| 73 | NCT04301492 (ClinicalTrials.gov) | January 1, 2020 | 17/2/2020 | Tolerability, Safety and Efficacy of Vortioxetine | Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study | Depression | Drug: Vortioxetine | IRCCS San Raffaele | NULL | Recruiting | 30 Years | 80 Years | All | 20 | Phase 4 | Italy |
| 74 | NCT03815916 (ClinicalTrials.gov) | December 19, 2019 | 18/1/2019 | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease | A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Parkinson's Disease | Parkinson's Disease | Drug: Gold Nanocrystals | Clene Nanomedicine | University of Texas Southwestern Medical Center | Completed | 30 Years | 80 Years | All | 13 | Phase 2 | United States |
| 75 | NCT04175132 (ClinicalTrials.gov) | November 12, 2019 | 12/11/2019 | Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD) | Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease | Healthy;Parkinson Disease | Drug: foliglurax | H. Lundbeck A/S | NULL | Terminated | 50 Years | 70 Years | All | 6 | Phase 1 | Sweden |
| 76 | EUCTR2018-002233-37-GB (EUCTR) | 11/10/2019 | 14/02/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s 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 MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 77 | NCT04575259 (ClinicalTrials.gov) | October 10, 2019 | 29/9/2020 | OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001 | Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001 | Parkinson Disease Dementia | Drug: ANAVEX2-73 | Anavex Life Sciences Corp. | Anavex Australia Pty Ltd.;Anavex Germany GmbH | Active, not recruiting | 50 Years | 85 Years | All | 132 | Phase 2 | Australia;Spain |
| 78 | EUCTR2018-002234-21-DE (EUCTR) | 23/09/2019 | 16/05/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 79 | EUCTR2018-002144-85-NL (EUCTR) | 11/09/2019 | 27/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | 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: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan | ||
| 80 | EUCTR2018-002234-21-ES (EUCTR) | 21/08/2019 | 11/06/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | 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 States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 81 | EUCTR2018-002144-85-BE (EUCTR) | 20/08/2019 | 24/04/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | 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: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Spain;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan | ||
| 82 | JPRN-UMIN000037422 | 2019/08/01 | 01/08/2019 | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease | Parkinson disease | Prescription istradefylline 20 mg for 1 month, and if there are no side effects, increase to 40 mg and prescribe for 2 months. | Ichinomiya Nishi Hospital | NULL | Recruiting | 40years-old | 85years-old | Male and Female | 25 | Not selected | Japan |
| 83 | JPRN-UMIN000037421 | 2019/08/01 | 01/08/2019 | A study on improvement of cognitive function by istradefylline for parkinson disease | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease | Parkinson disease | Prescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months. The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26. | Ichinomiya Nishi Hospital | NULL | Recruiting | 40years-old | 85years-old | Male and Female | 25 | Not selected | Japan |
| 84 | EUCTR2018-002144-85-GB (EUCTR) | 29/07/2019 | 13/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | 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: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Japan;United Kingdom | ||
| 85 | EUCTR2018-002144-85-ES (EUCTR) | 11/07/2019 | 12/04/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | 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: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Japan | ||
| 86 | EUCTR2018-002144-85-DK (EUCTR) | 08/07/2019 | 14/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | 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: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Belgium;Spain;Australia;Denmark;Germany;Netherlands;Italy;United Kingdom;Japan | ||
| 87 | EUCTR2018-002144-85-IT (EUCTR) | 21/06/2019 | 15/06/2021 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ABBV-951 Product Code: [ABBV-951] INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan;Italy | ||
| 88 | EUCTR2018-002234-21-CZ (EUCTR) | 14/06/2019 | 30/05/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 89 | NCT03938922 (ClinicalTrials.gov) | June 13, 2019 | 18/4/2019 | A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease Dementia | A Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia. | Parkinson Disease;Dementia | Drug: Active Investigational Treatment ENT-01 | Enterin Inc. | NULL | Active, not recruiting | 30 Years | 90 Years | All | 40 | Phase 1 | United States |
| 90 | NCT04389762 (ClinicalTrials.gov) | June 4, 2019 | 30/4/2020 | PS128 May Improve Off Duration on Parkinson's Disease | Lactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot Study | Parkinson Disease | Dietary Supplement: daily ingestion of Lactobacillus plantarum PS128 | Professor Lu Neurological Clinic | NULL | Completed | 40 Years | 80 Years | All | 60 | N/A | Taiwan |
| 91 | NCT04293159 (ClinicalTrials.gov) | May 14, 2019 | 19/2/2020 | Effect of Probiotic on Constipation in Patients With Parkinson's Disease | Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease | Parkinson Disease;Constipation | Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®) | University of Salerno | Roberto Erro;Maria Teresa Pellecchia;Antonella Santonicola;Carolina Ciacci | Recruiting | 18 Years | 75 Years | All | 30 | N/A | Italy |
| 92 | EUCTR2018-002233-37-IT (EUCTR) | 03/05/2019 | 07/01/2021 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson's 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. - NA | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: [IPX203] INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: [IR CD-LD] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | France;United States;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 93 | NCT03781167 (ClinicalTrials.gov) | April 29, 2019 | 18/12/2018 | A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD) | A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Active, not recruiting | 30 Years | N/A | All | 244 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France |
| 94 | JPRN-JapicCTI-194763 | 22/4/2019 | 20/05/2019 | Safety and PK study of LY03003 | An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. | Parkinson's Disease | Intervention name : Rotigotine INN of the intervention : Rotigotine Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week. Control intervention name : Rotigotine INN of the control intervention : Rotigotine Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day. | Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd. | NULL | complete | 20 | BOTH | 32 | Phase 1 | Japan | |
| 95 | EUCTR2018-002233-37-DE (EUCTR) | 17/04/2019 | 08/01/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s 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 MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 96 | NCT03877510 (ClinicalTrials.gov) | April 3, 2019 | 12/3/2019 | Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations | An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | Parkinson Disease | Drug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mg | Impax Laboratories, LLC | NULL | Enrolling by invitation | 40 Years | N/A | All | 300 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 97 | EUCTR2018-002233-37-CZ (EUCTR) | 18/03/2019 | 11/12/2018 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s 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 MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy | ||
| 98 | NCT03887884 (ClinicalTrials.gov) | March 5, 2019 | 1/3/2019 | Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) | Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease | Parkinson's Disease | Drug: CVT-301;Drug: Sinemet | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 23 | Phase 1 | United States |
| 99 | NCT03820037 (ClinicalTrials.gov) | March 2019 | 25/1/2019 | Relative Bioavailability and Bioequivalence of Opicapone | A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects | Parkinson Disease | Drug: Ongentys;Drug: BIA 9-1067 (test) | Bial - Portela C S.A. | NULL | Not yet recruiting | 18 Years | 55 Years | All | 45 | Phase 1 | United Kingdom |
| 100 | NCT03968744 (ClinicalTrials.gov) | February 18, 2019 | 19/4/2019 | Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease | A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study | Idiopathic Parkinson's Disease (at Later Stage) | Drug: Safinamide | Alain Kaelin | Clinical Trial Unit Ente Ospedaliero Cantonale | Recruiting | 18 Years | N/A | All | 23 | Phase 4 | Switzerland |
| 101 | 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 | ||
| 102 | NCT03826134 (ClinicalTrials.gov) | January 17, 2019 | 30/1/2019 | A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects | Interventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy Subjects | Parkinson Disease | Drug: [11C]PXT012253 | H. Lundbeck A/S | NULL | Completed | 20 Years | 50 Years | All | 7 | Early Phase 1 | Sweden |
| 103 | NCT03391882 (ClinicalTrials.gov) | December 19, 2018 | 2/1/2018 | A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations | Motor OFF Episodes Associated With Parkinson's Disease | Drug: APL-130277;Drug: subcutaneous apomorphine | Sunovion | NULL | Completed | 18 Years | N/A | All | 113 | Phase 3 | Austria;France;Germany;Italy;Spain;United Kingdom |
| 104 | NCT03944447 (ClinicalTrials.gov) | December 1, 2018 | 3/5/2019 | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus | Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler | OMNI Medical Services, LLC | OMNI Medical Services Inc | Recruiting | 7 Years | N/A | All | 200000 | Phase 2 | United States |
| 105 | NCT03639064 (ClinicalTrials.gov) | December 2018 | 4/7/2018 | Cannabis Oil for Pain in Parkinson's Disease | A Phase II, Randomized, Open-label, Double-blind, Two-center Study to Evaluate the Tolerability, Safety and Dose-finding of Oil Cannabis Preparation for Pain in Parkinson's Disease | Parkinson Disease | Drug: Cannabis Oil | University Health Network, Toronto | Parkinson Society Canada | Unknown status | 18 Years | N/A | All | 15 | Phase 2 | NULL |
| 106 | NCT03733561 (ClinicalTrials.gov) | November 9, 2018 | 6/11/2018 | A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 40 | Phase 1 | United States |
| 107 | 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 |
| 108 | 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 |
| 109 | NCT03773796 (ClinicalTrials.gov) | August 6, 2018 | 19/7/2018 | Nabilone for Non-motor Symptoms in Parkinson's Disease | Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy | Parkinson Disease | Drug: Nabilone 0.25 mg | Medical University Innsbruck | NULL | Recruiting | 30 Years | 100 Years | All | 48 | Phase 3 | Austria |
| 110 | EUCTR2018-001209-95-IT (EUCTR) | 05/07/2018 | 03/08/2021 | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease - IN 18001 | 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: Accordion Pill¿ Carbidopa/levodopa Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA Trade Name: SINEMET - 100 MG + 25 MG COMPRESSE 50 COMPRESSE DIVISIBILI Product Name: Sinemet Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Spain;Italy | ||
| 111 | NCT03521635 (ClinicalTrials.gov) | July 3, 2018 | 11/4/2018 | The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa | A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD) | Parkinson Disease | Drug: Pramipexole SR;Drug: Pramipexole IR | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 98 | Phase 4 | China |
| 112 | NCT03566589 (ClinicalTrials.gov) | July 2, 2018 | 12/6/2018 | Effects of PS128 on Parkinsonian Symptoms | Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot Study | Parkinson Disease | Dietary Supplement: Lactobacillus plantarum PS128 | Professor Lu Neurological Clinic | NULL | Completed | 40 Years | 80 Years | All | 30 | N/A | Taiwan |
| 113 | NCT03576638 (ClinicalTrials.gov) | July 2018 | 25/6/2018 | Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients | An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease | Parkinson Disease | Drug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 12 | Phase 2 | NULL |
| 114 | EUCTR2017-004006-18-NL (EUCTR) | 07/06/2018 | 15/11/2017 | The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease | Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease | Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia. 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] | Product Name: Levodopa powder for inhalation Product Code: Levodopa Cyclops INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: Madopar 125 mg, orodispersible tablet | Pharmaceutical Technology and Biopharmacy, University of Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Phase 2 | Netherlands | ||
| 115 | EUCTR2017-002780-17-ES (EUCTR) | 21/05/2018 | 12/02/2018 | Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa. | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL 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 | 50 | Phase 3 | France;United States;Spain;Austria;Netherlands;Italy | ||
| 116 | NCT03589066 (ClinicalTrials.gov) | May 15, 2018 | 8/6/2018 | Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease | An Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's Disease | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 117 | EUCTR2016-003456-70-IT (EUCTR) | 04/05/2018 | 02/02/2021 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Disease patients | An Open-Label Randomized Crossover Trial, utilizing a Single-Blinded Rater to evaluate APL- 130277 compared to S.C. Apomorphine in Levodopa Responsive Subjects with Parkinson¿s Disease Complicated by Motor Fluctuations - A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Di | Levodopa Responsive Patients with Parkinson¿s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;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: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine Product Code: n/a INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 | SUNOVION PHARMACEUTICALS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 118 | EUCTR2017-002780-17-FR (EUCTR) | 26/04/2018 | 27/02/2018 | - | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Austria;Netherlands;Italy | ||
| 119 | NCT03374917 (ClinicalTrials.gov) | April 18, 2018 | 8/12/2017 | A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment | An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Completed | 30 Years | 85 Years | All | 20 | Phase 1 | United States |
| 120 | EUCTR2017-004253-16-AT (EUCTR) | 13/04/2018 | 27/02/2018 | Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-Motor symptoms (e.g.sleeping dirsorders, cognitive dysfunction, hallucinations, autonomic dysfunction,...) | Nabilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy | Subject 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): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Austria | ||
| 121 | 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 |
| 122 | EUCTR2017-002780-17-IT (EUCTR) | 10/04/2018 | 04/11/2020 | study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered | Parkinson¿s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | ||
| 123 | EUCTR2016-003456-70-DE (EUCTR) | 04/04/2018 | 03/04/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;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 Trade Name: APO-go Product Name: s.c. apomorphine 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: Apomor | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 124 | 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 | ||
| 125 | NCT03482882 (ClinicalTrials.gov) | March 9, 2018 | 23/3/2018 | Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression | An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression | Treatment of Depression in Adults With Parkinson's Disease (PD) | Drug: Pimavanserin | ACADIA Pharmaceuticals Inc. | NULL | Completed | 50 Years | N/A | All | 47 | Phase 2 | United States |
| 126 | EUCTR2016-000637-43-IT (EUCTR) | 05/03/2018 | 21/01/2021 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patientswith Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes). - Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease. | Levodopa Responsive Patients with Parkinson's Disease complicated by Motor Fluctuations (OFF Episodes) MedDRA version: 22.1;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: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride | SUNOVION PHARMACEUTICALS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy | ||
| 127 | NCT04265027 (ClinicalTrials.gov) | February 20, 2018 | 7/2/2020 | Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC) | An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers. | Parkinson Disease | Drug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg Ongentys | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | United Kingdom |
| 128 | NCT03419806 (ClinicalTrials.gov) | February 16, 2018 | 10/1/2018 | Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease | Levodopa Pharmacokinetics in Patients With Parkinson's Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa | Parkinson Disease | Drug: Infudopa i.v.;Drug: Infudopa s.c.;Drug: LCIG (Duodopa) | Vastra Gotaland Region | The Swedish Research Council;Dizlin Medical Design AB;Göteborg University | Completed | 30 Years | N/A | All | 25 | Phase 1 | Sweden |
| 129 | NCT03496870 (ClinicalTrials.gov) | February 8, 2018 | 1/3/2018 | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa. | A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease | Parkinson Disease | Drug: Opicapone;Drug: Carbidopa Levodopa | Neurocrine Biosciences | NULL | Completed | 18 Years | 85 Years | All | 16 | Phase 1 | United States |
| 130 | EUCTR2016-003456-70-ES (EUCTR) | 06/02/2018 | 07/12/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 20.0;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 Trade Name: APO-go Product Name: s.c. apomorphine 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 | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 85 | Phase 3 | Spain;Austria;United Kingdom | ||
| 131 | EUCTR2016-000637-43-ES (EUCTR) | 06/02/2018 | 07/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy 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: 20.0;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 Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 132 | EUCTR2016-000637-43-AT (EUCTR) | 01/02/2018 | 15/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy 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: 22.1;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 | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy | ||
| 133 | EUCTR2016-001403-23-HU (EUCTR) | 23/01/2018 | 22/01/2018 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease 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: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 134 | EUCTR2016-003456-70-AT (EUCTR) | 04/01/2018 | 16/11/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;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 Trade Name: APO-go Product Name: s.c. apomorphine 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: Apomor | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 135 | 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 | ||
| 136 | 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 | ||
| 137 | 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 | ||
| 138 | NCT03250117 (ClinicalTrials.gov) | October 10, 2017 | 11/8/2017 | Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole | An Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-Dopa | Parkinson Disease | Drug: Ropinirole oral product;Drug: Ropinirole Implant | Titan Pharmaceuticals | NULL | Terminated | 30 Years | 80 Years | All | 3 | Phase 1/Phase 2 | United States |
| 139 | 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 | ||
| 140 | EUCTR2017-000128-81-DE (EUCTR) | 20/09/2017 | 06/07/2017 | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | Parkinson’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PF-06649751 - 1mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 5mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 15mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Canada;Spain;Germany | ||
| 141 | EUCTR2016-003961-25-CZ (EUCTR) | 07/09/2017 | 15/05/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease 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] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 142 | NCT03272230 (ClinicalTrials.gov) | September 6, 2017 | 3/8/2017 | Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System | Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease | Apathy;Frontotemporal Dementia;Parkinson Disease;Depressive Symptoms | Behavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Recruiting | 40 Years | 85 Years | All | 135 | N/A | France |
| 143 | EUCTR2017-000128-81-ES (EUCTR) | 28/08/2017 | 12/07/2017 | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | Parkinson’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PF-06649751 - 1mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 5mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 15mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Canada;Spain;Germany | ||
| 144 | 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 | ||
| 145 | EUCTR2014-004865-26-GR (EUCTR) | 01/08/2017 | 25/04/2017 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease 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: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden | ||
| 146 | 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 | ||
| 147 | 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 | ||
| 148 | NCT03178786 (ClinicalTrials.gov) | July 18, 2017 | 5/6/2017 | Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease | Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease | Parkinson Disease | Behavioral: PAT sessions | NYU Langone Health | NULL | Completed | 40 Years | 75 Years | All | 72 | N/A | United States |
| 149 | EUCTR2017-000262-30-IT (EUCTR) | 10/07/2017 | 04/11/2020 | Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations | Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations - NA | Parkinson's Desease (PD) 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: EXN-44(LEVODOPA) Product Code: EXN-44 Trade Name: Sinemet Product Name: EXN-32 (CARBIDOPA E LEVODOPA) Product Code: EXN-32 | DR. REDDY’S LABORATORIES LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| 150 | NCT03185481 (ClinicalTrials.gov) | July 6, 2017 | 9/6/2017 | Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson's Disease With Motor Fluctuations | Drug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD | Pfizer | NULL | Terminated | 40 Years | 87 Years | All | 5 | Phase 2 | United States |
| 151 | EUCTR2015-005814-31-BE (EUCTR) | 06/07/2017 | 05/05/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: 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 | 170 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany | ||
| 152 | EUCTR2016-003961-25-DE (EUCTR) | 30/06/2017 | 01/02/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom | ||
| 153 | 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 |
| 154 | EUCTR2015-005814-31-ES (EUCTR) | 22/06/2017 | 21/04/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: 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 | 170 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany | ||
| 155 | NCT03116295 (ClinicalTrials.gov) | June 20, 2017 | 12/4/2017 | Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone | A Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy Subjects | Parkinson Disease | Drug: Opicapone (OPC) | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 56 | Phase 1 | Germany |
| 156 | EUCTR2015-005814-31-HU (EUCTR) | 14/06/2017 | 20/04/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: 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 | 170 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Belgium;Poland;Germany | ||
| 157 | EUCTR2016-003961-25-ES (EUCTR) | 08/06/2017 | 27/04/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 158 | EUCTR2016-003961-25-HU (EUCTR) | 31/05/2017 | 03/04/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 159 | 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 | ||
| 160 | EUCTR2015-005814-31-PL (EUCTR) | 25/05/2017 | 14/02/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: 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 | 210 | Phase 2 | United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy;France | ||
| 161 | NCT03065192 (ClinicalTrials.gov) | May 11, 2017 | 10/2/2017 | Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's Disease | An Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Using a Posterior Trajectory Into the Putamen of Participants With Parkinson's Disease With Fluctuating Responses to Levodopa | Idiopathic Parkinson's Disease;Parkinson's Disease;Basal Ganglia Disease;Brain Diseases;Central Nervous System Diseases;Movement Disorders;Nervous System Diseases;Neurodegenerative Diseases;Parkinsonian Disorders | Drug: VY-AADC01 | Neurocrine Biosciences | Voyager Therapeutics | Completed | 40 Years | 75 Years | All | 16 | Phase 1 | United States |
| 162 | EUCTR2015-004507-23-FI (EUCTR) | 08/05/2017 | 30/03/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 163 | NCT03119636 (ClinicalTrials.gov) | May 2017 | 6/4/2017 | Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease | A Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's Disease | Parkinson's Disease | Biological: NPC transplantation;Drug: Levodopa | Chinese Academy of Sciences | The First Affiliated Hospital of Zhengzhou University | Recruiting | 50 Years | 80 Years | All | 50 | Phase 1/Phase 2 | China |
| 164 | NCT03128450 (ClinicalTrials.gov) | April 15, 2017 | 9/2/2017 | A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient | A Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's Disease | Parkinson Disease | Biological: human neural stem cell | Second Affiliated Hospital of Soochow University | NULL | Enrolling by invitation | 35 Years | 70 Years | All | 12 | Phase 2/Phase 3 | China |
| 165 | NCT03051607 (ClinicalTrials.gov) | April 10, 2017 | 9/2/2017 | Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease. | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off | Idiopathic Parkinson Disease | Drug: Tozadenant | Biotie Therapies Inc. | Acorda Therapeutics | Terminated | 30 Years | 80 Years | All | 66 | Phase 3 | United States;Canada;United Kingdom |
| 166 | EUCTR2016-003961-25-GB (EUCTR) | 04/04/2017 | 16/02/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease 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] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | 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 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom | ||
| 167 | EUCTR2016-001403-23-GR (EUCTR) | 31/03/2017 | 14/10/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 168 | EUCTR2016-003456-70-GB (EUCTR) | 22/03/2017 | 26/01/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 21.1;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 Trade Name: APO-go Product Name: s.c. apomorphine 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: Apomorp | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;Italy;United Kingdom | ||
| 169 | EUCTR2015-003513-24-SK (EUCTR) | 14/03/2017 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 170 | EUCTR2015-005814-31-CZ (EUCTR) | 03/03/2017 | 01/12/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: 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 | 210 | 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;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
| 171 | EUCTR2015-004507-23-HU (EUCTR) | 24/02/2017 | 04/01/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 172 | EUCTR2016-001403-23-FI (EUCTR) | 22/02/2017 | 31/08/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 173 | NCT02799381 (ClinicalTrials.gov) | February 9, 2017 | 10/6/2016 | A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER) | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication) | Parkinson's Disease (PD) | Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 63 | Phase 3 | United States;Finland;Greece;Hungary;Italy;Slovakia;Spain |
| 174 | EUCTR2015-005814-31-DE (EUCTR) | 07/02/2017 | 24/05/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) | Subjects with advanced 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: 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 | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany | ||
| 175 | EUCTR2015-004344-19-DE (EUCTR) | 07/02/2017 | 27/09/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | 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: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | 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 | France;Canada;Germany;United Kingdom | ||
| 176 | NCT03119194 (ClinicalTrials.gov) | January 27, 2017 | 13/4/2017 | Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 | An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male Subjects | Parkinson Disease | Drug: [14C]-BIA 9-1067 | Bial - Portela C S.A. | NULL | Completed | 30 Years | 65 Years | Male | 7 | Phase 1 | United Kingdom |
| 177 | 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 |
| 178 | NCT02934919 (ClinicalTrials.gov) | December 2016 | 14/10/2016 | Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study | Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study | Impulse Control Disorders;Parkinson Disease | Drug: Nalmefene | University Hospital, Clermont-Ferrand | NULL | Not yet recruiting | 18 Years | 80 Years | Both | 30 | Phase 2 | France |
| 179 | NCT02941822 (ClinicalTrials.gov) | December 2016 | 5/9/2016 | Ambroxol in Disease Modification in Parkinson Disease | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients With Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease | Parkinson Disease | Drug: Ambroxol | University College, London | The Cure Parkinson's Trust | Completed | 40 Years | 80 Years | All | 23 | Phase 2 | United Kingdom |
| 180 | EUCTR2016-001403-23-SK (EUCTR) | 29/11/2016 | 07/09/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease 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: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;European Union;Slovakia;Greece;Finland;Spain | ||
| 181 | NCT03007888 (ClinicalTrials.gov) | November 14, 2016 | 6/12/2016 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease | A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: IR CD-LD;Drug: ER CD-LD | Impax Laboratories, LLC | NULL | Completed | 40 Years | 100 Years | All | 28 | Phase 2 | United States |
| 182 | EUCTR2016-001403-23-ES (EUCTR) | 14/11/2016 | 15/11/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 183 | 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 |
| 184 | NCT02871427 (ClinicalTrials.gov) | October 20, 2016 | 15/8/2016 | Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder | An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder | Lewy Body Dementia;Dementia With Lewy Bodies;Parkinson's Disease Dementia;Visual Hallucinations;REM Sleep Behavior Disorder | Drug: Nelotanserin | Axovant Sciences Ltd. | NULL | Terminated | 50 Years | N/A | All | 80 | Phase 2 | United States |
| 185 | EUCTR2015-002571-24-GB (EUCTR) | 14/10/2016 | 12/02/2019 | A Pilot Study to Evaluate the Safety, Tolerability (any side effects of the drug) and Pharmacodynamic (biochemical and physiological effects of drugs). The effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease. | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease - AiM-PD | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AMBROSAN 60mg Tablets Product Name: Ambroxol INN or Proposed INN: Ambroxol hydrochloride | Joint Research Office | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 186 | NCT02935842 (ClinicalTrials.gov) | October 1, 2016 | 18/8/2016 | Evaluation of Intensive Language Therapy | Effectiveness of High-frequency Specific Speech Therapy on Verbal Fluency Decline and/ or Verbal Apraxia in Patients With Parkinson's Disease With and Without Deep Brain Stimulation (DBS) - a Randomized Controlled Single-blinded Trial | Parkinson's Disease | Other: Specific SL-therapy;Other: Rhythmic Balance-Movement Training (rBMT) | University Hospital, Basel, Switzerland | NULL | Completed | 45 Years | 80 Years | All | 38 | N/A | Switzerland |
| 187 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan | |
| 188 | EUCTR2016-001403-23-IT (EUCTR) | 13/09/2016 | 06/09/2021 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease. | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparativeinterventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced 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: Duodopa Product Name: na Product Code: [na] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain;Italy | ||
| 189 | EUCTR2015-003513-24-DE (EUCTR) | 08/09/2016 | 15/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 190 | EUCTR2015-005814-31-AT (EUCTR) | 29/08/2016 | 11/05/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) | Subjects with advanced 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: 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 | 210 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
| 191 | EUCTR2014-001014-25-ES (EUCTR) | 20/07/2016 | 15/07/2016 | Brain amyloid beta burden as per florbetaben PET | Brain Amyloid-Beta burden as per florbetaben (Neuraceq) pet and cognitive outcomes after deep brain stimulation in Parkinsin'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] | Trade Name: Neuraceq Product Name: Neuraceq INN or Proposed INN: FLORBETABEN (18F) | Fundació Clínic per la Recerca Biomèdica | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Spain | |||
| 192 | NCT02615873 (ClinicalTrials.gov) | July 2016 | 23/11/2015 | A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004 | An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004 | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | 100 Years | All | 460 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom |
| 193 | NCT02452723 (ClinicalTrials.gov) | July 2016 | 18/5/2015 | A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease | A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease | Parkinson Disease | Biological: ISC-hpNSC | Cyto Therapeutics Pty Limited | NULL | Active, not recruiting | 30 Years | 70 Years | All | 12 | Phase 1 | Australia |
| 194 | EUCTR2015-004344-19-FR (EUCTR) | 29/06/2016 | 20/04/2016 | An international trial of deferiprone in patients with parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | 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: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma Inc. | 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 States;France;Canada;Germany;Italy;United Kingdom | ||
| 195 | EUCTR2015-003513-24-BG (EUCTR) | 27/06/2016 | 26/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 196 | EUCTR2015-005814-31-IT (EUCTR) | 23/06/2016 | 14/01/2021 | Not available | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | advanced Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Soluzione di levodopa/carbidopa Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA (LD) INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA (CD) | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
| 197 | EUCTR2015-003513-24-IT (EUCTR) | 23/06/2016 | 05/11/2020 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 198 | 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 | 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 | |
| 199 | JPRN-UMIN000009062 | 2016/05/30 | 09/10/2012 | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease | Parkinson's disease | Take oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dL | Dept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 1 | Japan | |
| 200 | EUCTR2015-003513-24-HU (EUCTR) | 24/05/2016 | 02/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 201 | EUCTR2015-003513-24-ES (EUCTR) | 18/05/2016 | 18/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 202 | EUCTR2016-000637-43-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy 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: 22.1;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 | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 203 | EUCTR2015-003887-34-PL (EUCTR) | 06/05/2016 | 26/02/2016 | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders 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: 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 | 300 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 204 | NCT02728947 (ClinicalTrials.gov) | May 2016 | 31/3/2016 | Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | A Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | Parkinson's Disease | Drug: ROTIGOTINE | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 99 Years | Both | 28 | Phase 1 | United States |
| 205 | NCT02726386 (ClinicalTrials.gov) | May 2016 | 29/3/2016 | A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC Infusion | A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease | Parkinson's Disease | Drug: ND0612 | NeuroDerm Ltd. | NULL | Active, not recruiting | 30 Years | N/A | All | 210 | Phase 2 | United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain |
| 206 | EUCTR2015-003513-24-GB (EUCTR) | 28/04/2016 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 207 | EUCTR2015-004507-23-DE (EUCTR) | 25/04/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 208 | 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 | ||
| 209 | EUCTR2015-003887-34-DE (EUCTR) | 12/04/2016 | 23/12/2015 | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders 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: 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 | 300 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 210 | NCT03034538 (ClinicalTrials.gov) | April 8, 2016 | 25/1/2017 | An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease | An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease | Parkinson Disease;Parkinsonism;Dyskinesias | Drug: Zonegran | The Cooper Health System | NULL | Suspended | 18 Years | N/A | All | 20 | Phase 4 | United States |
| 211 | NCT02764125 (ClinicalTrials.gov) | April 8, 2016 | 13/1/2016 | Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC) | Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off | Parkinson's Disease | Drug: Stalevo;Drug: levodopa MR | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | All | 84 | Phase 2 | Finland;Germany;Hungary;Latvia |
| 212 | EUCTR2015-004344-19-GB (EUCTR) | 31/03/2016 | 16/02/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | 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: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Canada;Germany;United Kingdom | ||
| 213 | EUCTR2015-003887-34-IT (EUCTR) | 25/03/2016 | 21/01/2021 | A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease - A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinso | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders 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: 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 | 300 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy | ||
| 214 | EUCTR2015-004507-23-LV (EUCTR) | 15/03/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC | Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Finland;Germany;Latvia | ||
| 215 | EUCTR2015-003887-34-CZ (EUCTR) | 02/03/2016 | 30/12/2015 | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders 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: 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 | 300 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 216 | JPRN-UMIN000021236 | 2016/03/01 | 01/03/2016 | Investigation in effect of aroma therapy using magnetoencepharography | Normal volunteer, Epilepsy patients, Parkinson disease patients | aroma 1 Trans-nasal administration of lavender essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. aroma 2 Trans-nasal administration of grapefruit essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. fragrant Trans-nasal administration of fragrant Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. | Osaka University Graduate School of Medicine Department of Neurosurgery | NULL | Complete: follow-up continuing | 20years-old | 80years-old | Male and Female | 10 | Phase 1 | Japan | |
| 217 | 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 | 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 | |
| 218 | 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 |
| 219 | NCT02649608 (ClinicalTrials.gov) | January 2016 | 6/1/2016 | An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients | Interventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's Disease | Parkinson Disease | Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621;Drug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621 | H. Lundbeck A/S | NULL | Completed | 45 Years | 75 Years | All | 15 | Phase 1 | United States |
| 220 | NCT02579473 (ClinicalTrials.gov) | January 2016 | 13/10/2015 | A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214 | A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose Titration | Parkinson's Disease | Drug: SER-214 | Serina Therapeutics | NULL | Active, not recruiting | 40 Years | 80 Years | All | 20 | Phase 1 | United States |
| 221 | 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 | ||
| 222 | NCT02610231 (ClinicalTrials.gov) | December 2015 | 13/11/2015 | Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Istradefylline 20 mg or 40 mg | Kyowa Hakko Kirin Pharma, Inc. | Kyowa Kirin Co., Ltd. | Completed | 30 Years | N/A | All | 239 | Phase 3 | United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic |
| 223 | EUCTR2015-002631-17-ES (EUCTR) | 19/11/2015 | 03/11/2015 | A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients | An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa Product Name: Duodopa Trade Name: Sinemet Plus Product Name: Sinemet Plus | Institut de Recerca del Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 224 | JPRN-jRCTs041180070 | 04/11/2015 | 07/03/2019 | Trerief Impact in PD PET Study | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS | Parkinson's disease Parkinson's disease;D010300 | [1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Ouchi Yasuomi | NULL | Not Recruiting | Not applicable | < 80age old | Both | 20 | N/A | Japan |
| 225 | NCT02271503 (ClinicalTrials.gov) | November 2015 | 13/10/2014 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease | A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease | Parkinson's Disease | Drug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mg | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 26 | Phase 2 | United States |
| 226 | 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;University of Western Ontario, Canada;London Health Sciences Centre | Recruiting | 50 Years | N/A | All | 75 | Phase 2 | Canada |
| 227 | 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 | ||
| 228 | JPRN-UMIN000019524 | 2015/10/01 | 28/10/2015 | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) | Parkinson's Disease | Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | Not applicable | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 229 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Canada;Spain;Austria;Germany;Italy | ||
| 230 | 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 | ||
| 231 | EUCTR2014-004865-26-IT (EUCTR) | 21/09/2015 | 29/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | |||
| 232 | NCT02549092 (ClinicalTrials.gov) | September 9, 2015 | 11/9/2015 | A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD) | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study | Advanced Parkinson's Disease | Drug: ABT-SLV187 | AbbVie | NULL | Active, not recruiting | 30 Years | 99 Years | All | 89 | Phase 3 | United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden |
| 233 | NCT02542696 (ClinicalTrials.gov) | August 31, 2015 | 3/9/2015 | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease | Drug: APL-130277 | Sunovion | NULL | Recruiting | 18 Years | N/A | All | 226 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom |
| 234 | EUCTR2014-004865-26-DE (EUCTR) | 27/08/2015 | 22/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 235 | EUCTR2014-004865-26-SE (EUCTR) | 05/08/2015 | 25/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 236 | NCT02337751 (ClinicalTrials.gov) | July 10, 2015 | 9/1/2015 | A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 198 | Phase 3 | Japan |
| 237 | EUCTR2014-000657-36-NL (EUCTR) | 22/06/2015 | 03/06/2015 | Trial to investigate the efficacy of treatments in apomorphine-induced skin reactions | Open-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hydrocortisone cream 10mg/g FNA Fagron Product Name: Hydrocortisone cream Trade Name: Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial' Product Name: Solu-Cortef Trade Name: APO-go Product Name: Apomorphine | University Medical Center Groningen | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands | ||
| 238 | EUCTR2014-004865-26-ES (EUCTR) | 19/06/2015 | 15/06/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 239 | EUCTR2014-003739-20-AT (EUCTR) | 19/06/2015 | 01/04/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Spain;Austria;Germany | ||
| 240 | NCT02230930 (ClinicalTrials.gov) | June 2015 | 29/8/2014 | Treatment of Apomorphine-induced Skin Reactions: a Pilot Study | Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions | Parkinson's Disease;Apomorphine-induced Skin Reactions | Drug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mg | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 20 | Phase 2 | Netherlands |
| 241 | NCT02769793 (ClinicalTrials.gov) | June 2015 | 9/5/2016 | Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON | Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over Trial | Parkinson Disease | Drug: Levodopa dispersible;Drug: Levodopa | Seoul National University Hospital | SMG-SNU Boramae Medical Center;Samsung Medical Center | Completed | 31 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
| 242 | NCT02604914 (ClinicalTrials.gov) | May 2015 | 3/11/2015 | A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects | 1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal Gel | Parkinson's Disease | Drug: ND0612;Drug: LCIG | NeuroDerm Ltd. | Quotient Clinical | Completed | 30 Years | 65 Years | All | 36 | Phase 1 | United Kingdom |
| 243 | NCT02448914 (ClinicalTrials.gov) | May 2015 | 12/5/2015 | A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients | A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease | Parkinson's Disease | Drug: TRIGEL;Drug: Duodopa | LobSor Pharmaceuticals AB | TFS Trial Form Support | Completed | 30 Years | N/A | All | 11 | Phase 1 | Sweden |
| 244 | EUCTR2014-003739-20-DE (EUCTR) | 23/04/2015 | 21/01/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Spain;Austria;Germany | ||
| 245 | EUCTR2014-002697-37-GB (EUCTR) | 15/04/2015 | 19/03/2015 | Study of Melatonin for treatment of Nocturia in PD | Single-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease - Study of Melatonin for treatment of Nocturia in PD | Parkinson's DiseaseNocturia MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;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] | Trade Name: Circadin® Product Name: Melatonin Product Code: AS2 INN or Proposed INN: Melatonin | University College London | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United Kingdom | ||
| 246 | EUCTR2014-003739-20-FR (EUCTR) | 10/04/2015 | 19/06/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | 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 States;France;Spain;Austria;Germany | ||
| 247 | NCT02359448 (ClinicalTrials.gov) | April 2015 | 4/2/2015 | Melatonin for Nocturia in Parkinson's Disease | Single-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's Disease | Parkinson's Disease;Nocturia | Drug: Melatonin | University College, London | NULL | Not yet recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United Kingdom |
| 248 | EUCTR2014-003739-20-ES (EUCTR) | 24/03/2015 | 16/02/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Austria;Germany | ||
| 249 | NCT02337764 (ClinicalTrials.gov) | February 3, 2015 | 9/1/2015 | A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 222 | Phase 3 | Japan |
| 250 | NCT02339064 (ClinicalTrials.gov) | February 2015 | 31/3/2014 | Infusion of Apomorphine: Long-term Safety Study | A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy | Idiopathic Parkinson's Disease | Drug: apomorphine infusion | US WorldMeds LLC | NULL | Active, not recruiting | 30 Years | N/A | All | 99 | Phase 3 | United States |
| 251 | JPRN-JapicCTI-152762 | 27/1/2015 | A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Patients | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's disease | Intervention name : TVP-1012 (1 mg/day) with levodopa Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period. Control intervention name : null | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | 30 | 79 | BOTH | 215 | Phase 3 | NULL | ||
| 252 | ChiCTR-DDD-17010794 | 2014-11-08 | 2017-03-05 | The study on early diagnosis of Parkinson 's disease by transcranial ultrasonography | the study on early diagnosis of Parkinson 's disease by transcranial ultrasonography | Parkinson's Disease | Gold Standard:Diagnosis of Parkinson disease needs to meet 3 or more: unilateral onset;resting tremor;progressive course; long term asymmetry, the most obvious symptoms is the onset side; a good response to levodopa (70% ~ 100%); levodopa induced chorea; a reaction of levodopa lasts 5 years or more; clinical course last;Index test:Laboratory apparatus As shown in Figure 1, The ultrasound equipment, Philips IE33-BOMJH1 color Doppler ultrasonography, Model IE-ELite, with 2-4MHz phased array probe (S5-1 probe) was used for TCS to examine SN in our study. Transcranial ultrasound study Ultrasonography through temporal window, alon; | Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital | NULL | Completed | 36 | 84 | Both | Target condition:135;Difficult condition:0 | China | |
| 253 | NCT02281474 (ClinicalTrials.gov) | November 2014 | 27/10/2014 | Nilotinib in Cognitively Impaired Parkinson Disease Patients 001 | Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-Synuclein | Parkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body Disease | Drug: Nilotinib | Georgetown University | NULL | Completed | 40 Years | 90 Years | Both | 12 | Phase 1 | United States |
| 254 | NCT02224664 (ClinicalTrials.gov) | October 2014 | 15/8/2014 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s Disease | A Phase 1b, 2-period, Open Label, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Parkinson`s Disease And Motor Fluctuations | Parkinson`s Disease | Drug: PF-06649751 | Pfizer | NULL | Completed | 30 Years | 80 Years | All | 50 | Phase 1 | United States;Belgium |
| 255 | NCT02225548 (ClinicalTrials.gov) | September 2014 | 22/8/2014 | Sagene 2014 - Parkinson's Disease and Erectile Dysfunction | An Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction. | Parkinson's Disease;Erectile Dysfunction | Drug: Selegiline;Drug: Tadalafil | University of South Florida | NULL | Recruiting | 40 Years | 64 Years | Male | 10 | Phase 4 | United States |
| 256 | NCT02438215 (ClinicalTrials.gov) | August 2014 | 7/8/2014 | Study of IRX4204 for Treatment of Early Parkinson's Disease | An Open-Label, Single Site Study Using [123I]ß-CIT Single Photon Emission Tomography (SPECT) to Evaluate Dopamine Transporter Binding Following Treatment With IRX4204 in Early Parkinson's Disease Subjects | Parkinson's Disease | Drug: IRX4204 | Io Therapeutics | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 1 | United States |
| 257 | NCT02230267 (ClinicalTrials.gov) | August 2014 | 27/8/2014 | High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease | High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease | Parkinson's Disease | Other: High intensity exercise and balance training;Other: Usual care arm exercise | University of Nevada, Las Vegas | NULL | Completed | 45 Years | 85 Years | Both | 27 | Phase 2 | United States |
| 258 | NCT02236065 (ClinicalTrials.gov) | August 2014 | 8/9/2014 | Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders | A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders | Brain Injury;Cerebral Palsy;Amyotrophic Lateral Sclerosis;Parkinson's Disease | Procedure: Umbilical cord blood therapy;Biological: Filgrastim | MinYoung Kim, M.D. | NULL | Completed | 19 Years | 75 Years | All | 10 | N/A | Korea, Republic of |
| 259 | NCT02202551 (ClinicalTrials.gov) | July 2014 | 25/7/2014 | Open-Label Safety Study of ADS-5102 in PD Patients With LID | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID) | Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease (PD) | Drug: ADS-5102 | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 223 | Phase 3 | United States;Austria;Canada;France;Germany;Spain |
| 260 | 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 |
| 261 | NCT02082249 (ClinicalTrials.gov) | March 10, 2014 | 14/2/2014 | An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications | An Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications | Advanced Parkinson's Disease | Drug: ABT-SLV187 | AbbVie | NULL | Completed | 30 Years | 99 Years | All | 30 | Phase 3 | Japan;Korea, Republic of;Taiwan |
| 262 | 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 |
| 263 | 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 |
| 264 | 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 |
| 265 | 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 |
| 266 | NCT02263235 (ClinicalTrials.gov) | October 8, 2013 | 18/9/2014 | In Vivo Alzheimer Proteomics | Use of Targeted Quantitative Proteomics and Metabolic Labelling With Stable Isotopes for the Diagnosis and the Investigation of Neurological Disorders and in Particular Alzheimer Disease | Probable Alzheimer Disease;Parkinson Disease;Neurological Disease Without Cognitive Degradation;Brain Trauma;Acute Hydrocephaly | Biological: administration of stable isotope-labelled leucine-;Other: collection of CSF, blood, urine, saliva | University Hospital, Montpellier | Assistance Publique - Hôpitaux de Paris;University Hospital, Clermont-Ferrand;International Atomic Energy Agency | Terminated | 55 Years | 85 Years | All | 89 | N/A | France |
| 267 | NCT01960842 (ClinicalTrials.gov) | October 2013 | 9/10/2013 | A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 31 | Phase 3 | Japan;Korea, Republic of;Taiwan |
| 268 | NCT01973543 (ClinicalTrials.gov) | October 2013 | 25/10/2013 | Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's Disease | An Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Into the Putamen of Subjects With Parkinson's Disease With Fluctuating Responses to Levodopa | Parkinson's Disease | Biological: VY-AADC01 | Neurocrine Biosciences | University of California, San Francisco;Veristat, Inc.;Feinstein Institute for Medical Research;Oregon Health and Science University;Voyager Therapeutics | Completed | 40 Years | 70 Years | All | 15 | Phase 1 | United States |
| 269 | NCT01931488 (ClinicalTrials.gov) | August 2013 | 14/8/2013 | 124I-MIBG Tracer Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. | The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. Comparison With 123I-MIBG. | Parkinson Disease;Neuroendocrine Tumors | Other: MIBG label with I123 or I124;Device: SPECT imaging | Tel-Aviv Sourasky Medical Center | NULL | Recruiting | 18 Years | N/A | Both | 40 | Phase 2 | Israel |
| 270 | 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 |
| 271 | EUCTR2013-000827-15-IT (EUCTR) | 11/05/2013 | 15/03/2013 | LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE | LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rotigotine Product Name: neurpro Product Code: SPM962 | Unità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 272 | EUCTR2011-002828-41-EE (EUCTR) | 23/04/2013 | 08/02/2013 | A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage 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. | 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: REQUIP-MODUTAB, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 273 | 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 |
| 274 | EUCTR2011-002828-41-SK (EUCTR) | 27/03/2013 | 04/03/2013 | A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage 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. | Advanced 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: Requip Modutab, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 275 | NCT01736176 (ClinicalTrials.gov) | March 2013 | 27/11/2012 | A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease | An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets | AbbVie (prior sponsor, Abbott) | NULL | Completed | 30 Years | N/A | All | 39 | Phase 3 | United States |
| 276 | NCT01014858 (ClinicalTrials.gov) | January 2013 | 16/11/2009 | Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease | Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease | Parkinson's Disease | Drug: Donepezil | Newcastle-upon-Tyne Hospitals NHS Trust | University of Newcastle Upon-Tyne;University of Cambridge;University of Manchester;University of Birmingham;Bangor University;London School of Economics and Political Science;University College, London;Lancashire Care NHS Foundation Trust;Newcastle University;King's College London | Terminated | 18 Years | N/A | All | 64 | Phase 3 | United Kingdom |
| 277 | NCT01770145 (ClinicalTrials.gov) | December 2012 | 7/1/2013 | Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) | A Phase 4, Open-Label, Efficacy and Safety Study of Apokyn® for Rapid and Reliable Improvement of Motor Symptoms in Parkinson Disease Subjects With Delayed Onset of L-Dopa Action | Parkinson's Disease;Motor Symptoms;Akinesia;Hypomobility;Delayed Levodopa Onset | Drug: APOKYN;Drug: L-dopa;Drug: Trimethobenzamide | US WorldMeds LLC | NULL | Completed | 18 Years | N/A | All | 127 | Phase 4 | United States |
| 278 | NCT01796483 (ClinicalTrials.gov) | October 2012 | 13/2/2013 | EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD | Exploration électroencéphalographie et Pharmacologique Des Dysfonctionnements exécutifs Induits Par la Stimulation cérébrale Profonde du Noyau Sous-thalamique Dans la Maladie de Parkinson | Parkinson Disease | Device: Clonidine (Catapressan);Device: Placebo 90 minutes before EEG | Hospices Civils de Lyon | NULL | Completed | 40 Years | 70 Years | All | 37 | N/A | France |
| 279 | 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 |
| 280 | NCT01723904 (ClinicalTrials.gov) | October 2012 | 6/11/2012 | A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease | An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B | Advanced Parkinson's Disease | Drug: Rotigotine | UCB BIOSCIENCES GmbH | Otsuka Pharmaceutical Co., Ltd. | Completed | 30 Years | 80 Years | All | 90 | Phase 3 | Australia;Korea, Republic of;Malaysia;Singapore;Taiwan |
| 281 | EUCTR2011-004378-27-AT (EUCTR) | 04/09/2012 | 20/07/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | 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 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 282 | NCT01711866 (ClinicalTrials.gov) | September 2012 | 18/10/2012 | A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease | An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4 | Advanced Idiopathic Parkinson's Disease | Drug: Rotigotine | UCB BIOSCIENCES GmbH | Otsuka Pharmaceutical Co., Ltd. | Completed | 30 Years | 80 Years | All | 87 | Phase 4 | United States;Korea, Republic of;Malaysia;Singapore;Taiwan |
| 283 | NCT02764892 (ClinicalTrials.gov) | August 2012 | 25/9/2015 | A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease | An Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male Volunteers | Parkinson's Disease | Drug: V81444 | Vernalis (R&D) Ltd | NULL | Completed | 25 Years | 55 Years | Male | 6 | Phase 1 | NULL |
| 284 | NCT00947037 (ClinicalTrials.gov) | August 2012 | 24/7/2009 | Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects | Parkinson's Disease | Drug: AP-CD/LD | Intec Pharma Ltd. | NULL | Withdrawn | 30 Years | 95 Years | Both | 0 | Phase 2 | Israel |
| 285 | EUCTR2011-004378-27-DE (EUCTR) | 15/05/2012 | 24/02/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | 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 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 286 | EUCTR2011-004378-27-SK (EUCTR) | 02/05/2012 | 12/04/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | 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 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 287 | JPRN-UMIN000007896 | 2012/05/01 | 07/05/2012 | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Parkinson's disease and other parkinsonian syndromes | The patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. | Kansai Medical University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan | |
| 288 | NCT01652313 (ClinicalTrials.gov) | May 2012 | 23/7/2012 | Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women | A Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women | Parkinson's Disease | Drug: Rasagiline | H. Lundbeck A/S | NULL | Completed | 18 Years | 45 Years | Both | 12 | Phase 1 | China |
| 289 | NCT01550484 (ClinicalTrials.gov) | April 2012 | 6/3/2012 | A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders | An Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain Diagnosis | Parkinson's Disease;Primary Parkinsonism;Lewy Body Parkinson's Disease | Drug: 18F-AV-133 | Avid Radiopharmaceuticals | NULL | Completed | 40 Years | N/A | All | 170 | Phase 2/Phase 3 | United States;Australia |
| 290 | EUCTR2011-004378-27-HU (EUCTR) | 28/03/2012 | 15/02/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | 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 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;France;Hungary;Canada;Spain;Austria;Germany;Italy | |||
| 291 | EUCTR2011-004378-27-IT (EUCTR) | 27/03/2012 | 02/03/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias | 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: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;Hungary;Canada;Spain;Austria;Germany;Italy | |||
| 292 | 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 |
| 293 | NCT01491932 (ClinicalTrials.gov) | March 2012 | 1/12/2011 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 129 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 294 | NCT01519882 (ClinicalTrials.gov) | March 2012 | 24/1/2012 | 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. | Advanced Idiopathic Parkinson's Disease | Other: Placebo;Other: Rotigotine | UCB Pharma SA | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 4 | United Kingdom |
| 295 | NCT01525641 (ClinicalTrials.gov) | February 2012 | 1/2/2012 | Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease | Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease | Parkinson Disease | Drug: Mirapex LA | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 615 | N/A | Japan |
| 296 | NCT01673724 (ClinicalTrials.gov) | February 2012 | 23/8/2012 | Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease | Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study | Parkinson's Disease | Drug: pramipexole;Drug: Bromocriptine | Sandoz | NULL | Completed | 30 Years | N/A | All | 121 | Phase 4 | Korea, Republic of |
| 297 | NCT01515410 (ClinicalTrials.gov) | January 2012 | 11/1/2012 | Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations | A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations | Parkinson's Disease;Motor Fluctuations | Drug: DM-1992;Drug: Sinemet IR | Depomed | NULL | Completed | 30 Years | N/A | All | 34 | Phase 2 | United States |
| 298 | EUCTR2009-017412-32-IT (EUCTR) | 13/12/2011 | 27/04/2010 | RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND | RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND | Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10013363 | Trade Name: BOTOX INN or Proposed INN: Botulinum toxin Trade Name: NEUROBLOC INN or Proposed INN: Botulinum toxin | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 299 | EUCTR2009-015162-57-NL (EUCTR) | 21/11/2011 | 11/05/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Merck Sharp & Dohme corp. | 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 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 300 | EUCTR2009-015162-57-PT (EUCTR) | 04/11/2011 | 12/08/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 301 | EUCTR2009-015162-57-PL (EUCTR) | 25/10/2011 | 30/08/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 302 | 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 | ||||
| 303 | JPRN-UMIN000006521 | 2011/10/01 | 11/10/2011 | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole | Parkinson's disease | Rapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks. | Department of Neurology, Juntendo University | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 304 | NCT01479127 (ClinicalTrials.gov) | October 2011 | 26/9/2011 | Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: ABT-SLV187;Drug: Oral Levodopa/Carbidopa;Device: Infusion Pump: CADD-Legacy® 1400 Pump;Device: NJ-Tube: Silicon ED Tube;Device: Adaptor: Hakko Adaptor | AbbVie (prior sponsor, Abbott) | Abbott Japan Co.,Ltd | Completed | 30 Years | 99 Years | All | 8 | Phase 2 | Japan |
| 305 | EUCTR2009-015162-57-IT (EUCTR) | 22/09/2011 | 27/04/2011 | A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND | A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND | Parkinson`s disease 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: SCH420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Trade Name: Azilect INN or Proposed INN: Rasagiline | Schering-Plough Research Institute, division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Lithuania;Bulgaria;Netherlands;Latvia;United Kingdom;Italy;Sweden | ||
| 306 | EUCTR2011-000612-26-IT (EUCTR) | 19/09/2011 | 05/03/2012 | Open-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARK | Open-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARK | Syndrome Gilles de la Tourette's disease Parkinosn Pounding 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] | Trade Name: PROSCAR*30CPR RIV 5MG INN or Proposed INN: Finasteride | AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 307 | NCT01515774 (ClinicalTrials.gov) | September 2011 | 10/1/2012 | Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID) | An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease | Parkinson's Disease | Drug: Mirapex ER | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 200 | Phase 4 | Korea, Republic of |
| 308 | EUCTR2009-015162-57-GB (EUCTR) | 16/08/2011 | 26/01/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | 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 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 309 | EUCTR2009-015162-57-BG (EUCTR) | 04/08/2011 | 09/06/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE | 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 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 310 | 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 | |||
| 311 | NCT01411137 (ClinicalTrials.gov) | August 2011 | 4/8/2011 | Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study | An Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PD | Parkinson's Disease | Drug: IPX066 | Impax Laboratories, LLC | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 43 | Phase 3 | United States |
| 312 | EUCTR2009-015162-57-LT (EUCTR) | 25/07/2011 | 21/04/2011 | An Active-Controlled Extension Study to P04938 and 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'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 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 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 313 | 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 | |||
| 314 | EUCTR2009-015162-57-LV (EUCTR) | 19/07/2011 | 11/05/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153 AM1) | 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'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: 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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate 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 | Serbia;Portugal;United States;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 315 | EUCTR2009-015162-57-SE (EUCTR) | 12/07/2011 | 31/05/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 316 | 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 | ||
| 317 | 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 | |||
| 318 | 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 | ||
| 319 | EUCTR2010-022200-46-LV (EUCTR) | 21/06/2011 | 01/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease. | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC | Parkinson's disease 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] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 320 | EUCTR2009-015162-57-CZ (EUCTR) | 17/06/2011 | 15/04/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate 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 | Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden;Canada;Mexico;Czech Republic;United Kingdom;Austria;Turkey;Lithuania;Finland;Latvia;Netherlands;South Africa;Peru;France;India;Italy;Colombia;Chile;Russian Federation;Israel;Ukraine;Spain;Portugal;Serbia;United States | ||
| 321 | EUCTR2008-005492-94-BG (EUCTR) | 25/05/2011 | 23/03/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 322 | EUCTR2009-015162-57-ES (EUCTR) | 23/05/2011 | 31/03/2011 | Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153) | Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153) | Enfermedad 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: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate 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;Lithuania;Austria;United Kingdom;Italy;Czech Republic;Poland;Bulgaria;Latvia;Netherlands;Sweden | ||
| 323 | EUCTR2010-022200-46-FI (EUCTR) | 13/05/2011 | 23/03/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease 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: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Germany;Latvia;Lithuania | |||
| 324 | EUCTR2010-022200-46-LT (EUCTR) | 09/05/2011 | 05/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease 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: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 325 | NCT01856439 (ClinicalTrials.gov) | May 2011 | 14/5/2013 | Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease | A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease. | Parkinson's Disease | Drug: ProSavin | Axovant Sciences Ltd. | Oxford BioMedica | Active, not recruiting | N/A | N/A | All | 15 | Phase 1/Phase 2 | France;United Kingdom |
| 326 | EUCTR2008-005492-94-PT (EUCTR) | 14/04/2011 | 19/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic 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: 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 | 1285 | Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Finland;Korea, Republic of;Netherlands;South Africa;Peru;Malaysia;France;India;Italy;Switzerland;Colombia;Chile;Spain;Thailand;Slovakia;Estonia;Taiwan;Portugal;United States | |||
| 327 | EUCTR2009-015162-57-AT (EUCTR) | 17/03/2011 | 03/02/2011 | An Active-Controlled Extension Study to P04938 and 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'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 MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 328 | EUCTR2008-005492-94-CZ (EUCTR) | 14/03/2011 | 03/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 329 | 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 | |||
| 330 | EUCTR2008-005492-94-FI (EUCTR) | 04/03/2011 | 13/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;New Zealand;Germany;Bulgaria;Croatia;Romania;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom | |||
| 331 | EUCTR2009-015162-57-FI (EUCTR) | 02/03/2011 | 20/01/2011 | An Active-Controlled Extension Study to P04938 and 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'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 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 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 332 | NCT02169427 (ClinicalTrials.gov) | March 2011 | 24/1/2012 | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Following a Single Dose Oral Administration | Parkinson's Disease (PD) | Drug: OPC | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | Male | 6 | Phase 1 | Netherlands |
| 333 | NCT01264861 (ClinicalTrials.gov) | March 2011 | 20/12/2010 | A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging | Open-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients | Parkinson Disease | Drug: Safinamide | Newron | NULL | Terminated | 40 Years | 80 Years | All | 5 | Phase 2 | United States |
| 334 | EUCTR2008-001329-33-GB (EUCTR) | 24/02/2011 | 15/03/2010 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies 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] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom | ||
| 335 | 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 | ||||
| 336 | 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 | |||
| 337 | 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 |
| 338 | 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 | ||
| 339 | 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 | |||
| 340 | 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 | |||
| 341 | NCT01256905 (ClinicalTrials.gov) | January 1, 2011 | 8/12/2010 | Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies | Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies | Parkinsons Disease;Lewy Bodies Disease | Drug: Armodafinil | NYU Langone Health | Cephalon | Withdrawn | 50 Years | 80 Years | All | 0 | N/A | United States |
| 342 | 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 | |||
| 343 | 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 | |||
| 344 | 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 |
| 345 | 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 | |||
| 346 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Spain;Italy | ||
| 347 | 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 |
| 348 | 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 |
| 349 | 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 | |||
| 350 | EUCTR2010-019418-25-DE (EUCTR) | 01/10/2010 | 19/07/2010 | Open label, safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 16.0;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 | Novartis Pharma Sevices AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Canada;Finland;Australia;Germany;Italy;Japan | |||
| 351 | NCT01173731 (ClinicalTrials.gov) | October 2010 | 28/7/2010 | Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | Parkinson Disease;Dyskinesia, Drug-Induced;Levodopa | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 66 | Phase 2 | United States;Australia;Canada;France;Germany;Italy;Finland;Spain |
| 352 | EUCTR2010-019418-25-FR (EUCTR) | 29/09/2010 | 15/07/2010 | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;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 | 244 | France;Finland;Germany;Italy | |||
| 353 | EUCTR2009-017238-39-DE (EUCTR) | 16/09/2010 | 28/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 3 | France;Belgium;Germany;Italy | ||
| 354 | EUCTR2009-017238-39-FR (EUCTR) | 15/09/2010 | 09/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | France;Belgium;Germany;Italy | ||
| 355 | EUCTR2010-019418-25-FI (EUCTR) | 08/09/2010 | 21/07/2010 | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Finland;Germany;Italy | |||
| 356 | NCT01536574 (ClinicalTrials.gov) | September 2, 2010 | 19/1/2012 | Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528 | An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528 | Parkinson Disease | Drug: Requip PR | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 295 | Phase 3 | China |
| 357 | EUCTR2009-017238-39-BE (EUCTR) | 27/08/2010 | 14/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Nacom 100 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | France;Belgium;Germany;Italy | ||
| 358 | EUCTR2009-017253-35-GB (EUCTR) | 20/08/2010 | 06/08/2010 | Long-term study of patients who received ProSavin in the PS1/001/07 clinical trial. | A multicentre, open-label extension study to determine the long term safety, tolerability and efficacy of ProSavin® in patients with bilateral, idiopathic Parkinson’s disease | Patients with bilateral, idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ProSavin INN or Proposed INN: ProSavin | Oxford BioMedica (UK) Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 27 | United Kingdom | |||
| 359 | NCT01190735 (ClinicalTrials.gov) | August 2010 | 26/8/2010 | Caffeine for Motor Manifestations of Parkinson's Disease | Caffeine for Motor Manifestations of Parkinson's Disease: An Open-Label Dose-Response Study. | Parkinson's Disease | Drug: Caffeine alkaloid | Ron Postuma | Canadian Institutes of Health Research (CIHR) | Completed | 18 Years | N/A | Both | 28 | Phase 2 | Canada |
| 360 | EUCTR2009-017182-38-ES (EUCTR) | 26/07/2010 | 25/05/2010 | Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. | Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. | Enfermedad de Parkinson idiopática (parálisis agitante) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Estonia;Poland;Spain;Lithuania;Germany;Latvia | ||
| 361 | EUCTR2010-018650-12-FR (EUCTR) | 13/07/2010 | 06/05/2010 | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | maladie de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: CYMBALTA Product Name: duloxetine Trade Name: APOKINON Product Name: apomorphine Trade Name: MODOPAR Product Name: levodopa Trade Name: MOTILIUM Product Name: dompéridone | CHU de Toulouse | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 362 | EUCTR2009-017182-38-LT (EUCTR) | 10/07/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 363 | EUCTR2009-017182-38-DE (EUCTR) | 09/07/2010 | 07/05/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | Idiopathic Parkinson’s disease (paralysis agitans). MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division | NULL | Not Recruiting | Female: yes Male: yes | 500 | Estonia;Spain;Poland;Lithuania;Latvia;Germany | |||
| 364 | EUCTR2009-017182-38-PL (EUCTR) | 07/07/2010 | 20/05/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | Idiopathic Parkinson’s disease (paralysis agitans). MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 365 | NCT01174810 (ClinicalTrials.gov) | July 2010 | 2/8/2010 | Exendin-4 as a Treatment for Parkinson's Disease - Pilot Study | An Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease. | Parkinson's Disease | Drug: Exenatide | University College, London | NULL | Active, not recruiting | 45 Years | 70 Years | Both | 40 | Phase 2 | United Kingdom |
| 366 | EUCTR2009-017238-39-IT (EUCTR) | 21/06/2010 | 13/07/2010 | A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND | A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536 | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA LEVODOPA Trade Name: NACOM 100 INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone | IMPAX LABORATORIES, INC. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Germany;France;Italy | |||
| 367 | EUCTR2009-017182-38-LV (EUCTR) | 11/06/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 368 | EUCTR2010-018904-94-IT (EUCTR) | 31/05/2010 | 14/03/2012 | EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE | EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE | Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria MedDRA version: 14.1;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: NERIXIA*IM EV 1F 25MG INN or Proposed INN: Bisphosphonates Other descriptive name: Neridronic acid | FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 369 | EUCTR2010-019396-29-IT (EUCTR) | 18/05/2010 | 05/03/2012 | Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease. | Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD. - LAMP-PD | Patients with idiopathic Parkinson's Disease.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: STALEVO*100CPR 50/12,5/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor Trade Name: STALEVO*100CPR 100/25/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor | AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 370 | EUCTR2009-017182-38-EE (EUCTR) | 14/05/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 371 | 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 |
| 372 | NCT01130493 (ClinicalTrials.gov) | May 2010 | 24/5/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease | Parkinson's Disease | Drug: IPX066;Drug: CLE | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 110 | Phase 3 | United States;France;Germany;Italy |
| 373 | EUCTR2009-018137-37-GB (EUCTR) | 14/04/2010 | 18/03/2010 | An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial | An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Byetta 5 micrograms Product Name: Exenatide 5 micrograms Trade Name: Exenatide 10 micrograms Product Name: Exenatide 10 micrograms | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 374 | NCT01096186 (ClinicalTrials.gov) | March 2010 | 25/3/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX066 95 mg;Drug: IPX066 145 mg;Drug: IPX066 195 mg;Drug: IPX066 245 mg | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 617 | Phase 3 | United States;Canada;Estonia;Germany;Latvia;Lithuania;Poland;Romania;Spain;Ukraine |
| 375 | NCT02101190 (ClinicalTrials.gov) | March 2010 | 20/1/2012 | Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment | Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment | Parkinson's Disease | Drug: BIA 9-1067 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 65 Years | All | 16 | Phase 1 | France;Russian Federation |
| 376 | 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 |
| 377 | EUCTR2009-014688-37-PL (EUCTR) | 09/02/2010 | 20/01/2010 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 378 | EUCTR2008-005492-94-BE (EUCTR) | 25/01/2010 | 12/08/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 379 | EUCTR2009-017416-33-DE (EUCTR) | 18/01/2010 | 21/12/2009 | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 380 | EUCTR2008-005492-94-NL (EUCTR) | 18/01/2010 | 25/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients - | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1285 | Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain | ||||
| 381 | EUCTR2008-001329-33-CZ (EUCTR) | 18/01/2010 | 03/12/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies 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: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 3 | Portugal;Czech Republic;Poland;Thailand;Australia;Russian Federation;Israel;United Kingdom;New Zealand;Italy | ||
| 382 | EUCTR2009-014688-37-ES (EUCTR) | 30/12/2009 | 21/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Sinemet-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 383 | EUCTR2009-011541-24-NL (EUCTR) | 30/12/2009 | 29/05/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | |||
| 384 | EUCTR2009-014688-37-DE (EUCTR) | 15/12/2009 | 07/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 385 | EUCTR2008-005492-94-GB (EUCTR) | 09/12/2009 | 01/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 386 | EUCTR2009-014688-37-FR (EUCTR) | 04/12/2009 | 09/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | France;Poland;Spain;Germany | ||
| 387 | 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 |
| 388 | NCT01032486 (ClinicalTrials.gov) | December 2009 | 11/12/2009 | Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease | An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects | Parkinson's Disease | Drug: Rasagiline mesylate | Teva Pharmaceutical Industries | NULL | Completed | N/A | N/A | Both | 120 | Canada | |
| 389 | 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 | ||||
| 390 | EUCTR2008-005492-94-FR (EUCTR) | 25/11/2009 | 01/10/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 391 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 246 | France;Spain | |||
| 392 | EUCTR2008-005492-94-ES (EUCTR) | 23/11/2009 | 18/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson 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 | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 393 | NCT00660673 (ClinicalTrials.gov) | November 13, 2009 | 15/4/2008 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD | Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump | AbbVie | IQVIA, formerly Quintiles | Completed | 30 Years | 99 Years | All | 262 | Phase 3 | United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic |
| 394 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 246 | France;Spain | |||
| 395 | EUCTR2008-005492-94-HU (EUCTR) | 27/10/2009 | 22/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | |||
| 396 | EUCTR2008-005492-94-SK (EUCTR) | 14/10/2009 | 22/10/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 397 | EUCTR2009-011541-24-GB (EUCTR) | 09/10/2009 | 29/05/2009 | A trial to follow-up subjects with Parkinson's disease who participated to the ADAGIO study in order to study the long-term effects of the drug rasagiline | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 13.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Romania;Germany;Netherlands | ||
| 398 | EUCTR2008-005492-94-AT (EUCTR) | 02/10/2009 | 03/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic 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: 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 | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 399 | EUCTR2008-001329-33-PT (EUCTR) | 02/10/2009 | 19/08/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies 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] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 275 | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;United Kingdom;New Zealand | |||
| 400 | EUCTR2008-005492-94-EE (EUCTR) | 01/10/2009 | 15/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 401 | NCT01631825 (ClinicalTrials.gov) | October 2009 | 25/6/2012 | A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 321 | Phase 3 | Japan |
| 402 | EUCTR2006-005186-18-NL (EUCTR) | 25/09/2009 | 29/05/2008 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 403 | EUCTR2009-011541-24-DE (EUCTR) | 22/09/2009 | 27/07/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Portugal;France;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom | |||
| 404 | NCT01371682 (ClinicalTrials.gov) | September 18, 2009 | 10/6/2010 | A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda | An Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and Aranda | Parkinson Disease | Drug: Ropinirole XL | GlaxoSmithKline | NULL | Completed | 18 Years | 50 Years | All | 50 | Phase 1 | Belgium |
| 405 | EUCTR2009-011541-24-PT (EUCTR) | 09/09/2009 | 29/07/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | France;Portugal;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | |||
| 406 | NCT00986245 (ClinicalTrials.gov) | September 2009 | 24/9/2009 | Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily | An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease | Parkinson Disease | Drug: Ropinirole Prolonged release | Seoul National University Hospital | NULL | Completed | 30 Years | 80 Years | All | 82 | Phase 4 | Korea, Republic of |
| 407 | NCT00974974 (ClinicalTrials.gov) | September 2009 | 10/9/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease | Parkinson's Disease | Drug: IPX066;Drug: IR CD-LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 471 | Phase 3 | United States;Canada;France;Germany;Poland;Romania;Spain;Ukraine |
| 408 | EUCTR2009-011541-24-ES (EUCTR) | 27/08/2009 | 26/06/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up | Parkinson's Disease Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT 1 mg comprimidos INN or Proposed INN: RASAGILINA MESILATO Other descriptive name: RASAGILINA MESILATO | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 409 | 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 | ||
| 410 | EUCTR2009-011541-24-FR (EUCTR) | 17/07/2009 | 19/06/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 411 | EUCTR2009-011541-24-HU (EUCTR) | 10/07/2009 | 05/06/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 412 | NCT00936676 (ClinicalTrials.gov) | July 2009 | 8/7/2009 | ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects Who Participated in the ADAGIO Study | Parkinson's Disease | Drug: rasagiline mesylate | Teva Pharmaceutical Industries | Teva Neuroscience, Inc.;H. Lundbeck A/S | Completed | N/A | N/A | Both | 684 | N/A | United States;Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom |
| 413 | EUCTR2009-011541-24-IT (EUCTR) | 24/06/2009 | 26/06/2009 | An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson?s disease subjects who participated in the ADAGIO study - ADAGIO Follow -Up | An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson?s disease subjects who participated in the ADAGIO study - ADAGIO Follow -Up | Parkinson?s disease MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Portugal;France;Hungary;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 414 | 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 | ||
| 415 | 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 | |||
| 416 | 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 | |||
| 417 | NCT00360568 (ClinicalTrials.gov) | June 2009 | 3/8/2006 | Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects | Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Dyskinesias;Parkinson's Disease;Severe Motor Fluctuations | Drug: Levodopa-carbidopa intestinal gel;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 | 62 | Phase 3 | United States;Germany;New Zealand |
| 418 | EUCTR2006-000578-53-DE (EUCTR) | 08/05/2009 | 30/10/2008 | Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 70 | United States;Germany;New Zealand | |||
| 419 | 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 | |||
| 420 | NCT01515891 (ClinicalTrials.gov) | May 2009 | 19/1/2012 | Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral Administration | Parkinson Disease | Drug: BIA 9-1067 | Bial - Portela C S.A. | NULL | Completed | 40 Years | 55 Years | Male | 4 | Phase 1 | Switzerland |
| 421 | EUCTR2008-005492-94-IT (EUCTR) | 30/04/2009 | 15/04/2009 | OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND | OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND | 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 | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 422 | EUCTR2008-008210-38-FR (EUCTR) | 16/04/2009 | 19/03/2009 | Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I | Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I | Patients ayant une maladie de Parkinson Patients à un stade évolué de la maladie avec des troubles de la marche sévères MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease MedDRA version: 9.1;Level: PT;Term: Parkinson's disease | Trade Name: EBIXA® Product Name: mémantine Trade Name: L-Dopa/ MODOPAR Product Name: L-Dopa | Chru de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | France | |||
| 423 | EUCTR2007-004234-16-AT (EUCTR) | 14/04/2009 | 10/03/2008 | 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). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 424 | EUCTR2007-004235-37-AT (EUCTR) | 02/04/2009 | 10/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 425 | NCT00865579 (ClinicalTrials.gov) | April 2009 | 10/3/2009 | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Parkinson's Disease | Drug: Safinamide | Newron | NULL | Terminated | 30 Years | N/A | All | 964 | Phase 3 | Romania |
| 426 | 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 |
| 427 | EUCTR2007-003035-22-AT (EUCTR) | 30/03/2009 | 26/05/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability 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 | 560 | Phase 2;Phase 3 | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 428 | EUCTR2006-005186-18-CZ (EUCTR) | 09/02/2009 | 21/11/2007 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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] | Trade Name: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand | |||
| 429 | EUCTR2008-006045-10-FR (EUCTR) | 06/02/2009 | 24/03/2009 | Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP | Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP | L’objectif thérapeutique principal dans la maladie de Parkinson est de contrôler les fluctuations motrices. Cependant des fluctuations non motrices (FNM) sont fréquemment observées et semblent corrélées à la sévérité de la maladie. La stabilité dans le temps de l’efficacité du traitement dopaminergique est le moyen le plus pertinent pour améliorer les fluctuations tant motrices que non motrices. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Apokinon | CHU de Rennes | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 430 | EUCTR2007-003035-22-PT (EUCTR) | 09/01/2009 | 01/07/2008 | A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | MedDRA version: 18.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate Other descriptive name: N/A | ACADIA Pharmaceuticals Inc | 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 | Portugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden | ||
| 431 | EUCTR2007-003035-22-IT (EUCTR) | 07/01/2009 | 23/07/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease - ACP-103-015 | Psychosis in Parkinson?s Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: primavanserin tartrate Product Code: ACP-103 INN or Proposed INN: primavanserin tartrate | ACADIA PHARMACEUTICALS INC. | NULL | Not Recruiting | Female: yes Male: yes | 486 | Portugal;United Kingdom;Belgium;France;Italy;Austria;Sweden | ||||
| 432 | EUCTR2008-004906-15-FR (EUCTR) | 05/01/2009 | 16/03/2009 | EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson | EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson | Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DATSCAN | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 433 | EUCTR2004-000148-26-AT (EUCTR) | 31/12/2008 | 26/11/2008 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden | ||
| 434 | EUCTR2006-005186-18-GB (EUCTR) | 19/11/2008 | 27/06/2008 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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] | Trade Name: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | 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;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand | ||
| 435 | EUCTR2007-006721-27-GB (EUCTR) | 11/11/2008 | 25/02/2009 | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: CERE-120 Product Code: CERE-120 | Ceregene Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
| 436 | EUCTR2007-003035-22-GB (EUCTR) | 05/11/2008 | 20/12/2007 | A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease - ACP-103-015 | Psychosis in Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate Other descriptive name: N/a | ACADIA Pharmaceuticals Inc. | 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 | United States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden | ||
| 437 | NCT00869791 (ClinicalTrials.gov) | November 2008 | 24/3/2009 | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | Parkinson's Disease | Drug: IPX066;Drug: IR CD-LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 27 | Phase 2 | United States |
| 438 | EUCTR2007-006721-27-AT (EUCTR) | 20/10/2008 | 15/09/2008 | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: CERE-120 Product Code: CERE-120 | Ceregene Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Austria;United Kingdom | ||
| 439 | EUCTR2007-004235-37-IT (EUCTR) | 02/10/2008 | 28/11/2007 | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Patients with advanced idiopathic PD 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 ING. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 440 | EUCTR2007-000350-31-IT (EUCTR) | 02/10/2008 | 11/02/2008 | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND | mild to moderately severe dementia associated with Parkinson?s disease (PDD) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| 441 | EUCTR2006-005186-18-DE (EUCTR) | 30/09/2008 | 13/11/2008 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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] | Trade Name: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand | |||
| 442 | EUCTR2007-003035-22-BE (EUCTR) | 02/09/2008 | 21/05/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability 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: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2;Phase 3 | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 443 | 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 |
| 444 | EUCTR2007-004235-37-GB (EUCTR) | 19/08/2008 | 26/11/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 445 | EUCTR2004-005234-39-DE (EUCTR) | 11/08/2008 | 02/12/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 446 | NCT00601978 (ClinicalTrials.gov) | August 2008 | 11/1/2008 | Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off | Parkinson's Disease | Drug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/Entacapone | Novartis Pharmaceuticals | NULL | Withdrawn | 45 Years | 75 Years | Both | 0 | Phase 4 | United States |
| 447 | EUCTR2004-000148-26-HU (EUCTR) | 26/07/2008 | 19/07/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Finland;Hungary;Czech Republic;Spain;Italy;Sweden | ||
| 448 | EUCTR2008-001336-13-FR (EUCTR) | 16/07/2008 | 09/06/2008 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Maladie Parkinson MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Nicorette 5 mg/ 16 h Product Name: Nicorette 5 mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 10mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 15 mg/ 16 h INN or Proposed INN: Nicotine | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 449 | 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 | |||
| 450 | EUCTR2007-003134-42-DE (EUCTR) | 19/06/2008 | 20/02/2008 | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | Idiopathic Parkinson’s disease and end-of-dose wearing off. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten Product Name: Stalevo INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONE Trade Name: Nacom 100 Product Name: Nacom INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany | |||
| 451 | EUCTR2007-003035-22-SE (EUCTR) | 11/06/2008 | 16/05/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability 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: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2;Phase 3 | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 452 | NCT00822913 (ClinicalTrials.gov) | June 2008 | 14/1/2009 | Botulinum A Toxin in Patients With Parkinson's Disease | The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity. | Parkinson's Disease;Multiple System Atrophy;Detrusor Overactivity | Drug: Intravesical injection of Botulinum A toxin | University Of Perugia | University of Roma La Sapienza | Enrolling by invitation | 18 Years | 80 Years | Both | 20 | Phase 4 | NULL |
| 453 | EUCTR2007-004235-37-PL (EUCTR) | 29/05/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden | |||
| 454 | EUCTR2007-004235-37-SE (EUCTR) | 23/04/2008 | 25/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 455 | EUCTR2007-004234-16-FI (EUCTR) | 16/04/2008 | 12/02/2008 | 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). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 520 | Hungary;Finland;Czech Republic;Netherlands;France;Austria | |||
| 456 | EUCTR2007-001096-10-SK (EUCTR) | 11/04/2008 | 09/04/2008 | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of 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 | 500 | Phase 3 | Hungary;Slovakia | ||
| 457 | EUCTR2007-001096-10-HU (EUCTR) | 27/03/2008 | 15/02/2008 | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of 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 | 500 | Hungary | |||
| 458 | EUCTR2007-004235-37-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Hungary;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 459 | EUCTR2007-004234-16-HU (EUCTR) | 17/03/2008 | 17/01/2008 | 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). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 460 | EUCTR2006-005186-18-PT (EUCTR) | 07/03/2008 | 14/11/2007 | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 461 | EUCTR2007-003035-22-FR (EUCTR) | 29/02/2008 | 15/02/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability 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 | 486 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 462 | EUCTR2007-000350-31-ES (EUCTR) | 13/02/2008 | 21/12/2007 | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Farmacéutica S.A | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | France;Spain;Italy | ||
| 463 | EUCTR2006-005186-18-IT (EUCTR) | 08/02/2008 | 14/11/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND | Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Duodopa gel intestinale INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals BV. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy | ||||
| 464 | EUCTR2007-004235-37-ES (EUCTR) | 24/01/2008 | 08/03/2010 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Poland;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 465 | EUCTR2006-005186-18-ES (EUCTR) | 23/01/2008 | 29/11/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | ||
| 466 | EUCTR2007-000350-31-FR (EUCTR) | 22/01/2008 | 25/10/2007 | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | Mild to moderately severe dementia associated with Parkinson’s disease (PDD). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| 467 | EUCTR2007-004234-16-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | 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). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 468 | EUCTR2007-004235-37-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden | |||
| 469 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1121 | Phase 3 | Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria | ||
| 470 | 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 | ||
| 471 | EUCTR2007-004235-37-SK (EUCTR) | 14/01/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced 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 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 472 | EUCTR2007-004234-16-SK (EUCTR) | 14/01/2008 | 18/04/2008 | 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). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
| 473 | EUCTR2007-004234-16-FR (EUCTR) | 11/01/2008 | 19/11/2007 | 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). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | BOEHRINGER INGELHEIM | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
| 474 | 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 |
| 475 | NCT01628965 (ClinicalTrials.gov) | January 2008 | 25/6/2012 | A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 143 | Phase 2/Phase 3 | Japan |
| 476 | NCT00335153 (ClinicalTrials.gov) | January 2008 | 8/6/2006 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;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 | 354 | Phase 3 | United States;Australia;Canada;Czech Republic;Finland;Germany;Israel;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Spain;Thailand;United Kingdom;Greece |
| 477 | NCT00725478 (ClinicalTrials.gov) | January 2008 | 28/7/2008 | SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease | Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices. | Parkinson's Disease | Drug: Piribedil | Desitin Arzneimittel GmbH | NULL | Completed | 18 Years | N/A | Both | 250 | N/A | NULL |
| 478 | NCT00623103 (ClinicalTrials.gov) | January 2008 | 14/2/2008 | Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD) | A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD) | Parkinson's Disease Dementia | Drug: Rivastigmine capsule;Drug: Rivastigmine transdermal patch | Novartis | NULL | Completed | 50 Years | 85 Years | All | 583 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom |
| 479 | 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 | ||||
| 480 | EUCTR2007-000801-30-HU (EUCTR) | 20/12/2007 | 15/11/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 481 | EUCTR2006-006907-35-IT (EUCTR) | 19/12/2007 | 20/04/2007 | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER | Patient with Idiopathic Parkinson Diesease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: rotigotine INN or Proposed INN: rotigotine | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 482 | 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 |
| 483 | EUCTR2007-000801-30-ES (EUCTR) | 29/11/2007 | 12/09/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras | Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | France;Hungary;Estonia;Czech Republic;Poland;Spain;Lithuania;Latvia;Italy | ||
| 484 | NCT00537017 (ClinicalTrials.gov) | November 23, 2007 | 27/9/2007 | Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175) | A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175) | Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain Diseases | Drug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatments | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | N/A | All | 140 | Phase 2 | Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States |
| 485 | EUCTR2006-005186-18-FI (EUCTR) | 16/11/2007 | 04/10/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 486 | NCT00560508 (ClinicalTrials.gov) | November 2007 | 16/11/2007 | A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period | A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER | Parkinson Disease | Drug: Pramipexole Immediate Release;Drug: Pramipexole Extended Release | Boehringer Ingelheim | NULL | Completed | 1 Year | N/A | All | 112 | Phase 2/Phase 3 | Japan |
| 487 | EUCTR2007-004234-16-NL (EUCTR) | 29/10/2007 | 17/10/2007 | 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). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 488 | EUCTR2007-001717-42-FR (EUCTR) | 25/10/2007 | 11/09/2007 | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias | Product Name: SCH 420814 Product Code: N/A | Schering Plough Research Institute | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | France;Spain | ||
| 489 | EUCTR2007-000801-30-FR (EUCTR) | 22/10/2007 | 23/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy | ||
| 490 | EUCTR2006-006907-35-GB (EUCTR) | 09/10/2007 | 26/04/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH, UCB Group | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 491 | 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 | |||
| 492 | EUCTR2007-002874-75-IT (EUCTR) | 10/09/2007 | 14/01/2008 | Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 | Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 | Psycosis associated to Parkinson's Disease MedDRA version: 9.1;Level: HLT;Classification code 10027361;Term: Mental disorders due to a general medical condition NEC | Product Name: Melperon | OVATION PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 90 | Italy | |||
| 493 | EUCTR2007-000801-30-LT (EUCTR) | 07/09/2007 | 05/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 494 | NCT00594464 (ClinicalTrials.gov) | September 2007 | 21/12/2007 | A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery | An Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | 80 Years | All | 14 | Phase 4 | Germany |
| 495 | EUCTR2007-000801-30-PL (EUCTR) | 29/08/2007 | 17/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | Spain;Poland;Lithuania;Latvia;Italy;France;Hungary;Estonia;Czech Republic | ||
| 496 | EUCTR2007-000801-30-EE (EUCTR) | 22/08/2007 | 17/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 497 | EUCTR2006-000859-18-DE (EUCTR) | 13/08/2007 | 05/04/2007 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | 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) hydrochloride Product Code: SLV308 | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Czech Republic;Germany;Netherlands;Estonia;Italy;Lithuania | |||
| 498 | EUCTR2007-000801-30-CZ (EUCTR) | 01/08/2007 | 15/06/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 499 | NCT00407095 (ClinicalTrials.gov) | August 2007 | 30/11/2006 | An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | Advanced Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 140 | Phase 3 | United States;Albania;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine |
| 500 | NCT00335374 (ClinicalTrials.gov) | August 2007 | 8/6/2006 | An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients | An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients | Early Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 202 | Phase 3 | United States;Australia;Czech Republic;Estonia;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Taiwan;Thailand;France;Spain;United Kingdom |
| 501 | 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 |
| 502 | EUCTR2007-000801-30-LV (EUCTR) | 27/07/2007 | 05/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 503 | EUCTR2007-000801-30-IT (EUCTR) | 17/07/2007 | 13/11/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND | Parkinson's Disease Subjects with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy | ||
| 504 | EUCTR2006-005318-11-FR (EUCTR) | 06/07/2007 | 10/05/2007 | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | maladie de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: APOKINON | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 505 | NCT00550238 (ClinicalTrials.gov) | July 2007 | 26/10/2007 | A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate (ACP-103) | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 459 | Phase 3 | United States;Austria;Belgium;Canada;France;India;Italy;Poland;Portugal;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom |
| 506 | NCT00593606 (ClinicalTrials.gov) | July 2007 | 21/12/2007 | Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine | A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 124 | Phase 3 | NULL |
| 507 | NCT00519532 (ClinicalTrials.gov) | July 2007 | 21/8/2007 | Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease | A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Terminated | 18 Years | N/A | All | 84 | Phase 3 | United States;Australia;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Austria |
| 508 | NCT00505622 (ClinicalTrials.gov) | July 2007 | 9/7/2007 | Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations | Parkinson's Disease | Drug: Perampanel | Eisai Limited | NULL | Terminated | 30 Years | N/A | All | 328 | Phase 3 | France |
| 509 | EUCTR2006-005438-19-DE (EUCTR) | 12/06/2007 | 28/03/2007 | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | idiopathic Parkinson´s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch INN or Proposed INN: Rotigotine | SCHWARZ PHARMA Deutschland GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany | |||
| 510 | 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 | ||||
| 511 | EUCTR2006-000858-45-SE (EUCTR) | 05/06/2007 | 04/04/2007 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of 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 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Finland;Sweden | |||
| 512 | NCT00460954 (ClinicalTrials.gov) | June 2007 | 16/4/2007 | A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects | An Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy Subjects | Parkinson's Disease | Drug: Sinemet® controlled release (Carbidopa/levodopa) | Bristol-Myers Squibb | NULL | Completed | 50 Years | 75 Years | Both | 20 | N/A | Canada |
| 513 | 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 | ||
| 514 | 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 | ||
| 515 | EUCTR2006-006907-35-ES (EUCTR) | 27/05/2007 | 27/03/2007 | EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER | EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER | Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 516 | EUCTR2006-006907-35-HU (EUCTR) | 17/05/2007 | 12/04/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Finland;Hungary;United Kingdom;Germany;Spain;Italy;Austria | ||
| 517 | EUCTR2006-006907-35-FI (EUCTR) | 09/05/2007 | 21/03/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 518 | EUCTR2006-002339-26-PT (EUCTR) | 27/04/2007 | 07/03/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Hungary;Portugal;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 519 | EUCTR2006-000577-29-DE (EUCTR) | 27/04/2007 | 12/10/2006 | 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 Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe 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] | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate Trade Name: Sinemet®25-100 INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate | Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories) | NULL | Not Recruiting | Female: yes Male: yes | 31 | United States;Germany | |||
| 520 | 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 | |||
| 521 | EUCTR2006-002339-26-ES (EUCTR) | 19/04/2007 | 30/01/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. | Levodopa treated Parkinson's disease patients with motor fluctuations.Pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 522 | EUCTR2006-006907-35-AT (EUCTR) | 17/04/2007 | 21/05/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 523 | EUCTR2006-002339-26-DE (EUCTR) | 10/04/2007 | 22/12/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 524 | NCT00434304 (ClinicalTrials.gov) | April 9, 2007 | 9/2/2007 | Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD) | Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - | Parkinson Disease | Drug: Ropinirole prolonged release/extended release(PR/XR) | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 62 | Phase 2 | Japan |
| 525 | 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 |
| 526 | NCT00460148 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole | An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany;South Africa |
| 527 | EUCTR2006-006209-94-DE (EUCTR) | 15/03/2007 | 26/01/2007 | An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. | An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Product Name: Ropinirole Product Code: SK&F101468 INN or Proposed INN: Ropinirole | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 36 | Germany | |||
| 528 | 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 | ||
| 529 | NCT00437125 (ClinicalTrials.gov) | March 2007 | 16/2/2007 | Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease | An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease | Major Depressive Disorder;Idiopathic Parkinson Disease | Drug: Duloxetine hydrochloride | Eli Lilly and Company | NULL | Completed | 30 Years | 75 Years | All | 151 | Phase 4 | Italy |
| 530 | 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 |
| 531 | EUCTR2006-002408-32-ES (EUCTR) | 27/02/2007 | 07/02/2007 | Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa. | Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa. | Fluctuaciones motoras, cognitivas y del humor en la enfermedad de Parkinson. MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo 150 Product Name: Levodopa-carbidopa-entacapone Trade Name: Sinemet Product Name: Levodopa/Carbidopa | Institut de Recerca del Hospital de la Santa Creu i Sant Pau | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Spain | |||
| 532 | EUCTR2006-005183-91-LT (EUCTR) | 14/02/2007 | 20/12/2006 | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study | Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | 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 | 220 | Latvia;Lithuania | |||
| 533 | 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 | |||
| 534 | 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 | |||
| 535 | EUCTR2006-005183-91-LV (EUCTR) | 02/02/2007 | 11/01/2007 | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of 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 | 140 | Latvia;Lithuania | |||
| 536 | NCT00332917 (ClinicalTrials.gov) | February 2007 | 1/6/2006 | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients | Early Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 224 | 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 |
| 537 | NCT00427011 (ClinicalTrials.gov) | February 2007 | 24/1/2007 | A Study of E2007 In Patients With Parkinson's Disease | A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing-Off Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Terminated | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 538 | EUCTR2006-000859-18-NL (EUCTR) | 25/01/2007 | 05/04/2007 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | 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 | 247 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 539 | EUCTR2006-002339-26-HU (EUCTR) | 24/01/2007 | 24/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 540 | EUCTR2006-000859-18-PT (EUCTR) | 04/01/2007 | 18/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | 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 | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 541 | 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 |
| 542 | EUCTR2006-002339-26-GB (EUCTR) | 28/12/2006 | 16/10/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 543 | 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 | ||
| 544 | EUCTR2006-000858-45-FI (EUCTR) | 18/12/2006 | 26/06/2006 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of 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 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Finland;Sweden | |||
| 545 | 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 | |||
| 546 | 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 | |||
| 547 | 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 | |||
| 548 | NCT01631812 (ClinicalTrials.gov) | December 2006 | 25/6/2012 | A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 130 | Phase 2 | Japan |
| 549 | EUCTR2006-000859-18-LT (EUCTR) | 07/11/2006 | 07/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | 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 | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 550 | EUCTR2006-000859-18-EE (EUCTR) | 03/11/2006 | 01/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | 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 | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 551 | EUCTR2006-002339-26-CZ (EUCTR) | 01/11/2006 | 21/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 552 | 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 | |||
| 553 | EUCTR2006-002339-26-EE (EUCTR) | 20/10/2006 | 15/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania;Germany;Hungary;Portugal | |||
| 554 | EUCTR2006-002339-26-SE (EUCTR) | 19/10/2006 | 22/09/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Lithuania;Sweden | |||
| 555 | EUCTR2006-002339-26-BE (EUCTR) | 16/10/2006 | 24/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 556 | EUCTR2006-000858-45-SK (EUCTR) | 11/10/2006 | 28/09/2006 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of 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) hydrochlo | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Finland;Sweden | ||
| 557 | EUCTR2006-002339-26-LT (EUCTR) | 05/10/2006 | 07/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 558 | NCT00360412 (ClinicalTrials.gov) | October 2006 | 2/8/2006 | A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Terminated | 30 Years | N/A | Male | 997 | Phase 3 | Germany |
| 559 | NCT00399477 (ClinicalTrials.gov) | October 2006 | 10/11/2006 | A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease | Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD) | Parkinson's Disease | Drug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with Requip | Teva Neuroscience, Inc. | NULL | Completed | 30 Years | N/A | Both | 200 | Phase 4 | United States |
| 560 | EUCTR2006-002339-26-AT (EUCTR) | 25/09/2006 | 18/10/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 561 | EUCTR2006-000859-18-CZ (EUCTR) | 11/09/2006 | 02/08/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | 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 | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 562 | EUCTR2004-005234-39-LV (EUCTR) | 06/09/2006 | 29/09/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 563 | EUCTR2006-000680-28-ES (EUCTR) | 07/07/2006 | 22/05/2006 | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Enfermedad de Parkinson (Parkinson Disease) | Trade Name: Stalevo 100 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA Trade Name: Sinemet plus Product Name: Sinemet plus (levodopa/carbidopa) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Stalevo 150 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA | NOVARTIS FARMACEUTICA, S.A | NULL | Not Recruiting | Female: yes Male: yes | 200 | Spain | |||
| 564 | 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 | |||
| 565 | EUCTR2004-005234-39-LT (EUCTR) | 09/05/2006 | 24/03/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania | |||
| 566 | 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 |
| 567 | 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 |
| 568 | 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 | ||
| 569 | NCT03095105 (ClinicalTrials.gov) | January 24, 2006 | 23/3/2017 | Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects | An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol) | Parkinson Disease | Drug: 200 mg BIA 6-512 | Bial - Portela C S.A. | NULL | Completed | 18 Years | N/A | All | 25 | Phase 1 | Germany |
| 570 | 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 |
| 571 | NCT00275275 (ClinicalTrials.gov) | January 2006 | 9/1/2006 | Pramipexole Conversion to Ropinirole Controlled Release (CR) | An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Requip PR;Drug: Mirapex | Rajesh Pahwa, MD | GlaxoSmithKline | Completed | 18 Years | N/A | All | 61 | Phase 3 | United States |
| 572 | NCT02772614 (ClinicalTrials.gov) | January 2006 | 12/5/2016 | Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration | Parkinson's Disease | Drug: BIA 3-202 (200 mg) | Bial - Portela C S.A. | NULL | Completed | 40 Years | 55 Years | Male | 4 | Phase 1 | Switzerland |
| 573 | 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 | |||
| 574 | EUCTR2005-000444-84-GB (EUCTR) | 23/11/2005 | 13/09/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | 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 | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 575 | EUCTR2005-002010-38-DE (EUCTR) | 21/11/2005 | 10/02/2006 | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Advanced Parkinson´s Disease | Product Name: Trivastal Product Code: S 90049 INN or Proposed INN: Piribedil | Institut de Recherches Internationales Servier (I.R.I.S.) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Germany | |||
| 576 | 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 |
| 577 | NCT00260793 (ClinicalTrials.gov) | November 2005 | 1/12/2005 | Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease | Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease | Parkinson's Disease | Drug: Ropinirole Hydrochloride | Agarwal, Pinky, M.D. | Colorado Neurology;GlaxoSmithKline | Recruiting | 25 Years | N/A | Both | 20 | Phase 3 | United States |
| 578 | EUCTR2004-005234-39-IE (EUCTR) | 20/10/2005 | 16/08/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | ||
| 579 | NCT00199381 (ClinicalTrials.gov) | October 2005 | 12/9/2005 | An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001 | An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline. | Parkinson's Disease | Drug: Istradefylline | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Terminated | 30 Years | N/A | All | 504 | Phase 3 | United States |
| 580 | NCT00239564 (ClinicalTrials.gov) | October 2005 | 13/10/2005 | Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease | An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 100 mg;Drug: IPX054 150 mg;Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: IPX054 300 mg | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 1/Phase 2 | United States |
| 581 | EUCTR2004-005234-39-FI (EUCTR) | 22/09/2005 | 03/06/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 582 | EUCTR2005-000444-84-FI (EUCTR) | 08/09/2005 | 26/07/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | 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 | 800 | Phase 3 | Finland;United Kingdom;Spain;Italy | ||
| 583 | EUCTR2004-005234-39-DK (EUCTR) | 04/08/2005 | 31/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 584 | 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 | ||
| 585 | EUCTR2004-002844-93-AT (EUCTR) | 20/07/2005 | 15/06/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | |||
| 586 | EUCTR2005-000444-84-ES (EUCTR) | 12/07/2005 | 22/05/2006 | An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O | An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O | 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 | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 587 | EUCTR2004-002844-93-IT (EUCTR) | 06/07/2005 | 21/09/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | |||||
| 588 | EUCTR2005-000444-84-AT (EUCTR) | 22/06/2005 | 18/05/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | 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 | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 589 | EUCTR2004-005234-39-SE (EUCTR) | 08/06/2005 | 02/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 590 | EUCTR2004-005234-39-GB (EUCTR) | 27/05/2005 | 22/03/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet | Orion Corporation, ORION PHARMA, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | ||
| 591 | EUCTR2004-002641-12-GB (EUCTR) | 16/05/2005 | 30/06/2005 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Austria;Italy;United Kingdom | ||
| 592 | EUCTR2004-002641-12-ES (EUCTR) | 25/04/2005 | 10/07/2006 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Austria;Italy;United Kingdom | ||
| 593 | 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 | |||
| 594 | EUCTR2004-002844-93-ES (EUCTR) | 01/04/2005 | 04/11/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 595 | EUCTR2004-002844-93-EE (EUCTR) | 08/03/2005 | 07/03/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 596 | EUCTR2004-002598-21-GB (EUCTR) | 02/03/2005 | 07/07/2005 | A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | Idiopathic Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Austria;United Kingdom | ||
| 597 | NCT00203957 (ClinicalTrials.gov) | March 2005 | 13/9/2005 | Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa | A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy | Parkinson's Disease | Drug: Istradefylline | University of Chicago | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 3 | United States |
| 598 | EUCTR2004-002844-93-LT (EUCTR) | 08/02/2005 | 03/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 599 | EUCTR2004-002650-59-GB (EUCTR) | 03/02/2005 | 30/06/2005 | A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a | A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a | Idiopathic Parkinson's disease | Product Name: rotigotine Product Code: SPM 962 INN or Proposed INN: rotigotine | SCHWARZ BIOSCIENCES | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United Kingdom | ||
| 600 | 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 | |||
| 601 | EUCTR2004-002844-93-GB (EUCTR) | 01/02/2005 | 23/02/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain | ||||
| 602 | NCT00505687 (ClinicalTrials.gov) | February 2005 | 20/7/2007 | An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease | A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 186 | Phase 3 | United States;Austria;Germany;Israel;Italy;South Africa;Spain;United Kingdom |
| 603 | EUCTR2004-002844-93-LV (EUCTR) | 28/01/2005 | 31/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 604 | EUCTR2004-002641-12-AT (EUCTR) | 21/01/2005 | 17/12/2004 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Austria;Italy;United Kingdom | ||
| 605 | NCT00286949 (ClinicalTrials.gov) | January 6, 2005 | 3/2/2006 | Treatment of Executive Dysfunction in Parkinson's Disease | Atomoxetine for the Treatment of Executive Dysfunction in Patients With Parkinson's Disease: A Pilot Open-label Study | Parkinson's Disease | Drug: Atomoxetine | Johns Hopkins University | Eli Lilly and Company | Completed | 21 Years | 65 Years | All | 12 | N/A | United States |
| 606 | NCT01634243 (ClinicalTrials.gov) | January 2005 | 27/6/2012 | A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients | A Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease Patients | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 64 | Phase 2 | Japan |
| 607 | NCT00144300 (ClinicalTrials.gov) | January 2005 | 2/9/2005 | Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients | A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients | Parkinson Disease | Drug: Mirapex;Drug: Requip | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 246 | Phase 4 | United States |
| 608 | NCT00219284 (ClinicalTrials.gov) | January 2005 | 30/6/2005 | Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease | A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off | Parkinson's Disease With End of Dose Wearing Off | Drug: Carbidopa/levodopa/entacapone | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 85 Years | All | 359 | Phase 4 | United States;Puerto Rico |
| 609 | EUCTR2004-002598-21-AT (EUCTR) | 22/12/2004 | 17/11/2004 | A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Austria;United Kingdom | ||
| 610 | EUCTR2004-002609-66-IT (EUCTR) | 21/12/2004 | 03/03/2006 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | Idiopathic Parkinson Disease in early stage MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: rotigotine Product Code: SPM 926 Trade Name: REQUIP 21 CPR 0,25 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 0,5 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 1 MG INN or Proposed INN: Ropinirole Trade Name: REQUIP 21 CPR 2 MG INN or Proposed INN: Ropinirole | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 611 | 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 | |||
| 612 | EUCTR2004-002609-66-DE (EUCTR) | 06/12/2004 | 22/04/2005 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 613 | NCT00242008 (ClinicalTrials.gov) | December 2004 | 18/10/2005 | A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease | A Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | United States | |
| 614 | NCT00243945 (ClinicalTrials.gov) | December 2004 | 24/10/2005 | A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease | A Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease | IDIOPATHIC PARKINSON'S DISEASE | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 58 | Phase 3 | Germany |
| 615 | NCT01518309 (ClinicalTrials.gov) | November 17, 2004 | 16/12/2008 | An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients | An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients | Parkinson's Disease Psychosis | Drug: pimavanserin tartrate (ACP-103) | ACADIA Pharmaceuticals Inc. | NULL | Completed | N/A | N/A | All | 39 | Phase 2 | United States |
| 616 | 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 | ||
| 617 | NCT01634360 (ClinicalTrials.gov) | November 2004 | 3/7/2012 | Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations | A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period Dyskinesias | Parkinson's Disease | Drug: Perampanel | Eisai Inc. | NULL | Terminated | N/A | N/A | All | 185 | Phase 2 | NULL |
| 618 | NCT00243971 (ClinicalTrials.gov) | November 2004 | 24/10/2005 | A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease | A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: SPM 962 | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | Germany | |
| 619 | EUCTR2004-000361-35-IT (EUCTR) | 22/10/2004 | 23/05/2005 | A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. | A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. | Parkinson's disease. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: NA Product Code: E2007 Other descriptive name: NA | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | Czech Republic;Italy | ||||
| 620 | 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 | |||
| 621 | EUCTR2004-000361-35-CZ (EUCTR) | 18/10/2004 | 22/10/2004 | A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. | A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. | Parkinson's Disease | Product Name: MARS Product Code: E2007 Other descriptive name: MARS Other descriptive name: MARS Other descriptive name: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 225 | Czech Republic;Italy | |||
| 622 | EUCTR2004-000148-26-ES (EUCTR) | 13/10/2004 | 16/09/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden | ||
| 623 | EUCTR2004-000148-26-CZ (EUCTR) | 12/10/2004 | 11/10/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 624 | NCT00199368 (ClinicalTrials.gov) | October 2004 | 12/9/2005 | An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018 | A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Drug: Istradefylline ( KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | Kyowa Hakko Kirin UK, Ltd. | Completed | 30 Years | N/A | Both | 1100 | Phase 3 | United States |
| 625 | EUCTR2004-000148-26-SE (EUCTR) | 29/09/2004 | 05/07/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 626 | 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 | |||
| 627 | EUCTR2004-003355-39-AT (EUCTR) | 14/09/2004 | 08/10/2004 | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | Dementia associated with Parkinson's disease | Trade Name: Aricept 5 mg-Filmtabletten Product Name: Aricept 5mg-Filmtabletten | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 468 | Austria | |||
| 628 | NCT00641186 (ClinicalTrials.gov) | September 2004 | 18/3/2008 | Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) | A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease | Parkinson Disease | Drug: sodium oxybate | Baylor College of Medicine | Jazz Pharmaceuticals | Completed | 30 Years | 75 Years | Both | 30 | Phase 2 | NULL |
| 629 | NCT00501969 (ClinicalTrials.gov) | August 2004 | 16/7/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease | An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa | Advanced Stage Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 395 | Phase 3 | Australia;Austria;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;South Africa;Spain;Sweden;United Kingdom |
| 630 | EUCTR2004-000148-26-FI (EUCTR) | 30/07/2004 | 28/06/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Italy;Sweden | ||
| 631 | EUCTR2004-000148-26-IT (EUCTR) | 14/06/2004 | 26/07/2007 | A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa | A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa | Advanced stage Parkinson's Disease | INN or Proposed INN: rotigotine | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 632 | NCT00203138 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease | A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease | Parkinson's Disease | Drug: rasagiline mesylate | Teva Pharmaceutical Industries | NULL | Completed | 35 Years | N/A | Both | 306 | Phase 3 | United States |
| 633 | NCT00200447 (ClinicalTrials.gov) | March 2004 | 12/9/2005 | An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN) | Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN) | Parkinson's Disease | Drug: carbidopa/l-dopa;Drug: carbidopa/l-dopa/entacapone;Drug: Stalevo;Procedure: [123I]-IBZM imaging | Molecular NeuroImaging | NULL | Completed | 30 Years | N/A | Both | 3 | Phase 2 | NULL |
| 634 | NCT00673088 (ClinicalTrials.gov) | February 2004 | 5/5/2008 | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions | Parkinson's Disease;Restless Leg Syndrome | Drug: Ropinirole Hydrochloride | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 30 | N/A | NULL |
| 635 | NCT00674310 (ClinicalTrials.gov) | February 2004 | 5/5/2008 | A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions | A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions | Parkinson's Disease;Restless Leg Syndrome | Drug: Ropinirole Hydrochloride | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 29 | N/A | NULL |
| 636 | NCT00632736 (ClinicalTrials.gov) | February 2004 | 4/3/2008 | An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease | An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169 | Parkinson Disease;Parkinson's Disease | Drug: Ropinirole XL (formerly CR) | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 419 | Phase 3 | United States;Belgium;Czech Republic;France;Hungary;Italy;Poland;Spain;United Kingdom;Germany;Philippines |
| 637 | NCT00139867 (ClinicalTrials.gov) | January 2004 | 29/8/2005 | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | Parkinson's Disease | Drug: PARCOPA | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | United States | |
| 638 | NCT02231905 (ClinicalTrials.gov) | January 2004 | 3/9/2014 | Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease | Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole | Parkinson Disease | Drug: BI-Sifrol® | Boehringer Ingelheim | NULL | Completed | 20 Years | N/A | Both | 29 | Phase 4 | NULL |
| 639 | NCT00111982 (ClinicalTrials.gov) | December 2003 | 27/5/2005 | Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin | Multi-Center, Open-Label Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin (Protocol 20020168) | Parkinson's Disease | Biological: Liatermin | Amgen | Medtronic | Completed | 35 Years | 70 Years | Both | 34 | Phase 1/Phase 2 | United States |
| 640 | NCT00095810 (ClinicalTrials.gov) | July 2003 | 9/11/2004 | Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease | An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease | Parkinson's Disease;Psychoses | Drug: aripiprazole | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka America Pharmaceutical | Completed | 50 Years | N/A | Both | 50 | Phase 4 | United States |
| 641 | 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 |
| 642 | NCT00056524 (ClinicalTrials.gov) | February 2003 | 15/3/2003 | Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter) | An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect. | Alzheimer's Disease;Stroke;Parkinson's Disease;Traumatic Brain Injury | Drug: AVP-923 | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | Both | 600 | Phase 3 | United States |
| 643 | NCT00599196 (ClinicalTrials.gov) | August 2002 | 24/12/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease | An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease | Early Stage Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 381 | Phase 3 | Australia;Austria;Belgium;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;South Africa;Spain;Sweden;Switzerland;United Kingdom |
| 644 | NCT00594386 (ClinicalTrials.gov) | August 2002 | 24/12/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease | An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease. | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 258 | Phase 3 | United States;Canada |
| 645 | NCT00955045 (ClinicalTrials.gov) | August 2002 | 4/8/2009 | A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: istradefylline | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | Phase 2/Phase 3 | United States | |
| 646 | NCT00594165 (ClinicalTrials.gov) | June 2002 | 24/12/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease. | An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease. | Early-Stage Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 217 | Phase 3 | United States;Canada |
| 647 | NCT00650104 (ClinicalTrials.gov) | May 2002 | 27/3/2008 | Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164 | 101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164 | Parkinson Disease | Drug: Ropinirole XL (formerly CR) | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 76 | Phase 3 | United States;Belgium;France;Netherlands;Norway |
| 648 | 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 |
| 649 | 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 |
| 650 | NCT00036205 (ClinicalTrials.gov) | August 2000 | 8/5/2002 | Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease | Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease. | Parkinson Disease | Drug: sumanirole | Pfizer | NULL | Terminated | 30 Years | N/A | Both | 984 | Phase 3 | United States;Argentina;Colombia;Puerto Rico |
| 651 | NCT00134784 (ClinicalTrials.gov) | April 2000 | 23/8/2005 | Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression | [123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's Disease | Parkinson Disease | Drug: [123I]B-CIT SPECT imaging | Institute for Neurodegenerative Disorders | United States Department of Defense | Completed | 22 Years | N/A | All | 142 | Phase 2 | NULL |
| 652 | 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 |
| 653 | NCT00142545 (ClinicalTrials.gov) | July 1999 | 31/8/2005 | Long Term Safety and Efficacy of SC Apomorphine in Treatment of Off Episodes in Late-Stage Parkinson's Disease | Long-Term 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 | 800 | Phase 3 | United States |
| 654 | NCT02233023 (ClinicalTrials.gov) | June 1998 | 4/9/2014 | Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease | Matched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine and other dopamine agonists | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 705 | Phase 4 | NULL |
| 655 | NCT00004733 (ClinicalTrials.gov) | January 1998 | 25/2/2000 | Timing of Levodopa Treatment in Parkinson's Disease | Earlier Versus Later L-Dopa in Parkinson's Disease | Parkinson's Disease | Drug: levodopa | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 30 Years | N/A | Both | Phase 3 | United States | |
| 656 | JPRN-JapicCTI-111699 | 22/11/2011 | Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects with Advanced Parkinson's Disease | Advanced Parkinson's disease | Intervention name : ABT-SLV187 Dosage And administration of the intervention : Usually 2-6 ml/hour (40-120 mg levodopa/hour), dose will be individually optimized for each subject based on the subject's symptoms Control intervention name : null | Abbott Japan Co., Ltd. | NULL | 30 | BOTH | 8 | Phase 2 | NULL | |||
| 657 | EUCTR2010-022200-46-DE (EUCTR) | 13/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease 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: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Latvia;Germany | ||||
| 658 | EUCTR2009-014341-84-DE (EUCTR) | 07/10/2009 | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | idiopathic Parkinson's disease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 2mg/24h(10cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 4mg/24h (20cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 6mg/24h (30cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 8mg/24h (40cm2) INN or Proposed INN: rotigotine | Schwarz Pharma Deutschland GmbH, UCB Group | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | |||||
| 659 | EUCTR2006-006907-35-DE (EUCTR) | 30/01/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | |||
| 660 | EUCTR2008-005492-94-DE (EUCTR) | 11/08/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | 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 | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | NCT05232825 (ClinicalTrials.gov) | March 31, 2022 | 27/1/2022 | A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis | A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis | Relapsing Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Ocrelizumab IV;Drug: Ocrelizumab SC;Drug: Methylprednisolone IV;Drug: Diphenhydramine IV;Drug: Dexamethasone given orally;Drug: Desloratadine given orally | Hoffmann-La Roche | NULL | Not yet recruiting | 18 Years | 65 Years | All | 232 | Phase 3 | United States;Brazil;Canada;Czechia;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine |
| 2 | NCT04998812 (ClinicalTrials.gov) | March 31, 2022 | 6/8/2021 | A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy | A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | Hoffmann-La Roche | PPD;LabCorp;Illingworth | Recruiting | 18 Years | 40 Years | Female | 44 | Phase 4 | United States;France;Spain;United Kingdom;Canada;Germany;Italy;Switzerland |
| 3 | NCT05265728 (ClinicalTrials.gov) | March 25, 2022 | 23/2/2022 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis | A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab | Biogen | NULL | Not yet recruiting | 18 Years | 65 Years | All | 20 | Phase 3 | NULL |
| 4 | NCT05269004 (ClinicalTrials.gov) | March 15, 2022 | 11/2/2022 | A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis | A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Not yet recruiting | 18 Years | N/A | All | 1300 | Phase 3 | NULL |
| 5 | EUCTR2020-005448-48-CZ (EUCTR) | 15/03/2022 | 05/05/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS | Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;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] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 232 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Russian Federation;Italy;France;Czech Republic;Canada;Poland;Brazil;Australia;New Zealand | ||
| 6 | 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 | ||
| 7 | NCT05090371 (ClinicalTrials.gov) | March 2, 2022 | 12/10/2021 | A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation | A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS) | Relapsing-Remitting Multiple Sclerosis | Drug: Ofatumumab;Drug: Disease modifying treatment (DMT) | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 50 Years | All | 150 | Phase 4 | United States |
| 8 | NCT05208840 (ClinicalTrials.gov) | February 28, 2022 | 12/1/2022 | A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis | Open-Label Multicenter Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 4 | Russian Federation |
| 9 | NCT05199688 (ClinicalTrials.gov) | February 28, 2022 | 3/12/2021 | A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder;NMOSD | Drug: Satralizumab | Hoffmann-La Roche | NULL | Not yet recruiting | 2 Years | 11 Years | All | 8 | Phase 3 | United States;Argentina;Italy;Mexico;Ukraine |
| 10 | JPRN-jRCT2051210146 | 24/02/2022 | 26/12/2021 | Phase 3 Study to Evaluate Efficacy, Safety, PK, and PD of SC Natalizumab in Japanese Participants With RRMS | A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis via a Subcutaneous Route of Administration | Relapsing-Remitting Multiple Sclerosis | Participants will receive natalizumab 300 mg SC Q4W for 48 weeks. | Amir Hadi Maghzi | NULL | Pending | >= 18age old | <= 65age old | Both | 20 | Phase 3 | Japan |
| 11 | EUCTR2020-005899-36-SK (EUCTR) | 21/02/2022 | 22/11/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | 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 | 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: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Hong Kong;Slovakia;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Latvia;Netherlands;China;Czechia;Guatemala;Lithuania;United Kingdom;Hungary;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 12 | EUCTR2020-004128-41-BG (EUCTR) | 15/02/2022 | 15/10/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 13 | EUCTR2020-005929-89-ES (EUCTR) | 11/02/2022 | 22/12/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | 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 | 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: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 14 | EUCTR2020-005899-36-ES (EUCTR) | 11/02/2022 | 29/12/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | 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 | 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: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Slovakia;Spain | ||
| 15 | EUCTR2020-001205-23-SE (EUCTR) | 08/02/2022 | 06/12/2021 | Ocrelizumab VErsus Rituximab off-Label at the Onset of Relapsing MS Disease | Ocrelizumab VErsus Rituximab off-Label at the Onset of RelapsingMS Disease (OVERLORD-MS) - OVERLORD-MS | Remitting Relapsing 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: Ocrevus Product Name: Ocrelizumab Trade Name: Rituximab Product Name: Rituximab | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 211 | Phase 3 | Sweden | ||
| 16 | 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;Spain;Ukraine;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Denmark;Germany;Greece;Hungary;Italy;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Switzerland;Turkey;United Kingdom |
| 17 | EUCTR2020-005929-89-SE (EUCTR) | 01/02/2022 | 09/11/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | 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 | 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: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 18 | NCT05119569 (ClinicalTrials.gov) | January 28, 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 | Not yet recruiting | 18 Years | 55 Years | All | 102 | Phase 2 | NULL |
| 19 | NCT05084638 (ClinicalTrials.gov) | January 25, 2022 | 7/10/2021 | Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls. | AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes. | Relapse Remitting Multiple Sclerosis | Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 35 Years | All | 168 | Phase 4 | United States |
| 20 | NCT03807973 (ClinicalTrials.gov) | December 30, 2021 | 14/1/2019 | Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes. | Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes. | Fibromyalgia;Chronic Fatigue Syndrome;Multiple Sclerosis;Healthy | Drug: [Zr-89]Oxine-labeled leukocytes PET/MR | University of Alabama at Birmingham | NULL | Not yet recruiting | 18 Years | 65 Years | All | 120 | Phase 1 | NULL |
| 21 | EUCTR2020-004128-41-NL (EUCTR) | 22/12/2021 | 14/09/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 22 | EUCTR2021-001088-26-IT (EUCTR) | 21/12/2021 | 18/10/2021 | A Clinical, Imaging and Biomarker Study in Neuromyelitis Optica Spectrum Disorder (NMOSD) with Satralizumab as an Intervention | SAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION - SAKURABONSAI | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Enspryng 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 | 100 | Phase 3 | France;United States;Canada;Turkey;Germany;Italy;Korea, Republic of;India | ||
| 23 | NCT05147220 (ClinicalTrials.gov) | December 16, 2021 | 24/11/2021 | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis | 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 | Relapsing Multiple Sclerosis | Drug: Remibrutinib;Drug: Teriflunomide | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 800 | Phase 3 | United States |
| 24 | EUCTR2019-003919-53-DE (EUCTR) | 13/12/2021 | 11/02/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 25 | NCT05156281 (ClinicalTrials.gov) | December 13, 2021 | 1/12/2021 | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) | 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 | Relapsing Multiple Sclerosis | Drug: Remibrutinib;Drug: Teriflunomide | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 800 | Phase 3 | United States |
| 26 | EUCTR2020-004128-41-BE (EUCTR) | 10/12/2021 | 10/12/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 27 | JPRN-jRCT2051210115 | 09/12/2021 | 29/10/2021 | A Study of Diroximel Fumarate (DRF) in Adult Participants from the Asia-Pacific Region with Relapsing Forms of Multiple Sclerosis (RMS) | An Open-Label, Single-Arm, Multicenter, Phase 3 Study to Evaluate the Safety and Tolerability, and Pharmacokinetics of Diroximel Fumarate (BIIB098) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis (RMS) | Research Name: BIIB098 (also known as ALK8700) Generic Name: Diroximel Fumarate (DRF) Trade Name: Vumerity Participants will initiate treatment with DRF 231 mg twice daily on Day 1 through Day 7, followed by 462 mg twice daily from Day 8 onwards. | Hanna Jerome Thomas | NULL | Recruiting | >= 18age old | <= 65age old | Both | 100 | Phase 3 | China;Japan |
| 28 | EUCTR2020-002700-39-HR (EUCTR) | 29/11/2021 | 06/12/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany | ||
| 29 | EUCTR2020-004128-41-GR (EUCTR) | 23/11/2021 | 06/10/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 30 | EUCTR2019-003919-53-BG (EUCTR) | 16/11/2021 | 16/07/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 31 | NCT05028634 (ClinicalTrials.gov) | October 27, 2021 | 25/8/2021 | Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-ß or No Disease Modifying Therapy | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Immune Response to, and the Safety of, Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Oral Ozanimod Compared to Non-Pegylated Interferon (IFN)-ß or No Disease Modifying Therapy | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Biological: Tetanus, diphtheria, and acellular pertussis vaccine;Biological: Pneumococcal polysaccharide vaccine;Biological: Seasonal influenza vaccine | Celgene | NULL | Recruiting | 18 Years | 55 Years | All | 60 | Phase 3 | United States;Germany |
| 32 | EUCTR2021-000063-79-ES (EUCTR) | 22/10/2021 | 23/07/2021 | A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;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: Ocrevus 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 | 20 | Phase 4 | France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy | ||
| 33 | NCT05064436 (ClinicalTrials.gov) | October 20, 2021 | 22/9/2021 | A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis | A Phase 1, Open-label, Multi-part Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution, and CNS Signal of the Positron Emission Tomography Ligand 11C-BMS-986196 in Healthy Participants After Intravenous Administration and to Evaluate the Safety, Tolerability, Kinetics, and CNS Signal Repeatability of 11C-BMS-986196 After Repeat Intravenous Administration in Participants With Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: 11C-BMS-986196 | Bristol-Myers Squibb | NULL | Not yet recruiting | 18 Years | 55 Years | All | 14 | Phase 1 | United States;United Kingdom |
| 34 | EUCTR2020-004128-41-IT (EUCTR) | 11/10/2021 | 07/10/2021 | 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 - Operetta 2 | 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: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE Product Name: N/A Product Code: [N/A] INN or Proposed INN: FINGOLIMOD Trade Name: GILENYA - 0.25 MG - CAPSULE RIGIDE - USO ORALE Product Name: N/A Product Code: [N/A] INN or Proposed INN: FINGOLIMOD Trade Name: Ocrevus Product Name: N/A Product Code: [N/A] INN or Proposed INN: Ocrelizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 35 | EUCTR2021-000062-14-ES (EUCTR) | 08/10/2021 | 23/07/2021 | A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus 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 | 44 | Phase 4 | France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy | ||
| 36 | 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;France;Germany;India;Latvia;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Turkey |
| 37 | EUCTR2020-004128-41-PL (EUCTR) | 04/10/2021 | 13/09/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 38 | EUCTR2020-002700-39-SK (EUCTR) | 04/10/2021 | 16/06/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany | ||
| 39 | EUCTR2020-002700-39-PL (EUCTR) | 29/09/2021 | 10/08/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany | ||
| 40 | NCT04925557 (ClinicalTrials.gov) | September 27, 2021 | 24/5/2021 | Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis | Open-label, Single-blind, Observational, Comparative, Prospective, 36-month, Longitudinal, Controlled Study to Assess Efficacy of Siponimod (Mayzent®) on Microglia in Patients With Active Secondary Progressive Forms of Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Drug: Mayzent;Drug: Ocrevus | Robert Zivadinov, MD, PhD | NULL | Recruiting | 18 Years | 60 Years | All | 60 | Phase 4 | United States |
| 41 | EUCTR2020-004505-32-IT (EUCTR) | 24/09/2021 | 12/10/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mgSC monthly vs. First Line DMT - physician’s choice in the treatment of newly diagnosed RMS (STHENOS) - STHENOS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE 28 SIRINGHE PRERIEMPITE Product Name: COPAXONE Product Code: [-] INN or Proposed INN: glatiramer acetato Trade Name: Rebif Product Name: Rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: Rebif Product Name: rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: plegridy Product Name: plegridy Product Code: [-] INN or Proposed INN: peginterferone beta 1a Trade Name: Avonex Product Name: Avonex Product Code: [-] INN or Proposed INN: Interferone beta 1a Trade Name: Extavia Product Name: Extavia Product Code: [-] INN or Proposed INN: interferone beta-1b Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Germany;Italy | ||
| 42 | NCT04998851 (ClinicalTrials.gov) | September 16, 2021 | 6/8/2021 | A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab | A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | Hoffmann-La Roche | PPD;LabCorp;Illingworth | Recruiting | 18 Years | 40 Years | Female | 20 | Phase 4 | United States;United Kingdom;Australia;Canada;France;Germany;Italy;Spain;Switzerland |
| 43 | EUCTR2020-002700-39-IT (EUCTR) | 15/09/2021 | 17/08/2021 | 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-labelextension (NEOS). - NEOS | Multiple Sclerosis in pediatric patients 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: siponimob Product Code: [BAF312] INN or Proposed INN: siponimob Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimob Product Code: [BAF312] INN or Proposed INN: Siponimob Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: ofatumumab Product Name: fingolimod Product Code: [FTY720] INN or Proposed INN: fingolimob Other descriptive name: FINGOLIMOD HYDROCHLORIDE Product Name: Siponimob Product Code: [BAF312] INN or Proposed INN: Siponimob | NOVARTIS PHARMA SERVICES AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany | ||
| 44 | EUCTR2020-005448-48-PL (EUCTR) | 13/09/2021 | 09/07/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS | Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;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] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 232 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Russian Federation;Italy;France;Canada;Poland;Brazil;Australia;New Zealand | ||
| 45 | EUCTR2020-002700-39-DE (EUCTR) | 10/09/2021 | 20/05/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany | ||
| 46 | EUCTR2020-002700-39-LV (EUCTR) | 09/09/2021 | 28/07/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | ||
| 47 | EUCTR2019-003919-53-DK (EUCTR) | 07/09/2021 | 01/03/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Australia;Denmark;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 48 | EUCTR2020-002700-39-PT (EUCTR) | 03/09/2021 | 24/05/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta 20 mg solution for injection in pre-filled pen Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent 2 mg film-coated tablets Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent 0.25 mg fi | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | ||
| 49 | EUCTR2019-001341-40-LV (EUCTR) | 02/09/2021 | 28/07/2021 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 50 | NCT05013463 (ClinicalTrials.gov) | September 1, 2021 | 16/8/2021 | Hydroxychloroquine and Indapamide in SPMS | Open-label, Single-center, Single-arm Futility Trial Evaluating the Combination of Oral Hydroxychloroquine 200mg BID and Indapamide 2.5mg OD for Reducing Progression of Disability in People With Secondary Progressive Multiple Sclerosis (SPMS) | Multiple Sclerosis, Secondary Progressive | Drug: Hydroxychloroquine and Indapamide | University of Calgary | NULL | Not yet recruiting | 18 Years | 60 Years | All | 35 | Phase 2 | NULL |
| 51 | NCT04941781 (ClinicalTrials.gov) | September 1, 2021 | 18/6/2021 | PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers | A Phase 1, Open-label Study of PIPE-307 to Determine Muscarinic Type I Receptor (M1AChR) Occupancy Parameters by [11C] PIPE-307 PET Imaging in Healthy Volunteers | Multiple Sclerosis | Drug: PIPE-307 | Pipeline Therapeutics, Inc. | NULL | Completed | 25 Years | 65 Years | All | 6 | Phase 1 | United Kingdom |
| 52 | NCT04909502 (ClinicalTrials.gov) | September 2021 | 14/5/2021 | Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis | A Phase II, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 | Relapsing Forms of Multiple Sclerosis | Drug: EHP-101 25 mg OD;Drug: EHP-101 25 mg BID;Drug: EHP-101 50 mg OD;Drug: EHP-101 50 mg BID | Emerald Health Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 55 Years | All | 50 | Phase 2 | NULL |
| 53 | NCT04956744 (ClinicalTrials.gov) | August 31, 2021 | 22/6/2021 | A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis | A Phase 1, Dose-Escalating, Open-label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Single Dose of IV IMS001 in Subjects With Multiple Sclerosis and Treatment Failure to Prior Disease Modifying Treatments (DMTs) | Multiple Sclerosis | Biological: IMS001 | ImStem Biotechnology | Rho, Inc. | Recruiting | 18 Years | 65 Years | All | 30 | Phase 1 | United States |
| 54 | EUCTR2017-004886-29-HR (EUCTR) | 24/08/2021 | 03/12/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 55 | EUCTR2020-004128-41-HU (EUCTR) | 24/08/2021 | 15/07/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 56 | EUCTR2019-001341-40-SI (EUCTR) | 20/08/2021 | 12/07/2021 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Saudi Arabia;Estonia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 57 | EUCTR2020-002700-39-AT (EUCTR) | 17/08/2021 | 07/06/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | ||
| 58 | EUCTR2020-005448-48-ES (EUCTR) | 11/08/2021 | 14/06/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS | Multiple Sclerosis (MS) 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] - Immune System Diseases [C20] | Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | 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 | 232 | Phase 3 | France;Czechia;Brazil;Spain;Italy | ||
| 59 | EUCTR2020-002700-39-LT (EUCTR) | 10/08/2021 | 07/06/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | ||
| 60 | NCT04982991 (ClinicalTrials.gov) | August 5, 2021 | 20/7/2021 | A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants. | A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants. | Multiple Sclerosis Healthy Subjects | Drug: RIPK1 inhibitor | Sanofi | NULL | Completed | 20 Years | 55 Years | All | 14 | Phase 1 | United Kingdom |
| 61 | NCT04815967 (ClinicalTrials.gov) | July 30, 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: rimabotulinumtoxinB;Drug: Placebo | Supernus Pharmaceuticals, Inc. | NULL | Not yet recruiting | 18 Years | 80 Years | All | 272 | Phase 2/Phase 3 | NULL |
| 62 | EUCTR2017-004886-29-HU (EUCTR) | 27/07/2021 | 01/06/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Sweden;Netherlands;Norway;Bulgaria;Denmark;Belgium;Brazil;Poland;Argentina;Mexico;Hungary;Czech Republic;France;Italy;United Kingdom;Turkey;Ireland;Spain;Finland;Slovenia;Slovakia;Estonia;Czechia;Portugal | ||
| 63 | NCT04788615 (ClinicalTrials.gov) | July 23, 2021 | 8/3/2021 | Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS | Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS | Multiple Sclerosis | Drug: Ofatumumab;Drug: First line DMT | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 45 Years | All | 236 | Phase 3 | France;Germany;Spain;United Kingdom |
| 64 | EUCTR2020-002700-39-ES (EUCTR) | 14/07/2021 | 23/06/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala | ||
| 65 | EUCTR2020-004505-32-DE (EUCTR) | 06/07/2021 | 25/05/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Product Name: Glatiramer acetate INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Product Name: Glatiramer acetate INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Product Name: Interferon ß-1b INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Germany;Italy | ||
| 66 | EUCTR2020-005448-48-IT (EUCTR) | 05/07/2021 | 17/08/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS - - | Multiple Sclerosis (MS) 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] - Immune System Diseases [C20] | Trade Name: Ocrevus Product Name: ocrelizumab Product Code: [RO4964913] INN or Proposed INN: Ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab Product Code: [RO4964913] INN or Proposed INN: Ocrelizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 3 | France;Czechia;Spain;Brazil;Italy | ||
| 67 | EUCTR2020-002700-39-FR (EUCTR) | 05/07/2021 | 27/05/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | ||
| 68 | EUCTR2017-004886-29-SK (EUCTR) | 02/07/2021 | 15/03/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus 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 | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 69 | NCT04925778 (ClinicalTrials.gov) | June 30, 2021 | 8/6/2021 | Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate | An Open-label, Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® (Monomethyl Fumarate) From Dimethyl Fumarate (PERSIST) | Relapsing Remitting Multiple Sclerosis | Drug: monomethyl fumarate | Banner Life Sciences LLC | NULL | Withdrawn | 18 Years | N/A | All | 0 | NULL | |
| 70 | EUCTR2017-004886-29-BG (EUCTR) | 29/06/2021 | 15/04/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Portugal;Czechia;Estonia;Slovakia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Norway;Sweden | ||
| 71 | 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 | Barts & The London NHS Trust;University Hospital Plymouth NHS Trust;University of Edinburgh;The Leeds Teaching Hospitals NHS Trust;St George's University Hospitals NHS Foundation Trust;University Hospital Birmingham NHS Foundation Trust;Bedfordshire Hospitals NHS Foundation Trust;Northern Care Alliance NHS Foundation Trust;Walton Centre NHS Foundation Trust;Sheffield Teaching Hospitals NHS Foundation Trust;Belfast Health and Social Care Trust;NHS Lothian;NHS Lanarkshire;Barking, Havering and Redbridge University Hospitals NHS Trust;Royal Free London NHS Trust;Swansea Bay University Health Board;NHS Greater Glasgow and Clyde;Nottingham University Hospitals NHS Trust | Recruiting | 18 Years | N/A | All | 200 | Phase 2/Phase 3 | United Kingdom |
| 72 | EUCTR2019-003919-53-HU (EUCTR) | 17/06/2021 | 23/04/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 73 | NCT04878211 (ClinicalTrials.gov) | June 10, 2021 | 3/5/2021 | A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | Relapsing Multiple Sclerosis (RMS) | Drug: Ofatumumab;Biological: mRNA COVID-19 vaccine;Drug: interferon or glatiramer acetate | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 66 | Phase 4 | United States |
| 74 | EUCTR2020-004505-32-FR (EUCTR) | 09/06/2021 | 26/04/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Product Name: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Product Name: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Product Name: Interferon ß-1b Other descriptive name: INTERFERON BETA-1B Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Germany | ||
| 75 | JPRN-UMIN000043910 | 2021/06/01 | 01/06/2021 | Association between brain atrophy and intestinal permeability in patients with multiple sclerosis | Association between brain atrophy and intestinal permeability in patients with multiple sclerosis - Brain atrophy and intestinal permeability in MS | multiple sclerosis | A standard solution of lactulose (5 g) and mannitol (2 g)in 500 mL of tap water was ingested before bed. Urine was collected the following morning in a container (with 5 mL of thymol solution). | Department of Neurology and Neurological Science, Tokyo Medical and Dental University | NULL | Pending | 18years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 76 | NCT04869358 (ClinicalTrials.gov) | May 27, 2021 | 29/4/2021 | Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab | Tracking the Immune Response to SARS-CoV-2 modRNA Vaccines in an Open-label Multicenter Study in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab s.c. (KYRIOS) | Multiple Sclerosis | Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 100 Years | All | 40 | Phase 4 | Germany |
| 77 | EUCTR2017-004886-29-PT (EUCTR) | 25/05/2021 | 12/03/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 78 | NCT04847596 (ClinicalTrials.gov) | May 21, 2021 | 14/4/2021 | A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | Relapsing Multiple Sclerosis | Other: Ofatumumab;Other: Covid-19 vaccine | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 22 | United States;Puerto Rico | |
| 79 | 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 | ||
| 80 | EUCTR2019-004857-10-HU (EUCTR) | 06/05/2021 | 18/03/2021 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) 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 Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | Portugal;France;United States;Hungary;Finland;Germany;Netherlands | ||
| 81 | EUCTR2021-000307-20-DE (EUCTR) | 28/04/2021 | 12/02/2021 | Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS) | Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS) | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: Kesimpta 20 mg Injektionslösung im Fertigpen Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Comirnaty Konzentrat zur Herstellung einer Injektionsdispersion INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified) Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Trade Name: Spikevax INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) | Novartis Pharma Vertriebs GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Germany | ||
| 82 | EUCTR2020-000644-55-DE (EUCTR) | 22/04/2021 | 17/06/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's TyrosineKinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 83 | NCT04843774 (ClinicalTrials.gov) | April 20, 2021 | 9/4/2021 | Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA) | Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA) | Multiple Sclerosis | Drug: SARS-COV-2 mRNA Vaccine | NYU Langone Health | NULL | Recruiting | 18 Years | 65 Years | All | 60 | United States | |
| 84 | NCT04792567 (ClinicalTrials.gov) | April 19, 2021 | 8/3/2021 | Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) | An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod) | Secondary Progressive Multiple Sclerosis | Drug: BAF312;Drug: Baseline disease modifying therapies (DMTs) | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 100 Years | All | 41 | Phase 4 | Germany |
| 85 | EUCTR2020-003413-35-BG (EUCTR) | 16/04/2021 | 17/02/2021 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optic 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: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Enspryng 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 | 127 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 86 | EUCTR2019-003919-53-PT (EUCTR) | 09/04/2021 | 11/02/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | Portugal;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 87 | EUCTR2019-004857-10-DE (EUCTR) | 29/03/2021 | 11/12/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) 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 Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 736 | Phase 3 | Portugal;France;United States;Hungary;Finland;Netherlands;Germany;Italy | ||
| 88 | 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;Russian Federation;Turkey;United Kingdom |
| 89 | EUCTR2019-003919-53-AT (EUCTR) | 19/03/2021 | 29/12/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | Switzerland;France;Denmark;Peru;Australia;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand;United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation | ||
| 90 | EUCTR2019-004980-36-SI (EUCTR) | 18/03/2021 | 06/10/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Latvia;Kuwait;Tunisia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 91 | EUCTR2020-005752-38-DE (EUCTR) | 18/03/2021 | 19/01/2021 | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | secondary progressive multiple sclerosis (SPMS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mayzent 2 mg Filmtabletten Product Name: Mayzent 2 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Mayzent 0,25 mg Filmtabletten Product Name: Mayzent 0,25 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Spikevax INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE INN or Proposed INN: TERIFLUNOMIDE INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE INN or Proposed INN: RECOMBINANT INTERFERON BE | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Germany | ||
| 92 | EUCTR2019-003919-53-GR (EUCTR) | 18/03/2021 | 24/12/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 93 | 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;Finland;Germany;Hong Kong;Hungary;Italy;Netherlands;Peru;Portugal;Russian Federation;Spain;Switzerland;Taiwan;Ukraine |
| 94 | EUCTR2017-004886-29-PL (EUCTR) | 09/03/2021 | 15/01/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Portugal;Czechia;Estonia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Bulgaria;Norway;Netherlands;Sweden | ||
| 95 | EUCTR2017-004886-29-SI (EUCTR) | 04/03/2021 | 23/12/2020 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Portugal;Estonia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Sweden | ||
| 96 | NCT04660539 (ClinicalTrials.gov) | March 2, 2021 | 24/11/2020 | A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroids | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 127 | Phase 3 | United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 97 | JPRN-jRCT2031200333 | 02/03/2021 | 29/01/2021 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optica Spectrum Disorder (NMOSD) | Satralizumab: 120 mg SC injection every 4 weeks (Q4W) | Hans-Christian von Buedingen | NULL | Not Recruiting | Not applicable | Not applicable | Both | 127 | Phase 4 | Italy;Taiwan;United States;Poland;Canada;United Kingdom;Ukraine;Bulgaria;Turkey;Korea;Romania;Georgia;Malaysia;Croatia;Hungary;Spain;Germany;Japan |
| 98 | EUCTR2020-001168-28-DK (EUCTR) | 01/03/2021 | 30/11/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) 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 Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffman-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 736 | Phase 3 | United States;Portugal;Greece;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Brazil;Poland;Denmark;Bulgaria;Korea, Republic of | ||
| 99 | EUCTR2020-000894-26-GR (EUCTR) | 26/02/2021 | 06/11/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 699 | Phase 3 | United States;Portugal;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 100 | EUCTR2020-000645-14-PT (EUCTR) | 26/02/2021 | 23/11/2020 | 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 | Belarus;Portugal;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 | ||
| 101 | EUCTR2017-004886-29-BE (EUCTR) | 24/02/2021 | 14/12/2020 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 102 | EUCTR2020-000893-69-DK (EUCTR) | 24/02/2021 | 16/09/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 786 | Phase 3 | Germany;New Zealand;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;United Kingdom;Turkey;Czechia;Netherlands;Peru;Denmark;Australia;France;Switzerland;Italy;Russian Federation;Israel;Ukraine;Spain;Greece;Portugal;United States | ||
| 103 | 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 | ||
| 104 | NCT04667949 (ClinicalTrials.gov) | February 20, 2021 | 8/12/2020 | Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients | A 24-month, Open-label, Prospective, Multicenter Interventional, Single-arm Study Assessing the Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Relapsing Multiple Sclerosis (RMS) Patients in China | Relapsing Multiple Sclerosis (RMS) | Drug: Fingolimod 0.5mg | Novartis Pharmaceuticals | NULL | Recruiting | 10 Years | 65 Years | All | 100 | Phase 4 | China |
| 105 | EUCTR2020-001168-28-BG (EUCTR) | 19/02/2021 | 30/11/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) 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 Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | United States;France;Finland;Bulgaria;Netherlands | ||
| 106 | EUCTR2020-000894-26-BG (EUCTR) | 15/02/2021 | 29/01/2021 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive Multiple Sclerosis (MS) 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 | 699 | Phase 3 | United States;Portugal;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 107 | 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 | ||
| 108 | EUCTR2020-003413-35-IT (EUCTR) | 10/02/2021 | 24/05/2021 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) - - | Neuromyelitis Optic 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: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Enspryng 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 | 127 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 109 | EUCTR2019-004857-10-PT (EUCTR) | 09/02/2021 | 14/12/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) 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 Trade Name: Aubagio 14 mg film-coated tablets Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | United States;France;Portugal;Finland;Germany;Netherlands | ||
| 110 | EUCTR2020-003413-35-HU (EUCTR) | 05/02/2021 | 16/11/2020 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optic 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: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Enspryng 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 | 127 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 111 | EUCTR2020-003413-35-DE (EUCTR) | 03/02/2021 | 27/10/2020 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optic 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: 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 | 127 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 112 | EUCTR2020-000894-26-DK (EUCTR) | 02/02/2021 | 02/09/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 699 | Phase 3 | United States;Portugal;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 113 | EUCTR2019-004857-10-NL (EUCTR) | 01/02/2021 | 16/11/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) 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 Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 736 | Phase 3 | Portugal;France;United States;Hungary;Finland;Germany;Netherlands;Italy | ||
| 114 | EUCTR2019-004857-10-IT (EUCTR) | 28/01/2021 | 24/05/2021 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;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 Trade Name: Aubagio Product Name: Teriflunomide Product Code: [-] INN or Proposed INN: TERIFLUNOMIDE | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | Italy;France;United States;Hungary;Finland;Germany;Netherlands;Portugal | ||
| 115 | EUCTR2020-001168-28-IT (EUCTR) | 28/01/2021 | 30/08/2021 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;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 Trade Name: Aubagio Product Name: Teriflunomide Product Code: [-] INN or Proposed INN: TERIFLUNOMIDE | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | France;United States;Finland;Denmark;Bulgaria;Netherlands;Italy | ||
| 116 | 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 | ||
| 117 | EUCTR2020-000893-69-GR (EUCTR) | 26/01/2021 | 06/11/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand | ||
| 118 | EUCTR2019-001341-40-PL (EUCTR) | 20/01/2021 | 17/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 119 | NCT04667117 (ClinicalTrials.gov) | January 14, 2021 | 8/12/2020 | A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | Relapsing Multiple Sclerosis | Biological: Quadrivalent influenza vaccine;Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 66 | Phase 4 | United States |
| 120 | EUCTR2020-003413-35-HR (EUCTR) | 11/01/2021 | 02/09/2021 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optic 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: 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 | 127 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 121 | 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 | ||
| 122 | NCT04670770 (ClinicalTrials.gov) | December 24, 2020 | 10/12/2020 | An Open Label Study of the Effects of SHR1459 in NMOSDs Patients | An Open Label Phase II Clinical Trial Evaluating the Efficacy and Safety of SHR1459 in Adult Patients With Neuromyelitis Optical Spectrum Disorders (NMOSDs) | Neuromyelitis Optica Spectrum Disorders | Drug: Drug - SHR1459 | Reistone Biopharma Company Limited | NULL | Active, not recruiting | 18 Years | 75 Years | All | 10 | Phase 2 | China |
| 123 | EUCTR2020-000644-55-FR (EUCTR) | 22/12/2020 | 15/06/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 124 | EUCTR2019-003919-53-GB (EUCTR) | 17/12/2020 | 26/11/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients 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 | 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] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 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 | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 125 | EUCTR2019-004980-36-NO (EUCTR) | 16/12/2020 | 03/07/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Not Recruiting | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 126 | EUCTR2020-000644-55-HU (EUCTR) | 11/12/2020 | 12/10/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway | ||
| 127 | NCT04548999 (ClinicalTrials.gov) | December 3, 2020 | 9/9/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS) | A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 699 | Phase 3 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 128 | 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 | ||
| 129 | NCT04544436 (ClinicalTrials.gov) | November 26, 2020 | 4/9/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) | A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 786 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czechia;Israel;Mexico;Netherlands |
| 130 | NCT05283551 (ClinicalTrials.gov) | November 25, 2020 | 24/2/2022 | Famciclovir in Multiple Sclerosis | A Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis. | Multiple Sclerosis | Drug: Famciclovir | Queen Mary University of London | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United Kingdom |
| 131 | EUCTR2020-000894-26-IT (EUCTR) | 24/11/2020 | 25/01/2021 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - - | Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Denmark;Peru;Bulgaria;Germany;New Zealand | ||
| 132 | EUCTR2020-000644-55-PT (EUCTR) | 23/11/2020 | 17/09/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway | ||
| 133 | EUCTR2019-004857-10-FI (EUCTR) | 20/11/2020 | 03/11/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | 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 (RMS) 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 Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 736 | Phase 3 | Portugal;France;United States;Hungary;Finland;Germany;Netherlands;Italy | ||
| 134 | EUCTR2020-000893-69-DE (EUCTR) | 19/11/2020 | 11/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 135 | 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 | ||
| 136 | EUCTR2020-000893-69-NL (EUCTR) | 11/11/2020 | 10/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) 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] | 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 | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 137 | EUCTR2020-000644-55-NL (EUCTR) | 09/11/2020 | 10/09/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 138 | EUCTR2020-000894-26-DE (EUCTR) | 03/11/2020 | 26/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 139 | 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 | ||
| 140 | NCT04578639 (ClinicalTrials.gov) | November 2, 2020 | 22/9/2020 | Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease | Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing | Relapsing Remitting Multiple Sclerosis | Drug: Rituximab;Drug: Ocrelizumab | Haukeland University Hospital | University Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North Norway | Recruiting | 18 Years | 60 Years | All | 211 | Phase 3 | Norway |
| 141 | NCT04150549 (ClinicalTrials.gov) | November 2020 | 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 |
| 142 | EUCTR2020-000893-69-IT (EUCTR) | 29/10/2020 | 24/05/2021 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS - NA | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 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: Ocrevus Product Name: Ocrelizumab Product Code: [RO4964913/F07-01] INN or Proposed INN: Ocrelizumab Other descriptive name: NA | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 143 | 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 | ||
| 144 | EUCTR2020-000893-69-PL (EUCTR) | 28/10/2020 | 09/07/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 145 | 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 | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 946 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Colombia;Denmark;France;Greece;Hungary;Israel;Mexico;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Belgium;Czechia;Germany;Italy;New Zealand |
| 146 | NCT04855617 (ClinicalTrials.gov) | October 26, 2020 | 19/4/2021 | Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis | Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | NYU Langone Health | Genentech, Inc. | Active, not recruiting | 18 Years | 80 Years | All | 122 | United States | |
| 147 | EUCTR2020-000893-69-BE (EUCTR) | 23/10/2020 | 23/10/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Peru;Australia;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand | ||
| 148 | EUCTR2019-004980-36-LT (EUCTR) | 22/10/2020 | 25/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Latvia;Kuwait;Tunisia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 149 | NCT04626921 (ClinicalTrials.gov) | October 22, 2020 | 30/10/2020 | A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis | VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: CNM-Au8 | Clene Nanomedicine | George Clinical | Active, not recruiting | 18 Years | 55 Years | All | 150 | Phase 2/Phase 3 | Australia |
| 150 | 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 | ||
| 151 | EUCTR2019-001829-26-DE (EUCTR) | 19/10/2020 | 08/01/2020 | A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Soliris Product Name: Soliris Product Code: Soliris INN or Proposed INN: ECULIZUMAB Other descriptive name: h5G1.1-mAb | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Italy;Japan;Korea, Republic of | ||
| 152 | 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 | ||
| 153 | JPRN-jRCT2051210017 | 15/10/2020 | 07/05/2021 | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | This study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects. | Sato Toshiyuki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 154 | 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 | ||
| 155 | EUCTR2020-000894-26-PT (EUCTR) | 12/10/2020 | 13/07/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 156 | EUCTR2020-000893-69-PT (EUCTR) | 12/10/2020 | 09/07/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 157 | EUCTR2019-004980-36-BG (EUCTR) | 12/10/2020 | 19/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 158 | EUCTR2020-000893-69-HU (EUCTR) | 09/10/2020 | 06/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand | ||
| 159 | EUCTR2020-000644-55-SK (EUCTR) | 09/10/2020 | 07/09/2020 | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 160 | EUCTR2020-000894-26-FR (EUCTR) | 08/10/2020 | 11/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 699 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand | ||
| 161 | EUCTR2020-000644-55-CZ (EUCTR) | 07/10/2020 | 03/09/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway | ||
| 162 | 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 | ||
| 163 | 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 | Japan;Sweden;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 | ||
| 164 | EUCTR2019-004980-36-DE (EUCTR) | 29/09/2020 | 08/09/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 165 | EUCTR2020-000893-69-GB (EUCTR) | 25/09/2020 | 29/07/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS - BN42082 Study to evaluate high dose Ocrelizumab in RMS | Relapsing Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand | ||
| 166 | EUCTR2020-000894-26-GB (EUCTR) | 25/09/2020 | 30/07/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a HigherDose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - BN42083 Study to evaluate high dose Ocrelizumab in PPMS | Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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] | 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: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand | ||
| 167 | NCT04561557 (ClinicalTrials.gov) | September 22, 2020 | 10/9/2020 | Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System | An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System | Autoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum Disorder | Biological: CT103A cells;Drug: Cyclophosphamide and fludarabine | Tongji Hospital | Nanjing IASO Biotherapeutics Co.,Ltd | Recruiting | 18 Years | 75 Years | All | 12 | Early Phase 1 | China |
| 168 | EUCTR2020-000894-26-HU (EUCTR) | 22/09/2020 | 06/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 169 | EUCTR2020-000644-55-LV (EUCTR) | 21/09/2020 | 04/09/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway;United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine | ||
| 170 | EUCTR2019-004980-36-PT (EUCTR) | 21/09/2020 | 22/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 171 | NCT04510220 (ClinicalTrials.gov) | September 21, 2020 | 31/7/2020 | 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis | Open-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ofatumumab;Drug: [F-18]PBR06 | Brigham and Women's Hospital | Novartis | Recruiting | 18 Years | 60 Years | All | 10 | Phase 3 | United States |
| 172 | EUCTR2020-000644-55-GR (EUCTR) | 18/09/2020 | 10/09/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's TyrosineKinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 173 | NCT04528121 (ClinicalTrials.gov) | September 15, 2020 | 22/8/2020 | Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis | Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Other: CoDuSe balance training and step square exercises;Other: conventional balance training | Lama Saad El-Din Mahmoud | NULL | Completed | 20 Years | 40 Years | All | 52 | N/A | Egypt |
| 174 | EUCTR2019-004980-36-LV (EUCTR) | 14/09/2020 | 01/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 175 | EUCTR2019-001341-40-AT (EUCTR) | 10/09/2020 | 07/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 176 | EUCTR2019-001341-40-IT (EUCTR) | 09/09/2020 | 19/05/2021 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 177 | EUCTR2020-000644-55-GB (EUCTR) | 04/09/2020 | 03/09/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | 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 Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio 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 | 1200 | Phase 3 | United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 178 | EUCTR2019-004980-36-IT (EUCTR) | 31/08/2020 | 21/01/2021 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: Evobrutinib Product Code: [M2951] INN or Proposed INN: Evobrutinib Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio Product Code: [non applicabile] INN or Proposed INN: TERIFLUNOMIDE | MERCK HEALTHCARE KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 179 | EUCTR2019-003625-16-HR (EUCTR) | 26/08/2020 | 12/11/2020 | An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis | An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis | 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: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603, TGTX1101 | TG Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Romania;Croatia;Russian Federation;Georgia | ||
| 180 | 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 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Latvia;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 181 | EUCTR2019-004980-36-SK (EUCTR) | 31/07/2020 | 27/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 182 | EUCTR2019-004980-36-GR (EUCTR) | 31/07/2020 | 02/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | 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. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | 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: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 183 | NCT04377555 (ClinicalTrials.gov) | July 30, 2020 | 1/5/2020 | Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab. | An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab | Multiple Sclerosis, Relapsing | Drug: Ocrelizumab | Genentech, Inc. | NULL | Recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | United States;Kenya;Puerto Rico |
| 184 | NCT04353492 (ClinicalTrials.gov) | July 14, 2020 | 16/4/2020 | An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab | A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy | Relapsing Multiple Sclerosis | Biological: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 60 Years | All | 550 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Estonia;Germany;Greece;Hungary;Italy;Latvia;Lebanon;Mexico;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Slovakia;Slovenia;Spain;Switzerland;Turkey;United Kingdom |
| 185 | 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 | 930 | 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;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;Turkey;Ukraine |
| 186 | EUCTR2019-001829-26-IT (EUCTR) | 19/06/2020 | 22/01/2021 | A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD). | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder. - NA | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML) Product Name: Soliris Product Code: [Soliris] INN or Proposed INN: ECULIZUMAB Trade Name: MENVEO Product Name: MENVEO Product Code: [NA] Other descriptive name: N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197 Trade Name: Bexsero Product Name: Bexsero Product Code: [NA] Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN Trade Name: Hiberix Product Name: Hiberix Product Code: [NA] Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) Trade Name: Prevenar 13 Product Name: Prevenar 13 Product Code: [NA] Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 187 | EUCTR2019-001341-40-PT (EUCTR) | 15/06/2020 | 31/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 188 | EUCTR2019-001341-40-BG (EUCTR) | 12/06/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 189 | NCT04410991 (ClinicalTrials.gov) | June 11, 2020 | 28/5/2020 | 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 | Relapsing Multiple Sclerosis | Drug: Tolebrutinib;Drug: Teriflunomide HMR1726;Drug: Placebo to match Tolebrutinib;Drug: Placebo to match Teriflunomide | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 900 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;Chile;Croatia;Czechia;France;Germany;Greece;Hungary;India;Israel;Korea, Republic of;Latvia;Netherlands;Norway;Portugal;Puerto Rico;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 190 | 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 | ||
| 191 | EUCTR2019-001341-40-GR (EUCTR) | 20/05/2020 | 10/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 192 | 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 | ||
| 193 | EUCTR2019-001341-40-DE (EUCTR) | 08/05/2020 | 05/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod. | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 194 | EUCTR2019-001341-40-CZ (EUCTR) | 07/05/2020 | 11/02/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom | ||
| 195 | EUCTR2019-001341-40-HU (EUCTR) | 29/04/2020 | 11/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 196 | EUCTR2019-001341-40-BE (EUCTR) | 29/04/2020 | 17/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 197 | EUCTR2019-001341-40-ES (EUCTR) | 24/04/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 198 | EUCTR2017-001313-93-DE (EUCTR) | 27/03/2020 | 12/02/2020 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: 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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 199 | 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 | Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of;France;Italy;United Kingdom;Russian Federation;Austria;Turkey;Spain;United States | ||
| 200 | 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 | ||
| 201 | 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 | Bulgaria;Germany;New Zealand;Georgia;Romania;Croatia;Poland;Belgium;Brazil;Canada;Mexico;Hungary;Egypt;United Kingdom;Austria;Netherlands;Australia;France;Italy;Colombia;Russian Federation;Ireland;Ukraine;Spain;Portugal;Serbia;United States | ||
| 202 | EUCTR2018-003008-38-DE (EUCTR) | 10/03/2020 | 06/05/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a 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 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 Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United States;Portugal;Serbia;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Germany;Kuwait;Tunisia | ||
| 203 | EUCTR2016-002667-34-PL (EUCTR) | 06/03/2020 | 14/11/2019 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting multiple sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 | 24 | Phase 2 | United States;Poland;Italy | ||
| 204 | 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 | ||
| 205 | 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 | ||
| 206 | 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 | ||
| 207 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 208 | NCT04291456 (ClinicalTrials.gov) | January 31, 2020 | 18/11/2019 | Minocycline in MS: Confirmation of Benefit | Open-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment Benefit | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Minocycline 100mg | University of Calgary | Hotchkiss Brain Institute, University of Calgary | Recruiting | 18 Years | 60 Years | All | 148 | Phase 3 | Canada |
| 209 | NCT04140305 (ClinicalTrials.gov) | January 16, 2020 | 24/10/2019 | Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) | A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) | Multiple Sclerosis | Drug: RPC-1063 | Celgene | NULL | Recruiting | 18 Years | 65 Years | All | 250 | Phase 3 | United States;Canada;Puerto Rico |
| 210 | 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 | ||
| 211 | NCT04155424 (ClinicalTrials.gov) | January 14, 2020 | 5/11/2019 | A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Eculizumab | Alexion Pharmaceuticals | NULL | Recruiting | 2 Years | 17 Years | All | 15 | Phase 2/Phase 3 | United States;Canada;Germany;Italy;Japan;Korea, Republic of;Spain |
| 212 | NCT04075266 (ClinicalTrials.gov) | January 9, 2020 | 14/8/2019 | A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis | An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 10 Years | 18 Years | All | 36 | Phase 2 | United States;Italy;Poland |
| 213 | EUCTR2019-000069-19-HR (EUCTR) | 24/12/2019 | 20/02/2020 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | 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): no Therapeutic use (Phase 4): yes | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 214 | 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 | |||
| 215 | NCT03993171 (ClinicalTrials.gov) | December 19, 2019 | 31/5/2019 | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis. | A Phase 2, Open-Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: gold nanocrystals | Clene Nanomedicine | University of Texas Southwestern Medical Center | Recruiting | 18 Years | 55 Years | All | 30 | Phase 2 | United States |
| 216 | EUCTR2019-001829-26-ES (EUCTR) | 18/12/2019 | 06/11/2019 | A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Soliris INN or Proposed INN: ECULIZUMAB Other descriptive name: h5G1.1-mAb | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 217 | 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 | Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;United Kingdom;Austria;Netherlands;Australia;France;Italy;Colombia;Russian Federation;Ireland;Ukraine;Spain;Portugal;United States;Belarus;Serbia | ||
| 218 | 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 | ||
| 219 | 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 Pharmaceuticals | 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 |
| 220 | EUCTR2018-003008-38-HR (EUCTR) | 10/12/2019 | 17/01/2020 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | 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;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany | ||
| 221 | NCT04130997 (ClinicalTrials.gov) | November 18, 2019 | 16/10/2019 | An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis | An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis (RMS) | Biological: Ublituximab | TG Therapeutics, Inc. | NULL | Enrolling by invitation | 18 Years | N/A | All | 900 | Phase 3 | United States;Belarus;Croatia;Georgia;Poland;Russian Federation;Serbia;Ukraine |
| 222 | NCT04171310 (ClinicalTrials.gov) | November 13, 2019 | 19/11/2019 | Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects | An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male Subjects | Multiple Sclerosis | Drug: SAR442168 | Sanofi | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 223 | NCT03958877 (ClinicalTrials.gov) | October 18, 2019 | 20/5/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | Multiple Sclerosis, Relapsing-Remitting | Drug: BIIB017 (peginterferon beta-1a);Drug: Interferon beta type 1a | Biogen | NULL | Recruiting | 10 Years | 18 Years | All | 142 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Croatia;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Kuwait;Portugal;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Tunisia;Turkey |
| 224 | NCT04121403 (ClinicalTrials.gov) | October 16, 2019 | 23/9/2019 | Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) | Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) A Prospective Randomized Open-label Blinded Endpoint (PROBE) Multicenter Non-inferiority Study | Relapsing Multiple Sclerosis;Multiple Sclerosis | Biological: Rituximab;Drug: Cladribine | Oslo University Hospital | University of Oslo;Göteborg University;Sykehuset Ostfold;Sykehuset Telemark;Vestre Viken Hospital Trust;Sorlandet Hospital HF;Helse Stavanger HF;Sykehuset Innlandet HF;Sykehuset i Vestfold HF;Helse Forde;University Hospital of North Norway;St. Olavs Hospital | Recruiting | 18 Years | 65 Years | All | 264 | Phase 3 | Norway |
| 225 | JPRN-JapicCTI-205119 | 15/10/2019 | 20/01/2020 | A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients | A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients | neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD) | Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter 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 | 30 | NA | Japan |
| 226 | EUCTR2019-000069-19-PT (EUCTR) | 14/10/2019 | 13/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Estonia;United States;Portugal;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 227 | EUCTR2019-000069-19-IT (EUCTR) | 11/10/2019 | 01/09/2021 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribina Product Code: [Not applicable] | MERCK KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 228 | 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 | 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 | ||
| 229 | 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 | ||
| 230 | EUCTR2019-000069-19-PL (EUCTR) | 08/09/2019 | 27/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 231 | EUCTR2019-000069-19-BG (EUCTR) | 05/09/2019 | 04/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 232 | EUCTR2016-002667-34-IT (EUCTR) | 03/09/2019 | 20/01/2022 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY,TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSINGREMITTINGMULTIPLE SCLEROSIS - A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizum | Relapsing-remitting multiple sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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: na | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Poland;Italy | ||
| 233 | 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 | ||
| 234 | EUCTR2018-003008-38-PT (EUCTR) | 02/09/2019 | 02/04/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a 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 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 Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Kuwait;Germany | ||
| 235 | EUCTR2019-000069-19-LT (EUCTR) | 27/08/2019 | 10/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 236 | EUCTR2019-000069-19-ES (EUCTR) | 23/08/2019 | 04/07/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: CLADRIBINE | Merck KGaA | 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): no Therapeutic use (Phase 4): yes | Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 237 | 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 | ||
| 238 | EUCTR2019-000069-19-SE (EUCTR) | 14/08/2019 | 10/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 239 | NCT03972306 (ClinicalTrials.gov) | August 12, 2019 | 29/5/2019 | A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis | A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: Ocrelizumab;Drug: rHuPH20 | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 65 Years | All | 135 | Phase 1 | United States;Canada |
| 240 | 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;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;Brazil;Netherlands |
| 241 | EUCTR2019-001505-24-NO (EUCTR) | 25/07/2019 | 28/05/2019 | A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis | Norwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS | Relapsing Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;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] - Nervous System Diseases [C10] | Trade Name: Rituximab konsentrat til infusjonsvaeske oppløsning 10 mg/ml Product Name: Rituximab Trade Name: Mavenclad tabletter 10 mg Product Name: Cladribine | Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Norway | ||
| 242 | EUCTR2018-003008-38-BE (EUCTR) | 17/07/2019 | 19/04/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a 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 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 Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait | ||
| 243 | EUCTR2018-003008-38-BG (EUCTR) | 10/07/2019 | 05/04/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a, 30 µg/0.5 ml Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a 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 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 Trade Name: AVONEX® Product Name: interferon beta-1a, 30 µg/0.5 ml Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United States;Portugal;Serbia;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany | ||
| 244 | EUCTR2018-003008-38-IT (EUCTR) | 02/07/2019 | 15/06/2021 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension - na | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: [BIIB017] INN or Proposed INN: PEGINTERFERONE LAMBDA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: [IFN ß-1a] INN or Proposed INN: INTERFERON BETA - 1A Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: [BIIB017] INN or Proposed INN: PEGINTERFERONE LAMBDA-1A Other descriptive name: PEGINTERFERONE BETA-1A Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: [BIIB 017] INN or Proposed INN: PEGINTERFERONE LAMBDA-1A Trade Name: AVONEX Product Name: interferon beta-1a Product Code: [IFN ß-1a] INN or Proposed INN: INTERFERON BETA - 1A | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;France;Australia;Tunisia;Kuwait;Czechia;Turkey;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 245 | EUCTR2018-003008-38-GR (EUCTR) | 27/06/2019 | 03/05/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a 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 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 Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait | ||
| 246 | EUCTR2018-003008-38-SK (EUCTR) | 24/06/2019 | 26/04/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension | 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: 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a 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 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 Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany | ||
| 247 | EUCTR2017-004703-51-GB (EUCTR) | 18/06/2019 | 15/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;Austria;Turkey;Lithuania;Finland;Latvia;Netherlands;South Africa;Denmark;Australia;Peru;France;India;Switzerland;Italy;Israel;Russian Federation;Spain;Thailand;Greece;Slovakia;Estonia;Taiwan;United States;Portugal | ||
| 248 | EUCTR2019-000069-19-EE (EUCTR) | 17/06/2019 | 22/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;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: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;United States;Portugal | ||
| 249 | EUCTR2018-003008-38-CZ (EUCTR) | 17/06/2019 | 06/03/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension | 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Tunisia;Germany;Kuwait;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic | ||
| 250 | EUCTR2017-004703-51-BE (EUCTR) | 17/06/2019 | 15/01/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 251 | EUCTR2018-003008-38-HU (EUCTR) | 30/05/2019 | 08/04/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | 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;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Germany;Tunisia | ||
| 252 | EUCTR2017-004703-51-HR (EUCTR) | 06/05/2019 | 03/06/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 253 | EUCTR2017-004703-51-GR (EUCTR) | 24/04/2019 | 27/03/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: Ofatumumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 254 | EUCTR2018-003008-38-ES (EUCTR) | 02/04/2019 | 17/05/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;Germany | ||
| 255 | EUCTR2017-004703-51-NL (EUCTR) | 29/03/2019 | 16/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Japan;Sweden;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Bulgaria;Norway;Germany;Croatia;Belgium;Poland;Argentina;Canada;Mexico;Hungary;United Kingdom;Austria;Turkey;Lithuania;Finland;Czechia;Netherlands;Latvia;South Africa;Denmark;Australia;Peru;France;India;Italy;Switzerland;Israel | ||
| 256 | EUCTR2017-004703-51-LV (EUCTR) | 28/03/2019 | 24/01/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: Ofatumumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 257 | EUCTR2018-002145-11-GB (EUCTR) | 21/03/2019 | 11/10/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329 | Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Phase 3 | United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom | ||
| 258 | EUCTR2017-004703-51-PT (EUCTR) | 18/03/2019 | 24/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 259 | EUCTR2018-002145-11-NL (EUCTR) | 14/03/2019 | 05/11/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration | Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Phase 3 | United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;Italy | ||
| 260 | NCT03799718 (ClinicalTrials.gov) | March 13, 2019 | 7/1/2019 | Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS | A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS | Multiple Sclerosis, Chronic Progressive | Biological: NurOwn (MSC-NTF cells) | Brainstorm-Cell Therapeutics | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 2 | United States |
| 261 | EUCTR2018-002145-11-FR (EUCTR) | 08/03/2019 | 31/10/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - NOVA | Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 262 | EUCTR2017-004703-51-LT (EUCTR) | 19/02/2019 | 03/12/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 263 | EUCTR2018-002145-11-DE (EUCTR) | 15/02/2019 | 17/10/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | France;United States;Canada;Spain;Belgium;Australia;Israel;Netherlands;New Zealand;Italy;United Kingdom;Germany | ||
| 264 | NCT03623243 (ClinicalTrials.gov) | February 14, 2019 | 7/8/2018 | Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients. | Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study | Multiple Sclerosis;Relapsing Multiple Sclerosis;Advancing Multiple Sclerosis | Drug: Siponimod | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 65 Years | All | 400 | Phase 3 | United States;Puerto Rico |
| 265 | NCT03696485 (ClinicalTrials.gov) | February 1, 2019 | 30/9/2018 | Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS | A Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS) | Secondary Progressive Multiple Sclerosis (SPMS) | Biological: SCM-010 | Stem Cell Medicine Ltd. | NULL | Not yet recruiting | 18 Years | 60 Years | All | 12 | Phase 1/Phase 2 | Israel |
| 266 | NCT03825601 (ClinicalTrials.gov) | February 1, 2019 | 21/1/2019 | PET With [18F]Flumazenil as an Index of Neurodegeneration in MS | PET With [18F]Flumazenil as an Index of Neurodegeneration in MS: Sensitivity at an Early Disease Stage and Pathophysiological Meaning | Multiple Sclerosis;Relapsing-Remitting Multiple Sclerosis | Diagnostic Test: PET with [11C]Flumazenil | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Not yet recruiting | 18 Years | 55 Years | All | 45 | N/A | NULL |
| 267 | NCT03784547 (ClinicalTrials.gov) | February 1, 2019 | 13/12/2018 | Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM | Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America | Multiple Sclerosis | Drug: Ocrelizumab | Hospital Italiano de Buenos Aires | NULL | Recruiting | N/A | N/A | All | 100 | Argentina | |
| 268 | EUCTR2017-004703-51-ES (EUCTR) | 31/01/2019 | 25/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 269 | EUCTR2017-004702-17-PL (EUCTR) | 25/01/2019 | 17/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 270 | EUCTR2017-004703-51-FR (EUCTR) | 18/01/2019 | 22/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 271 | EUCTR2017-004703-51-DK (EUCTR) | 18/01/2019 | 11/12/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Peru;South Africa;Latvia;Netherlands;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden | ||
| 272 | EUCTR2017-004886-29-IE (EUCTR) | 11/01/2019 | 09/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1127 | Phase 3 | Portugal;Czechia;Estonia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Norway;Sweden | ||
| 273 | EUCTR2017-004703-51-CZ (EUCTR) | 10/01/2019 | 08/11/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 274 | EUCTR2017-004703-51-DE (EUCTR) | 10/01/2019 | 27/09/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: Ofatumumab Product Code: OMB157 INN or Proposed INN: Ofatumumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 275 | EUCTR2017-005129-18-IT (EUCTR) | 08/01/2019 | 26/03/2018 | Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis. | Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis. | Relapsing-remitting multiple sclerosis with paediatric onset 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: Copaxone 40 mg/ml solution for injection, pre-filled syringe INN or Proposed INN: Glatiramer Acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: AVONEX 30 µg/0,5 ml solution for injection INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Università degli Studi Aldo Moro | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Italy | ||
| 276 | EUCTR2018-002145-11-ES (EUCTR) | 02/01/2019 | 05/11/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom | ||
| 277 | EUCTR2017-004703-51-FI (EUCTR) | 02/01/2019 | 11/12/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: Ofatumumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 278 | NCT03689972 (ClinicalTrials.gov) | December 26, 2018 | 27/9/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab | Biogen | NULL | Active, not recruiting | 18 Years | 60 Years | All | 500 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom |
| 279 | EUCTR2017-004703-51-SE (EUCTR) | 17/12/2018 | 15/11/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: Ofatumumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 280 | EUCTR2017-004702-17-ES (EUCTR) | 12/12/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 284 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 281 | EUCTR2017-004702-17-BG (EUCTR) | 03/12/2018 | 23/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 282 | NCT03944447 (ClinicalTrials.gov) | December 1, 2018 | 3/5/2019 | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus | Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler | OMNI Medical Services, LLC | OMNI Medical Services Inc | Recruiting | 7 Years | N/A | All | 200000 | Phase 2 | United States |
| 283 | EUCTR2017-004703-51-HU (EUCTR) | 29/11/2018 | 11/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 284 | EUCTR2017-004703-51-AT (EUCTR) | 28/11/2018 | 17/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 285 | NCT03650114 (ClinicalTrials.gov) | November 22, 2018 | 17/8/2018 | Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS | An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Biological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigen | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 2010 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom |
| 286 | EUCTR2017-004703-51-SK (EUCTR) | 21/11/2018 | 28/09/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: Ofatumumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2328 | Phase 3 | United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 287 | NCT03593590 (ClinicalTrials.gov) | November 12, 2018 | 11/7/2018 | Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis | A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 1700 | Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Portugal;Qatar;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel | |
| 288 | NCT03691077 (ClinicalTrials.gov) | November 11, 2018 | 28/9/2018 | Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714 | A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714 | Multiple Sclerosis;Relapse;Primary Progressive Multiple Sclerosis | Drug: Ocrelizumab | Assistance Publique - Hôpitaux de Paris | Roche Pharma AG;Institut du Cerveau et de la Moelle épinière | Recruiting | 18 Years | 60 Years | All | 51 | Phase 3 | France |
| 289 | EUCTR2017-004702-17-IT (EUCTR) | 07/11/2018 | 04/11/2020 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND | Multiple sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders 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: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Product Name: Formistin 10 mg Product Code: [Formistin 10 mg] Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [Tachipirina CPR 500mg] Other descriptive name: paracetamolo 500 mg Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Solumedrol IM 125mg/2ml Product Code: [Metilprednisolone] Other descriptive name: Metilprednisolone sodio succinato Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: Ofatumumab Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: OFATUMUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia | ||
| 290 | EUCTR2017-004702-17-LV (EUCTR) | 02/11/2018 | 03/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy | ||
| 291 | EUCTR2017-004702-17-LT (EUCTR) | 31/10/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 292 | EUCTR2017-004702-17-CZ (EUCTR) | 23/10/2018 | 16/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 293 | EUCTR2016-004719-10-GR (EUCTR) | 15/10/2018 | 24/07/2018 | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | Relapsing multiple sclerosis. 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Serbia;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 294 | EUCTR2017-004702-17-EE (EUCTR) | 17/09/2018 | 28/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 295 | NCT03606460 (ClinicalTrials.gov) | September 14, 2018 | 23/7/2018 | A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS) | A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3 | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | All | 141 | Phase 3 | United States |
| 296 | NCT03560739 (ClinicalTrials.gov) | September 11, 2018 | 15/5/2018 | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | Multiple Sclerosis | Combination Product: ofatumumab with PRF;Combination Product: ofatumumab with AI | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 284 | Phase 2 | United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain |
| 297 | EUCTR2017-004886-29-NL (EUCTR) | 05/09/2018 | 27/06/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 298 | EUCTR2017-004702-17-AT (EUCTR) | 01/09/2018 | 10/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 299 | 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 | ||
| 300 | EUCTR2017-004886-29-CZ (EUCTR) | 08/08/2018 | 10/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 301 | NCT03589105 (ClinicalTrials.gov) | August 6, 2018 | 5/7/2018 | A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting | An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mg | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 423 | Phase 4 | France |
| 302 | EUCTR2016-004719-10-FI (EUCTR) | 25/07/2018 | 12/06/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | Relapsing multiple sclerosis. 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Romania;Bulgaria;Georgia;Germany;Sweden;Croatia;Poland;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Finland;Czechia;Bosnia and Herzegovina;Latvia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Portugal;Belarus;Serbia;United States | ||
| 303 | EUCTR2017-004886-29-SE (EUCTR) | 23/07/2018 | 05/06/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 304 | NCT03567057 (ClinicalTrials.gov) | July 18, 2018 | 22/5/2018 | A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Multiple Sclerosis;Walking Impairment | Drug: ADS-5102, 274 mg | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 424 | Phase 3 | United States;Canada |
| 305 | NCT03599245 (ClinicalTrials.gov) | July 12, 2018 | 25/6/2018 | This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS) | A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 1500 | Phase 3 | Argentina;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Hungary;Ireland;Italy;Kuwait;Mexico;Netherlands;Norway;Poland;Portugal;Slovakia;Slovenia;Spain;Sweden;Turkey;United Kingdom |
| 306 | EUCTR2017-001313-93-CZ (EUCTR) | 09/07/2018 | 26/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: 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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 307 | EUCTR2017-004886-29-FR (EUCTR) | 05/07/2018 | 17/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | 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 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 308 | EUCTR2017-004886-29-GB (EUCTR) | 03/07/2018 | 02/07/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 1224 | Phase 3 | France;Czech Republic;Estonia;Finland;Spain;Ireland;Denmark;Netherlands;United Kingdom;Sweden | ||
| 309 | EUCTR2016-004719-10-PT (EUCTR) | 02/07/2018 | 12/02/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 310 | EUCTR2017-004886-29-IT (EUCTR) | 25/06/2018 | 17/06/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL - A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis | Multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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: Ocrelizumab Product Code: RO4964913 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 | 1224 | Phase 3;Phase 4 | Portugal;Czechia;Estonia;Slovakia;Slovenia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Bulgaria;Netherlands;Norway;Sweden | ||
| 311 | EUCTR2017-004886-29-DK (EUCTR) | 21/06/2018 | 18/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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 MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 312 | EUCTR2017-001313-93-HU (EUCTR) | 21/06/2018 | 25/04/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) 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 10053395;Term: 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 Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria | ||
| 313 | EUCTR2017-004886-29-FI (EUCTR) | 19/06/2018 | 15/06/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 314 | EUCTR2017-001313-93-PL (EUCTR) | 08/06/2018 | 15/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: 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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 315 | EUCTR2017-004886-29-EE (EUCTR) | 31/05/2018 | 18/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 316 | NCT03552211 (ClinicalTrials.gov) | May 30, 2018 | 25/4/2018 | Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis | Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: biotin;Other: propensity score | University Hospital, Clermont-Ferrand | OFSEP (Observatoire Français de la Sclérose en Plaques);SFSEP (Société Francophone de la Sclérose en Plaques);MedDay Pharmaceuticals SA | Unknown status | 18 Years | 80 Years | All | 3000 | France | |
| 317 | NCT03523858 (ClinicalTrials.gov) | May 28, 2018 | 16/4/2018 | A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis | An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis (PMS) | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 900 | Phase 3 | United States;Bosnia and Herzegovina;Brazil;Canada;Colombia;Costa Rica;Czechia;Denmark;Egypt;France;Germany;Guatemala;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;Netherlands;Panama;Poland;Russian Federation;Saudi Arabia;Spain;United Arab Emirates;Algeria |
| 318 | EUCTR2017-004886-29-ES (EUCTR) | 22/05/2018 | 09/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) 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;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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 Other descriptive name: OCRELIZUMAB | Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd | 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 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 319 | EUCTR2017-001313-93-ES (EUCTR) | 11/05/2018 | 02/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) 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 10053395;Term: 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 Other descriptive name: OCRELIZUMAB | Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria | ||
| 320 | EUCTR2017-001313-93-IE (EUCTR) | 03/05/2018 | 06/02/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: 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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 321 | NCT03585569 (ClinicalTrials.gov) | May 1, 2018 | 16/3/2018 | Treating MS Patients With Lower Extremity Spasticity Using Dysport | A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport | Multiple Sclerosis;Spasticity, Muscle | Biological: Abobotulinumtoxin A | Neurology Center of New England P.C. | Ipsen | Unknown status | N/A | N/A | All | 30 | Phase 3 | United States |
| 322 | EUCTR2017-004101-40-HR (EUCTR) | 27/04/2018 | 16/05/2019 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | 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 | 300 | Phase 3 | Serbia;Belarus;Bosnia and Herzegovina;Moldova, Republic of;Bulgaria;Russian Federation;Croatia;Ukraine;Poland;United States | ||
| 323 | EUCTR2018-000780-91-FR (EUCTR) | 26/04/2018 | 30/03/2018 | STUDY TO ASSESS OCRELIZUMAB EFFICACY, SAFETY AND IMPACT ON PATIENT REPORTED OUTCOMES (PROS) IN PATIENTS WITH ACTIVE RELAPSING MULTIPLE SCLEROSIS(PRO-MSACTIVE) | AN OPEN-LABEL, SINGLE-ARM PHASE IV STUDY TO ASSESS OCRELIZUMAB EFFICACY, SAFETY AND IMPACT ON PATIENT REPORTED OUTCOMES (PROS) IN PATIENTS WITH ACTIVE RELAPSING MULTIPLE SCLEROSIS(PRO-MSACTIVE) - PRO-MSActive | ACTIVE RELAPSING MULTIPLE SCLEROSIS (Active RMS) 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 10063400;Term: Secondary progressive multiple sclerosis;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: Ocrevus 300 mg, solution à diluer pour perfusion Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 570 | Phase 4 | France | ||
| 324 | EUCTR2016-004719-10-GB (EUCTR) | 26/04/2018 | 22/05/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 325 | EUCTR2017-001313-93-DK (EUCTR) | 04/04/2018 | 23/02/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS | Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: 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 Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 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 | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 326 | NCT03319732 (ClinicalTrials.gov) | April 3, 2018 | 13/10/2017 | A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005) | Multiple Sclerosis;Spasticity, Muscle | Drug: Arbaclofen | Osmotica Pharmaceutical US LLC | NULL | Active, not recruiting | 18 Years | 65 Years | All | 323 | Phase 3 | United States |
| 327 | EUCTR2016-004719-10-HR (EUCTR) | 27/03/2018 | 12/04/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | 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;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 328 | EUCTR2017-004101-40-BG (EUCTR) | 23/03/2018 | 09/01/2018 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | 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 | 300 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 329 | EUCTR2017-004101-40-PL (EUCTR) | 21/03/2018 | 12/02/2018 | Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity | An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). | 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 | 300 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 330 | 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 |
| 331 | 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 |
| 332 | NCT03551275 (ClinicalTrials.gov) | February 22, 2018 | 13/2/2018 | Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis | A Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132 | Biocad | NULL | Completed | 18 Years | 60 Years | All | 24 | Phase 1 | Russian Federation |
| 333 | EUCTR2016-004719-10-LV (EUCTR) | 30/01/2018 | 10/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | 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;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 334 | EUCTR2016-004719-10-BG (EUCTR) | 24/01/2018 | 01/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Belarus;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 335 | 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 | ||
| 336 | EUCTR2016-004719-10-CZ (EUCTR) | 22/01/2018 | 29/09/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 337 | 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 | ||
| 338 | EUCTR2016-004719-10-HU (EUCTR) | 11/01/2018 | 20/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 339 | EUCTR2016-004719-10-LT (EUCTR) | 29/12/2017 | 04/12/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 340 | 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 | ||
| 341 | 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 | Sweden;Netherlands;Germany;Australia;Poland;Belgium;Canada;Hungary;Czech Republic;France;Italy;Switzerland;United Kingdom;Israel;Spain;United States | ||
| 342 | NCT03362294 (ClinicalTrials.gov) | December 11, 2017 | 15/11/2017 | Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS | A Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: GA Depot 40mg once monthly;Drug: GA Depot 25mg once monthly | Mapi Pharma Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 30 | Phase 2 | Israel;Moldova, Republic of |
| 343 | EUCTR2016-004719-10-PL (EUCTR) | 02/12/2017 | 24/08/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 344 | EUCTR2016-003100-30-DE (EUCTR) | 29/11/2017 | 07/03/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 345 | EUCTR2016-002937-31-HR (EUCTR) | 29/11/2017 | 13/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 346 | 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 |
| 347 | NCT03350633 (ClinicalTrials.gov) | November 1, 2017 | 10/11/2017 | Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders | Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial | Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica | Drug: Tocilizumab Injection;Drug: Azathioprine | Tianjin Medical University General Hospital | NULL | Completed | 18 Years | N/A | All | 118 | Phase 2/Phase 3 | China |
| 348 | EUCTR2016-003100-30-GR (EUCTR) | 27/10/2017 | 21/04/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden | ||
| 349 | NCT03368664 (ClinicalTrials.gov) | October 24, 2017 | 2/11/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis | Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 10 Years | 17 Years | All | 50 | Phase 3 | Austria;Belgium;France;Italy;Netherlands;Poland;Portugal;Russian Federation;Turkey;United Kingdom;Bulgaria;Czechia;Germany;Greece;Norway;Spain;Switzerland |
| 350 | 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 | Recruiting | 18 Years | 60 Years | All | 225 | Phase 1/Phase 2 | United States;Australia |
| 351 | 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 | Authorised-recruitment may be ongoing or finished | 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 | United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of | ||
| 352 | EUCTR2016-003100-30-NO (EUCTR) | 12/10/2017 | 12/04/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden | ||
| 353 | EUCTR2016-004719-10-SE (EUCTR) | 04/10/2017 | 28/07/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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 10063399;Term: Relapsing-remitting 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 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 354 | EUCTR2016-004719-10-ES (EUCTR) | 02/10/2017 | 04/07/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis 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: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 355 | EUCTR2016-003100-30-NL (EUCTR) | 28/09/2017 | 11/05/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden | ||
| 356 | NCT03257358 (ClinicalTrials.gov) | September 19, 2017 | 18/8/2017 | A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod | A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT] | Relapsing Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 382 | Phase 4 | United States |
| 357 | EUCTR2016-002937-31-NO (EUCTR) | 12/09/2017 | 18/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Norway;Germany;Sweden;Slovakia;Portugal;United States | ||
| 358 | EUCTR2016-002937-31-DE (EUCTR) | 11/09/2017 | 02/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 359 | EUCTR2016-002937-31-GB (EUCTR) | 06/09/2017 | 05/09/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 360 | EUCTR2016-003100-30-PT (EUCTR) | 28/08/2017 | 04/05/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 361 | NCT03183869 (ClinicalTrials.gov) | August 24, 2017 | 9/5/2017 | Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients | Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients | Autoimmune Diseases;Relapsing Multiple Sclerosis | Drug: Fecal microbiota | Lawson Health Research Institute | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 2 | Canada |
| 362 | EUCTR2016-002937-31-NL (EUCTR) | 21/08/2017 | 15/06/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1228 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 363 | EUCTR2016-003100-30-AT (EUCTR) | 03/08/2017 | 10/08/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | ||
| 364 | EUCTR2016-002937-31-BG (EUCTR) | 02/08/2017 | 30/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 365 | EUCTR2016-002937-31-ES (EUCTR) | 31/07/2017 | 29/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Roche Farma S.A. (Soc.unipersonal)que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 366 | EUCTR2016-002937-31-FR (EUCTR) | 26/07/2017 | 30/10/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 | 600 | Phase 3 | United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 367 | EUCTR2016-002937-31-IT (EUCTR) | 24/07/2017 | 17/06/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to Evaluate the Effectiveness and Safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis - ENSEMBLE | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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: 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 | 600 | Phase 3 | United States;Portugal;Slovakia;Spain;Italy;Switzerland;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 368 | EUCTR2016-002937-31-PT (EUCTR) | 24/07/2017 | 04/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 369 | EUCTR2016-003100-30-BE (EUCTR) | 14/07/2017 | 22/05/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | ||
| 370 | EUCTR2016-002937-31-BE (EUCTR) | 10/07/2017 | 05/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 371 | NCT03232073 (ClinicalTrials.gov) | July 5, 2017 | 20/7/2017 | Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis | Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod | Actelion | NULL | Active, not recruiting | 18 Years | 65 Years | All | 877 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom |
| 372 | EUCTR2016-002937-31-HU (EUCTR) | 29/06/2017 | 08/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 373 | EUCTR2016-002937-31-PL (EUCTR) | 26/06/2017 | 10/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 | 1225 | Phase 3 | Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden;Mexico;Hungary;United Kingdom;Austria;Turkey;Slovenia;Netherlands;Kuwait;Australia;Denmark;France;Italy;Switzerland;Lebanon;Spain;Slovakia;Portugal;United States | ||
| 374 | EUCTR2016-002820-10-DE (EUCTR) | 26/06/2017 | 08/11/2016 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) | Remitting-Relapsing 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] | Trade Name: Zinbryta Product Name: Daclizumab Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Canada;Germany;Italy;United Kingdom | ||
| 375 | EUCTR2016-002937-31-SE (EUCTR) | 19/06/2017 | 20/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Netherlands;Kuwait;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Sweden | ||
| 376 | EUCTR2016-002937-31-AT (EUCTR) | 19/06/2017 | 20/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 377 | EUCTR2016-002937-31-SI (EUCTR) | 16/06/2017 | 13/06/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden;United States;Portugal;Slovakia | ||
| 378 | EUCTR2016-002937-31-SK (EUCTR) | 16/06/2017 | 11/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 379 | EUCTR2016-002937-31-DK (EUCTR) | 08/06/2017 | 28/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: 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 MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB 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 | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 380 | NCT03239860 (ClinicalTrials.gov) | June 6, 2017 | 12/7/2017 | Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GNbAC1 Monoclonal Antibody | GeNeuro SA | Les Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales Servier | Terminated | 18 Years | 55 Years | All | 220 | Phase 2 | Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 381 | EUCTR2016-003100-30-GB (EUCTR) | 05/06/2017 | 27/03/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | ||
| 382 | NCT03381170 (ClinicalTrials.gov) | June 1, 2017 | 18/12/2017 | An Extension of the TG1101-RMS201 Trial | An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Biological: Ublituximab | TG Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 48 | Phase 2 | United States |
| 383 | EUCTR2015-002500-91-SE (EUCTR) | 01/06/2017 | 27/06/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia | ||
| 384 | EUCTR2016-003587-39-SE (EUCTR) | 22/05/2017 | 23/03/2017 | This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval. | COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) | Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3700 | Phase 4 | Sweden | ||
| 385 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;France;Macedonia, the former Yugoslav Republic of;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland;Bulgaria | ||
| 386 | 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 | ||
| 387 | EUCTR2015-005419-33-IT (EUCTR) | 09/05/2017 | 25/05/2021 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 - Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing form | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: ARZERRA - 100 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONE(VETRO) - 5 ML(20MG/ML) 3 FLACONI Product Name: ofatumumab Product Code: [OMB 157] INN or Proposed INN: Ofatumumab Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BISTER (ALU/ALU) PERFORATO MONODOSE - 10 X 1 COMPRESSA Product Name: Teriflunomide Product Code: [NA] INN or Proposed INN: Teriflunomide Other descriptive name: Aubagio | NOVARTIS PHARMA SERVICES AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Italy;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 388 | 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 | Authorised-recruitment may be ongoing or finished | 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 | ||
| 389 | NCT02881567 (ClinicalTrials.gov) | April 18, 2017 | 24/8/2016 | Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: Daclizumab | Biogen | AbbVie | Terminated | 18 Years | 55 Years | All | 41 | Phase 3 | United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom |
| 390 | 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 | ||
| 391 | EUCTR2016-003100-30-IT (EUCTR) | 11/04/2017 | 14/05/2019 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) - na | 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: Lemtrada INN or Proposed INN: alemtuzumab | GENZYME CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 392 | EUCTR2016-003100-30-ES (EUCTR) | 04/04/2017 | 22/02/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 393 | EUCTR2016-002820-10-IT (EUCTR) | 31/03/2017 | 13/01/2021 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | Remitting-Relapsing 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: Zinbryta Product Name: Daclizumab Product Code: BIIB019 INN or Proposed INN: DACLIZUMAB Other descriptive name: DAC HYP | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Canada;Denmark;Germany;United Kingdom;Italy | ||
| 394 | 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 | ||
| 395 | NCT03085810 (ClinicalTrials.gov) | March 24, 2017 | 16/3/2017 | Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS) | An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 1225 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Denmark;France;Germany;Hungary;Italy;Kuwait;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Slovakia;Slovenia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Finland |
| 396 | EUCTR2013-002318-11-FR (EUCTR) | 21/03/2017 | 17/06/2015 | A study on the safety and effectiveness of BG00012 in children from 10 to less than 18 years old with a type of Multiple Sclerosis that is called Relapsing-Remitting Multiple Sclerosis. | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting 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 Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Sweden;United Kingdom;Ukraine;Spain;Serbia | ||
| 397 | 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 | ||
| 398 | EUCTR2016-002820-10-GB (EUCTR) | 13/03/2017 | 08/11/2016 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - 205MS305_Biogen | Remitting-Relapsing 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] | Trade Name: Zinbryta Product Name: Zinbryta Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Italy;Germany;Denmark;Canada;United States;France | ||
| 399 | 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 |
| 400 | 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 | ||
| 401 | 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 | ||
| 402 | EUCTR2015-005419-33-HR (EUCTR) | 10/02/2017 | 05/06/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 403 | NCT02949908 (ClinicalTrials.gov) | February 9, 2017 | 17/10/2016 | MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS) | A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line Treatment | Multiple Sclerosis | Drug: Rebif | Merck KGaA, Darmstadt, Germany | Merck B.V., Netherlands | Terminated | 18 Years | 65 Years | All | 2 | Phase 4 | Germany |
| 404 | 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 | ||
| 405 | NCT03062579 (ClinicalTrials.gov) | February 1, 2017 | 13/2/2017 | A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD | Single-center, Open Label Trial of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders (NMOSD) | Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica;Devic's Disease | Drug: Tocilizumab | Fu-Dong Shi | NULL | Completed | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | China |
| 406 | EUCTR2015-005419-33-CZ (EUCTR) | 31/01/2017 | 20/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 407 | NCT03177083 (ClinicalTrials.gov) | January 30, 2017 | 26/1/2017 | Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy | Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | Relapsing Remitting Multiple Sclerosis | Drug: peginterferon beta-1a;Drug: interferon beta-1a;Drug: interferon beta-1b | Biogen | NULL | Completed | 18 Years | 65 Years | All | 80 | Phase 4 | Portugal |
| 408 | 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 | ||
| 409 | EUCTR2015-005419-33-BG (EUCTR) | 19/01/2017 | 25/11/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany;United States;Portugal | ||
| 410 | NCT04570670 (ClinicalTrials.gov) | January 6, 2017 | 22/9/2020 | Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects | A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions | Relapsing Remitting Multiple Sclerosis | Drug: monomethyl fumarate 190 mg;Drug: dimethyl fumarate 240 mg | Banner Life Sciences LLC | NULL | Completed | 18 Years | 55 Years | All | 50 | Phase 1 | NULL |
| 411 | 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 | ||
| 412 | 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 | ||
| 413 | EUCTR2015-004616-37-DE (EUCTR) | 24/11/2016 | 05/08/2016 | A Study to Explore the Mechanism of Action of Ocrelizumab and B-cell Biology in Patients with Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis. | An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis or primary progressive multiple sclerosis. | - Relapsing multiple sclerosis (RMS)/Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;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/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | GENENTECH Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 3 | United States;Germany;Switzerland;Sweden | ||
| 414 | EUCTR2016-000434-21-PT (EUCTR) | 14/11/2016 | 14/09/2016 | PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | 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: Plegridy 125 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A Trade Name: Rebif 22 micrograms INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Extavia 250 micrograms/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Plegridy 63 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A | Biogen Portugal | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 4 | Portugal | ||
| 415 | EUCTR2015-005419-33-LV (EUCTR) | 03/11/2016 | 11/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United States;United Arab Emirates;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 416 | NCT02913157 (ClinicalTrials.gov) | November 2016 | 20/9/2016 | Hydroxychloroquine in Primary Progressive Multiple Sclerosis | Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS) | Multiple Sclerosis, Primary Progressive | Drug: Hydroxychloroquine | University of Calgary | NULL | Completed | 18 Years | 65 Years | All | 35 | Phase 2 | Canada |
| 417 | EUCTR2015-005419-33-DE (EUCTR) | 21/10/2016 | 07/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany;United Kingdom;Austria;Lithuania;Turkey;Finland;Latvia;South Africa;Australia;Peru;France;India;Switzerland;Russian Federation;Spain;Slovakia;Taiwan;Portugal;United States | ||
| 418 | EUCTR2015-005419-33-FR (EUCTR) | 14/10/2016 | 12/01/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 419 | EUCTR2015-005419-33-GB (EUCTR) | 11/10/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 420 | EUCTR2015-005597-38-CZ (EUCTR) | 07/10/2016 | 17/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 421 | EUCTR2015-005419-33-PT (EUCTR) | 06/10/2016 | 28/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Italy;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 422 | EUCTR2015-005419-33-LT (EUCTR) | 03/10/2016 | 23/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Bulgaria;United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Germany | ||
| 423 | NCT02807285 (ClinicalTrials.gov) | October 2016 | 16/6/2016 | Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis | An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Genentech, Inc. | NULL | No longer available | 18 Years | 55 Years | All | N/A | United States | |
| 424 | EUCTR2015-005419-33-BE (EUCTR) | 26/09/2016 | 11/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 425 | EUCTR2015-005419-33-HU (EUCTR) | 21/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 426 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan | |
| 427 | EUCTR2015-005419-33-FI (EUCTR) | 20/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 428 | EUCTR2015-005419-33-SK (EUCTR) | 19/09/2016 | 03/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 429 | EUCTR2015-005597-38-FI (EUCTR) | 12/09/2016 | 21/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 430 | NCT02861014 (ClinicalTrials.gov) | September 9, 2016 | 5/8/2016 | A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) | An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment | Multiple Sclerosis, Relapsing-Remitting | Biological: Ocrelizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | 55 Years | All | 681 | Phase 3 | Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong |
| 431 | EUCTR2015-005597-38-IT (EUCTR) | 08/09/2016 | 04/11/2020 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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: Ocrelizumab Product Code: [RO4964913/F07] INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czechia;Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 432 | EUCTR2015-005419-33-ES (EUCTR) | 03/09/2016 | 05/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;Portugal;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 433 | 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 |
| 434 | EUCTR2015-005419-33-AT (EUCTR) | 16/08/2016 | 15/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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 | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 435 | EUCTR2015-004616-37-SE (EUCTR) | 03/08/2016 | 19/04/2016 | A Study to Explore the Mechanism of Action of Ocrelizumab and B-cell Biology in Patients with Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis | An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis or primary progressive multiple sclerosis | Relapsing Multiple Sclerosis (RMS)/Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;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/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | GENENTECH Inc. | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 3 | United States;Germany;Switzerland;Sweden | ||
| 436 | EUCTR2015-005160-41-DE (EUCTR) | 27/07/2016 | 04/03/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults 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] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Bulgaria;Russian Federation;Germany | ||
| 437 | EUCTR2015-005597-38-BE (EUCTR) | 14/07/2016 | 16/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 438 | EUCTR2015-005597-38-NL (EUCTR) | 11/07/2016 | 01/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;Estonia;France;Czech Republic;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 439 | EUCTR2015-005597-38-DE (EUCTR) | 29/06/2016 | 07/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 440 | EUCTR2015-005160-41-BG (EUCTR) | 27/06/2016 | 04/05/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 | 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: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 441 | NCT02797015 (ClinicalTrials.gov) | June 23, 2016 | 26/5/2016 | Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS | A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: RPC1063 | Celgene | NULL | Completed | 18 Years | 55 Years | All | 22 | Phase 1 | United States |
| 442 | EUCTR2015-003282-29-DE (EUCTR) | 17/06/2016 | 11/02/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With 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] | 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 | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany | ||
| 443 | EUCTR2016-000464-42-DE (EUCTR) | 13/06/2016 | 11/04/2016 | The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab | A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse | 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] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab Other descriptive name: ALEMTUZUMAB | Genzyme GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany | ||
| 444 | EUCTR2015-002500-91-HR (EUCTR) | 13/06/2016 | 06/07/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 445 | EUCTR2015-005160-41-PL (EUCTR) | 07/06/2016 | 13/04/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 | 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: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Canada;Belgium;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 446 | EUCTR2015-005160-41-ES (EUCTR) | 06/06/2016 | 20/04/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis | 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: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 447 | EUCTR2015-002500-91-PT (EUCTR) | 06/06/2016 | 13/04/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 448 | EUCTR2015-005597-38-DK (EUCTR) | 02/06/2016 | 06/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 449 | EUCTR2015-002500-91-LT (EUCTR) | 31/05/2016 | 17/03/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 450 | EUCTR2015-005597-38-EE (EUCTR) | 25/05/2016 | 06/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 451 | EUCTR2015-005597-38-SE (EUCTR) | 25/05/2016 | 15/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 452 | EUCTR2015-005597-38-FR (EUCTR) | 23/05/2016 | 15/02/2018 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 453 | EUCTR2015-005597-38-GB (EUCTR) | 19/05/2016 | 09/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 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 | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 454 | EUCTR2015-003282-29-BG (EUCTR) | 14/05/2016 | 02/03/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: 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 | 18 | Phase 3 | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany | ||
| 455 | EUCTR2015-005597-38-IE (EUCTR) | 13/05/2016 | 10/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) 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 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 456 | NCT02720107 (ClinicalTrials.gov) | May 12, 2016 | 21/3/2016 | Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01) | Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720) | Relapsing-remitting Multiple Sclerosis | Drug: fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 133 | Phase 4 | Germany |
| 457 | EUCTR2015-003282-29-CZ (EUCTR) | 05/05/2016 | 25/02/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: 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 | 18 | Phase 3 | Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany;United States;Czech Republic;Poland;Belgium | ||
| 458 | NCT02688985 (ClinicalTrials.gov) | April 29, 2016 | 18/2/2016 | Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS) | An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis | Relapsing Multiple Sclerorsis;Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: Antihistamine | Genentech, Inc. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 127 | Phase 3 | United States;Canada;Germany;Sweden |
| 459 | EUCTR2015-003282-29-BE (EUCTR) | 29/04/2016 | 19/02/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With 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] | 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 | 18 | Phase 3 | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany | ||
| 460 | EUCTR2015-005160-41-BE (EUCTR) | 27/04/2016 | 07/03/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis | 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: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 461 | EUCTR2015-005597-38-ES (EUCTR) | 26/04/2016 | 18/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Roche Farma S.A. que representa en España a F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 462 | EUCTR2015-003282-29-LV (EUCTR) | 20/04/2016 | 02/03/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: 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 | 18 | Phase 3 | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Kuwait;Germany;Latvia | ||
| 463 | EUCTR2015-002500-91-LV (EUCTR) | 20/04/2016 | 19/02/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | Germany;New Zealand;Sweden;Georgia;Bulgaria;Romania;Croatia;Poland;Belgium;Hungary;United Kingdom;Lithuania;Bosnia and Herzegovina;Moldova, Republic of;Latvia;South Africa;Italy;Russian Federation;Ukraine;Spain;Greece;Slovakia;Estonia;Portugal;Belarus;Serbia;United States | ||
| 464 | EUCTR2013-002318-11-DE (EUCTR) | 15/04/2016 | 03/09/2015 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE 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 | 132 | Phase 3 | Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 465 | EUCTR2015-002500-91-EE (EUCTR) | 04/04/2016 | 07/03/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 466 | 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 |
| 467 | EUCTR2013-002318-11-ES (EUCTR) | 02/03/2016 | 08/05/2015 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis - CONNECT | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Serbia;Portugal;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Croatia;Denmark;Sweden | ||
| 468 | NCT02555215 (ClinicalTrials.gov) | February 22, 2016 | 17/9/2015 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 10 Years | 17 Years | All | 20 | Phase 3 | United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic |
| 469 | EUCTR2015-001973-42-PL (EUCTR) | 22/02/2016 | 19/01/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Belgium;Poland;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 470 | EUCTR2015-000922-12-DE (EUCTR) | 12/02/2016 | 02/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 471 | EUCTR2015-001973-42-BG (EUCTR) | 11/02/2016 | 02/02/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 472 | NCT02637856 (ClinicalTrials.gov) | February 11, 2016 | 18/12/2015 | A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) | An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | All | 608 | Phase 3 | United States;Canada |
| 473 | EUCTR2015-001973-42-LT (EUCTR) | 11/02/2016 | 27/11/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 474 | EUCTR2015-002500-91-IT (EUCTR) | 09/02/2016 | 22/01/2021 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Product Name: 1.0mg RPC1063 Product Code: RPC1063 | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 475 | EUCTR2015-000922-12-FR (EUCTR) | 28/01/2016 | 26/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 476 | EUCTR2015-001973-42-HR (EUCTR) | 26/01/2016 | 28/04/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Slovakia;Canada;Poland;Belgium;Lithuania;Turkey;Croatia;Austria;Bulgaria;Kuwait;Sweden | ||
| 477 | EUCTR2015-002500-91-SK (EUCTR) | 22/01/2016 | 28/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain | ||
| 478 | EUCTR2015-002500-91-PL (EUCTR) | 20/01/2016 | 01/12/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 479 | EUCTR2015-002500-91-BG (EUCTR) | 13/01/2016 | 20/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru | ||
| 480 | EUCTR2015-000922-12-ES (EUCTR) | 12/01/2016 | 13/01/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 820 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 481 | EUCTR2015-000922-12-PL (EUCTR) | 05/01/2016 | 03/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 482 | EUCTR2015-000922-12-BE (EUCTR) | 04/01/2016 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 483 | NCT02644044 (ClinicalTrials.gov) | January 2016 | 23/3/2015 | Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study | Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study | To Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MS | Drug: Intrathecal methotrexate | Tel-Aviv Sourasky Medical Center | NULL | Not yet recruiting | 18 Years | 75 Years | Both | 30 | Phase 0 | NULL |
| 484 | NCT02276963 (ClinicalTrials.gov) | January 2016 | 21/10/2014 | Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses | Phase I, Single-Center, Open Label Trial of Ublituximab + Glucocorticoids for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Ublituximab | Johns Hopkins University | NULL | Completed | 18 Years | 100 Years | All | 6 | Phase 1 | United States |
| 485 | EUCTR2015-000922-12-IE (EUCTR) | 22/12/2015 | 09/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 486 | EUCTR2015-001973-42-BE (EUCTR) | 17/12/2015 | 23/11/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Czech Republic;Canada;Poland;Belgium;Lithuania;Croatia;Turkey;Austria;Bulgaria;Kuwait | ||
| 487 | EUCTR2015-000922-12-FI (EUCTR) | 15/12/2015 | 07/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 488 | EUCTR2015-000922-12-HR (EUCTR) | 11/12/2015 | 04/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 489 | NCT02634307 (ClinicalTrials.gov) | December 10, 2015 | 16/12/2015 | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ALKS 8700 | Biogen | Alkermes, Inc. | Completed | 18 Years | 65 Years | All | 1057 | Phase 3 | United States;Belgium;Bulgaria;Canada;Germany;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 490 | EUCTR2013-001151-12-HR (EUCTR) | 08/12/2015 | 01/02/2016 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing Neuromyelitis Optica MedDRA version: 20.0;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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Saudi Arabia;Taiwan;Hong Kong;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| 491 | NCT02583594 (ClinicalTrials.gov) | December 6, 2015 | 16/10/2015 | A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis | A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: Dexchlorpheniramine | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | Spain |
| 492 | NCT02893111 (ClinicalTrials.gov) | December 2015 | 27/8/2016 | Efficacy and Safety of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder | Single-center, Open Label Trial of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder | Drug: Bortezomib | Tianjin Medical University General Hospital | NULL | Completed | 18 Years | N/A | Female | 5 | Phase 2 | China |
| 493 | EUCTR2011-005677-23-HR (EUCTR) | 25/11/2015 | 01/02/2016 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 494 | EUCTR2015-002500-91-ES (EUCTR) | 24/11/2015 | 05/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 18.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Receptos, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2350 | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | |||
| 495 | EUCTR2015-000922-12-AT (EUCTR) | 19/11/2015 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | 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] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 496 | EUCTR2012-003735-32-GR (EUCTR) | 19/11/2015 | 06/08/2015 | Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Relapsing-remitting multiple sclerosis (RR MS) 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: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 497 | EUCTR2015-002500-91-GR (EUCTR) | 18/11/2015 | 04/11/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 498 | EUCTR2015-002500-91-GB (EUCTR) | 10/11/2015 | 18/09/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 499 | EUCTR2015-002500-91-BE (EUCTR) | 10/11/2015 | 02/09/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden;Poland;Belgium;Hungary;United Kingdom;Lithuania;Bosnia and Herzegovina;Moldova, Republic of;Latvia;South Africa;Italy;Russian Federation;Ukraine;Spain;Greece;Slovakia;Estonia;Portugal;United States;Belarus;Serbia | ||
| 500 | 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 | ||
| 501 | EUCTR2015-000922-12-IT (EUCTR) | 05/11/2015 | 28/02/2018 | A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) 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: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO | TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 502 | NCT02686684 (ClinicalTrials.gov) | November 2015 | 11/2/2016 | Tecfidera Diffusion Tensor Imaging | An Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging | Drug: Dimethyl fumarate | University at Buffalo | NULL | Completed | 18 Years | N/A | Both | 115 | N/A | NULL |
| 503 | NCT02545868 (ClinicalTrials.gov) | October 27, 2015 | 8/9/2015 | A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis | A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: 23-PPV;Biological: 13-PCV Booster;Biological: Influenza Vaccine;Biological: KLH;Drug: OCR;Biological: TT Vaccine | Hoffmann-La Roche | NULL | Completed | 18 Years | 55 Years | All | 102 | Phase 3 | United States;Canada |
| 504 | EUCTR2012-000540-10-PT (EUCTR) | 23/10/2015 | 21/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE 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 | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Hungary;United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 505 | EUCTR2012-000540-10-LT (EUCTR) | 21/10/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals 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 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 506 | NCT02576717 (ClinicalTrials.gov) | October 16, 2015 | 28/9/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | 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: RPC1063 | Celgene | NULL | Active, not recruiting | 18 Years | 55 Years | All | 2495 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Germany;Greece;Hungary;Italy;Latvia;Lithuania;Moldova, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Ukraine;United Kingdom |
| 507 | EUCTR2012-000540-10-HU (EUCTR) | 15/10/2015 | 19/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE 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 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 508 | EUCTR2015-002500-91-HU (EUCTR) | 12/10/2015 | 26/08/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 509 | EUCTR2014-005003-24-DE (EUCTR) | 12/10/2015 | 25/02/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 510 | EUCTR2012-000540-10-SE (EUCTR) | 07/10/2015 | 14/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE 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 | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 511 | 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 | |||
| 512 | EUCTR2012-000540-10-GR (EUCTR) | 02/10/2015 | 05/11/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals 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 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 513 | NCT02410200 (ClinicalTrials.gov) | September 30, 2015 | 2/4/2015 | Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 10 Years | 17 Years | All | 22 | Phase 2 | United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic |
| 514 | EUCTR2014-005003-24-PL (EUCTR) | 25/09/2015 | 12/06/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 515 | EUCTR2012-000540-10-LV (EUCTR) | 25/09/2015 | 14/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | 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 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 516 | EUCTR2012-000540-10-FI (EUCTR) | 23/09/2015 | 19/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals 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 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 517 | EUCTR2012-000540-10-DE (EUCTR) | 23/09/2015 | 03/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE 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 | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 518 | EUCTR2012-000540-10-HR (EUCTR) | 23/09/2015 | 01/10/2015 | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE 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 | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 519 | EUCTR2012-000540-10-ES (EUCTR) | 21/09/2015 | 11/09/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE 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 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Serbia;Portugal;Belarus;United States;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 520 | EUCTR2014-005003-24-CZ (EUCTR) | 21/09/2015 | 02/03/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United States;Lebanon;Turkey;Lithuania;Israel;Italy;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 521 | EUCTR2012-000540-10-CZ (EUCTR) | 15/09/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals 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 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 522 | EUCTR2014-002320-27-NL (EUCTR) | 15/09/2015 | 08/01/2015 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 523 | EUCTR2012-000540-10-PL (EUCTR) | 25/08/2015 | 12/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE 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 | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 524 | EUCTR2014-005003-24-BG (EUCTR) | 21/08/2015 | 13/05/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United States;Lebanon;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 525 | NCT02525874 (ClinicalTrials.gov) | August 11, 2015 | 10/7/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 65 Years | All | 218 | Phase 3 | United States;Belgium;Bulgaria;Kuwait;Lithuania;Poland;Turkey;Croatia |
| 526 | NCT02499900 (ClinicalTrials.gov) | August 10, 2015 | 1/7/2015 | CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily | CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily | Multiple Sclerosis | Drug: Copaxone® | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | N/A | All | 861 | Phase 4 | United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey |
| 527 | EUCTR2014-000395-26-DE (EUCTR) | 07/08/2015 | 09/04/2014 | Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take Tecfidera | A 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISION | Relapsing Remitting Multiple Sclerosis (RRMS) 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] | Trade Name: Tecfidera INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 4 | Germany | ||
| 528 | NCT02683863 (ClinicalTrials.gov) | August 2015 | 14/1/2016 | Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers | An Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: BG00012 (DMF) (Tecfidera®.) | Multiple Sclerosis Center of Northeastern New York | Biogen | Completed | 25 Years | 65 Years | All | 20 | Phase 4 | United States |
| 529 | EUCTR2012-000540-10-FR (EUCTR) | 31/07/2015 | 03/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis 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: 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 Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals 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 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 530 | EUCTR2014-005003-24-BE (EUCTR) | 29/07/2015 | 30/06/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting 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 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 531 | EUCTR2014-002320-27-HR (EUCTR) | 27/07/2015 | 01/10/2015 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 532 | EUCTR2014-002320-27-GB (EUCTR) | 22/07/2015 | 17/06/2015 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: 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 | 1200 | Phase 3 | Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Lithuania;Bosnia and Herzegovina;Moldova, Republic of;Latvia;Netherlands;South Africa;Peru;Switzerland;Colombia;Russian Federation;Ukraine;Spain;Estonia;United States;Belarus;Portugal;Serbia | ||
| 533 | EUCTR2013-002318-11-PL (EUCTR) | 03/07/2015 | 09/06/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects Withrelapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Serbia;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 534 | EUCTR2014-002320-27-HU (EUCTR) | 03/07/2015 | 11/05/2015 | 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. | 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;Portugal;Serbia;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 535 | NCT02506751 (ClinicalTrials.gov) | July 2015 | 12/7/2015 | Open-label Study of Liothyronine in MS | A Phase 1b, Open-label Study to Evaluate the Safety and Tolerability of the Putative Remyelinating Agent, Liothyronine, in Individuals With MS | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive | Drug: liothyronine | Johns Hopkins University | NULL | Completed | 18 Years | 58 Years | All | 20 | Phase 1 | United States |
| 536 | NCT02665221 (ClinicalTrials.gov) | July 2015 | 22/1/2016 | Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY | Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size. | Multiple Sclerosis | Other: No Treatment Arm;Drug: Topical Preparation H arm | New York University School of Medicine | NULL | Terminated | 18 Years | 70 Years | All | 32 | Phase 4 | United States |
| 537 | 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 | |||
| 538 | EUCTR2014-002320-27-LT (EUCTR) | 09/06/2015 | 17/04/2015 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 539 | NCT02425644 (ClinicalTrials.gov) | June 4, 2015 | 21/4/2015 | Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis | Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: ponesimod;Drug: teriflunomide | Actelion | NULL | Completed | 18 Years | 55 Years | All | 1133 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic |
| 540 | EUCTR2014-005003-24-LV (EUCTR) | 01/06/2015 | 19/02/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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 Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Latvia;Germany;Kuwait | ||
| 541 | NCT02090348 (ClinicalTrials.gov) | June 2015 | 14/3/2014 | Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY) | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | NULL |
| 542 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Germany;Netherlands;Italy;United Kingdom | ||
| 543 | EUCTR2013-001025-53-ES (EUCTR) | 18/05/2015 | 03/03/2015 | A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate) | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule (TECNERGY) - TECNERGY | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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 (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera (BG00012) Product Name: Tecfidera 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 | 320 | Finland;Spain;Denmark;Norway;Netherlands;United Kingdom | |||
| 544 | 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 | ||
| 545 | 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 | ||
| 546 | NCT02323269 (ClinicalTrials.gov) | May 2015 | 18/12/2014 | Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve) | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve) | Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | N/A | Both | 24 | N/A | Canada |
| 547 | EUCTR2014-005548-17-FR (EUCTR) | 28/04/2015 | 03/06/2015 | TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY | TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY | PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR MedDRA version: 18.0;Level: PT;Classification code 10029864;Term: Nystagmus;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: NEURONTIN Product Name: Gabapentine Product Code: N03AX12 Other descriptive name: GABAPENTIN Trade Name: EBIXA Product Name: MEMANTINE Product Code: N06DX01 INN or Proposed INN: MEMANTINE | HOSPICES CIVILS DE LYON | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | France | |||
| 548 | EUCTR2013-001151-12-CZ (EUCTR) | 22/04/2015 | 19/09/2014 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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: 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 | 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;Saudi Arabia;Thailand;Spain;Russian Federation;Chile;Colombia;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;Martinique;Hong Kong;Taiwan | ||
| 549 | EUCTR2014-002320-27-ES (EUCTR) | 21/04/2015 | 09/02/2015 | 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 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. - Sunbeam | Relapsing Multiple Sclerosis MedDRA version: 18.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 550 | JPRN-UMIN000017217 | 2015/04/21 | 21/04/2015 | An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica | An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2 | Neuromyelitis optica | Rituximab intravenous infusion | Clinical Research Center, Utano National Hospital, National Hospital Organization | Zenyaku Kogyo Co., Ltd. | Complete: follow-up complete | 16years-old | 80years-old | Male and Female | 40 | Phase 2,3 | Japan |
| 551 | 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 |
| 552 | EUCTR2012-003735-32-SK (EUCTR) | 01/04/2015 | 09/04/2015 | Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: 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 | Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 553 | EUCTR2013-001151-12-DK (EUCTR) | 25/03/2015 | 11/02/2015 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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: 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;Hong Kong;Taiwan;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Singapore;Croatia;Romania;Germany;Japan;Sweden | ||
| 554 | 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 | ||
| 555 | EUCTR2014-002320-27-BG (EUCTR) | 19/03/2015 | 21/01/2015 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 556 | EUCTR2013-001025-53-DK (EUCTR) | 05/03/2015 | 24/03/2014 | A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate) | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule - TECNERGY | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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 (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera (BG00012) Product Name: Tecfidera 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 | 320 | Phase 4 | Finland;Spain;Denmark;Norway;Netherlands;United Kingdom | ||
| 557 | EUCTR2014-002320-27-PL (EUCTR) | 01/03/2015 | 27/01/2015 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 558 | NCT02097849 (ClinicalTrials.gov) | February 28, 2015 | 25/3/2014 | Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis. | An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis. | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate;Biological: tetanus diphtheria toxoids vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent);Drug: non-pegylated interferon | Biogen | NULL | Completed | 18 Years | 55 Years | All | 71 | Phase 2 | United States |
| 559 | NCT02343159 (ClinicalTrials.gov) | February 28, 2015 | 9/1/2015 | Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients. | A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients. | Multiple Sclerosis | Drug: dimethyl fumarate;Device: Medication Event Monitoring System (MEMS);Behavioral: Adherence counseling | Biogen | NULL | Terminated | 18 Years | 65 Years | All | 84 | Phase 4 | United States |
| 560 | 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 | ||
| 561 | EUCTR2013-004622-29-DE (EUCTR) | 23/02/2015 | 11/11/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) 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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 562 | 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 | ||
| 563 | EUCTR2014-002320-27-SE (EUCTR) | 12/02/2015 | 08/12/2014 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 564 | 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 | ||
| 565 | NCT02587715 (ClinicalTrials.gov) | February 2015 | 26/10/2015 | A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy | Novo Cellular Medicine Institute LLP | NULL | Recruiting | 18 Years | 60 Years | Both | 69 | Phase 1/Phase 2 | Trinidad and Tobago |
| 566 | NCT02587806 (ClinicalTrials.gov) | February 2015 | 26/10/2015 | A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy | Novo Cellular Medicine Institute LLP | NULL | Recruiting | 18 Years | 60 Years | Both | 69 | Phase 1/Phase 2 | India;Trinidad and Tobago |
| 567 | NCT02418325 (ClinicalTrials.gov) | February 2015 | 8/4/2015 | A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy | Genesis Limited | NULL | Terminated | 18 Years | 60 Years | Both | 69 | Phase 1/Phase 2 | Trinidad and Tobago |
| 568 | NCT02418351 (ClinicalTrials.gov) | February 2015 | 8/4/2015 | A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy | Genesis Limited | NULL | Terminated | 18 Years | 60 Years | Both | 69 | Phase 1/Phase 2 | India;Trinidad and Tobago |
| 569 | NCT02490046 (ClinicalTrials.gov) | February 2015 | 28/4/2015 | D-mannose for the Prevention of UTIs in Multiple Sclerosis | Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis | Multiple Sclerosis;Recurrent Urinary Tract Infections | Dietary Supplement: D Mannose | University College, London | UCLH | Recruiting | 18 Years | 65 Years | Both | 20 | Phase 1 | United Kingdom |
| 570 | NCT02308137 (ClinicalTrials.gov) | February 2015 | 2/12/2014 | Domperidone in Secondary Progressive Multiple Sclerosis (SPMS) | Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Domperidone 10mg QID for Reducing Progression of Disability in Patients With Secondary Progressive Multiple Sclerosis (SPMS) | Multiple Sclerosis, Secondary Progressive | Drug: Domperidone | University of Calgary | Alberta Innovates Health Solutions | Completed | 18 Years | 60 Years | All | 64 | Phase 2 | Canada |
| 571 | EUCTR2013-005586-39-DE (EUCTR) | 29/01/2015 | 02/09/2014 | Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other Therapies | A Phase 4 Multicenter, Open-Label, Single Arm Study toEvaluate Switching from BRACET/Gilenya® to Natalizumabin Subjects with Relapsing Forms of Multiple Sclerosis (MS) | Multiple Sclerosis (MS) 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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United States;Germany;Italy | ||
| 572 | EUCTR2013-004622-29-DK (EUCTR) | 29/01/2015 | 04/12/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 573 | EUCTR2014-002320-27-LV (EUCTR) | 23/01/2015 | 30/10/2014 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: 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 | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 574 | 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 |
| 575 | NCT02003144 (ClinicalTrials.gov) | January 2015 | 18/11/2013 | An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients | A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Biological: eculizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 119 | Phase 3 | United States;Argentina;Australia;Canada;Colombia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;France;Singapore |
| 576 | 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 | ||
| 577 | EUCTR2013-004622-29-SE (EUCTR) | 30/12/2014 | 29/09/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 578 | 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 | ||
| 579 | 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 | ||
| 580 | 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 | ||
| 581 | EUCTR2013-004622-29-ES (EUCTR) | 03/12/2014 | 03/10/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 582 | 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 |
| 583 | NCT02142192 (ClinicalTrials.gov) | December 2014 | 16/5/2014 | Natalizumab Subcutaneous Immunogenicity and Safety Study | A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Terminated | 18 Years | 65 Years | Both | 2 | Phase 2 | Belgium;Denmark;Germany;Italy |
| 584 | NCT02342704 (ClinicalTrials.gov) | November 30, 2014 | 15/1/2015 | Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Relapsing-Remitting Multiple Sclerosis | Drug: natalizumab;Drug: fingolimod | Biogen | NULL | Terminated | 18 Years | 60 Years | All | 111 | Phase 4 | United States;Australia;Czechia;France;Germany;Italy;Spain;Sweden;United Kingdom;Czech Republic;Denmark |
| 585 | 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 | ||
| 586 | EUCTR2014-000917-30-DE (EUCTR) | 25/11/2014 | 03/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;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: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Phase 2 | Belgium;Denmark;Germany;Italy | ||
| 587 | EUCTR2014-002320-27-PT (EUCTR) | 21/11/2014 | 08/10/2014 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Peru;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Serbia;Belarus;United States;Portugal | ||
| 588 | EUCTR2014-002320-27-EE (EUCTR) | 21/11/2014 | 08/10/2014 | 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 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. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: 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 | 1346 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 589 | EUCTR2011-005677-23-EE (EUCTR) | 21/11/2014 | 22/10/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | 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] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Not Recruiting | Female: yes Male: yes | 190 | 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;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 590 | EUCTR2013-004622-29-GB (EUCTR) | 20/11/2014 | 28/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) 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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 591 | EUCTR2013-002378-26-SE (EUCTR) | 13/11/2014 | 15/08/2013 | Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes | Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext | The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. 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] | Trade Name: Mabthera® Product Name: Mabthera | Västerbottens Läns Landsting | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 2 | Sweden | ||
| 592 | EUCTR2013-004622-29-IT (EUCTR) | 10/11/2014 | 05/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden | |||
| 593 | NCT02253264 (ClinicalTrials.gov) | November 2014 | 29/9/2014 | A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients | A Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal Enhancement | Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Drug: Rituximab | Johns Hopkins University | NULL | Completed | 18 Years | N/A | All | 8 | Phase 1 | United States |
| 594 | NCT02310048 (ClinicalTrials.gov) | November 2014 | 14/11/2014 | Comparative Oral Bioavailability Study of MT-1303 | A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male Subjects | Relapsing-remitting Multiple Sclerosis | Drug: MT-1303-FormA;Drug: MT-1303-FormB | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 18 Years | 55 Years | Male | 34 | Phase 1 | United Kingdom |
| 595 | EUCTR2013-004622-29-CZ (EUCTR) | 31/10/2014 | 13/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (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] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 596 | EUCTR2014-003669-97-BE (EUCTR) | 27/10/2014 | 02/09/2014 | A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA. | A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA. | Relapsing Forms of Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB | Biogen Idec | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 4 | Belgium | ||
| 597 | 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 | ||
| 598 | EUCTR2014-000917-30-BE (EUCTR) | 21/10/2014 | 24/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;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: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 599 | EUCTR2011-005677-23-RO (EUCTR) | 08/10/2014 | 30/05/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 600 | NCT02234869 (ClinicalTrials.gov) | October 2014 | 5/9/2014 | Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy | Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017) | Relapsing Multiple Sclerosis | Drug: Interferon Beta;Drug: BIIB017 (Peginterferon beta-1a) | Biogen Idec | NULL | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 4 | NULL |
| 601 | NCT02269930 (ClinicalTrials.gov) | October 2014 | 17/10/2014 | Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers | An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers | Multiple Sclerosis | Drug: peginterferon beta-1a;Drug: Rebif | Biogen Idec | NULL | Completed | 18 Years | 45 Years | Both | 30 | Phase 1 | United States |
| 602 | NCT02212886 (ClinicalTrials.gov) | October 2014 | 5/8/2014 | Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS | A Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: GA Depot 80 mg;Drug: GA Depot 40 mg | Mapi Pharma Ltd. | NULL | Active, not recruiting | 18 Years | 70 Years | All | 25 | Phase 1/Phase 2 | Israel |
| 603 | NCT02296346 (ClinicalTrials.gov) | October 2014 | 18/11/2014 | Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis | A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS) | Secondary Progressive Multiple Sclerosis | Drug: SoluMedrol;Device: Extracorporeal Photopheresis | University of Utah | Mallinckrodt | Terminated | 18 Years | 75 Years | All | 13 | N/A | United States |
| 604 | NCT02241785 (ClinicalTrials.gov) | September 30, 2014 | 12/9/2014 | Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies | A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS) | Relapsing Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Terminated | 18 Years | 60 Years | All | 47 | Phase 4 | United States;Germany |
| 605 | NCT02232061 (ClinicalTrials.gov) | September 29, 2014 | 2/9/2014 | Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod | Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 6 | Phase 4 | Belgium;Germany;Italy |
| 606 | 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 | United States;Serbia;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 | ||
| 607 | EUCTR2014-000917-30-DK (EUCTR) | 02/09/2014 | 10/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;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: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 608 | NCT02293967 (ClinicalTrials.gov) | September 2014 | 14/11/2014 | Mass Balance Study of MT-1303 | An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects. | Relapsing-remitting Multiple Sclerosis | Drug: MT-1303 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 30 Years | 65 Years | Male | 8 | Phase 1 | United Kingdom |
| 609 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom | ||
| 610 | NCT02283853 (ClinicalTrials.gov) | August 28, 2014 | 3/11/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Drug: Interferon ß-1a | Biogen | NULL | Active, not recruiting | 10 Years | 17 Years | All | 156 | Phase 3 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Kuwait;Poland;Serbia;Spain;Sweden;Turkey;United Kingdom;Argentina;Czech Republic;Romania |
| 611 | EUCTR2011-005677-23-NL (EUCTR) | 19/08/2014 | 25/02/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Estonia;Slovakia;Spain;Lithuania;Austria;United Kingdom;Italy;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Netherlands;Latvia;Germany;Sweden | ||
| 612 | 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 | ||
| 613 | EUCTR2011-005677-23-SE (EUCTR) | 07/08/2014 | 12/03/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| 614 | 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 |
| 615 | EUCTR2014-000917-30-IT (EUCTR) | 25/07/2014 | 07/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;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: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 616 | EUCTR2013-001151-12-AT (EUCTR) | 23/07/2014 | 14/02/2014 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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: 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;Taiwan;Hong Kong;Saudi Arabia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 617 | 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 | |||
| 618 | 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 |
| 619 | EUCTR2011-005677-23-GB (EUCTR) | 15/07/2014 | 12/03/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | 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;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 620 | EUCTR2013-002318-11-DK (EUCTR) | 14/07/2014 | 25/04/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects Withrelapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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 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 | 132 | Phase 3 | United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 621 | 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 | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria;France;Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;Italy | ||
| 622 | EUCTR2013-002318-11-CZ (EUCTR) | 10/07/2014 | 02/05/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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 Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden | ||
| 623 | EUCTR2013-002318-11-GB (EUCTR) | 08/07/2014 | 16/03/2015 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 624 | 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 | ||
| 625 | 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 | ||
| 626 | EUCTR2013-002318-11-BE (EUCTR) | 17/06/2014 | 17/03/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With relapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, with Optional Open-Label Extension - CONNECT | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden | ||
| 627 | EUCTR2013-001656-35-CZ (EUCTR) | 11/06/2014 | 26/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Belgium;Spain;Austria;Italy | ||
| 628 | EUCTR2013-001656-35-ES (EUCTR) | 06/06/2014 | 01/04/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera? (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Belgium;Spain;Austria;Italy | ||
| 629 | EUCTR2013-002318-11-SE (EUCTR) | 05/06/2014 | 14/03/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE 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 | 132 | Phase 3 | Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden | ||
| 630 | 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 |
| 631 | NCT02117050 (ClinicalTrials.gov) | June 2014 | 15/4/2014 | RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate | RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw) | Multiple Sclerosis | Drug: Rebif® | EMD Serono | NULL | Terminated | 18 Years | 65 Years | All | 1 | Phase 4 | United States |
| 632 | NCT02125604 (ClinicalTrials.gov) | June 2014 | 25/4/2014 | Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany | A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE) | Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 214 | Phase 4 | Germany |
| 633 | NCT02064816 (ClinicalTrials.gov) | May 31, 2014 | 13/2/2014 | A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis | Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif® | Merck KGaA, Darmstadt, Germany | NULL | Completed | 18 Years | 60 Years | All | 200 | Phase 4 | Germany |
| 634 | EUCTR2013-002318-11-HU (EUCTR) | 27/05/2014 | 08/04/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Sweden | ||
| 635 | EUCTR2013-002351-15-ES (EUCTR) | 26/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with 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: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;Portugal;Belarus;United States;United Arab Emirates;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Peru;Denmark;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 636 | EUCTR2013-001656-35-BE (EUCTR) | 26/05/2014 | 24/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 637 | 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 | 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 | ||
| 638 | EUCTR2013-002351-15-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis 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 Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;Egypt;United Kingdom;Austria;Lithuania;Turkey;Finland;Bosnia and Herzegovina;Tunisia;Latvia;Peru;Denmark;Jordan;France;Italy;Colombia;Russian Federation | ||
| 639 | EUCTR2013-002351-15-BG (EUCTR) | 21/05/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis 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 Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Interferon-ß-1a Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 640 | 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 | ||
| 641 | EUCTR2013-001151-12-FR (EUCTR) | 13/05/2014 | 25/09/2015 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 642 | EUCTR2013-002318-11-IT (EUCTR) | 13/05/2014 | 20/03/2014 | A study on the safety and effectiveness of BG00012 in children from 10 to less than 18 years old with a type of Multiple Sclerosis that is called Relapsing-Remitting Multiple Sclerosis. | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | France;Serbia;Hungary;Czech Republic;Belgium;Poland;Ukraine;Denmark;United Kingdom;Italy;Sweden | |||
| 643 | EUCTR2013-001656-35-SI (EUCTR) | 12/05/2014 | 09/05/2014 | A Study that evaluates effectiveness of Tecfidera™ (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Spain;Belgium;Austria;Italy | ||
| 644 | EUCTR2013-002351-15-PT (EUCTR) | 09/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis 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 Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Portugal;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 645 | EUCTR2013-001486-17-DE (EUCTR) | 06/05/2014 | 05/03/2014 | TOLERATE - A Study that evaluates the Gastrointestinal Tolerability of DMF in Multiple Sclerosis Patients | A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects with Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE) | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | Germany | ||||
| 646 | NCT02046629 (ClinicalTrials.gov) | May 2014 | 23/1/2014 | A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers | An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects | Multiple Sclerosis | Drug: Teriflunomide HMR1726;Drug: cholestyramine | Sanofi | NULL | Completed | 18 Years | 45 Years | Both | 12 | Phase 1 | China |
| 647 | EUCTR2013-001656-35-SK (EUCTR) | 28/04/2014 | 10/03/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 648 | EUCTR2013-001656-35-IT (EUCTR) | 14/04/2014 | 26/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Spain;Belgium;Austria;Italy | ||
| 649 | EUCTR2013-001656-35-PT (EUCTR) | 14/04/2014 | 25/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 650 | EUCTR2013-001656-35-HU (EUCTR) | 11/04/2014 | 21/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | Portugal;France;Czech Republic;Hungary;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 651 | EUCTR2013-001656-35-FR (EUCTR) | 07/04/2014 | 17/06/2015 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 652 | EUCTR2013-001656-35-AT (EUCTR) | 07/04/2014 | 18/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera 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 | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 653 | NCT04256252 (ClinicalTrials.gov) | April 2014 | 2/2/2020 | Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE) | Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial | Neuromyelitis Optica Spectrum Disorder | Drug: Rituximab | Tang-Du Hospital | NULL | Completed | 16 Years | 75 Years | All | 108 | Phase 4 | NULL |
| 654 | NCT02865018 (ClinicalTrials.gov) | April 2014 | 9/8/2016 | Neuromyelitis Optica (NMO) & Cetirizine | An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica | Neuromyelitis Optica | Drug: cetirizine | Icahn School of Medicine at Mount Sinai | Guthy Jackson Foundation | Completed | 18 Years | 85 Years | Both | 16 | Phase 1/Phase 2 | United States |
| 655 | 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 | ||
| 656 | EUCTR2013-002351-15-AT (EUCTR) | 13/03/2014 | 28/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis 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 Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 657 | EUCTR2013-002351-15-EE (EUCTR) | 13/03/2014 | 18/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis 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 Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 658 | EUCTR2013-002351-15-LV (EUCTR) | 03/03/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis 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 Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden;Turkey;Finland;Bosnia and Herzegovina;Tunisia;Latvia;Peru;Denmark;Jordan;France;Italy;Colombia;Russian Federation;Chile;Lebanon;Ukraine;Spain;Slovakia;Morocco;Estonia;Serbia;Belarus;Portugal;United Arab Emirates;United States | ||
| 659 | NCT02087813 (ClinicalTrials.gov) | March 2014 | 11/3/2014 | Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses | A Single Center Open Label Pilot Study of Alpha1-Antitrypsin: A Novel Treatment to Mitigate Neuromyelitis Optica Attacks | Neuromyelitis Optica | Drug: Alpha1-antitrypsin;Drug: methylprednisolone | Stanford University | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 660 | NCT01973491 (ClinicalTrials.gov) | February 28, 2014 | 23/10/2013 | ATX-MS-1467 in Multiple Sclerosis | An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and Its Effect on Immune Tolerance in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: ATX-MS-1467 | Merck KGaA | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 2 | Germany |
| 661 | 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 |
| 662 | 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 |
| 663 | EUCTR2013-001151-12-GB (EUCTR) | 18/02/2014 | 25/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Russian Federation;Colombia;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 664 | 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 |
| 665 | EUCTR2011-005677-23-AT (EUCTR) | 24/01/2014 | 19/12/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex Product Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Sweden;Germany;Bulgaria;Romania;Croatia;Poland;Brazil;Canada;Mexico;United Kingdom;Austria;Turkey;Lithuania;Netherlands | ||
| 666 | EUCTR2011-005677-23-PL (EUCTR) | 13/01/2014 | 20/11/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 667 | EUCTR2013-002082-19-NL (EUCTR) | 09/01/2014 | 17/10/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) 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 to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | 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) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 668 | EUCTR2013-002082-19-ES (EUCTR) | 02/01/2014 | 31/10/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) 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 to Interferon beta-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon beta-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | 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) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 669 | NCT01975298 (ClinicalTrials.gov) | January 2014 | 28/10/2013 | A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | Relapsing Remitting Multiple Sclerosis | Drug: Laquinimod;Drug: Avonex® | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Withdrawn | 18 Years | 55 Years | All | 0 | Phase 3 | Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom |
| 670 | EUCTR2011-005677-23-DE (EUCTR) | 16/12/2013 | 09/04/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 671 | EUCTR2013-002916-28-LV (EUCTR) | 12/12/2013 | 16/10/2013 | An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis | An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ATX-MS-1467 Product Code: MSC2358825A INN or Proposed INN: MSC2304479A INN or Proposed INN: MSC2304480A INN or Proposed INN: MSC2304481A INN or Proposed INN: MSC2304482A | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Russian Federation;Latvia | ||
| 672 | EUCTR2013-001151-12-DE (EUCTR) | 12/12/2013 | 02/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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: 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;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 673 | EUCTR2013-002082-19-FI (EUCTR) | 04/12/2013 | 15/10/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) 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 to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis 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: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 674 | EUCTR2013-002082-19-DK (EUCTR) | 03/12/2013 | 03/12/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) 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 to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | 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) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 675 | EUCTR2011-005677-23-BG (EUCTR) | 28/11/2013 | 15/11/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 676 | EUCTR2013-002082-19-BE (EUCTR) | 25/11/2013 | 13/09/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) 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 to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | 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] | 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 INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 677 | EUCTR2013-002082-19-SE (EUCTR) | 21/11/2013 | 13/09/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) 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 to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | 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] | 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 INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 678 | EUCTR2013-002082-19-GB (EUCTR) | 13/11/2013 | 06/11/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) 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 to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | 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) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden | ||
| 679 | NCT01939002 (ClinicalTrials.gov) | November 2013 | 23/8/2013 | Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017) | An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017 | Relapsing Multiple Sclerosis | Drug: BIIB017;Drug: naproxen | Biogen | NULL | Completed | 18 Years | 65 Years | All | 251 | Phase 3 | United States |
| 680 | 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 |
| 681 | NCT01930708 (ClinicalTrials.gov) | October 31, 2013 | 15/8/2013 | A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 1114 | Phase 4 | Austria;Belgium;Canada;Czechia;France;Hungary;Italy;Portugal;Slovakia;Slovenia;Spain;Czech Republic |
| 682 | EUCTR2012-003176-39-DK (EUCTR) | 30/10/2013 | 25/10/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden;Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada | ||
| 683 | EUCTR2013-001151-12-ES (EUCTR) | 17/10/2013 | 08/08/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden | ||
| 684 | NCT01863888 (ClinicalTrials.gov) | October 2013 | 23/5/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: teriflunomide HMR1726;Drug: cholestyramine;Drug: charcoal | Sanofi | NULL | Completed | 18 Years | 55 Years | Both | 70 | Phase 3 | Belgium;Germany;Netherlands |
| 685 | 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 | |||
| 686 | EUCTR2012-005324-16-NL (EUCTR) | 26/09/2013 | 03/05/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | 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 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Germany;Netherlands | |||
| 687 | EUCTR2013-001151-12-IT (EUCTR) | 17/09/2013 | 09/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Taiwan;Saudi Arabia;Hong Kong;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Singapore;Germany;Japan;Sweden | ||
| 688 | EUCTR2012-005324-16-BE (EUCTR) | 27/08/2013 | 17/04/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | 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 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Germany;Netherlands | |||
| 689 | 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 | ||
| 690 | EUCTR2012-005324-16-DE (EUCTR) | 05/08/2013 | 06/06/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | 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 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Netherlands;Germany | |||
| 691 | EUCTR2012-003176-39-IE (EUCTR) | 01/08/2013 | 11/04/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 692 | NCT01903291 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 333 | N/A | United States |
| 693 | 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 |
| 694 | EUCTR2012-003176-39-GB (EUCTR) | 31/07/2013 | 12/04/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 695 | 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 |
| 696 | EUCTR2012-003176-39-GR (EUCTR) | 14/07/2013 | 22/05/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| 697 | 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 | ||
| 698 | NCT01900093 (ClinicalTrials.gov) | July 2013 | 11/7/2013 | Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses | An Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous Methylprednisolone | Multiple Sclerosis | Drug: Acthar Gel | Aaron Miller | Mallinckrodt | Recruiting | 18 Years | 65 Years | All | 10 | N/A | United States |
| 699 | NCT01884935 (ClinicalTrials.gov) | July 2013 | 20/6/2013 | PK and PD Study of Natalizumab in Pediatric Subjects With RRMS | A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS) | Relapsing-Remitting Multiple Sclerosis | Biological: Natalizumab | Biogen | NULL | Completed | 10 Years | 17 Years | Both | 13 | Phase 1 | Italy |
| 700 | EUCTR2012-003176-39-FI (EUCTR) | 11/06/2013 | 14/05/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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 Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 701 | NCT01621269 (ClinicalTrials.gov) | June 2013 | 24/4/2012 | ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon | A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 4 | Germany |
| 702 | NCT01777412 (ClinicalTrials.gov) | June 2013 | 21/1/2013 | Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations | An Open-label Phase 1b Study of Avastin® (Bevacizumab) for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD). | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Bevacizumab | Johns Hopkins University | Genentech, Inc.;Guthy Jackson Charitable Foundation | Completed | 18 Years | 70 Years | All | 10 | Phase 1 | United States |
| 703 | NCT01874145 (ClinicalTrials.gov) | June 2013 | 6/6/2013 | Safety and Tolerability of Glatiramer Acetate | An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: GA 20 mg/mL;Drug: GA 40 mg/mL | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | All | 209 | Phase 3 | United States |
| 704 | 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 | ||
| 705 | EUCTR2012-003176-39-DE (EUCTR) | 31/05/2013 | 14/12/2012 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 706 | EUCTR2012-003176-39-FR (EUCTR) | 28/05/2013 | 20/06/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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 Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| 707 | EUCTR2012-003176-39-ES (EUCTR) | 24/05/2013 | 21/03/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 708 | 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 | ||
| 709 | EUCTR2012-002639-27-IT (EUCTR) | 21/05/2013 | 11/04/2013 | A phase II, multicentre study to evaluate the long-term safety and efficacyof MT-1303 in subjects with relapsing-remitting multiple sclerosis whohave completed the MT-1303-E04 study | A phase II, multicentre study to evaluate the long-term safety and efficacyof MT-1303 in subjects with relapsing-remitting multiple sclerosis whohave completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 [0.1] Product Code: MT-1303 Product Name: MT-1303 [0.2] Product Code: MT-1303 Product Name: MT-1303 [0.4] Product Code: MT-1303 | MITSUBISHI TANABE PHARMA CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Bulgaria;Germany;Latvia;Sweden;Bosnia and Herzegovina | ||
| 710 | EUCTR2012-002639-27-CZ (EUCTR) | 15/05/2013 | 28/02/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) 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 | United Kingdom;Hungary;Czech Republic;Canada;Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 711 | NCT01854359 (ClinicalTrials.gov) | May 11, 2013 | 11/5/2013 | Idebenone for Primary Progressive Multiple Sclerosis | Open Label Extension Trial of Idebenone for Primary Progressive Multiple Sclerosis | Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Idebenone | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Unknown status | 18 Years | N/A | All | 61 | Phase 1/Phase 2 | United States |
| 712 | EUCTR2011-005677-23-LT (EUCTR) | 10/05/2013 | 11/02/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | United States;Serbia;Belarus;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 713 | EUCTR2012-003176-39-SE (EUCTR) | 07/05/2013 | 14/03/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 714 | NCT01873417 (ClinicalTrials.gov) | May 2013 | 9/5/2013 | Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States | A Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release Capsules | Relapsing Forms of Multiple Sclerosis | Drug: BG00012 (DMF) | Biogen | NULL | Completed | 18 Years | N/A | All | 237 | Phase 4 | United States |
| 715 | EUCTR2012-002639-27-BG (EUCTR) | 30/04/2013 | 13/03/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) 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: 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 | ||
| 716 | EUCTR2011-005677-23-LV (EUCTR) | 29/04/2013 | 19/03/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase. | Relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | |||
| 717 | EUCTR2011-005677-23-ES (EUCTR) | 26/04/2013 | 09/04/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric 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] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Farmaceutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Brazil;Spain;Lithuania;Latvia | |||
| 718 | EUCTR2012-003176-39-HU (EUCTR) | 23/04/2013 | 28/02/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 719 | EUCTR2012-003176-39-PL (EUCTR) | 17/04/2013 | 04/03/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden;Serbia | ||
| 720 | EUCTR2012-003176-39-CZ (EUCTR) | 16/04/2013 | 07/02/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | 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] | Trade Name: Zinbryta Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 721 | 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 | |||
| 722 | EUCTR2012-005507-40-IT (EUCTR) | 15/04/2013 | 25/02/2013 | Study to provide access to fingolimod to Multiple Sclerosis patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug | An open-label, single arm study to provide access to fingolimod to MS patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug | 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: Gilenya Product Code: FTY720 INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD HYDROCHLORIDE | NOVARTIS FARMA S.p.A | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 723 | 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 | ||
| 724 | 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 | ||
| 725 | EUCTR2011-005677-23-IT (EUCTR) | 02/04/2013 | 11/02/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 15.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Farma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Spain;Brazil;Lithuania;Latvia;Italy | |||
| 726 | EUCTR2012-005082-13-IT (EUCTR) | 02/04/2013 | 18/02/2013 | A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis | A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric 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] | Trade Name: TYSABRI Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 1 | Italy | ||
| 727 | 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 |
| 728 | NCT01844232 (ClinicalTrials.gov) | April 2013 | 24/4/2013 | One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity | A One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With Spasticity | Multiple Sclerosis;Spasticity | Drug: arbaclofen | Osmotica Pharmaceutical US LLC | NULL | Completed | 18 Years | 70 Years | All | 150 | Phase 3 | United States;Russian Federation;Ukraine |
| 729 | EUCTR2011-005677-23-SK (EUCTR) | 27/03/2013 | 04/03/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase - PARADIGMS | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 730 | 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 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 731 | 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 | |||
| 732 | 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;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 733 | 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 | |||
| 734 | EUCTR2012-003176-39-IT (EUCTR) | 14/03/2013 | 11/01/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis WhoHave Completed 203MS301. | A Multicenter, Open-Label, Extension Study to Evaluate the Long TermSafety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have CompletedStudy 205MS301. - EXTEND | 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 Product Code: BIIB019 INN or Proposed INN: DACLIZUMAB Other descriptive name: Daclizumab HYP (DAC HYP | BIOGEN IDEC RESEARCH LTD | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Georgia;Germany;Sweden | ||
| 735 | EUCTR2012-002639-27-GB (EUCTR) | 11/03/2013 | 20/11/2012 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | 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 | ||
| 736 | 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 | ||
| 737 | EUCTR2012-002639-27-ES (EUCTR) | 27/02/2013 | 09/01/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 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] - 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 | ||
| 738 | 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 | ||
| 739 | 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 |
| 740 | EUCTR2012-002639-27-FI (EUCTR) | 19/02/2013 | 29/01/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) 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 | ||
| 741 | NCT01797965 (ClinicalTrials.gov) | February 15, 2013 | 15/2/2013 | Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: BIIB019 (Daclizumab) | Biogen | AbbVie | Terminated | 18 Years | N/A | All | 1501 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Czechia;Denmark;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;China;Czech Republic;Finland |
| 742 | EUCTR2012-000411-91-DE (EUCTR) | 13/02/2013 | 04/12/2012 | Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod | Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial - NKZellen-Version1.0 | relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya® Product Name: Gilenya® Product Code: Gilenya® INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | Charité - Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Germany | ||
| 743 | 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 | ||
| 744 | 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 | ||
| 745 | 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 | |||
| 746 | 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 | ||
| 747 | 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 | ||
| 748 | 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 | |||
| 749 | EUCTR2012-004847-61-GB (EUCTR) | 16/01/2013 | 18/12/2012 | INSPIRE: Raltegravir (Isentress) Pilot Study in Relapsing MS | A phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI - INSPIRE (Isentress Pilot Study in Relapsing MS) | 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: ISENTRESS Product Name: raltegravir INN or Proposed INN: lactose monohydrate | Queen Mary University of London | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom | ||
| 750 | 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 | ||
| 751 | 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 | ||
| 752 | 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 | ||
| 753 | 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 | |||
| 754 | EUCTR2012-002639-27-HU (EUCTR) | 10/01/2013 | 22/11/2012 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 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] - 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 | ||
| 755 | NCT01802931 (ClinicalTrials.gov) | January 7, 2013 | 4/1/2013 | GSK239512 DDI Study | An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK239512 | Multiple Sclerosis | Drug: GSK239512;Drug: ketoconazole | GlaxoSmithKline | NULL | Completed | 18 Years | 45 Years | Male | 22 | Phase 1 | Australia |
| 756 | 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 | ||
| 757 | 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 | ||
| 758 | 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 | ||
| 759 | NCT02249676 (ClinicalTrials.gov) | January 2013 | 15/9/2014 | Autologous Mesenchymal Stem Cells for the Treatment of Neuromyelitis Optica Spectrum Disorders | Autologous Mesenchymal Stem Cells for the Treatment of Progressive and Refractory Neuromyelitis Optica Spectrum Disorders: an Open-label Phase 2a Proof-of-concept Study | Devic's Syndrome;Devic's Neuromyelitis Optica;Devic Syndrome;Devic's Disease;Devic Disease | Biological: Autologous mesenchymal stem cells | Tianjin Medical University General Hospital | NULL | Completed | 18 Years | 80 Years | All | 15 | Phase 2 | China |
| 760 | 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 |
| 761 | 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 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 762 | 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 | 1653 | 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 |
| 763 | 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 | ||
| 764 | 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 | ||
| 765 | 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 | |||
| 766 | 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 | 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 | ||
| 767 | 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 | ||
| 768 | 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 | ||
| 769 | 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 | United States;Portugal;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;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 770 | 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 | ||
| 771 | 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 | ||
| 772 | 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 | United States;Portugal;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;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 773 | 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 | ||
| 774 | 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 | |||
| 775 | 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 | ||
| 776 | 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 | Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Argentina;Canada;Czech Republic;Hungary;United Kingdom;Austria;Lithuania;Turkey;China;Netherlands;Latvia;Australia;France;Italy;Switzerland;Russian Federation;Israel;Ireland;Spain;Greece;Slovakia;Estonia;Portugal;United States | ||
| 777 | 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 | |||
| 778 | 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 | |||
| 779 | 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 | ||
| 780 | 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 | ||
| 781 | 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 | |||
| 782 | NCT01767493 (ClinicalTrials.gov) | November 2012 | 13/12/2012 | Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients | An Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: [18F]Florbetapir PET imaging | Institute for Neurodegenerative Disorders | Biogen | Completed | 18 Years | 60 Years | All | 19 | Phase 4 | United States |
| 783 | NCT02137707 (ClinicalTrials.gov) | November 2012 | 12/5/2014 | Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya | An Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 Years | Multiple Sclerosis-Relapsing-Remitting | Drug: Gilenya | McGill University | Novartis | Completed | 18 Years | 65 Years | All | 135 | Phase 4 | Canada |
| 784 | 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 | ||
| 785 | 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 | ||
| 786 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| 787 | EUCTR2010-020315-36-CZ (EUCTR) | 18/10/2012 | 22/08/2012 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: 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 | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 788 | EUCTR2012-002637-11-DE (EUCTR) | 15/10/2012 | 09/10/2012 | A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis | A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis - STAY | Treatment statisfaction in patients with 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] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 789 | NCT01578330 (ClinicalTrials.gov) | October 2012 | 16/3/2012 | A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720 | A 12 -Month, Open-label, Multi-center Pilot Study to Explore the Health Outcomes of FTY720 in RRMS Patients Who Have Previously Been Treated With Other Disease Modifying Therapies (DMT)- Fine | Multiple Sclerosis;Relapsing-Remitting | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 42 | Phase 4 | Turkey |
| 790 | NCT01701856 (ClinicalTrials.gov) | September 2012 | 18/9/2012 | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b | Claudio Gobbi | Bayer | Terminated | 18 Years | 70 Years | Both | 5 | Phase 4 | Switzerland |
| 791 | EUCTR2010-024477-39-CZ (EUCTR) | 29/08/2012 | 24/04/2012 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | |||
| 792 | EUCTR2009-017978-21-PL (EUCTR) | 17/08/2012 | 06/03/2012 | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 793 | EUCTR2010-024477-39-GB (EUCTR) | 07/08/2012 | 20/03/2012 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | ||
| 794 | EUCTR2009-017978-21-PT (EUCTR) | 06/07/2012 | 11/08/2011 | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 795 | 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 |
| 796 | EUCTR2012-000653-32-DE (EUCTR) | 27/06/2012 | 12/04/2012 | A study to explore heart function during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis | A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START) - START | Conduction abnormalities in patients with 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: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 797 | NCT01623596 (ClinicalTrials.gov) | June 8, 2012 | 18/6/2012 | Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. | A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Disease Modifying therapy | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 881 | Phase 4 | United States;Puerto Rico |
| 798 | 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 | |||
| 799 | NCT01610310 (ClinicalTrials.gov) | June 2012 | 31/5/2012 | Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers | A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) Delivered by Pre-filled Syringe (PFS) or Autoinjector in Healthy Volunteers | Healthy;Multiple Sclerosis | Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS);Device: BIIB017 (peginterferon beta-1a) Autoinjector | Biogen Idec | NULL | Completed | 18 Years | 45 Years | Both | 55 | Phase 1 | United States |
| 800 | 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 | |||
| 801 | 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 | |||
| 802 | EUCTR2010-024477-39-GR (EUCTR) | 14/05/2012 | 18/04/2012 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | ||
| 803 | 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 | |||
| 804 | NCT02142205 (ClinicalTrials.gov) | May 2012 | 16/5/2014 | Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®). | Relapsing-Remitting Multiple Sclerosis | Biological: BG00002 | Biogen Idec | Biogen Idec International GmbH | Completed | 18 Years | 60 Years | Both | 100 | Phase 4 | Russian Federation |
| 805 | NCT01585298 (ClinicalTrials.gov) | April 29, 2012 | 23/4/2012 | STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) | A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: FTY720 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 6998 | Phase 4 | Germany |
| 806 | EUCTR2010-020337-99-NL (EUCTR) | 13/04/2012 | 19/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: ocrelizumab 300mg /10ml Product Code: RO4964913 F07 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 807 | 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 | |||
| 808 | EUCTR2010-020515-37-NO (EUCTR) | 22/03/2012 | 15/02/2011 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | 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 | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 809 | 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 |
| 810 | 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 | |
| 811 | EUCTR2011-006043-30-NL (EUCTR) | 27/02/2012 | 16/02/2012 | Study to evaluate the effect of oral BAF312 on a monophasic oral contraceptive in healthy female volunteers | An open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on the pharmacokinetices and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers - | healthy volunteers (Multiple sclerosis is the intended indication for BAF312) ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BAF312 0,25 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Product Name: BAF312 4 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Trade Name: Microgynon Product Name: Microgynon INN or Proposed INN: ETHINYLESTRADIOL Other descriptive name: LEVONORGESTREL | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: no | 24 | Netherlands | |||
| 812 | EUCTR2011-003507-38-IT (EUCTR) | 22/02/2012 | 02/03/2012 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Dailyon Quality of Life as Reported by Subjects with 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] | Trade Name: Fampyra INN or Proposed INN: FAMPRIDINE Other descriptive name: NA | BIOGEN IDEC RESEARCH LTD | NULL | Not Recruiting | Female: yes Male: yes | 800 | Portugal;Denmark;Australia;Netherlands;United Kingdom;Italy | |||
| 813 | NCT01485003 (ClinicalTrials.gov) | February 7, 2012 | 1/12/2011 | Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants | A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients | Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 231 | United States | |
| 814 | EUCTR2011-003507-38-PT (EUCTR) | 03/02/2012 | 28/11/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | 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 | 800 | France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 815 | NCT01497262 (ClinicalTrials.gov) | February 2012 | 5/12/2011 | Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 162 | Phase 3 | Argentina;Brazil;Colombia;Jordan;Malaysia;Mexico;Panama;Peru;Costa Rica |
| 816 | NCT01480076 (ClinicalTrials.gov) | February 2012 | 23/11/2011 | Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine | Biogen | NULL | Completed | 18 Years | 75 Years | All | 901 | Phase 4 | Australia;Belgium;Denmark;France;Germany;Italy;Netherlands;Portugal;United Kingdom;United States |
| 817 | NCT01433250 (ClinicalTrials.gov) | February 2012 | 26/8/2011 | A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis | An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: AIN457 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 39 | Phase 2 | Czech Republic;Russian Federation;Ukraine |
| 818 | 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 | |||
| 819 | EUCTR2011-003507-38-BE (EUCTR) | 23/01/2012 | 04/11/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis | 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 | 800 | Phase 4 | France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 820 | EUCTR2009-017978-21-GR (EUCTR) | 17/01/2012 | 08/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 821 | EUCTR2011-001629-25-CZ (EUCTR) | 10/01/2012 | 11/10/2011 | A clinical extension study to evaluate the safety, tolerability and efficacy of AIN457 in multiple sclerosis patients with relapses | An open label extension study to evaluate the safety, tolerability and efficacy of AIN457 in patients 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: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: rhumAb to IL-17A igG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Czech Republic;Ukraine;Russian Federation | |||
| 822 | 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 | |||
| 823 | 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 | ||
| 824 | EUCTR2011-003507-38-GB (EUCTR) | 06/01/2012 | 20/10/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | 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 | 800 | Phase 4 | United Kingdom;Sweden;France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy | ||
| 825 | EUCTR2011-003507-38-NL (EUCTR) | 05/01/2012 | 07/11/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | 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 | 800 | France;Portugal;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 826 | EUCTR2011-003507-38-DK (EUCTR) | 05/01/2012 | 05/12/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | 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 | 800 | France;Portugal;Belgium;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 827 | EUCTR2010-023023-19-DE (EUCTR) | 04/01/2012 | 18/11/2011 | Studyto compare the efficacy and safety of fingolimod and interferon-beta-1b in patients with mutliple sclerosis | A 18-month, open-label, rater-blinded, randomized, multicenter, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod in comparison to interferon beta 1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy | treating of cognitive symptoms in 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: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Other descriptive name: INTERFERON BETA-1B Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Product Name: Extavia Product Code: NVF233 Other descriptive name: INTERFERON BETA-1B | Novartis Farma S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | Germany;Italy | ||||
| 828 | NCT01535664 (ClinicalTrials.gov) | January 2012 | 7/2/2012 | An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS) | An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS | Multiple Sclerosis | Other: Withdrawal of dalfampridine-ER 10mg | Acorda Therapeutics | Prometrika, LLC;BCS Consulting, Inc. | Completed | 18 Years | 70 Years | All | 20 | United States | |
| 829 | NCT01534182 (ClinicalTrials.gov) | January 2012 | 8/2/2012 | Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 298 | Phase 4 | Russian Federation |
| 830 | NCT01498887 (ClinicalTrials.gov) | December 24, 2011 | 19/12/2011 | Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy | A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod (FTY720) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | All | 347 | Phase 4 | Australia;Spain |
| 831 | 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 | |||
| 832 | 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 | Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden;Ireland;Spain;Finland;United States | ||
| 833 | 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 |
| 834 | EUCTR2010-020315-36-BG (EUCTR) | 28/11/2011 | 19/08/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: 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 | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 835 | 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 | ||
| 836 | 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 | ||
| 837 | EUCTR2010-024477-39-BG (EUCTR) | 16/11/2011 | 20/09/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | ||
| 838 | EUCTR2010-020315-36-BE (EUCTR) | 14/11/2011 | 30/06/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 839 | EUCTR2010-020315-36-IE (EUCTR) | 04/11/2011 | 08/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 840 | NCT01436643 (ClinicalTrials.gov) | November 2011 | 16/9/2011 | Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression | A 21-week, Multicenter, Open Label Study to Evaluate the Safety and Tolerability Profile of the Combination of a SSRI or SNRI Antidepressive Therapy With Oral Fingolimod in the Treatment of RRMS Patients With Mild to Moderate Depression | Depression;Relapsing-remitting Multiple Sclerosis | Drug: Venlafaxine;Drug: Fluoxetine;Drug: Citalopram;Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 54 | Phase 4 | Germany |
| 841 | NCT01462318 (ClinicalTrials.gov) | November 2011 | 14/7/2011 | An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis | A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Midazolam;Other: Caffeine;Drug: S-warfarin;Other: Vitamin K;Drug: Omeprazole;Drug: Dextromethorphan;Biological: BIIB019 (Daclizumab) | Biogen | NULL | Completed | 18 Years | 65 Years | All | 133 | Phase 3 | United States;Czech Republic;Hungary;Poland;Russian Federation |
| 842 | EUCTR2011-003484-30-ES (EUCTR) | 26/10/2011 | 12/04/2012 | A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. | A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. - Earlims | Multiple Sclerosis relapsing-remitting course;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya INN or Proposed INN: Fingolimod | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 432 | Phase 3 | Spain;Australia | ||
| 843 | EUCTR2010-020337-99-PL (EUCTR) | 25/10/2011 | 13/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand | ||
| 844 | 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 | |||
| 845 | EUCTR2010-020315-36-GB (EUCTR) | 20/10/2011 | 16/08/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: 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 | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 846 | EUCTR2010-020337-99-GB (EUCTR) | 20/10/2011 | 05/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 847 | EUCTR2010-020315-36-SK (EUCTR) | 18/10/2011 | 28/06/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: 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 | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Belarus;United States;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 848 | EUCTR2010-020315-36-ES (EUCTR) | 18/10/2011 | 21/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Croatia;United States;Bosnia and Herzegovina;Spain;Argentina;Mexico;Belgium;Belarus;Peru;Canada;Ukraine;Russian Federation;United Kingdom;Brazil;Sweden;Italy;Ireland;Turkey;Colombia | |||
| 849 | 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 | |||
| 850 | EUCTR2010-023856-97-CZ (EUCTR) | 13/10/2011 | 09/08/2011 | Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe | A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE | 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: Daclizumab HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Hungary;Czech Republic;Poland | |||
| 851 | EUCTR2010-023856-97-PL (EUCTR) | 12/10/2011 | 26/08/2011 | Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe | A Multicenter, Single-Arm, Open-Label, Study to Evaluatethe Immunogenicity and Pharmacokinetics of BIIB019,Daclizumab High Yield Process (DAC HYP), PrefilledSyringe Administered by Subcutaneous Injection inSubjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE | Relapsing-remitting Multiple Sclerosis 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: Daclizumab HYP Product Code: BIIB019 INN or Proposed INN: - Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Hungary;Czech Republic;Poland;Russian Federation | |||
| 852 | EUCTR2010-020315-36-FR (EUCTR) | 07/10/2011 | 02/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 853 | 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 |
| 854 | EUCTR2010-024477-39-EE (EUCTR) | 29/09/2011 | 26/09/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | |||
| 855 | 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 | |||
| 856 | EUCTR2010-023856-97-HU (EUCTR) | 22/09/2011 | 15/07/2011 | Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe | A Multicenter, Single-Arm, Open-Label, Study to Evaluatethe Immunogenicity and Pharmacokinetics of BIIB019,Daclizumab High Yield Process (DAC HYP), PrefilledSyringe Administered by Subcutaneous Injection inSubjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE | 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 Product Code: BIIB019 Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Czech Republic;Hungary;Poland;Russian Federation | |||
| 857 | EUCTR2010-020315-36-DE (EUCTR) | 22/09/2011 | 08/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: 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 | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 858 | EUCTR2010-024477-39-DE (EUCTR) | 22/09/2011 | 21/06/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | ||
| 859 | EUCTR2010-020337-99-ES (EUCTR) | 21/09/2011 | 20/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;Serbia;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain | |||
| 860 | 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 | |||
| 861 | 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 | |||
| 862 | EUCTR2009-017978-21-DK (EUCTR) | 21/09/2011 | 12/09/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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 tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | 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;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 863 | 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 | Active, not recruiting | 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 |
| 864 | EUCTR2010-020337-99-IT (EUCTR) | 19/09/2011 | 29/03/2012 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a inPatients With Relapsing Multiple Sclerosis. | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study ToEvaluate The Efficacy And Safety Of Ocrelizumab In Comparison ToInterferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA I | Relapsing 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: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: OCRELIZUMAB Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA | ROCHE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain | |||
| 865 | 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 | ||
| 866 | EUCTR2010-024477-39-BE (EUCTR) | 19/09/2011 | 20/06/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | |||
| 867 | 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 |
| 868 | 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 | ||
| 869 | EUCTR2010-020337-99-DE (EUCTR) | 05/09/2011 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 870 | EUCTR2011-001442-15-ES (EUCTR) | 01/09/2011 | 07/07/2011 | Estudio para evaluar el control de la enfermedad y la seguridad en pacientes con esclerosis múltiple remitente recurrente que que cambian el tratamiento previo con natalizumab por fingolimod. | Estudio multicéntrico, aleatorizado, con enmascaramiento para el paciente y para el evaluador, de grupos paralelos, de 32 semanas de seguimiento, para evaluar el control de la enfermedad y la seguridad en pacientes con esclerosis múltiple remitente recurrente que cambian el tratamiento previo con natalizumab por fingolimod (FTY720) | Escelrosis Múltiple Remitente Recurrente 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: Fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: Hidrocloruro de fingolimod | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Germany;Switzerland;France;Italy;Austria;Sweden;Israel;Finland;United Kingdom;Czech Republic;Spain;Greece | |||
| 871 | NCT01450124 (ClinicalTrials.gov) | September 2011 | 18/9/2011 | Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) | Safety, Tolerability And Mechanism Of Action Of Boswellic Acids In Multiple Sclerosis and Clinically Isolated Syndrome: A MRI-Controlled, Multicenter, Baseline-To-Treatment, 32-Weeks, Open-Label, Phase IIa Trial | Relapsing Remitting Multiple Sclerosis | Drug: Boswellic acids (BOSWELAN) | Universitätsklinikum Hamburg-Eppendorf | NULL | Completed | 18 Years | 65 Years | All | 29 | Phase 2 | Germany |
| 872 | NCT01360489 (ClinicalTrials.gov) | September 2011 | 23/5/2011 | Arbaclofen Placarbil for the Treatment of Spasticity in Subjects With Multiple Sclerosis (MS) | An Open Label, 26-Week Study Assessing Arbaclofen Placarbil Safety and Efficacy in Subjects With Spasticity Associated With Multiple Sclerosis With an Addendum Open-Label, 36-Week Study Assessing Arbaclofen Placarbil Safety in Subjects With Spasticity Associated With Multiple Sclerosis | Multiple Sclerosis | Drug: arbaclofen placarbil | XenoPort, Inc. | NULL | Completed | 18 Years | 70 Years | Both | 218 | Phase 3 | United States |
| 873 | EUCTR2010-020315-36-SE (EUCTR) | 31/08/2011 | 05/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA II | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: 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 | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 874 | 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 | Active, not recruiting | 18 Years | 55 Years | All | 821 | Phase 3 | Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;United States;Czech Republic;Morocco;New Zealand;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France |
| 875 | EUCTR2010-024477-39-ES (EUCTR) | 22/08/2011 | 28/06/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | Relapsing Multiple Sclerosis MedDRA version: 14.0;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: Interferon Beta 1a pegilado Product Code: BIIB017 INN or Proposed INN: Interferón beta 1a Other descriptive name: Interferón beta 1a pegilado | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | United States;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 876 | 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 | |||
| 877 | 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 | |||
| 878 | NCT01420055 (ClinicalTrials.gov) | August 2011 | 17/8/2011 | Fingolimod -Response According to Coping - Evaluation | A 4-month, Prospective, Open-label, Multi-center Phase IV Study to Assess Response to Fingolimod Initiation According to Coping Profile in Adult Patients With Highly Active Relapsing Remitting Multiple Sclerosis in France | Multiple Sclerosis, Relapsing-Remitting | Drug: fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | Both | 189 | Phase 4 | France |
| 879 | 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 | ||
| 880 | EUCTR2009-017978-21-LT (EUCTR) | 25/07/2011 | 30/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 881 | 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 | ||
| 882 | EUCTR2009-017978-21-ES (EUCTR) | 13/07/2011 | 17/11/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina. 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 tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | 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;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 883 | EUCTR2009-017978-21-BE (EUCTR) | 12/07/2011 | 29/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | 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;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 884 | EUCTR2008-005008-24-GB (EUCTR) | 07/07/2011 | 19/05/2011 | Worms for immune regulation of multiple sclerosis - MS and hookworm | Worms for immune regulation of multiple sclerosis - MS and hookworm | Relapsing Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Necator americanus Other descriptive name: Live Necator americanus larvae | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 885 | EUCTR2010-020337-99-SK (EUCTR) | 23/06/2011 | 14/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 886 | EUCTR2011-001280-49-FR (EUCTR) | 14/06/2011 | 14/04/2011 | « GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude clinique menée dans plusieurs centres français, d'une durée de 4 mois, visant à comparer la réponse à l'initiation du traitement par fingolimod (Gilenya®) selon le profil d'anxiété chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active. | « GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude multicentrique de phase IV, prospective, en ouvert, d'une durée de 4 mois, visant à comparer la réponse à l’initiation du fingolimod (Gilenya®) selon le profil de « coping » chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active en France. - GRACE | Sclérose en plaques rémittente-récurrente active 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] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma S.A.S | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | France | ||
| 887 | EUCTR2009-015318-23-DE (EUCTR) | 09/06/2011 | 08/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | 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: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 888 | EUCTR2009-017978-21-SE (EUCTR) | 08/06/2011 | 03/05/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 889 | 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 | ||
| 890 | EUCTR2009-017978-21-FI (EUCTR) | 07/06/2011 | 28/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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 tablets INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | 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;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 891 | EUCTR2009-017978-21-CZ (EUCTR) | 06/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 892 | 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 | ||
| 893 | EUCTR2009-017978-21-GB (EUCTR) | 03/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 894 | 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 | ||
| 895 | EUCTR2009-017978-21-IT (EUCTR) | 16/05/2011 | 05/01/2012 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE). - PREMIERE | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;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: Cladribine Tablet INN or Proposed INN: CLADRIBINE Other descriptive name: 2-CdA, 2-chloro-2'-deoxy-ß-D-adenosine | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Portugal;United Arab Emirates;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;India;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United States Minor Outlying Islands;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 896 | 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 | ||
| 897 | 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 | ||
| 898 | EUCTR2010-024477-39-LV (EUCTR) | 06/05/2011 | 21/03/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | 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: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Intereron Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand | |||
| 899 | EUCTR2009-017978-21-LV (EUCTR) | 06/05/2011 | 18/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | 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;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 900 | EUCTR2009-017978-21-AT (EUCTR) | 05/05/2011 | 31/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 901 | NCT01333501 (ClinicalTrials.gov) | May 2011 | 8/4/2011 | Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms | A 18-month, Open-label, Rater-blinded, Randomized, Multi-center, Active-controlled, Parallel-group Pilot Study to Assess Efficacy and Safety of Fingolimod in Comparison to Interferon Beta 1b in Treating the Cognitive Symptoms Associated to Relapsing-remitting Multiple Sclerosis and to Assess Possible Relationship of These Effects to Regional Brain Atrophy | Multiple Sclerosis | Drug: Fingolimod;Drug: Interferon beta 1b | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | All | 151 | Phase 4 | Germany;Italy |
| 902 | NCT01317004 (ClinicalTrials.gov) | May 2011 | 15/3/2011 | Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Standard MS DMT | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 61 | Phase 4 | Italy |
| 903 | 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 | ||
| 904 | EUCTR2009-017978-21-EE (EUCTR) | 21/04/2011 | 13/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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 tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | 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;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 905 | EUCTR2011-000770-60-IT (EUCTR) | 12/04/2011 | 01/09/2011 | An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND | An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND | approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed. MedDRA version: 14.0;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: fingolimod Product Code: FTY720D INN or Proposed INN: other nervous system drugs | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Italy | |||
| 906 | 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 | ||
| 907 | NCT01332019 (ClinicalTrials.gov) | April 2011 | 24/3/2011 | Long-Term Safety and Efficacy Study of Peginterferon Beta-1a | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: peginterferon beta-1a | Biogen | NULL | Completed | 18 Years | 65 Years | All | 1077 | 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 |
| 908 | EUCTR2010-023560-40-SE (EUCTR) | 23/03/2011 | 21/12/2010 | Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed. | Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST | 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 | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol | Uppsala l?ns landsting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United States;Canada;Brazil;Sweden | |||
| 909 | EUCTR2010-024017-31-IT (EUCTR) | 15/03/2011 | 08/02/2011 | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: FINGOLIMOD Product Code: FTY720D Trade Name: EXTAVIA INN or Proposed INN: Interferon beta-1b Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 910 | 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 | ||
| 911 | EUCTR2010-020337-99-BG (EUCTR) | 07/03/2011 | 17/12/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 912 | 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 |
| 913 | 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 | ||
| 914 | EUCTR2010-020337-99-BE (EUCTR) | 23/02/2011 | 12/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 915 | EUCTR2010-023021-38-SE (EUCTR) | 23/02/2011 | 26/11/2010 | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB | Västerbottens läns landsting | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 916 | EUCTR2010-020337-99-CZ (EUCTR) | 21/02/2011 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 917 | 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 | |||
| 918 | EUCTR2010-020515-37-DK (EUCTR) | 14/02/2011 | 03/01/2011 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. - | Relapsing multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | 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 | 5000 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Denmark;Estonia;Spain;Greece | ||||
| 919 | EUCTR2009-017978-21-BG (EUCTR) | 08/02/2011 | 11/09/2015 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 920 | EUCTR2010-020337-99-PT (EUCTR) | 04/02/2011 | 29/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Portugal;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 921 | 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 |
| 922 | NCT01310166 (ClinicalTrials.gov) | February 2011 | 24/2/2011 | Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | Both | 447 | Phase 4 | Germany |
| 923 | 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 | ||
| 924 | EUCTR2010-019029-32-SK (EUCTR) | 27/01/2011 | 12/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 925 | 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 | ||
| 926 | 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 | 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 | ||
| 927 | EUCTR2010-020337-99-AT (EUCTR) | 20/01/2011 | 18/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 928 | 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 | ||
| 929 | EUCTR2010-022066-28-DE (EUCTR) | 18/01/2011 | 29/09/2010 | A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis | A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients 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] | Trade Name: Gilenya Product Name: Gilenya Other descriptive name: Fingolimod | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 3 | Germany | ||
| 930 | EUCTR2010-020337-99-LT (EUCTR) | 17/01/2011 | 27/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 931 | 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 | Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Lithuania;Finland;Czechia;Netherlands;Denmark;Australia;Peru;France;Italy;Switzerland;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Portugal;United States | ||
| 932 | 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 | ||
| 933 | EUCTR2010-020515-37-IE (EUCTR) | 04/01/2011 | 13/10/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 18.0;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: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 934 | EUCTR2010-020515-37-CZ (EUCTR) | 03/01/2011 | 27/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Romania;Norway;Germany;Sweden;Poland;Belgium;Brazil | ||
| 935 | EUCTR2010-020337-99-LV (EUCTR) | 29/12/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 936 | 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 | ||
| 937 | EUCTR2010-023023-19-IT (EUCTR) | 28/12/2010 | 19/11/2010 | A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - ND | A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - ND | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: FINGOLIMOD Product Code: FTY720D Trade Name: EXTAVIA INN or Proposed INN: Interferon beta-1b | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | Germany;Italy | ||||
| 938 | NCT01466322 (ClinicalTrials.gov) | December 22, 2010 | 3/11/2011 | A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers. | An Open-label, Randomised, Crossover Study to Assess the Relative Bioavailability of Different 2mg Formulations of GSK2018682(S1P1 Agonist) in Healthy Volunteers | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | Australia |
| 939 | 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 | ||
| 940 | EUCTR2009-017978-21-DE (EUCTR) | 20/12/2010 | 22/11/2010 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials 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: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 941 | EUCTR2010-020515-37-BE (EUCTR) | 17/12/2010 | 28/10/2010 | Long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily 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: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Greece;Spain;Costa Rica;Ireland;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;Sweden | ||
| 942 | 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 | ||
| 943 | EUCTR2010-020337-99-FI (EUCTR) | 15/12/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing 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: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 944 | 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 | ||
| 945 | 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 | ||
| 946 | EUCTR2010-020515-37-NL (EUCTR) | 01/12/2010 | 12/10/2010 | long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with 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;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 | 5000 | Phase 3 | United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Portugal;Comoros;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria | ||
| 947 | NCT01235221 (ClinicalTrials.gov) | December 2010 | 4/11/2010 | Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials. | Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials | Multiple Sclerosis | Drug: BIIB041 (Fampridine-SR) | Biogen Idec | Acorda Therapeutics | Completed | 18 Years | 70 Years | Both | 38 | Phase 3 | Canada |
| 948 | NCT01318421 (ClinicalTrials.gov) | December 2010 | 8/3/2011 | A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: ELND002 | Elan Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | Both | 12 | Phase 1 | NULL |
| 949 | EUCTR2010-020337-99-EE (EUCTR) | 26/11/2010 | 27/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing 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: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 950 | EUCTR2009-012989-30-AT (EUCTR) | 25/11/2010 | 14/12/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 951 | EUCTR2010-020515-37-FR (EUCTR) | 19/11/2010 | 06/09/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | 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 | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 952 | 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 | ||
| 953 | EUCTR2010-020337-99-HU (EUCTR) | 17/11/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients 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 - OPERA I | Relapsing Multiple Sclerosis 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 Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Portugal;United States;Serbia;Estonia;Morocco;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | |||
| 954 | 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 | ||
| 955 | 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 |
| 956 | EUCTR2010-020515-37-IT (EUCTR) | 25/10/2010 | 14/09/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND | MS (MULTIPLE SCLEROSIS) MedDRA version: 9.1;Level: LLT;Classification code 10048393 | Product Name: fingolimod Product Code: FTY720D | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 957 | EUCTR2010-020515-37-AT (EUCTR) | 21/10/2010 | 15/09/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | 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] | 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 | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 958 | 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 | ||
| 959 | EUCTR2010-020515-37-ES (EUCTR) | 20/10/2010 | 02/08/2010 | Estudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltiple | Estudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltiple | Esclerosis Múltiple Remitente Recurrente MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | 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 | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 960 | EUCTR2010-018705-11-ES (EUCTR) | 20/10/2010 | 27/07/2010 | ESTUDIO DE EXTENSIÓN DE 26 SEMANAS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A 26-WEEK SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS. | ESTUDIO DE EXTENSIÓN DE 26 SEMANAS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A 26-WEEK SAFETY AND EFFICACY EXTENSION STUDY 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 | 338 | Czech Republic;Greece;Belgium;Spain;Germany | |||
| 961 | EUCTR2010-020515-37-SK (EUCTR) | 18/10/2010 | 03/08/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | 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 | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 962 | EUCTR2009-015815-42-LT (EUCTR) | 11/10/2010 | 09/08/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 963 | EUCTR2010-020515-37-PT (EUCTR) | 11/10/2010 | 23/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | 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: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 964 | EUCTR2010-019029-32-BE (EUCTR) | 08/10/2010 | 03/08/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 2 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 965 | EUCTR2010-020515-37-EE (EUCTR) | 08/10/2010 | 09/09/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis (LONGTERMS). | 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] | 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 | 5000 | Phase 3 | Ireland;Portugal;United States;Estonia;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 966 | EUCTR2008-004753-14-BG (EUCTR) | 07/10/2010 | 11/06/2010 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 967 | EUCTR2010-020515-37-GR (EUCTR) | 05/10/2010 | 04/10/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | 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 | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 968 | NCT01416155 (ClinicalTrials.gov) | October 2010 | 24/3/2011 | Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis | A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 97 | Phase 2 | Japan;China |
| 969 | 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 |
| 970 | EUCTR2010-020515-37-HU (EUCTR) | 30/09/2010 | 11/08/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 971 | EUCTR2010-020515-37-SE (EUCTR) | 27/09/2010 | 24/08/2010 | Long-term safety, tolerability and efficacy study of 0.5 mg fingolimodonce daily in patients with multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis. | Multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 972 | EUCTR2010-020515-37-GB (EUCTR) | 27/09/2010 | 17/08/2010 | Long-term safety and tolerability of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | 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] | 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 | 5000 | 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;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 973 | EUCTR2010-020515-37-DE (EUCTR) | 13/09/2010 | 09/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | 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] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 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 | 5000 | 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;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 974 | NCT01201356 (ClinicalTrials.gov) | September 13, 2010 | 10/9/2010 | Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis | A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 4125 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;Egypt;Estonia;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Jordan;Korea, Republic of;Malaysia;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom;Costa Rica;Czech Republic |
| 975 | EUCTR2010-019029-32-CZ (EUCTR) | 02/09/2010 | 08/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Hungary;Denmark;Germany;Netherlands;Sweden | |||
| 976 | JPRN-JapicCTI-101335 | 01/9/2010 | 08/11/2010 | An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain | An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain) | Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain | Intervention name : pregabalin INN of the intervention : pregabalin Dosage And administration of the intervention : pregabalin capsules 150mg/day, 300mg/day, 450mg/day or 600mg/day BID Control intervention name : null | Pfizer Japan Inc. | NULL | 18 | BOTH | 100 | Phase 3 | NULL | ||
| 977 | NCT01202227 (ClinicalTrials.gov) | September 2010 | 31/8/2010 | An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain | An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain) | Spinal Cord Diseases;Spinal Cord Injuries;Neuralgia;Pain | Drug: pregabalin | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 104 | Phase 3 | Japan |
| 978 | EUCTR2009-015318-23-HU (EUCTR) | 31/08/2010 | 14/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | 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: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Czech Republic;Hungary;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 979 | EUCTR2010-020515-37-FI (EUCTR) | 06/08/2010 | 24/06/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | 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] | 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 | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 980 | EUCTR2010-019029-32-NL (EUCTR) | 05/08/2010 | 07/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 981 | EUCTR2010-019029-32-DK (EUCTR) | 02/08/2010 | 25/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 982 | NCT01216072 (ClinicalTrials.gov) | August 2010 | 7/9/2010 | A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC) | Relapsing Forms of Multiple Sclerosis | Drug: Fingolimod;Drug: Standard MS DMTs | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 1053 | Phase 4 | United States;Canada;Puerto Rico |
| 983 | NCT01191996 (ClinicalTrials.gov) | August 2010 | 30/8/2010 | Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis | A Phase 2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered MIS416 in Patients With Chronic Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Biological: MIS416 | Innate Immunotherapeutics | Primorus Clinical Trials;National Multiple Sclerosis Society | Completed | 18 Years | N/A | Both | 34 | Phase 1/Phase 2 | New Zealand |
| 984 | EUCTR2010-019029-32-AT (EUCTR) | 28/07/2010 | 08/06/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Greece;Spain;Denmark;Czech Republic;Slovakia;United Kingdom;Finland;Sweden;Austria;Italy;Ireland;Netherlands;Germany;Portugal;Hungary | |||
| 985 | 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 | ||||
| 986 | 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 | |||
| 987 | EUCTR2010-019029-32-HU (EUCTR) | 21/07/2010 | 31/03/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1850 | Italy;Austria;Hungary;Portugal;Germany;Netherlands;Sweden;Ireland;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 988 | EUCTR2009-009503-19-BE (EUCTR) | 20/07/2010 | 12/05/2009 | A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER | A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: Natalizumab | Biogen Idec International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Belgium | ||
| 989 | EUCTR2010-019029-32-GR (EUCTR) | 19/07/2010 | 14/07/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 2 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 990 | EUCTR2010-019029-32-IE (EUCTR) | 19/07/2010 | 18/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1850 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 991 | EUCTR2009-015815-42-CZ (EUCTR) | 12/07/2010 | 12/05/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 992 | EUCTR2010-019029-32-SE (EUCTR) | 12/07/2010 | 25/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 993 | EUCTR2009-015815-42-PL (EUCTR) | 08/07/2010 | 17/05/2010 | An extended clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-302 (BRAVO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 994 | EUCTR2010-019029-32-FI (EUCTR) | 07/07/2010 | 28/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 995 | EUCTR2009-015815-42-SK (EUCTR) | 06/07/2010 | 17/05/2010 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 9.1;Level: PT;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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1245 | Phase 3 | Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 996 | NCT01167426 (ClinicalTrials.gov) | July 2010 | 20/7/2010 | Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients | An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method. | Multiple Sclerosis | Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | N/A | All | 148 | Phase 3 | United States |
| 997 | EUCTR2009-012500-11-ES (EUCTR) | 24/06/2010 | 12/04/2010 | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (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 beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (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 beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Esclerosis Múltiple recidivante-remitente MedDRA version: 11;Level: PT;Classification code 10063399;Term: Esclerosis múltiple remitente-recurrente | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden | ||
| 998 | EUCTR2009-015556-15-LV (EUCTR) | 11/06/2010 | 13/04/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Sweden | |||
| 999 | EUCTR2009-015556-15-CZ (EUCTR) | 10/06/2010 | 29/03/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden | |||
| 1000 | EUCTR2008-004753-14-IT (EUCTR) | 07/06/2010 | 10/09/2010 | 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 - ND | 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 - ND | Relapsing-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Code: BG00012 | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 1001 | EUCTR2008-004753-14-NL (EUCTR) | 07/06/2010 | 04/03/2010 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1002 | EUCTR2009-015556-15-SI (EUCTR) | 07/06/2010 | 12/04/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | 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: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States | |||
| 1003 | NCT01156311 (ClinicalTrials.gov) | June 2010 | 1/7/2010 | BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis | An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA) | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 108 | Phase 2 | United States |
| 1004 | EUCTR2010-019029-32-PT (EUCTR) | 31/05/2010 | 07/05/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1850 | Portugal;Hungary;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1005 | NCT01047319 (ClinicalTrials.gov) | May 27, 2010 | 8/1/2010 | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Terminated | N/A | N/A | All | 1047 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Macedonia, The Former Yugoslav Republic of;Puerto Rico |
| 1006 | EUCTR2009-011470-15-ES (EUCTR) | 18/05/2010 | 22/03/2010 | Estudio de extensión del estudio AC-058B201, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, para evaluar la seguridad, tolerabilidad, y eficacia a largo plazo de 10, 20, y 40 mg/día de ACT-128800, un agonista oral de los receptores S1P1, en pacientes con esclerosis múltiple recurrente-remitente - | Esclerosi Múltiple Recurrente-Remitente MedDRA version: 12.1;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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;Sweden | ||||
| 1007 | EUCTR2009-015815-42-BG (EUCTR) | 18/05/2010 | 18/05/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 1008 | EUCTR2010-019029-32-GB (EUCTR) | 07/05/2010 | 16/04/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1009 | EUCTR2010-019029-32-DE (EUCTR) | 06/05/2010 | 02/03/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing 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 hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 1010 | EUCTR2009-015556-15-SE (EUCTR) | 06/05/2010 | 09/03/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack. INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden | |||
| 1011 | NCT01127750 (ClinicalTrials.gov) | May 2010 | 19/5/2010 | Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients | A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: FTY720 | Novartis | NULL | Completed | 18 Years | 65 Years | All | 2417 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 1012 | EUCTR2008-007459-28-BG (EUCTR) | 30/04/2010 | 29/04/2010 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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 | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 245 | France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany | |||
| 1013 | EUCTR2010-019029-32-IT (EUCTR) | 27/04/2010 | 09/04/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND | MS (MULTIPLE SCLEROSIS) MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece | |||
| 1014 | EUCTR2009-017003-28-IT (EUCTR) | 12/04/2010 | 08/04/2010 | Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome | Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome | multiple sclerosis MedDRA version: 9.1;Level: SOC;Classification code 10029205 MedDRA version: 9.1;Level: HLGT;Classification code 10012303 MedDRA version: 9.1;Level: HLT;Classification code 10052785 MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a | BIOGEN-DOMPE` SRL | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1015 | NCT01181115 (ClinicalTrials.gov) | April 2010 | 5/8/2010 | Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS) | An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Avonex | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 60 | Phase 3 | China |
| 1016 | EUCTR2009-012989-30-BG (EUCTR) | 31/03/2010 | 19/04/2010 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1017 | NCT01051349 (ClinicalTrials.gov) | March 31, 2010 | 15/1/2010 | Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis | A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab);Biological: trivalent seasonal influenza vaccine | Biogen | AbbVie | Completed | 18 Years | 60 Years | All | 410 | Phase 2 | Czechia;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Czech Republic |
| 1018 | EUCTR2009-015318-23-GB (EUCTR) | 31/03/2010 | 17/03/2010 | A study designed to determine safety and efficacy of Daclizumab High Yield Process (DAC HYP) in patients with Multiple Sclerosis Who Have Completed Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) - SELECTED | 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 1019 | EUCTR2008-005167-33-DE (EUCTR) | 29/03/2010 | 16/03/2010 | Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX | Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX | Patients with cerebellar ataxia with coordination deficits in walking, upper and lower limb movements and oculomtoor coordination deficits are included in the trial. The cause of their atayia is either a degenerative CNS disease (36 patients) such as autosomal dominant Spinocerebellar Ataxia or sporadic ataxia with late onset or inflammatory CNS disease (Multiple Sclerosis; 36 patients). | Trade Name: Neurontin 300 mg hard capsule Product Name: gabapentine 300mg Product Code: GBP INN or Proposed INN: Gabapentin Other descriptive name: GABAPENTIN | Charité University Medicine Berlin | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 1020 | 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 | ||
| 1021 | EUCTR2009-015815-42-IT (EUCTR) | 15/03/2010 | 01/03/2010 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10063399 | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: Laquinimod | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1245 | Phase 3 | Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 1022 | EUCTR2009-015815-42-EE (EUCTR) | 12/03/2010 | 12/02/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 1023 | 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 | |||
| 1024 | EUCTR2008-004753-14-GR (EUCTR) | 10/03/2010 | 21/10/2009 | 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 - N/A | 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 - 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 | 1700 | Phase 3 | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 1025 | NCT01097668 (ClinicalTrials.gov) | March 2010 | 31/3/2010 | ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis | SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS). | Relapsing Remitting Multiple Sclerosis | Biological: ATX-MS-1467 | Apitope Technology (Bristol) Ltd. | Aptiv Solutions;ClinStar, LLC | Completed | 18 Years | 55 Years | All | 43 | Phase 1 | Russian Federation;United Kingdom |
| 1026 | NCT01058005 (ClinicalTrials.gov) | March 2010 | 26/1/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetate | Biogen | Elan Pharmaceuticals | Terminated | 18 Years | 60 Years | All | 84 | Phase 3 | United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden |
| 1027 | EUCTR2009-012989-30-SE (EUCTR) | 23/02/2010 | 01/02/2010 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1028 | 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 | |||
| 1029 | EUCTR2008-004954-34-AT (EUCTR) | 21/01/2010 | 09/12/2008 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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: Rebif 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 | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 1030 | EUCTR2009-015318-23-CZ (EUCTR) | 21/01/2010 | 03/12/2009 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | 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: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 1031 | EUCTR2009-016140-39-ES (EUCTR) | 19/01/2010 | 28/10/2009 | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | Realce de contraste en resonancia magnética enpacientes con Síndrome Clínico Aislado orecaída de Esclerosis Múltiple con resonanciamagnética anormal anterior después de laadministración de dosis única y acumulada deGADOVIST®High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist® | Trade Name: GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado INN or Proposed INN: GADOBUTROL Other descriptive name: GADOBUTROL | Institut Diagnostic per la Imatge | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 1032 | EUCTR2009-012989-30-FR (EUCTR) | 18/01/2010 | 22/09/2009 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 9.1;Level: PT;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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 1033 | EUCTR2009-012989-30-LT (EUCTR) | 30/12/2009 | 02/10/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1034 | EUCTR2008-004753-14-AT (EUCTR) | 28/12/2009 | 10/11/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | 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;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1035 | 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 | ||
| 1036 | EUCTR2009-012989-30-GB (EUCTR) | 17/11/2009 | 13/07/2009 | A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 542 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1037 | EUCTR2009-012989-30-CZ (EUCTR) | 16/11/2009 | 10/09/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1038 | NCT00988052 (ClinicalTrials.gov) | November 10, 2009 | 28/9/2009 | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS | Relapsing Multiple Sclerosis | Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Terminated | 18 Years | 55 Years | All | 839 | Phase 3 | United States;Austria;Bulgaria;Canada;Czechia;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;Latvia |
| 1039 | 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 | |||
| 1040 | 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 | |||
| 1041 | EUCTR2009-012989-30-ES (EUCTR) | 21/10/2009 | 05/08/2009 | Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - - | Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - - | Esclerosis Múltiple Remitente Recurrente (RRMS). MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsulas 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 | Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 1042 | EUCTR2008-004753-14-GB (EUCTR) | 16/10/2009 | 09/11/2010 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1043 | EUCTR2008-005021-11-BE (EUCTR) | 14/10/2009 | 12/12/2008 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | 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 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 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 | 68 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 1044 | EUCTR2008-007459-28-DE (EUCTR) | 08/10/2009 | 23/12/2008 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 245 | France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany | |||
| 1045 | EUCTR2009-012989-30-IT (EUCTR) | 06/10/2009 | 11/09/2009 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | Relapsing - Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod INN or Proposed INN: Laquinimod | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 1046 | EUCTR2009-012989-30-NL (EUCTR) | 02/10/2009 | 20/07/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 632 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1047 | EUCTR2008-004753-14-EE (EUCTR) | 29/09/2009 | 14/08/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1048 | 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 | |||
| 1049 | EUCTR2008-007459-28-BE (EUCTR) | 21/09/2009 | 07/01/2009 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 500 | France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany | |||
| 1050 | EUCTR2008-004753-14-FR (EUCTR) | 18/09/2009 | 06/08/2009 | 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 - N/A | 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 - 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 | 1700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 1051 | EUCTR2008-004753-14-IE (EUCTR) | 17/09/2009 | 02/06/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1052 | 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 | ||
| 1053 | EUCTR2009-012989-30-EE (EUCTR) | 11/09/2009 | 05/08/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1054 | EUCTR2008-004954-34-PL (EUCTR) | 09/09/2009 | 05/06/2009 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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] | Trade Name: Rebif 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 | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 1055 | EUCTR2009-012989-30-HU (EUCTR) | 09/09/2009 | 14/08/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20] | 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 | 632 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 1056 | EUCTR2008-004753-14-ES (EUCTR) | 19/08/2009 | 01/07/2009 | 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 Estudio de extensión, multicéntrico y con dosis ciega para determinar la seguridad y la eficacia a largo plazo de dos dosis de BG00012 en monoterapia en pacientes con esclerosis múltiple recidivante-remitente - N/A | 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 Estudio de extensión, multicéntrico y con dosis ciega para determinar la seguridad y la eficacia a largo plazo de dos dosis de BG00012 en monoterapia en pacientes con esclerosis múltiple recidivante-remitente - N/A | Relapsing-Remitting Multiple Sclerosis Esclerosis 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 | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 1057 | EUCTR2008-004753-14-LV (EUCTR) | 13/08/2009 | 03/06/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | 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;Ireland;Israel;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1058 | EUCTR2008-005021-11-SE (EUCTR) | 12/08/2009 | 13/05/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | 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 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 1059 | EUCTR2009-013333-24-IT (EUCTR) | 03/08/2009 | 28/07/2009 | Multicenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGE | Multicenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGE | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: REBIF INN or Proposed INN: Interferon beta-1a | MERCK SERONO SPA | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Italy | |||
| 1060 | NCT00871780 (ClinicalTrials.gov) | August 2009 | 26/3/2009 | A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients | A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER Study | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: BG00002 (natalizumab) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 60 Years | All | 224 | Phase 4 | Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela |
| 1061 | EUCTR2008-005021-11-CZ (EUCTR) | 22/07/2009 | 08/06/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | 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 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | France;Czech Republic;Belgium;Sweden | ||
| 1062 | EUCTR2008-007459-28-CZ (EUCTR) | 22/07/2009 | 05/05/2009 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 245 | Hungary;Finland;Germany;Czech Republic;Denmark;Belgium;Bulgaria;France | |||
| 1063 | EUCTR2009-013129-41-NL (EUCTR) | 20/07/2009 | 03/06/2009 | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | clinical isolated syndrome MedDRA version: 9.1;Level: LLT;Classification code 10028248;Term: Multiple sclerosis-like syndrome | Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Amphia Ziekenhuis | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 1064 | EUCTR2008-007459-28-DK (EUCTR) | 09/07/2009 | 29/05/2009 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 245 | France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany | |||
| 1065 | 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 | ||
| 1066 | EUCTR2008-007459-28-FR (EUCTR) | 01/07/2009 | 15/05/2009 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany | ||
| 1067 | EUCTR2008-007459-28-HU (EUCTR) | 01/07/2009 | 27/04/2009 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Hungary;Czech Republic;Germany;Denmark;Belgium;Bulgaria;France | |||
| 1068 | NCT00947752 (ClinicalTrials.gov) | July 2009 | 25/7/2009 | Safety of New Formulation of Glatiramer Acetate | An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Experimental Glatiramer Acetate | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | All | 147 | Phase 3 | United States |
| 1069 | NCT00965497 (ClinicalTrials.gov) | July 2009 | 7/8/2009 | Escitalopram (Lexapro) for Depression MS or ALS | An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis | Major Depression;Multiple Sclerosis;Amyotrophic Lateral Sclerosis | Drug: escitalopram | University of South Carolina | NULL | Completed | 18 Years | 70 Years | All | 13 | Phase 3 | United States |
| 1070 | EUCTR2008-007459-28-FI (EUCTR) | 25/06/2009 | 18/03/2009 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects 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: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 245 | France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany | |||
| 1071 | 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 | ||
| 1072 | 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 | |||
| 1073 | 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 | |||
| 1074 | EUCTR2008-004753-14-DE (EUCTR) | 10/06/2009 | 08/05/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Tecfidera Other descriptive name: Dimethyl Fumarate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1075 | 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 |
| 1076 | 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 |
| 1077 | NCT00942214 (ClinicalTrials.gov) | June 2009 | 16/7/2009 | Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment | Biomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV Study | Multiple Sclerosis | Drug: Natalizumab | University Hospital, Toulouse | NULL | Completed | 18 Years | 55 Years | Both | 300 | Phase 4 | France |
| 1078 | EUCTR2008-004954-34-BG (EUCTR) | 28/05/2009 | 29/05/2009 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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: Rebif 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 | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 1079 | EUCTR2008-005021-11-FR (EUCTR) | 26/05/2009 | 24/03/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | 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 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | France;Czech Republic;Belgium;Sweden | ||
| 1080 | EUCTR2008-004954-34-GR (EUCTR) | 19/05/2009 | 06/03/2009 | 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) - REFLEXION | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | |||
| 1081 | EUCTR2008-004954-34-DE (EUCTR) | 05/05/2009 | 15/01/2009 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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: Rebif 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 | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 1082 | NCT00799942 (ClinicalTrials.gov) | May 2009 | 27/11/2008 | Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus | Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus | Nystagmus, Congenital;Nystagmus, Acquired;Multiple Sclerosis | Drug: Neramexane mesylate | Merz Pharmaceuticals GmbH | NULL | Terminated | 18 Years | 81 Years | Both | 48 | Phase 2 | United Kingdom |
| 1083 | 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 | |||
| 1084 | EUCTR2008-004954-34-IT (EUCTR) | 08/04/2009 | 12/03/2009 | 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) - REFLEXION | 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) - REFLEXION | Subjects at high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: REBIF*SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta-1a | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | |||
| 1085 | EUCTR2008-004954-34-FR (EUCTR) | 08/04/2009 | 17/03/2009 | 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) - REFLEXION | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif 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 | 492 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | ||
| 1086 | 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 |
| 1087 | 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 |
| 1088 | NCT00904826 (ClinicalTrials.gov) | April 2009 | 18/5/2009 | An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica | An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica | Neuromyelitis Optica;Devic's Disease | Drug: Eculizumab | Mayo Clinic | Alexion Pharmaceuticals | Completed | 18 Years | N/A | All | 14 | Phase 1/Phase 2 | United States |
| 1089 | EUCTR2008-004579-22-DE (EUCTR) | 31/03/2009 | 07/11/2008 | A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-cell/Antibody Response Panel to predict the clinical efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis | A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-cell/Antibody Response Panel to predict the clinical efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis | Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: octagam Product Name: Octagam 5% | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Austria;Germany | |||
| 1090 | EUCTR2008-006226-34-ES (EUCTR) | 25/03/2009 | 23/01/2009 | Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Esclerosis Múltiple------------------------Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: REBIF 44 microgramos solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy | |||
| 1091 | 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 | ||
| 1092 | EUCTR2008-004753-14-CZ (EUCTR) | 16/03/2009 | 22/01/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | 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;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1093 | EUCTR2008-004954-34-LV (EUCTR) | 12/03/2009 | 27/02/2009 | 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) - REFLEXION | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif 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 | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Germany | |||
| 1094 | EUCTR2008-004954-34-BE (EUCTR) | 09/03/2009 | 23/01/2009 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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: Rebif 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 | 492 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1095 | EUCTR2008-004174-40-FR (EUCTR) | 06/03/2009 | 25/11/2008 | Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP | Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP | Groupe I: volontaires sainsGroupe II: patients avec une sclérose en plaques d'évolution rémittente . MedDRA version: 8.1;Level: PT;Classification code 10012300;Term: Demyelinating disease (excl multiple sclerosis) | Product Name: 11C-PIB INN or Proposed INN: 11C-PIB | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1096 | EUCTR2008-004954-34-SK (EUCTR) | 05/03/2009 | 09/09/2009 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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] | Trade Name: Rebif 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 | 492 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | ||
| 1097 | EUCTR2008-004753-14-SK (EUCTR) | 04/03/2009 | 03/02/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1098 | EUCTR2008-004954-34-ES (EUCTR) | 03/03/2009 | 19/12/2008 | Extensión doble ciega del estudio 27025 (REFLEX) para obtener datos de seguimiento a largo plazo en pacientes con Esclerosis Múltiple clínicamente definida y en pacientes con un primer acontecimiento desmielinizante con alto riesgo de presentar conversión en Esclerosis Múltiple, tratados con Rebif® New Formulation (REFLEXION) - REFLEXION | Extensión doble ciega del estudio 27025 (REFLEX) para obtener datos de seguimiento a largo plazo en pacientes con Esclerosis Múltiple clínicamente definida y en pacientes con un primer acontecimiento desmielinizante con alto riesgo de presentar conversión en Esclerosis Múltiple, tratados con Rebif® New Formulation (REFLEXION) - REFLEXION | Pacientes con riesgo alto de conversión en Esclerosis Múltiple o pacientes que ya han convertido a Esclerosis Múltiple. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: REBIF 44 microgramos solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | ||
| 1099 | NCT00853762 (ClinicalTrials.gov) | March 2009 | 26/2/2009 | Atacicept in Multiple Sclerosis Extension Study, Phase II | An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension) | Relapsing Multiple Sclerosis | Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg | EMD Serono | Merck KGaA | Terminated | 18 Years | 60 Years | All | 74 | Phase 2 | United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 1100 | EUCTR2008-004954-34-EE (EUCTR) | 13/02/2009 | 08/01/2009 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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: Rebif 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 | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 1101 | EUCTR2008-005304-93-GB (EUCTR) | 13/02/2009 | 12/12/2008 | A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis | A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis | Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease. MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse MedDRA version: 9.1;Classification code 10065687;Term: Bone loss | Trade Name: Aclasta 5mg solution for infusion Product Name: Aclasta Product Code: ZOL446H | North Bristol Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 1102 | EUCTR2008-005906-38-FR (EUCTR) | 09/02/2009 | 19/03/2009 | Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques | Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques | sclérose en plaques MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Tysabri Product Name: Tysabri | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | France | |||
| 1103 | EUCTR2008-004954-34-PT (EUCTR) | 06/02/2009 | 05/01/2009 | 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) - REFLEXION | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif 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 | 492 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | ||
| 1104 | 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 |
| 1105 | 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 | ||
| 1106 | EUCTR2008-004954-34-FI (EUCTR) | 26/01/2009 | 17/12/2008 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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] | Trade Name: Rebif 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 | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 1107 | EUCTR2008-004753-14-BE (EUCTR) | 22/01/2009 | 23/12/2008 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | 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 - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | 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;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 1108 | EUCTR2008-003098-42-CZ (EUCTR) | 06/01/2009 | 27/10/2008 | A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis | A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis | To evaluate the immunogenicity of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: AVONEX INN or Proposed INN: interferon beta 1a | Biogen Idec Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Czech Republic | |||
| 1109 | NCT00828204 (ClinicalTrials.gov) | January 2009 | 20/1/2009 | Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects | An Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex® Prefilled Syringe in Multiple Sclerosis Subjects | Multiple Sclerosis | Device: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a) | Biogen | NULL | Completed | 18 Years | 65 Years | All | 95 | Phase 3 | United States |
| 1110 | NCT01031199 (ClinicalTrials.gov) | January 2009 | 11/12/2009 | Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers | Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for Its Diagnostic Potential in Either Drug-naïve or Specifically (IFN-beta) Pretreated Patients With Multiple Sclerosis (MS) With Acute Relapse or Patients With Clinically Isolated Syndrome (CIS), Compared to Healthy Volunteers | Positron-Emission Tomography;Multiple Sclerosis | Drug: F-18 FEDAA1106 (BAY85-8101) | Bayer | NULL | Completed | 20 Years | 55 Years | Both | 16 | Phase 1 | Australia;Sweden |
| 1111 | 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 | |||
| 1112 | EUCTR2008-004954-34-CZ (EUCTR) | 12/12/2008 | 21/11/2008 | 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) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to 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: Rebif 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 | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 1113 | 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 | |||
| 1114 | 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 |
| 1115 | NCT00771043 (ClinicalTrials.gov) | November 2008 | 7/10/2008 | A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a | Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a | Relapsing-Remitting Multiple Sclerosis | Drug: TYSABRI and AVONEX | Biogen Idec | NULL | Withdrawn | 18 Years | 55 Years | Both | 50 | Phase 4 | United States |
| 1116 | 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 | ||
| 1117 | EUCTR2008-004579-22-AT (EUCTR) | 14/10/2008 | 15/09/2008 | A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS) | A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS) | Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated. | Trade Name: Octagam 5% Product Name: Octagam 5% INN or Proposed INN: Immunoglobulin | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Austria | |||
| 1118 | 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 | ||
| 1119 | 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 | ||
| 1120 | EUCTR2008-000499-25-SE (EUCTR) | 02/10/2008 | 16/05/2008 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Rebif New Formulation 44mcg multidose cartridge INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Germany;Spain;Italy;Sweden | ||
| 1121 | NCT00784836 (ClinicalTrials.gov) | October 2008 | 29/10/2008 | Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients | A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: BG9418 (interferon beta 1-a) | Biogen | NULL | Terminated | 18 Years | 60 Years | All | 3 | Phase 3 | United States |
| 1122 | NCT00780455 (ClinicalTrials.gov) | October 2008 | 28/5/2008 | Rehabilitation Study in MS Patients | Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon® | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b, FRP within 15 days after randomization;Drug: Interferon beta-1b, FRP about 6 weeks after randomization | Bayer | NULL | Terminated | 18 Years | N/A | All | 4 | Phase 4 | France |
| 1123 | 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 | ||
| 1124 | 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 | ||
| 1125 | 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 | |||
| 1126 | 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 | |||
| 1127 | EUCTR2008-000499-25-ES (EUCTR) | 31/07/2008 | 10/06/2008 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS | Relapsing forms of Multiple Sclerosis (RMS) Esclerosis múltiple recidivante (EMR) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Rebif New Formulation 44mcg multidose cartridge INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Germany;Spain;Italy;Sweden | ||
| 1128 | 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 | ||
| 1129 | 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 |
| 1130 | EUCTR2008-000499-25-IT (EUCTR) | 24/07/2008 | 15/02/2010 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 9.1;Level: PT;Classification code 10063399 | INN or Proposed INN: Interferon beta-1a | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Spain;Germany;Italy;Sweden | ||
| 1131 | 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 | |||
| 1132 | 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 | ||
| 1133 | 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 | ||
| 1134 | 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 | ||
| 1135 | 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 | ||
| 1136 | 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 | ||
| 1137 | NCT00735007 (ClinicalTrials.gov) | July 2008 | 12/8/2008 | 12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis. | International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS) | Multiple Sclerosis | Drug: Rebif® New Formulation (RNF) using RebiSmartTM | EMD Serono | NULL | Completed | 18 Years | 65 Years | All | 106 | Phase 3 | United States;Canada;Germany;Italy;Spain;Sweden |
| 1138 | 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 | 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 | ||
| 1139 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Research Center | NULL | Recruiting | N/A | 71 Years | All | 40 | Phase 2 | United States |
| 1140 | 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 | |||
| 1141 | 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 | ||
| 1142 | 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 | ||
| 1143 | 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 | |||
| 1144 | 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 | ||
| 1145 | EUCTR2007-000888-15-ES (EUCTR) | 19/05/2008 | 27/02/2008 | ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple | ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple | Pacientes afectos de esclerosis múltiple MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: SOLU-MODERIN 1 g INN or Proposed INN: METHYLPREDNISOLONE Trade Name: URBASON 40 mg comprimidos INN or Proposed INN: METHYLPREDNISOLONE | Servicio de Neurología | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 1146 | EUCTR2007-005362-12-FR (EUCTR) | 13/05/2008 | 07/02/2008 | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de l'IRM multimodale 3 tesla dans l'analyse des lésions de la SEP et leur progression. Etude longitudinale sur 3 ans. - USPIO-Mitox | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de l'IRM multimodale 3 tesla dans l'analyse des lésions de la SEP et leur progression. Etude longitudinale sur 3 ans. - USPIO-Mitox | 1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive MedDRA version: 9.1;Classification code 10028246;Term: Multiple sclerosis aggravated MedDRA version: 9.1;Classification code 10028247;Term: Multiple sclerosis like syndrome MedDRA version: 9.1;Classification code 10028248;Term: Multiple sclerosis-like syndrome MedDRA version: 9.1;Classification code 10048393;Term: Multiple sclerosis relapse MedDRA version: 9.1;Classification code 10053395;Term: Progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063401;Term: Primary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10064137;Term: Progression of multiple sclerosis MedDRA version: 9.1;Level: PT;Term: Secondary progressive multiple sclerosis | Product Code: SH U 555 C | C.H.U. de RENNES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1147 | EUCTR2007-005363-10-FR (EUCTR) | 13/05/2008 | 11/12/2007 | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS | 1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive MedDRA version: 9.1;Classification code 10028246;Term: Multiple sclerosis aggravated MedDRA version: 9.1;Classification code 10028247;Term: Multiple sclerosis like syndrome MedDRA version: 9.1;Classification code 10028248;Term: Multiple sclerosis-like syndrome MedDRA version: 9.1;Classification code 10048393;Term: Multiple sclerosis relapse MedDRA version: 9.1;Classification code 10053395;Term: Progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063401;Term: Primary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10064137;Term: Progression of multiple sclerosis MedDRA version: 9.1;Level: PT;Term: Secondary progressive multiple sclerosis | Product Code: SH U 555 C | C.H.U. de RENNES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1148 | 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 | ||
| 1149 | 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 |
| 1150 | 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 | ||
| 1151 | 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 | ||
| 1152 | 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 | |||
| 1153 | 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 | ||
| 1154 | 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 | |||
| 1155 | 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 | |||
| 1156 | 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 | ||
| 1157 | 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 | ||
| 1158 | 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 | ||
| 1159 | 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 | |||
| 1160 | EUCTR2007-002179-15-FR (EUCTR) | 04/03/2008 | 22/11/2007 | Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH | Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH | Méthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie. MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1161 | NCT00616733 (ClinicalTrials.gov) | March 2008 | 4/2/2008 | 12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients | An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: CS-0777 tablets | Daiichi Sankyo Inc. | NULL | Completed | 18 Years | 65 Years | Both | 25 | Phase 1 | United States |
| 1162 | 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 |
| 1163 | EUCTR2007-001162-32-ES (EUCTR) | 22/02/2008 | 14/02/2008 | Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II | Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II | Esclerosis Múltiple de recaída-remisión MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | France;Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 1164 | 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 | |||
| 1165 | NCT00630383 (ClinicalTrials.gov) | February 2008 | 27/2/2008 | Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis. | Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis. | Multiple Sclerosis | Biological: Live Hookworm Larvae;Other: Histamine | University of Nottingham | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 2 | United Kingdom |
| 1166 | 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 | ||
| 1167 | 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 | |||
| 1168 | NCT00938366 (ClinicalTrials.gov) | January 2008 | 9/7/2009 | Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects | An Open-label, Cross Over Study, to Assess the Interactions of Pantoprazole (Proton Pump Inhibitor) With Oral Cladribine Administered in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Cladribine;Drug: Pantoprazole | Merck KGaA | Merck Serono S.A., Geneva | Completed | 18 Years | 65 Years | All | 18 | Phase 1 | NULL |
| 1169 | NCT00536120 (ClinicalTrials.gov) | January 2008 | 25/9/2007 | The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis | A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td) | Biogen | NULL | Completed | 18 Years | 60 Years | All | 60 | Phase 4 | United States |
| 1170 | NCT00464958 (ClinicalTrials.gov) | January 2008 | 22/4/2007 | One Year Extension Study To Protocol C2/5/TZ:MS-05 | Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension Study | Spasticity;Multiple Sclerosis | Drug: sublingual tizanidine 12 mg | Teva GTC | NULL | Terminated | 20 Years | 65 Years | Both | 10 | Phase 1/Phase 2 | Israel |
| 1171 | 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 | ||
| 1172 | 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 | |||
| 1173 | 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 | ||
| 1174 | 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 | |||
| 1175 | 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 | |||
| 1176 | 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 |
| 1177 | 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 |
| 1178 | 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 | |||
| 1179 | 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 | ||
| 1180 | 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 | ||
| 1181 | 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 | |||
| 1182 | NCT00595920 (ClinicalTrials.gov) | November 2007 | 3/1/2008 | Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis | An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00 | Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated Syndrome | Biological: Tovaxin | Opexa Therapeutics, Inc. | NULL | Terminated | N/A | N/A | All | 116 | Phase 2 | United States |
| 1183 | 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 | |||
| 1184 | 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 | |||
| 1185 | 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 | |||
| 1186 | 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 | |||
| 1187 | 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 | |||
| 1188 | 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 | |||
| 1189 | 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 |
| 1190 | NCT00559702 (ClinicalTrials.gov) | October 2007 | 7/11/2007 | Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) | A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Drug: natalizumab;Other: standard of care | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 65 Years | Both | 76 | Phase 1 | United States |
| 1191 | 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 | |||
| 1192 | 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 | ||
| 1193 | 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 | ||
| 1194 | 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 | |||
| 1195 | 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 | |||
| 1196 | 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 |
| 1197 | 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 | ||
| 1198 | 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 | |||
| 1199 | 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 | |||
| 1200 | NCT00649792 (ClinicalTrials.gov) | August 2007 | 28/3/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial | Multiple Sclerosis | Drug: Fampridine-SR | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 214 | Phase 3 | United States;Canada |
| 1201 | EUCTR2007-000590-37-FR (EUCTR) | 17/07/2007 | 23/05/2007 | Etude randomisée, en double aveugle, comparant l’efficacité et la tolérance de la méthylprednisolone administrée à forte dose par voie orale ou par voie intraveineuse dans le traitement des poussées de sclérose en plaques - COPOUSEP | Etude randomisée, en double aveugle, comparant l’efficacité et la tolérance de la méthylprednisolone administrée à forte dose par voie orale ou par voie intraveineuse dans le traitement des poussées de sclérose en plaques - COPOUSEP | Traitement des poussées de sclérose en plaques MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: METHYLPREDNISOLONE INN or Proposed INN: METHYLPREDNISOLONE Trade Name: methylprednisolone Product Name: methylprednisolone Trade Name: methylprednisolone Product Name: methylprednisolone | CHU Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1202 | 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 | ||
| 1203 | EUCTR2005-004061-41-AT (EUCTR) | 06/07/2007 | 15/12/2005 | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) | Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 900 | Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 1204 | 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 | |||
| 1205 | 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 | |||
| 1206 | EUCTR2004-000463-94-HU (EUCTR) | 03/07/2007 | 12/07/2004 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Relapsing-remitting multiple sclerosis (R-R MS) MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Glatiramer acetate 150mg enteric coated tablets INN or Proposed INN: Glatiramer Acetate Other descriptive name: COP-1/Copolymer-1 | TEVA Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Hungary;Italy | |||
| 1207 | EUCTR2006-005270-47-GR (EUCTR) | 03/07/2007 | 18/06/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1208 | NCT00619307 (ClinicalTrials.gov) | July 2007 | 8/2/2008 | Transition to Rebif New Formulation | A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis | Relapsing Multiple Sclerosis | Drug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRN | Merck KGaA | NULL | Completed | 18 Years | 60 Years | All | 117 | Phase 3 | France;Germany |
| 1209 | NCT01158183 (ClinicalTrials.gov) | July 2007 | 7/7/2010 | Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis | Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon ß-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: BAY86-5046_Interferon-beta-1b | Bayer | NULL | Completed | 18 Years | 65 Years | Both | 226 | N/A | United States |
| 1210 | NCT00469378 (ClinicalTrials.gov) | July 2007 | 2/5/2007 | Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple Sclerosis | An Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With Firategrast | Multiple Sclerosis | Drug: firategrast | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 46 | Phase 2 | Belgium;Czech Republic;Denmark;Norway;Sweden |
| 1211 | EUCTR2005-004061-41-SE (EUCTR) | 29/06/2007 | 15/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 521 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 1212 | 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 | |||
| 1213 | EUCTR2006-005270-47-IT (EUCTR) | 28/06/2007 | 19/07/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up | Relapsing multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: BETAFERON 250 mcg INN or Proposed INN: interferon beta-1b Product Name: BETAFERON 500 mcg Product Code: ZK 157046 INN or Proposed INN: interferon beta-1b | SCHERING | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1214 | EUCTR2006-007057-42-DK (EUCTR) | 25/06/2007 | 14/05/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 1215 | EUCTR2006-005972-42-DE (EUCTR) | 20/06/2007 | 15/08/2007 | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: NA Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF Product Code: NA INN or Proposed INN: Interferon beta-1a Other descriptive name: recombinant human IFN beta Trade Name: Ibuprofen Sandoz 400 mg Filmtabletten Product Name: Ibuprofen INN or Proposed INN: Ibuprofen | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | Germany;France | ||
| 1216 | EUCTR2006-005972-42-FR (EUCTR) | 12/06/2007 | 05/04/2007 | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: NA Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF Product Code: NA | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;Germany | ||
| 1217 | 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 |
| 1218 | 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 |
| 1219 | NCT00574041 (ClinicalTrials.gov) | June 2007 | 12/12/2007 | How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose | An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY) | Relapsing Remitting Multiple Sclerosis | Drug: Interferon beta-1a | Biogen Idec | NULL | Terminated | 18 Years | N/A | Both | 19 | Phase 4 | Australia |
| 1220 | 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 | ||
| 1221 | EUCTR2006-007057-42-BE (EUCTR) | 29/05/2007 | 14/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Belgium;Denmark;Sweden | |||
| 1222 | 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 | |||
| 1223 | EUCTR2006-005270-47-FR (EUCTR) | 22/05/2007 | 23/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 1224 | EUCTR2006-005270-47-SI (EUCTR) | 16/05/2007 | 04/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1225 | 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 | ||
| 1226 | EUCTR2006-007057-42-CZ (EUCTR) | 03/05/2007 | 16/03/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Denmark;Sweden | ||
| 1227 | EUCTR2006-007057-42-SE (EUCTR) | 02/05/2007 | 15/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 1228 | EUCTR2006-005270-47-LV (EUCTR) | 02/05/2007 | 03/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1229 | NCT00459667 (ClinicalTrials.gov) | May 2007 | 11/4/2007 | BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose | International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | All | 1420 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine |
| 1230 | NCT00461396 (ClinicalTrials.gov) | May 2007 | 17/4/2007 | Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron | Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon-1beta (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 50 Years | Both | 104 | Phase 4 | United States |
| 1231 | EUCTR2006-005270-47-FI (EUCTR) | 23/04/2007 | 19/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 1232 | NCT00548769 (ClinicalTrials.gov) | April 21, 2007 | 23/10/2007 | Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients | An Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple Sclerosis | Multiple Sclerosis | Drug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation D | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 1 | Czechia;Germany;Poland;Czech Republic |
| 1233 | EUCTR2006-005270-47-HU (EUCTR) | 16/04/2007 | 09/03/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1234 | 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 | |||
| 1235 | EUCTR2006-005270-47-BE (EUCTR) | 12/04/2007 | 22/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 1236 | EUCTR2006-005270-47-ES (EUCTR) | 08/04/2007 | 05/02/2007 | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Esclerosis Múltiple Recidivante | Trade Name: Betaferon 250 microgramos INN or Proposed INN: Interferon beta 1b Product Name: Betaferon 500 µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta 1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 1237 | EUCTR2006-005270-47-NL (EUCTR) | 02/04/2007 | 18/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1238 | 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 | ||
| 1239 | 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 | ||
| 1240 | 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 | ||
| 1241 | EUCTR2006-005270-47-SE (EUCTR) | 28/02/2007 | 02/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer AB, Bayer Health Care, Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 1242 | 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 | ||
| 1243 | EUCTR2006-005270-47-AT (EUCTR) | 22/02/2007 | 31/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden | ||
| 1244 | EUCTR2006-005270-47-IE (EUCTR) | 16/02/2007 | 10/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up | Relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Betaferon 250mcg Product Name: Betaferon 500mcg Product Code: ZK 157046 | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 1245 | EUCTR2006-003037-32-ES (EUCTR) | 09/02/2007 | 10/03/2010 | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.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. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.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. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Estonia;Spain;Lithuania;Germany;Italy | ||
| 1246 | EUCTR2006-002037-20-EE (EUCTR) | 02/02/2007 | 04/12/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: glatiramer acetate Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1247 | NCT00870155 (ClinicalTrials.gov) | February 2007 | 26/3/2009 | A Study for Patients With Multiple Sclerosis | An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: dirucotide | Eli Lilly and Company | BioMS Technology Corp. | Terminated | 18 Years | 65 Years | Both | 546 | Phase 2/Phase 3 | Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom |
| 1248 | NCT00845338 (ClinicalTrials.gov) | February 2007 | 16/2/2009 | Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity | A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity | Multiple Sclerosis;Overactive Detrusor | Drug: Darifenacin (BAY79-4998) | Bayer | NULL | Terminated | 18 Years | N/A | Both | 7 | Phase 2 | Germany |
| 1249 | 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 | ||
| 1250 | 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 | ||
| 1251 | EUCTR2006-002361-39-DE (EUCTR) | 01/12/2006 | 21/08/2006 | A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity | A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity | Neurogenic overactive bladder disaese in patients with multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10059617;Term: Overactive bladder | Trade Name: EMSELEX 7,5 mg Retardtabletten Product Name: Darifenacin Product Code: BAY 79-4998 INN or Proposed INN: Darifenacin Trade Name: EMSELEX 15 mg Retardtabletten Product Name: Darifenacin Product Code: BAY 79-4998 INN or Proposed INN: Darifenacin | Bayer Vital GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 1252 | NCT00428584 (ClinicalTrials.gov) | December 2006 | 29/1/2007 | RNF and Betaseron® Tolerability Study | A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: New Formulation of rebif - human interferon beta-1a;Drug: Interferon beta -1b | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | All | 129 | Phase 3 | United States |
| 1253 | EUCTR2006-002037-20-LT (EUCTR) | 30/11/2006 | 09/10/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate Trade Name: Copaxone 20mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: glatiramer acetate Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1254 | EUCTR2005-004061-41-HU (EUCTR) | 22/11/2006 | 20/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) 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: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 1255 | 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 |
| 1256 | NCT00370071 (ClinicalTrials.gov) | November 2006 | 29/8/2006 | Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis | Open Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 16 Years | 55 Years | All | 39 | Phase 3 | China |
| 1257 | EUCTR2005-004061-41-GR (EUCTR) | 31/10/2006 | 28/07/2006 | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 1258 | 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 | |||
| 1259 | EUCTR2006-002037-20-CZ (EUCTR) | 13/10/2006 | 28/08/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml, Solution for Injection, pre-filled syringes Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1260 | NCT00516893 (ClinicalTrials.gov) | October 2006 | 14/8/2007 | Natalizumab High Titer Immunogenicity and Safety | A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: BG00002-E (natalizumab high titer) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | All | 113 | Phase 2 | United States |
| 1261 | 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 | |||
| 1262 | EUCTR2006-002037-20-BE (EUCTR) | 27/09/2006 | 19/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1263 | 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 | |||
| 1264 | EUCTR2006-002037-20-GB (EUCTR) | 07/09/2006 | 23/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1265 | EUCTR2006-002037-20-DE (EUCTR) | 07/09/2006 | 20/10/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Czech Republic;United Kingdom;Germany;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1266 | EUCTR2006-002037-20-LV (EUCTR) | 06/09/2006 | 23/08/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: glatiramer acetate Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1267 | EUCTR2006-002037-20-ES (EUCTR) | 06/09/2006 | 07/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetato Trade Name: Copaxone 20 mg/ml solución para inyección en jeringa precargada Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom | ||
| 1268 | EUCTR2006-002037-20-HU (EUCTR) | 27/07/2006 | 23/05/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1269 | 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 | |||
| 1270 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Finland;United Kingdom;Netherlands;Denmark;Estonia;Spain;Latvia;Lithuania;Sweden | |||
| 1271 | 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 | ||
| 1272 | EUCTR2005-004061-41-BE (EUCTR) | 17/07/2006 | 29/11/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 521 | Phase 3 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 1273 | EUCTR2006-002037-20-FI (EUCTR) | 12/07/2006 | 15/06/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Phase 3 | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom | ||
| 1274 | EUCTR2006-002037-20-IT (EUCTR) | 12/07/2006 | 30/08/2006 | A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE | A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE | Patients with Relapsing - Remitting Multiple Sclerosis. MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: 40 mg Glatiramer acetato Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetate Trade Name: COPAXONE*SC 28SIR 20MG/ML INN or Proposed INN: Glatiramer acetate | Teva Pharmaceuticals Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1275 | 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 |
| 1276 | EUCTR2005-005679-13-IT (EUCTR) | 28/06/2006 | 23/06/2006 | An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - ND | An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - ND | multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10053395 | INN or Proposed INN: Naltrexone | OSPEDALE S. RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Italy | |||
| 1277 | 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 | ||
| 1278 | EUCTR2005-004061-41-DK (EUCTR) | 19/06/2006 | 09/01/2006 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;New Zealand;Sweden | |||
| 1279 | 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 | |||
| 1280 | 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 | ||
| 1281 | EUCTR2005-004061-41-GB (EUCTR) | 01/06/2006 | 25/10/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI 300 mg concentrate for solution for infusion Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1282 | 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 | ||
| 1283 | NCT00648908 (ClinicalTrials.gov) | June 2006 | 28/3/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial | Multiple Sclerosis | Drug: Fampridine-SR | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 269 | Phase 3 | United States;Canada |
| 1284 | 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 | |||
| 1285 | EUCTR2005-004061-41-DE (EUCTR) | 18/05/2006 | 14/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 521 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 1286 | NCT00324506 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis | A Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (CellCept) | University of Texas Southwestern Medical Center | Aspreva Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 43 | Phase 2 | United States |
| 1287 | 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 | |||
| 1288 | 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 | ||
| 1289 | NCT00297232 (ClinicalTrials.gov) | March 2006 | 27/2/2006 | Natalizumab (Tysabri) Re-Initiation of Dosing | An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation | Relapsing-Remitting Multiple Sclerosis | Drug: Natalizumab | Biogen | NULL | Terminated | 18 Years | N/A | All | 1094 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria |
| 1290 | NCT00306592 (ClinicalTrials.gov) | March 2006 | 31/1/2006 | Natalizumab Re-Initiation of Dosing | An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation | Multiple Sclerosis, Relapsing-Remitting | Biological: BG00002 (natalizumab) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | N/A | All | 404 | Phase 3 | United States;Canada |
| 1291 | NCT00317941 (ClinicalTrials.gov) | March 2006 | 24/4/2006 | Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif | The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®). | Relapsing-remitting Multiple Sclerosis | Drug: Betaferon/Betaseron;Drug: Rebif | Bayer | NULL | Completed | 18 Years | 55 Years | All | 220 | Phase 4 | France |
| 1292 | EUCTR2005-004061-41-IT (EUCTR) | 24/02/2006 | 21/04/2006 | Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatment | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | sclerosi multipla 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: Tysabri INN or Proposed INN: Natalizumab | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 700 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Australia;Germany;New Zealand;Sweden | |||
| 1293 | EUCTR2005-004334-41-CZ (EUCTR) | 13/02/2006 | 12/01/2006 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of 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 (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: 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 | 105 | Phase 2 | Hungary;Czech Republic;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 1294 | EUCTR2005-004334-41-GB (EUCTR) | 10/02/2006 | 31/10/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of 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 (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: 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 | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 1295 | EUCTR2005-004061-41-FI (EUCTR) | 10/02/2006 | 01/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 1296 | EUCTR2005-004061-41-CZ (EUCTR) | 26/01/2006 | 11/01/2006 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 1297 | EUCTR2005-004061-41-IE (EUCTR) | 20/01/2006 | 08/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 1298 | EUCTR2005-004334-41-DE (EUCTR) | 11/01/2006 | 21/11/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of 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 (RRMS) 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: 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 | 105 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 1299 | EUCTR2005-004334-41-ES (EUCTR) | 04/01/2006 | 10/11/2005 | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) 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 | 310 | Phase 2 | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 1300 | 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 |
| 1301 | EUCTR2005-004334-41-HU (EUCTR) | 20/12/2005 | 04/11/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of 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 (RRMS) 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: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 1302 | 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 | ||
| 1303 | 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 |
| 1304 | NCT00676156 (ClinicalTrials.gov) | December 2005 | 7/5/2008 | A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis | A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis | Multiple Sclerosis | Drug: oral lipoic acid (LA);Drug: lipoic acid (LA) with fish oil and LA without fish oil;Drug: R lipoic acid | Oregon Health and Science University | National Center for Complementary and Integrative Health (NCCIH) | Completed | 18 Years | 80 Years | Both | 40 | Phase 1 | United States |
| 1305 | NCT01142466 (ClinicalTrials.gov) | December 2005 | 10/6/2010 | A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone | Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1a (Rebif) | Merck KGaA | Gesellschaft für Therapieforschung mbH | Completed | 18 Years | 60 Years | All | 30 | Phase 4 | NULL |
| 1306 | EUCTR2005-004334-41-IT (EUCTR) | 30/11/2005 | 01/03/2006 | An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) 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). | An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) 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 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 Product Code: ABR-215062 INN or Proposed INN: LAQUINIMOD | Teva Pharmaceutical Industries Ldt | NULL | Not Recruiting | Female: yes Male: yes | 246 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy | ||
| 1307 | 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 | ||
| 1308 | 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 | |||
| 1309 | 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 | ||
| 1310 | NCT00257855 (ClinicalTrials.gov) | November 2005 | 22/11/2005 | A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis | A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis: Single Centre, Phase 2 Trial | Secondary Progressive Multiple Sclerosis | Drug: Lamotrigine | University College London Hospitals | NULL | Completed | 18 Years | 60 Years | Both | 120 | Phase 2 | United Kingdom |
| 1311 | 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 | ||
| 1312 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United Kingdom;Germany;Spain | ||
| 1313 | 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 | ||
| 1314 | 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 | ||
| 1315 | EUCTR2005-001949-42-GB (EUCTR) | 08/09/2005 | 04/07/2005 | A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis | A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis | Multiple sclerosis | Product Name: Lamotrigine extended release tablets Product Code: N/A INN or Proposed INN: Lamotrigine Other descriptive name: N/A | University College London | 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 | United Kingdom | ||
| 1316 | 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 | ||
| 1317 | 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 | |||
| 1318 | NCT00239993 (ClinicalTrials.gov) | August 2005 | 22/9/2005 | A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone® | An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®. | Multiple Sclerosis | Drug: glatiramer acetate;Procedure: Warm compress prior to injection of glatiramer acetate | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | 55 Years | All | 50 | Phase 4 | United States |
| 1319 | NCT00915577 (ClinicalTrials.gov) | August 2005 | 5/6/2009 | Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe | An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects | Multiple Sclerosis | Drug: Interferon beta-1a;Device: Single-use autoinjector | Biogen Idec | NULL | Completed | 18 Years | 65 Years | Both | 74 | Phase 3 | NULL |
| 1320 | EUCTR2005-001026-89-DE (EUCTR) | 14/07/2005 | 13/05/2005 | Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study) | Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study) | Relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) with relapses MedDRA version: 7.1;Level: LLT;Classification code 10028245 | Trade Name: Rebif Product Name: Rebif 8,8 µg, Rebif 22µg INN or Proposed INN: Interferon beta-1 a Trade Name: Rebif Product Name: Rebif 44 µg INN or Proposed INN: Interferon beta-1 a | Serono GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Germany | ||
| 1321 | 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 | ||
| 1322 | NCT00202423 (ClinicalTrials.gov) | July 2005 | 12/9/2005 | Use of Cannabinoids in Patients With Multiple Sclerosis | fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex | S. Andrea Hospital | University of Roma La Sapienza | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 2 | Italy |
| 1323 | 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 | ||
| 1324 | 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 | ||
| 1325 | 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 | ||
| 1326 | EUCTR2005-000171-18-FI (EUCTR) | 12/05/2005 | 18/04/2005 | A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/A | A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/A | Multiple Sclerosis (Relapsing-remitting MS and Secondary progressive MS with relapses) | Product Name: Temsirolimus Tablets Product Code: CCI-779 INN or Proposed INN: Temsirolimus Other descriptive name: WAY-130799 | Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development | NULL | Not Recruiting | Female: yes Male: yes | 180 | Finland | |||
| 1327 | NCT00942591 (ClinicalTrials.gov) | May 2005 | 17/7/2009 | Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis. | Multiple Sclerosis | Drug: Interferon beta 1b;Drug: Atorvastatin | University Hospital Inselspital, Berne | CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel | Completed | 18 Years | 55 Years | Both | 77 | Phase 2 | Switzerland |
| 1328 | 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 | |||
| 1329 | 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 | |||
| 1330 | EUCTR2004-003799-13-GB (EUCTR) | 16/03/2005 | 18/07/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 1331 | EUCTR2004-003799-13-LT (EUCTR) | 08/03/2005 | 27/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Sweden;Lithuania | ||
| 1332 | 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 |
| 1333 | EUCTR2004-003799-13-DK (EUCTR) | 24/02/2005 | 18/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 1334 | 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 | ||
| 1335 | EUCTR2004-003799-13-ES (EUCTR) | 17/02/2005 | 04/11/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;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 Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 1336 | 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 | ||
| 1337 | 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 | |||
| 1338 | EUCTR2004-003799-13-SE (EUCTR) | 03/02/2005 | 23/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Lithuania;Sweden | ||
| 1339 | 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 | ||||
| 1340 | 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 | ||
| 1341 | NCT00139789 (ClinicalTrials.gov) | January 2005 | 29/8/2005 | A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis | A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis | Multiple Sclerosis | Drug: Kemstro | UCB Pharma | NULL | Completed | 18 Years | 65 Years | Both | 60 | Phase 3 | United States |
| 1342 | NCT00110396 (ClinicalTrials.gov) | January 2005 | 6/5/2005 | Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis | A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: Interferon-beta-1a FBS-free/HSA-free | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | All | 260 | Phase 3 | United States |
| 1343 | NCT00203099 (ClinicalTrials.gov) | December 2004 | 13/9/2005 | Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine | A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS) | Relapse Remitting Multiple Sclerosis | Drug: Glatiramer Acetate, N-Acetylcysteine | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 18 | Phase 2 | Canada |
| 1344 | 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 |
| 1345 | 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 |
| 1346 | EUCTR2004-000759-40-IT (EUCTR) | 22/10/2004 | 15/02/2005 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit. MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: glatiramer acetate Product Code: TV-5010 INN or Proposed INN: Glatiramer acetate | TEVA | NULL | Not Recruiting | Female: yes Male: yes | 25 | Italy | |||
| 1347 | EUCTR2004-000463-94-IT (EUCTR) | 11/10/2004 | 16/02/2005 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Subject with relapsing remitting multiple sclerosis. Subject must have at least one documented relapse within one year prior to screening visit MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: glatiramer acetate Product Code: GA INN or Proposed INN: Glatiramer acetate | TEVA | NULL | Not Recruiting | Female: yes Male: yes | 25 | Hungary;Italy | |||
| 1348 | EUCTR2004-000762-13-IT (EUCTR) | 31/08/2004 | 31/08/2012 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit. 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] | Product Name: Glatiramer acetate Product Code: TV-5010 INN or Proposed INN: Glatiramer acetate | TEVA ITALIA srl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 7 | Italy | |||
| 1349 | NCT00220922 (ClinicalTrials.gov) | August 2004 | 20/9/2005 | A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®. | An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® | Multiple Sclerosis | Procedure: Alcohol Wipes vs. No Alcohol Wipes | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 4 | United States |
| 1350 | EUCTR2004-000462-13-IT (EUCTR) | 30/07/2004 | 17/09/2004 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Subjects with Relapsing-Remitting Multiple Sclerosis.Subjects must have had at least one documented relapse within one year prior to screening visit MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: glatiramer acetate Product Code: GA INN or Proposed INN: Glatiramer acetate | TEVA | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Italy | ||||
| 1351 | EUCTR2004-000047-18-SE (EUCTR) | 27/07/2004 | 28/06/2004 | An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803. | An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803. | Male and female subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803 | Product Name: natalizumab Product Code: AN100226 INN or Proposed INN: natalizumab | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1900 | Sweden | |||
| 1352 | EUCTR2004-000337-12-HU (EUCTR) | 23/07/2004 | 29/09/2004 | A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study | A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study | MS with 2 or more relapses within the last 2 years MedDRA version: 7.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Rebif Product Code: Not applicable INN or Proposed INN: Interferon beta-1a Other descriptive name: Recombinant human interferon beta Trade Name: Rebif Product Name: Rebif Product Code: Not applicable INN or Proposed INN: Interferon beta-1a Other descriptive name: Recombinant human interferon beta | Serono International SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 4 | Hungary | ||
| 1353 | EUCTR2004-000462-13-HU (EUCTR) | 12/07/2004 | 12/07/2004 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). | Relapsing-remitting multiple sclerosis (R-R MS) MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets INN or Proposed INN: Glatiramer Acetate Other descriptive name: COP-1/Copolymer-1 | TEVA Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Hungary;Italy | |||
| 1354 | NCT00493077 (ClinicalTrials.gov) | May 2004 | 25/6/2007 | Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy | A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy | Multiple Sclerosis | Drug: low immunogenic interferon-beta-1a | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 3 | Phase 4 | Sweden |
| 1355 | 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 |
| 1356 | NCT00078338 (ClinicalTrials.gov) | March 2004 | 23/2/2004 | Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis | Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Human interferon beta-1a and glatiramer acetate | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | Both | 764 | Phase 4 | United States;Argentina;Austria;Brazil;France;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;United Kingdom |
| 1357 | NCT00501748 (ClinicalTrials.gov) | January 2004 | 12/7/2007 | Safety and Tolerability of Rituximab in Neuromyelitis Optica | Open Label Study of Safety and Tolerability of Rituximab in Neuromyelitis Optica, Recurrent Transverse Myelitis and Recurrent Bilateral Simultaneous Optic Neuritis | Neuromyelitis Optica | Drug: Rituximab | University of California, San Francisco | Genentech, Inc. | Completed | 12 Years | 86 Years | Both | 20 | Phase 1 | United States |
| 1358 | NCT00246324 (ClinicalTrials.gov) | December 2003 | 27/10/2005 | Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis | An Open Label Trial of Safety and Efficacy of Combination Therapy With Interferon-B-1a and Oral Doxycycline in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Interferon beta 1a, oral doxycycline | Louisiana State University Health Sciences Center Shreveport | Biogen | Completed | 18 Years | 55 Years | All | 16 | Phase 4 | United States |
| 1359 | NCT00276172 (ClinicalTrials.gov) | December 2003 | 11/1/2006 | Open-Label Natalizumab Safety Extension Study | An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803 | Multiple Sclerosis | Drug: Natalizumab | Biogen Idec | NULL | Completed | 18 Years | N/A | Both | 1615 | Phase 3 | United States |
| 1360 | NCT00099502 (ClinicalTrials.gov) | November 2003 | 15/12/2004 | BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients | International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily. | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046);Drug: Copaxone | Bayer | NULL | Completed | 18 Years | 55 Years | Both | 2244 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine |
| 1361 | NCT00654927 (ClinicalTrials.gov) | November 2003 | 4/4/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR b.i.d. (Twice Daily) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 177 | Phase 3 | United States;Canada |
| 1362 | NCT00493116 (ClinicalTrials.gov) | October 2003 | 25/6/2007 | Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta | A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 20 | Phase 4 | Australia;New Zealand |
| 1363 | NCT00203073 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis. | A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantrone | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | Both | 40 | Phase 2 | United States;Canada |
| 1364 | NCT00235989 (ClinicalTrials.gov) | June 2003 | 10/10/2005 | Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis | An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta 1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | All | 63 | Phase 2 | United States |
| 1365 | NCT00095329 (ClinicalTrials.gov) | May 2003 | 2/11/2004 | Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor | A Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple Sclerosis | Multiple Sclerosis (MS) - Relapsing-remitting | Biological: sirolimus | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Terminated | 18 Years | 58 Years | Both | 14 | Phase 1/Phase 2 | United States |
| 1366 | NCT00492466 (ClinicalTrials.gov) | March 2003 | 25/6/2007 | Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies | A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 14 | Phase 4 | Finland |
| 1367 | NCT00298662 (ClinicalTrials.gov) | February 2003 | 2/3/2006 | Combination Therapy of Betaseron-Prograf in Multiple Sclerosis | A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents | Multiple Sclerosis | Drug: Interferon beta-1b and Tacrolimus | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | Canada |
| 1368 | NCT00912860 (ClinicalTrials.gov) | January 2003 | 2/6/2009 | Immunogenicity and Safety Study of Serum-Free Avonex | A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1a | Biogen Idec | NULL | Completed | 18 Years | 60 Years | Both | 155 | Phase 2 | NULL |
| 1369 | NCT00050778 (ClinicalTrials.gov) | December 2002 | 19/12/2002 | A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: Interferon beta-1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg | Genzyme, a Sanofi Company | Bayer | Completed | 18 Years | 50 Years | All | 334 | Phase 2 | United States;Croatia;Poland;Russian Federation;United Kingdom |
| 1370 | NCT00913666 (ClinicalTrials.gov) | November 2002 | 2/6/2009 | Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers | A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects | Multiple Sclerosis | Drug: Interferon beta-1a (Avonex) | Biogen Idec | NULL | Completed | 18 Years | 65 Years | Both | 121 | Phase 4 | NULL |
| 1371 | 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 |
| 1372 | NCT00587691 (ClinicalTrials.gov) | July 2002 | 21/12/2007 | Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis | An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive | Biological: Tovaxin Autologous T Cell Vaccine | Opexa Therapeutics, Inc. | NULL | Completed | 18 Years | 65 Years | All | 16 | Phase 1/Phase 2 | United States |
| 1373 | NCT00047580 (ClinicalTrials.gov) | June 2002 | 8/10/2002 | Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity. | A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe Spasticity | Multiple Sclerosis;Muscle Spasticity;Spinal Cord Injury;Stroke | Drug: tizanidine hydrochloride capsule | Elan Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 120 | Phase 3 | United States |
| 1374 | NCT00037115 (ClinicalTrials.gov) | May 2002 | 15/5/2002 | Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event. | An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results. | Demyelinating Disorders;Multiple Sclerosis;Optic Neuritis;Myelitis;Neuritis | Drug: interferon beta 1a;Drug: methotrexate;Drug: methylprednisolone | MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute | Consultants in Neurology | Withdrawn | 18 Years | 50 Years | All | 0 | Phase 4 | United States |
| 1375 | NCT01606137 (ClinicalTrials.gov) | February 2002 | 21/5/2012 | A Study of the Long-term Safety of Sativex Use | A Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine. | Multiple Sclerosis;Spasticity;Pain | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 507 | Phase 3 | United Kingdom |
| 1376 | NCT00037102 (ClinicalTrials.gov) | July 2001 | 15/5/2002 | Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis | An Open Label Study of the Safety and Efficacy of Combination Therapy With AVONEX and Bi-Monthly High Dose Intravenous Methotrexate With Leucovorin Rescue in the Treatment of Multiple Sclerosis | Multiple Sclerosis | Drug: interferon beta 1a;Drug: methotrexate | MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute | Consultants in Neurology;Biogen | Completed | 18 Years | 60 Years | All | 16 | Phase 4 | United States |
| 1377 | 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 |
| 1378 | 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 |
| 1379 | 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 |
| 1380 | NCT00011375 (ClinicalTrials.gov) | February 2001 | 16/2/2001 | Rolipram to Treat Multiple Sclerosis | Safety, Tolerability & Effects of Rolipram on Inflammatory Activity in the Central Nervous System in Multiple Sclerosis. A Phase II, Open Label Crossover Trial Using MRI as an Outcome Measure | Multiple Sclerosis | Drug: Rolipram | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 52 | Phase 2 | United States |
| 1381 | NCT00292266 (ClinicalTrials.gov) | November 1999 | 13/2/2006 | A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS) | An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif®;Drug: Avonex® | EMD Serono | Merck Serono International SA | Completed | 18 Years | 55 Years | Both | 677 | Phase 3 | NULL |
| 1382 | NCT00915460 (ClinicalTrials.gov) | September 1999 | 5/6/2009 | Open-Label Safety Extension Study of Avonex | An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830 | Multiple Sclerosis | Drug: Interferon beta-1a (Avonex) | Biogen Idec | NULL | Completed | N/A | N/A | Both | 408 | Phase 4 | NULL |
| 1383 | NCT00001781 (ClinicalTrials.gov) | February 1998 | 3/11/1999 | Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS) | Open-Label Baseline vs. Treatment Trial Evaluating the Safety, Tolerability and Effect on MRI Lesion and Immunology Parameters of CGP 77116 in Patients With Multiple Sclerosis Mark | Multiple Sclerosis | Drug: CGP 77116 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 25 | Phase 2 | United States |
| 1384 | NCT00203021 (ClinicalTrials.gov) | March 26, 1994 | 12/9/2005 | Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness | Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer acetate | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | N/A | All | 208 | Phase 4 | United States |
| 1385 | 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 | |||
| 1386 | EUCTR2006-005270-47-DE (EUCTR) | 09/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | |||
| 1387 | 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 | |||||
| 1388 | EUCTR2014-004613-93-Outside-EU/EEA (EUCTR) | 12/01/2015 | Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosis | Open label study to evaluate the effect, safety and tolerability of 250µg (8 MIU) interferon beta 1b (Betaferon) given subcutaneously every other day (for 24 weeks) in patients of Chinese origin with multiple sclerosis | 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: Betaseron Product Code: BAY86-5046 INN or Proposed INN: INTERFERON BETA-1B | Bayer HealthCare AG | NULL | NA | Female: yes Male: yes | 35 | China | ||||
| 1389 | EUCTR2009-014724-32-DE (EUCTR) | 26/10/2010 | Boswellic Acids in Multiple Sclerosis | SAFETY, TOLERABILITY AND MECHANISM OF ACTION OF BOSWELLIC ACIDS (BA) IN MULTIPLE SCLEROSIS (MS) AND CLINICALLY ISOLATED SYNDROME (CIS): A MRI-CONTROLLED, MULTICENTER, BASELINE-TO-TREATMENT, 32-WEEKS, OPEN-LABEL, PHASE IIA TRIAL IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS OR CLINICALLY ISOLATED SYNDROME - SABA | Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BOSWELAN Product Code: BOSWELAN INN or Proposed INN: BOSWELAN Other descriptive name: Boswellia serrata extract PS0201Bo capsules | University Medical Center Eppendorf | NULL | Not Recruiting | 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 | Germany | |||
| 1390 | EUCTR2020-002700-39-EE (EUCTR) | 27/05/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | |||
| 1391 | EUCTR2016-003100-30-PL (EUCTR) | 21/07/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | |||
| 1392 | EUCTR2008-000499-25-DE (EUCTR) | 13/05/2008 | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS | Relapsing forms of Multiple Sclerosis (RMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Rebif New Formulation 44mcg multidose cartridge INN or Proposed INN: INTERFERON BETA-1A | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Germany;Spain;Italy;Sweden | |||
| 1393 | EUCTR2020-004128-41-DK (EUCTR) | 02/09/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | |||
| 1394 | EUCTR2016-003100-30-FR (EUCTR) | 17/07/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 65 | Phase 3 | Sweden;Germany;Netherlands;Norway;Bulgaria;Belgium;Poland;Czech Republic;France;Italy;United Kingdom;Switzerland;Russian Federation;Austria;Turkey;Spain;Greece;Portugal | |||
| 1395 | EUCTR2016-003100-30-Outside-EU/EEA (EUCTR) | 16/06/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 65 | Phase 3 | Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Greece;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation | |||
| 1396 | EUCTR2020-002700-39-BE (EUCTR) | 31/05/2021 | 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. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients 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: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | |||
| 1397 | EUCTR2004-003799-13-IE (EUCTR) | 13/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | |||
| 1398 | 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 | Belgium;Poland;Romania;Bulgaria;Germany;Sweden;Argentina;Canada;Hungary;Czech Republic;Egypt;United Kingdom;Austria;Lithuania;Turkey;Latvia;Netherlands;Australia;France;Italy;Switzerland;Russian Federation;Israel;Ireland;Spain;Greece;Slovakia;Estonia;Portugal;United States | |||
| 1399 | EUCTR2020-003413-35-PL (EUCTR) | 01/03/2021 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optic 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: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Enspryng Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 127 | Phase 3 | United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of | |||
| 1400 | EUCTR2016-003100-30-BG (EUCTR) | 02/06/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | 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: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway | |||
| 1401 | EUCTR2021-000063-79-DE (EUCTR) | 25/08/2021 | A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 20 | Phase 4 | France;United States;Canada;Spain;Germany;United Kingdom;Switzerland;Italy | |||
| 1402 | 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 | |||
| 1403 | 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 | |||||
| 1404 | 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 | |||
| 1405 | EUCTR2018-003008-38-FR (EUCTR) | 29/03/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | 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: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | NA | Female: yes Male: yes | 142 | 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;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany | |||
| 1406 | 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 | ||||
| 1407 | EUCTR2020-004128-41-AT (EUCTR) | 01/12/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 1408 | EUCTR2011-001692-39-DE (EUCTR) | 08/06/2011 | A study to evaluate the safety and tolerability of the combination of an antidepressive therapy with oral fingolimod in the treatment of relapsing remitting multiple sclerosis patients with mild to moderate depression | A 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depression | Multiple SclerosisDepression MedDRA version: 14.1;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric 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] | Trade Name: Gilenya Product Name: Gilenya Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Venlafaxin Hexal Product Name: Venlafaxin Hexal Other descriptive name: VENLAFAXINE HYDROCHLORIDE Trade Name: Fluoxetin Hexal Product Name: Fluoxetin Hexal INN or Proposed INN: FLUOXETINE HYDROCHLORIDE Trade Name: Venlafaxin Hexal Product Name: Venlafaxin Hexal Other descriptive name: VENLAFAXINE HYDROCHLORIDE Trade Name: Fluoxetin Hexal Product Name: Fluoxetin Hexal INN or Proposed INN: FLUOXETINE HYDROCHLORIDE Trade Name: Gilenya Product Name: Gilenya Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | |||||
| 1409 | 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 | ||||
| 1410 | EUCTR2020-004128-41-FR (EUCTR) | 23/07/2021 | 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 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: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany |
75. クッシング病
臨床試験数 : 203 / 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128
| 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 | EUCTR2018-001616-30-DE (EUCTR) | 22/12/2020 | 16/03/2020 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | United States;Hungary;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy | ||
| 2 | NCT03708900 (ClinicalTrials.gov) | October 30, 2020 | 8/10/2018 | Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease | A Phase II, Multicenter, Open-label, Non-comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Osilodrostat in Children and Adolescent Patients With Cushing's Disease | Cushing's Disease | Drug: LCI699 | Novartis Pharmaceuticals | NULL | Recruiting | 6 Years | 18 Years | All | 12 | Phase 2 | Belgium;Bulgaria;Italy;Slovenia;United Kingdom |
| 3 | EUCTR2018-001616-30-BG (EUCTR) | 27/03/2020 | 24/02/2020 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | United States;Hungary;Canada;Spain;Poland;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy | ||
| 4 | EUCTR2018-001616-30-ES (EUCTR) | 14/02/2020 | 10/01/2020 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;Germany;Netherlands;Bulgaria;Israel;Austria;Romania;Spain;Poland;Canada;Hungary;United States | ||
| 5 | EUCTR2018-001522-25-IT (EUCTR) | 20/01/2020 | 28/04/2020 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy | ||
| 6 | EUCTR2017-002840-34-NL (EUCTR) | 14/11/2019 | 31/07/2019 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 7 | EUCTR2018-001522-25-ES (EUCTR) | 02/10/2019 | 26/07/2019 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Belgium;Spain;Bulgaria;Italy;United Kingdom | ||
| 8 | EUCTR2017-004647-20-NL (EUCTR) | 29/08/2019 | 23/11/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Hungary;Greece;Poland;Spain;Romania;Israel;Bulgaria;Netherlands;Italy | ||
| 9 | EUCTR2017-002840-34-FR (EUCTR) | 08/07/2019 | 14/06/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 10 | EUCTR2018-001522-25-BG (EUCTR) | 04/07/2019 | 26/03/2019 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy | ||
| 11 | EUCTR2017-002840-34-BG (EUCTR) | 18/06/2019 | 07/09/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 12 | EUCTR2018-001522-25-BE (EUCTR) | 05/06/2019 | 30/04/2019 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy | ||
| 13 | EUCTR2018-001522-25-SI (EUCTR) | 10/05/2019 | 16/10/2018 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Italy;United Kingdom;Bulgaria;Belgium;Spain;Slovenia;United States | ||
| 14 | EUCTR2017-004647-20-GR (EUCTR) | 21/03/2019 | 19/02/2019 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 15 | EUCTR2018-001522-25-GB (EUCTR) | 19/03/2019 | 27/09/2018 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;Italy;United Kingdom | ||
| 16 | EUCTR2017-004647-20-BG (EUCTR) | 11/02/2019 | 24/10/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Hungary;Greece;Poland;Spain;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 17 | EUCTR2017-002840-34-BE (EUCTR) | 07/02/2019 | 16/11/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 18 | EUCTR2017-004647-20-ES (EUCTR) | 17/01/2019 | 25/10/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 19 | EUCTR2017-004647-20-IT (EUCTR) | 11/01/2019 | 15/11/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 20 | NCT03621280 (ClinicalTrials.gov) | January 7, 2019 | 18/5/2018 | Open-label Treatment in Cushing's Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome | Cushing Syndrome;Cushing Disease | Drug: Levoketoconazole | Cortendo AB | NULL | Active, not recruiting | 18 Years | N/A | All | 60 | Phase 3 | United States;Bulgaria;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain;Denmark;Turkey |
| 21 | EUCTR2017-004647-20-HU (EUCTR) | 13/11/2018 | 26/09/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | Hungary;Poland;Romania;United States;Greece;Spain;Turkey;Israel;Italy;France;Denmark;Bulgaria;Netherlands | ||
| 22 | EUCTR2017-002840-34-ES (EUCTR) | 31/10/2018 | 11/07/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 23 | EUCTR2014-000162-22-RO (EUCTR) | 24/10/2018 | 27/07/2021 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules/ Cormeto Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | Hungary;Spain;Poland;Belgium;Turkey;Romania;Germany;Italy | ||
| 24 | NCT03606408 (ClinicalTrials.gov) | October 5, 2018 | 20/7/2018 | Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 | An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat | Cushing's Syndrome | Drug: osilodrostat | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 180 | Phase 2 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;China;Costa Rica;France;Germany;India;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Thailand;Turkey |
| 25 | EUCTR2017-002840-34-IT (EUCTR) | 01/10/2018 | 17/06/2021 | Roll-over study to assess long-term safety in patients with endogenous Cushing's syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat - NA | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Osilodrostat 1mg Product Code: [LCI699] INN or Proposed INN: Osilodrostat Product Name: Osilodrostat 5mg Product Code: [LCI699] INN or Proposed INN: Osilodrostat Product Name: Osilodrostat 10mg Product Code: [LCI699] INN or Proposed INN: Osilodrostat | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany | ||
| 26 | EUCTR2017-002840-34-AT (EUCTR) | 03/08/2018 | 22/05/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Thailand;Spain;Costa Rica;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 27 | EUCTR2018-001616-30-IT (EUCTR) | 19/07/2018 | 29/01/2021 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome - - | Endogenous Cushing Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Trade Name: NA Product Name: NA Product Code: [CORT125134] INN or Proposed INN: Relacorilant | CORCEPT THERAPEUTICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Hungary;Spain;Bulgaria;Germany;Italy | ||
| 28 | EUCTR2017-002840-34-DE (EUCTR) | 13/07/2018 | 29/05/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 29 | EUCTR2018-001616-30-HU (EUCTR) | 09/07/2018 | 14/05/2018 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Hungary;Italy | ||
| 30 | EUCTR2017-001219-35-NL (EUCTR) | 24/05/2018 | 29/11/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 3 | France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Bulgaria;Israel;Netherlands;Italy | ||
| 31 | EUCTR2017-001219-35-FR (EUCTR) | 23/05/2018 | 24/10/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 32 | EUCTR2017-001219-35-GR (EUCTR) | 08/05/2018 | 04/04/2018 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 33 | NCT03604198 (ClinicalTrials.gov) | May 7, 2018 | 1/5/2018 | Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome | Cushing Syndrome | Drug: relacorilant | Corcept Therapeutics | NULL | Enrolling by invitation | N/A | N/A | All | 75 | Phase 2 | United States;Austria;Bulgaria;Germany;Israel;Italy;Romania;Spain |
| 34 | EUCTR2017-001219-35-IT (EUCTR) | 20/02/2018 | 27/01/2021 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing¿s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing¿s Syndrome - - | Endogenous Cushing¿s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Levoketoconazole Product Code: [COR-003] INN or Proposed INN: levoketozonazole | CORTENDO AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 35 | EUCTR2017-001219-35-DK (EUCTR) | 14/02/2018 | 19/12/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 36 | EUCTR2017-001219-35-BG (EUCTR) | 23/01/2018 | 30/10/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 37 | EUCTR2017-001219-35-ES (EUCTR) | 22/01/2018 | 17/10/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 38 | EUCTR2017-001219-35-PL (EUCTR) | 16/01/2018 | 28/11/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | Denmark;Bulgaria;Israel;Netherlands;Italy;France;United States;Hungary;Greece;Spain;Poland;Romania | ||
| 39 | EUCTR2017-001219-35-HU (EUCTR) | 12/01/2018 | 16/11/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 40 | EUCTR2013-000267-84-BG (EUCTR) | 12/12/2017 | 18/09/2017 | Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment. | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment | Cushing's diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide 20mg Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide 40mg Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide 60mg Product Code: SOM230 INN or Proposed INN: pasireotide | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 4 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of | ||
| 41 | NCT03277690 (ClinicalTrials.gov) | September 26, 2017 | 7/9/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome | Endogenous Cushing's Syndrome | Drug: Levoketoconazole;Drug: Placebo | Cortendo AB | NULL | Completed | 18 Years | N/A | All | 44 | Phase 3 | United States;Bulgaria;Denmark;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain |
| 42 | ChiCTR-OPC-17011664 | 2017-08-01 | 2017-06-14 | A single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's disease | A single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's disease | Pituitary ACTH-secreting adenoma | Treatment group:lapatinib; | Peking Union Medical College Hospital | NULL | Pending | 18 | 75 | Both | Treatment group:30; | China | |
| 43 | EUCTR2013-000267-84-PT (EUCTR) | 24/04/2017 | 22/02/2017 | Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment. | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment | Cushing's diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma MedDRA version: 20.0;Level: PT;Classification code 10000599;Term: Acromegaly;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 21.0;Level: LLT;Classification code 10007271;Term: Carcinoid tumor;System Organ Class: 100000004864 MedDRA version: 21.0;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864 MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10027481;Term: Metastatic melanoma;System Organ Class: 100000004864 MedDRA version: 20.1;Classification code 10013810;Term: Dumping syndrome;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 21.1;Classification code 10064025;Term: Merkel cell carcinoma;System Organ Class: 100000004864;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide 20mg Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide 40mg Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide 60mg Product Code: SOM230 INN or Proposed INN: pasireotide | Recordati AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Thailand;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of | ||
| 44 | EUCTR2014-000162-22-PL (EUCTR) | 27/07/2016 | 21/04/2016 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Hungary;Belgium;Spain;Poland;Romania;Turkey;Germany;Italy | ||
| 45 | EUCTR2013-002133-37-HU (EUCTR) | 05/04/2016 | 24/09/2015 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | 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 | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden | ||
| 46 | EUCTR2013-002133-37-CZ (EUCTR) | 22/02/2016 | 27/07/2015 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole | Cortendo AB | 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 | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 47 | EUCTR2013-000267-84-PL (EUCTR) | 05/02/2016 | 16/12/2015 | Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment. | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment - Roll over protocol with pasireotide | Cushing's diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF MedDRA version: 21.0;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864 MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 20.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Not possible to specify | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of | ||
| 48 | EUCTR2013-002133-37-BG (EUCTR) | 15/10/2015 | 07/07/2015 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | 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 | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 49 | EUCTR2014-000162-22-HU (EUCTR) | 06/10/2015 | 08/07/2015 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 18.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | Hungary;Spain;Poland;Belgium;Germany;Italy | ||
| 50 | NCT02468193 (ClinicalTrials.gov) | September 24, 2015 | 8/6/2015 | Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome | A Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's Disease | Cushing's Syndrome;Ectopic Corticotropin Syndrome;Adrenal Adenoma;Adrenal Carcinoma;AIMAH;PPNAD | Drug: Osilodrostat | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 9 | Phase 2 | Japan |
| 51 | EUCTR2013-002133-37-DE (EUCTR) | 23/09/2015 | 12/06/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Sweden | ||
| 52 | EUCTR2013-002133-37-DK (EUCTR) | 31/07/2015 | 20/03/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden | ||
| 53 | EUCTR2012-002916-16-PL (EUCTR) | 29/06/2015 | 16/03/2015 | Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: pasireotide pamoate Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE PAMOATE Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE PAMOATE Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Phase 4 | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 54 | EUCTR2012-002916-16-BE (EUCTR) | 04/05/2015 | 31/03/2015 | Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 17.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 17.1;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 4 | United States;Spain;Thailand;Turkey;Russian Federation;India;Poland;Belgium;Brazil;Romania;Denmark;Peru;Bulgaria;Germany;Netherlands;China | ||
| 55 | EUCTR2014-000162-22-DE (EUCTR) | 04/05/2015 | 30/10/2014 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | Hungary;Spain;Poland;Belgium;Turkey;Romania;Germany;Italy | ||
| 56 | NCT02297945 (ClinicalTrials.gov) | April 2015 | 19/11/2014 | Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome | Prospective, Single Arm, Open-label, Multicenter, International Study to Assess the Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome During a 12-week Treatment Period Followed by an Extension Period of 24 Weeks | Cushing's Syndrome | Drug: metyrapone | HRA Pharma | NULL | Completed | 18 Years | N/A | All | 50 | Phase 3 | Belgium;Germany;Hungary;Italy;Poland;Romania;Spain;Turkey |
| 57 | EUCTR2014-000162-22-IT (EUCTR) | 19/03/2015 | 25/11/2014 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules/Cormeto Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United States;Hungary;Spain;Poland;Belgium;Germany;Switzerland;Italy;Sweden | ||
| 58 | EUCTR2013-000267-84-ES (EUCTR) | 11/03/2015 | 03/03/2015 | Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment. | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment - Roll over protocol with pasireotide | Cushing's disease Acromegaly Neuroendocrine tumors Pituitary tumors EctopicACTH secreting (EAS) tumors Dumping Syndrome Prostate cancer Melanomanegative for bRAF;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Taiwan;Greece;Spain;Thailand;Russian Federation;Israel;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;China;Korea, Republic of | |||
| 59 | EUCTR2014-000162-22-BE (EUCTR) | 11/03/2015 | 04/12/2014 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United States;Hungary;Spain;Poland;Belgium;Germany;Switzerland;Italy;Sweden | ||
| 60 | EUCTR2014-000162-22-ES (EUCTR) | 23/02/2015 | 16/01/2015 | Study to assess the effects of metyrapone in patients with Cushing?s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing?s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing?s syndrome MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Hungary;Poland;Belgium;Spain;Germany;Italy;Switzerland;Sweden | ||
| 61 | EUCTR2013-004766-34-NL (EUCTR) | 04/02/2015 | 21/08/2014 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Thailand;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 62 | EUCTR2013-004766-34-FR (EUCTR) | 28/11/2014 | 08/02/2019 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 63 | EUCTR2013-004766-34-GB (EUCTR) | 20/11/2014 | 22/07/2014 | Safety and efficacy of LCI699 for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 64 | EUCTR2013-002133-37-IT (EUCTR) | 17/11/2014 | 04/09/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) MedDRA version: 17.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole | Cortendo AB | 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 | United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden | ||
| 65 | EUCTR2013-002133-37-GB (EUCTR) | 17/11/2014 | 18/06/2013 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | 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 | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 66 | NCT02180217 (ClinicalTrials.gov) | October 6, 2014 | 17/6/2014 | Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease | Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease | Cushings Disease | Drug: osilodrostat;Drug: LCI699 matching placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 137 | Phase 3 | United States;Argentina;Austria;Bulgaria;Canada;China;Colombia;France;Germany;India;Italy;Japan;Korea, Republic of;Netherlands;Russian Federation;Spain;Thailand;Turkey;United Kingdom;Australia |
| 67 | EUCTR2013-004766-34-DE (EUCTR) | 06/10/2014 | 29/07/2014 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699, 1 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699, 5 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699, 10 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699, 20 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Thailand;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 68 | EUCTR2013-002133-37-SE (EUCTR) | 18/09/2014 | 12/03/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | 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 | Serbia;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 69 | EUCTR2012-002916-16-DE (EUCTR) | 19/08/2014 | 17/03/2014 | Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 300micrograms INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 600 micrograms INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 900 micrograms INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE DIASPARTATE Product Name: pasireotide LAR Product Code: SOM230 LAR, 20 mg INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 70 | EUCTR2013-004766-34-ES (EUCTR) | 13/08/2014 | 11/08/2014 | Safety and efficacy of LCI699 for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing?s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 71 | EUCTR2013-004766-34-AT (EUCTR) | 05/08/2014 | 31/07/2014 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 72 | EUCTR2013-004766-34-IT (EUCTR) | 01/08/2014 | 13/06/2014 | Safety and efficacy of LCI699 for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Korea, Republic of;Japan;China;Germany;Netherlands;Bulgaria;Australia;Argentina;Canada;France;India;Italy;United Kingdom;Colombia;Russian Federation;Austria;Turkey;Spain;Thailand;Slovakia;Taiwan | ||
| 73 | NCT01838551 (ClinicalTrials.gov) | August 2014 | 19/4/2013 | Treatment for Endogenous Cushing's Syndrome | An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome | Endogenous Cushing's Syndrome | Drug: Levoketoconazole | Cortendo AB | NULL | Completed | 18 Years | N/A | All | 90 | Phase 3 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Serbia;Spain;Turkey;Czech Republic;Georgia;Hungary;Sweden;Switzerland;United Kingdom |
| 74 | EUCTR2013-002133-37-NL (EUCTR) | 10/07/2014 | 11/03/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | 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 | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Germany;Netherlands;Sweden | ||
| 75 | EUCTR2013-002133-37-BE (EUCTR) | 09/07/2014 | 11/02/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden | ||
| 76 | EUCTR2012-002916-16-DK (EUCTR) | 01/07/2014 | 09/04/2014 | Study of management of pasireotide-induced hyperglycemiain adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study toinvestigate the management of pasireotide-inducedhyperglycemia with incretin based therapy or insulin inadult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: SOM230B Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide LAR Product Code: SOM230 LAR Other descriptive name: PASIREOTIDE PAMOATE Product Name: pasireotide LAR Product Code: SOM230 LAR Other descriptive name: PASIREOTIDE PAMOATE Product Name: pasireotide LAR Product Code: SOM230 LAR Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Phase 4 | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 77 | EUCTR2013-002133-37-ES (EUCTR) | 26/05/2014 | 12/11/2013 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have a medical condition in which they produce too much of a steriod hormone known as cortisol | An Open Label Study to Assess the Safety and Efficiacy of COR-003 (2S,4R- Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome (CS) Estudio abierto para evaluar la seguridad y la eficacia del producto COR-003 (2S, 4R-ketoconazol) en el tratamiento del síndrome de Cushing endógeno (SC) | Endogenous Cushing's syndrome (CS) MedDRA version: 16.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole | Cortendo AB | 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 | United States;Serbia;Spain;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Germany;China;Sweden | ||
| 78 | NCT02060383 (ClinicalTrials.gov) | May 23, 2014 | 10/2/2014 | Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly | A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly | Cushing's Disease;Acromegaly | Drug: Pasireotide s.c.;Drug: Sitagliptin;Drug: Liraglutide;Drug: Insulin;Drug: Pasireotide LAR;Drug: Metformin | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 249 | Phase 4 | United States;Belgium;Brazil;China;Denmark;Germany;India;Peru;Poland;Russian Federation;Thailand;Turkey |
| 79 | EUCTR2013-002063-26-IT (EUCTR) | 08/09/2013 | 23/07/2013 | A trial with Metyrapone in Cushing's syndrome | A prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma. - METYX01 | Cushing's syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Matyrapone Product Name: Metyrapone Product Code: Metyrapone | S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2 | Italy | ||
| 80 | EUCTR2013-000267-84-FR (EUCTR) | 07/08/2013 | 23/09/2015 | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment | Cushing’s diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Greece;Spain;Thailand;Russian Federation;Israel;Italy;France;Mexico;Canada;Belgium;Brazil;Australia;Germany;Norway;China | |||
| 81 | NCT01925092 (ClinicalTrials.gov) | August 2013 | 8/8/2013 | Mifepristone in Children With Refractory Cushing's Disease | An Open-label Study of the Safety, Pharmacokinetics and Pharmacodynamics of Mifepristone in Children With Refractory Cushing's Disease | Cushing's Disease | Drug: mifepristone | Corcept Therapeutics | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Withdrawn | 6 Years | 17 Years | Both | 0 | Phase 3 | United States |
| 82 | NCT01794793 (ClinicalTrials.gov) | June 10, 2013 | 15/2/2013 | Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies | An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment | Cushing's Disease;Acromegaly;Neuroendocrine Tumors;Pituitary Tumors;Ectopic ACTH Secreting (EAS) Tumors;Dumping Syndrome;Prostate Cancer;Melanoma Negative for bRAF;Melanoma Negative for nRAS | Drug: Pasireotide;Drug: Cabergoline | RECORDATI GROUP | NULL | Active, not recruiting | 18 Years | N/A | All | 413 | Phase 4 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Taiwan;Thailand;Turkey;China |
| 83 | EUCTR2013-000267-84-IT (EUCTR) | 07/06/2013 | 08/04/2013 | Protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment | Cushing’s diseaseNeuroendocrine tumors MedDRA version: 14.1;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864 MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE Other descriptive name: NA Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE Other descriptive name: NA Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE Other descriptive name: NA Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate | NOVARTIS FARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Mexico;Canada;Belgium;Brazil;Thailand;Australia;Israel;Russian Federation;China;Italy | |||
| 84 | EUCTR2013-000267-84-BE (EUCTR) | 05/06/2013 | 22/04/2013 | Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment. | An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment | Cushing's diseaseAcromegalyCarcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanomaMetastatic Merkel cell carcinoma;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;United States;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;China | ||
| 85 | EUCTR2010-024165-44-NL (EUCTR) | 24/04/2012 | 22/12/2011 | Study of pasireotide s.c. in patients with Cushing's disease | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: SOM230 INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;Czech Republic;Egypt;Netherlands;Argentina;Korea, Republic of;Romania;Thailand;Spain;Greece;Brazil | |||
| 86 | EUCTR2009-011128-70-NL (EUCTR) | 18/11/2011 | 10/08/2011 | A phase 3 studie to evaluate if pasireotide is safe and works in patients with Cushing’s disease | A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | Cushing's disease MedDRA version: 16.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Germany;China;Japan | ||
| 87 | NCT01374906 (ClinicalTrials.gov) | November 4, 2011 | 14/6/2011 | Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease | A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease | Cushing's Disease | Drug: pasireotide LAR;Drug: SOM230 LAR 30 mg;Drug: SOM230 LAR 10 mg | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 150 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;China;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Russian Federation;Spain;Thailand;Turkey;United Kingdom |
| 88 | EUCTR2009-011128-70-BE (EUCTR) | 25/10/2011 | 07/09/2011 | A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;China;Japan | ||
| 89 | EUCTR2009-011128-70-PL (EUCTR) | 12/10/2011 | 14/09/2011 | phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's disease | A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease - | Cushing's disease MedDRA version: 17.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Belgium;Poland;Brazil;Peru;Germany;China;Japan | ||
| 90 | EUCTR2009-011128-70-IT (EUCTR) | 10/10/2011 | 28/02/2012 | A phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing's disease | A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing's disease | Cushing's disease MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE Other descriptive name: NA Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;China;Japan | ||
| 91 | EUCTR2009-011128-70-DE (EUCTR) | 04/10/2011 | 22/07/2011 | phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's disease | A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: pasireotide pamoate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Peru;Germany;China;Japan | ||
| 92 | EUCTR2009-011128-70-ES (EUCTR) | 22/09/2011 | 18/07/2011 | Estudio de fase III, de muchos centros, aleatorizado a dos dosis distintas de medicación sin que el médico ni el paciente sepa en cual está, para evaluar la eficacia y seguridad de pasireotida LAR (de larga duración) en pacientes con enfermedad de Cushing. | Estudio de fase III, multicéntrico, aleatorizado y doble ciego, para evaluar la eficacia y seguridad de pasireotida LAR en pacientes con enfermedad de Cushing | Enfermedad de Cushing MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: Pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: Pasireotide | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Spain;Thailand;Turkey;Japan;China;Germany;Peru;Singapore;Brazil;Belgium;Poland;Argentina;Canada;United Kingdom;Italy;Russian Federation | ||
| 93 | EUCTR2010-024165-44-CZ (EUCTR) | 02/09/2011 | 18/07/2011 | safety and efficacy of pasireotide s.c. in patients with Cushing's disease | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE INN or Proposed INN: PASIREOTIDE DIASPARTATE INN or Proposed INN: PASIREOTIDE DIASPARTATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Czech Republic;Greece;Brazil;Thailand;Spain;Romania;Russian Federation;Netherlands;Germany;Korea, Republic of | |||
| 94 | EUCTR2009-011128-70-GB (EUCTR) | 24/08/2011 | 15/07/2011 | A randomized, double-blind, multicentre, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | A randomized, double-blind, multicentre, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | Cushing's disease MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;China;Japan | ||
| 95 | NCT01582061 (ClinicalTrials.gov) | August 16, 2011 | 12/4/2012 | An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. | An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape). | Cushing's Disease | Drug: Pasireotide sub-cutaneous | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 104 | Phase 3 | United States;Brazil;Czechia;Germany;Greece;Korea, Republic of;Lebanon;Romania;Russian Federation;Spain;Thailand;Czech Republic;Egypt;Netherlands |
| 96 | EUCTR2010-024165-44-GR (EUCTR) | 09/08/2011 | 22/06/2011 | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders | Product Name: N/A Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: - INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Czech Republic;Greece;Spain;Netherlands;Germany | |||
| 97 | EUCTR2010-024165-44-DE (EUCTR) | 05/08/2011 | 12/05/2011 | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Name: Signifor Product Code: SOM230 300µg INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: Signifor Product Code: SOM230 600µg INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: Signifor Product Code: SOM230 900µg INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Czech Republic;Greece;Spain;Netherlands;Germany | ||
| 98 | EUCTR2010-022403-22-IT (EUCTR) | 04/07/2011 | 20/09/2011 | Open-label, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s disease | A proof-of concept, open-label, forced titration, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s disease | Cushing's disease MedDRA version: 14.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: LCI699 Product Code: LCI699 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | United States;Italy | ||
| 99 | NCT01331239 (ClinicalTrials.gov) | March 23, 2011 | 6/4/2011 | Safety and Efficacy of LCI699 in Cushing's Disease Patients. | A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 Followed by a 12 - Week Treatment Period of LCI699 in Patients With Cushing's Disease | Cushing's Disease | Drug: LCI699 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 33 | Phase 2 | United States;France;Italy;Japan |
| 100 | NCT00936741 (ClinicalTrials.gov) | July 2009 | 9/7/2009 | An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome | An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome | Cushing's Syndrome | Drug: mifepristone | Corcept Therapeutics | NULL | Completed | 18 Years | N/A | All | 30 | Phase 3 | United States |
| 101 | EUCTR2008-002280-14-FR (EUCTR) | 18/07/2008 | 06/06/2008 | Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial | Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial | The Active substance of Osteopor is Ossein Hydroxyapatite.Treatment of processes characterized by decalcification: osteoporosis, Cushing syndrome, thyrotoxicosis. MedDRA version: 9.1;Level: LLT;Classification code 10006956;Term: Calcium deficiency | Trade Name: OSTEOPOR Product Name: OSTEOPOR Product Code: L0006CP03A INN or Proposed INN: ossein hydroxyapatite Trade Name: OROCAL Product Name: OROCAL INN or Proposed INN: calcium carbonate | Pierre Fabre Médicament | NULL | Not Recruiting | Female: yes Male: no | 60 | Phase 3 | France | ||
| 102 | NCT00569582 (ClinicalTrials.gov) | December 2007 | 5/12/2007 | A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome | An Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome | Cushing's Syndrome | Drug: mifepristone | Corcept Therapeutics | NULL | Completed | 18 Years | N/A | All | 50 | Phase 3 | United States |
| 103 | NCT00422201 (ClinicalTrials.gov) | May 15, 2007 | 12/1/2007 | Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion | Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion | Cushing's Syndrome | Drug: Mifepristone | HRA Pharma | NULL | Terminated | 18 Years | 85 Years | All | 18 | Phase 2 | United States;France;Germany;Italy;Netherlands;United Kingdom |
| 104 | EUCTR2006-004080-55-NL (EUCTR) | 26/04/2007 | 19/01/2007 | Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease | Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease | The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease | Product Name: SOM230 Product Code: SOM230B INN or Proposed INN: pasireotide Trade Name: Dostinex Product Name: Dostinex INN or Proposed INN: CABERGOLINE Trade Name: Nizoral Product Name: Ketoconazole INN or Proposed INN: KETOCONAZOLE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 105 | EUCTR2006-004679-36-DE (EUCTR) | 05/04/2007 | 09/10/2006 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. MedDRA version: 14.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Classification code 10014146;Term: Ectopic ACTH syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: HRA052015 INN or Proposed INN: mifepristone Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 35 | France;United States;Netherlands;Germany;Italy | |||
| 106 | NCT00612066 (ClinicalTrials.gov) | April 2007 | 8/2/2008 | Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease) | An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease | Cushing's Disease | Drug: rosiglitazone maleate | Jonsson Comprehensive Cancer Center | National Institutes of Health (NIH) | Terminated | 18 Years | 65 Years | All | 2 | Phase 2 | United States |
| 107 | EUCTR2006-004679-36-NL (EUCTR) | 22/03/2007 | 31/01/2007 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome | Product Code: HRA052015 INN or Proposed INN: mifepristone Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 22 | Germany;Netherlands;France;Italy | |||
| 108 | EUCTR2006-004679-36-IT (EUCTR) | 15/01/2007 | 30/01/2007 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EAS | Cushing s Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone ACTH Secretion MedDRA version: 9.1;Level: LLT;Classification code 10014146;Term: Ectopic ACTH syndrome | Product Name: Mifepristone Product Code: HRA052015 | LABORATOIRE HRA PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 22 | Germany;Netherlands;France;Italy | |||
| 109 | EUCTR2006-004679-36-FR (EUCTR) | 13/12/2006 | 29/09/2006 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome | Product Code: HRA052015 INN or Proposed INN: mifepristone Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 22 | France;Netherlands;Germany;Italy | |||
| 110 | NCT01959711 (ClinicalTrials.gov) | January 2006 | 6/10/2013 | Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy | Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-up | Adrenal Tumor;Pheochromocytoma;Conn's Syndrome;Cushing's Syndrome | Procedure: Posterior RA;Procedure: Lateral transperitoneal LA | Jagiellonian University | NULL | Completed | 18 Years | 80 Years | Both | 65 | Phase 4 | Poland |
| 111 | EUCTR2004-002407-32-GB (EUCTR) | 13/01/2005 | 27/06/2005 | Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's disease | Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's disease | Cushing’s disease is an endocrine disease that is caused by an Adrenocorticotropic hormone (ACTH) secreting pituitary adenoma, which is a benign tumor of the pituitary gland. This elevated ACTH stimulates the adrenal glands to produce excess cortisol and subsequent development of the clinical signs and symptoms which include: upper body obesity, severe fatigue and muscle weakness, high blood pressure, backache, elevated blood sugar, and menstrual disorders in women | Product Code: SOM230B INN or Proposed INN: Pasireotide Other descriptive name: Cyclo(diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) | Novartis Pharmaceuticals UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 26 | Italy;United Kingdom | |||
| 112 | EUCTR2004-002407-32-IT (EUCTR) | 21/10/2004 | 16/09/2004 | \\ | Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's disease | Treatment of Cushing's disease MedDRA version: 14.1;Level: PT;Classification code 10035109;Term: Pituitary-dependent Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NA Product Code: SOM230B INN or Proposed INN: PASIREOTIDE | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 26 | United Kingdom;Italy | |||
| 113 | NCT00088608 (ClinicalTrials.gov) | April 2004 | 30/7/2004 | A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease | A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease | Cushing's Syndrome | Drug: SOM230 s.c. | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | Both | 26 | Phase 2 | United States;France;Italy;United Kingdom |
| 114 | EUCTR2017-002840-34-PL (EUCTR) | 05/03/2020 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | NA | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Thailand;Spain;Costa Rica;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of |
76. 下垂体性ゴナドトロピン分泌亢進症
臨床試験数 : 28 / 薬物数 : 46 - (DrugBank : 14) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 19
| 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 | NCT05029622 (ClinicalTrials.gov) | August 10, 2021 | 9/8/2021 | A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. | A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty. | Central Precocious Puberty | Drug: Triptorelin Pamoate | Ipsen | NULL | Recruiting | N/A | 10 Years | All | 66 | Phase 3 | China |
| 2 | NCT04736602 (ClinicalTrials.gov) | March 27, 2021 | 29/1/2021 | Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. | An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 3-month Formulation in Chinese Children With Central Precocious Puberty | Central Precocious Puberty | Drug: Triptorelin pamoate 15mg | Ipsen | NULL | Active, not recruiting | N/A | 10 Years | All | 32 | Phase 3 | China |
| 3 | NCT03695237 (ClinicalTrials.gov) | October 24, 2018 | 2/10/2018 | A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Formulation in Children With Central Precocious Puberty (CPP) | A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP) | Central Precocious Puberty (CPP) | Drug: Leuprolide Acetate (LA) | AbbVie | NULL | Active, not recruiting | 2 Years | 11 Years | All | 40 | Phase 3 | United States;Puerto Rico |
| 4 | NCT02811471 (ClinicalTrials.gov) | June 2016 | 21/6/2016 | Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty | An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty—Part A and B | Central Precocious Puberty | Drug: Leuprolide | Nemours Children's Clinic | Tolmar Inc. | Recruiting | 2 Years | 9 Years | Both | 5 | Phase 3 | United States |
| 5 | NCT02452931 (ClinicalTrials.gov) | August 31, 2015 | 5/5/2015 | Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty | An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty | Precocious Puberty, Central | Drug: Leuprolide Acetate 45 mg | Tolmar Inc. | NULL | Completed | 2 Years | 9 Years | All | 64 | Phase 3 | United States;Argentina;Canada;Chile;Mexico;New Zealand |
| 6 | NCT02427958 (ClinicalTrials.gov) | August 7, 2015 | 23/4/2015 | A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants | An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty | Central Precocious Puberty | Drug: Leuprorelin | Takeda | NULL | Completed | 1 Year | 9 Years | All | 307 | Phase 4 | China |
| 7 | NCT01467882 (ClinicalTrials.gov) | April 2012 | 7/11/2011 | Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty | An Open-label, Non-comparative, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Triptorelin Pamoate (Embonate) 22.5 mg 6-month Formulation in Patients Suffering From Central (Gonadotropin-dependent) Precocious Puberty | Central Precocious Puberty | Drug: Triptorelin | Debiopharm International SA | NULL | Completed | 2 Years | 9 Years | All | 44 | Phase 3 | United States;Chile;Mexico |
| 8 | NCT00667446 (ClinicalTrials.gov) | December 2008 | 24/4/2008 | Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty | A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty | Precocious;Leuprolide Acetate;Luteinizing Hormone (LH);Gonadotrophin-releasing Hormone Agonist (GnRHa);Tanner Staging;Depot Formulation;Suppression of LH;Central Precocious Puberty (CPP);Gonadotrophin-releasing Hormone (GnRH);Lupron;GnRH Analog;Pediatrics Central Precocious Puberty | Drug: Leuprolide Acetate 3 Month Depot | AbbVie (prior sponsor, Abbott) | NULL | Completed | N/A | N/A | All | 72 | Phase 3 | United States;Puerto Rico |
| 9 | NCT00635817 (ClinicalTrials.gov) | June 2008 | 7/3/2008 | A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty | A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children With Central Precocious Puberty | Puberty, Precocious | Drug: Leuprolide acetate 11.25 mg;Drug: Leuprolide acetate 30 mg | Abbott | NULL | Completed | 2 Years | 11 Years | All | 84 | Phase 3 | United States;Puerto Rico |
| 10 | NCT00779103 (ClinicalTrials.gov) | September 2004 | 22/10/2008 | Histrelin Subcutaneous Implant in Children With Central Precocious Puberty | Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty | Central Precocious Puberty | Drug: Histrelin Subcutaneous Implant | Endo Pharmaceuticals | NULL | Completed | 2 Years | 10 Years | Both | 36 | Phase 3 | NULL |
| 11 | EUCTR2014-004494-16-Outside-EU/EEA (EUCTR) | 03/12/2014 | A clinical trial to determine safety and efficacy of Leuprolide Acetate 11.25mg and 30mg in children with central premature puberty | A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate theSafety of Leuprolide Acetate 11.25 mg and 30 mg Formulations inChildren with Central Precocious Puberty | Central Precocious Puberty MedDRA version: 17.1;Level: LLT;Classification code 10073186;Term: Central precocious puberty;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: trade name depends on the source of the product INN or Proposed INN: LEUPRORELIN ACETATE Trade Name: trade name depends on the source of the product’ INN or Proposed INN: LEUPRORELIN ACETATE | Abbvie previously known as Abbott | NULL | NA | Female: yes Male: yes | 72 | United States;Puerto Rico | ||||
| 12 | EUCTR2014-004493-42-Outside-EU/EEA (EUCTR) | 03/12/2014 | A clinical trial to determine safety and efficacy of Leuprolide Acetate 11.25mg and 30mg in children with central premature puberty | A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate theEfficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulationsin Children with Central Precocious Puberty | Central Precocious Puberty MedDRA version: 17.1;Level: LLT;Classification code 10073186;Term: Central precocious puberty;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: trade name depends on the source of the product Product Name: Leuprolide acetate depot INN or Proposed INN: LEUPRORELIN ACETATE Trade Name: trade name depends on the source of the product INN or Proposed INN: LEUPRORELIN ACETATE | Abbvie previously known as Abbott | NULL | NA | Female: yes Male: yes | 80 | Phase 3 | United States;Puerto Rico | |||
| 13 | EUCTR2015-001607-30-Outside-EU/EEA (EUCTR) | 24/04/2015 | Triptorelin 6-month formulation for children who mature too early because of a brain hormone | An open-label, non-comparative, multicenter study on the efficacy, safety, and pharmacokinetics of triptorelin pamoate (embonate) 22.5 mg 6-month formulation in patients suffering from central (gonadotropin-dependent) precocious puberty - Triptorelin 6-month Formulation in Patients With Central Precocious Puberty | Central Precocious Puberty MedDRA version: 18.0;Level: PT;Classification code 10058084;Term: Precocious puberty;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | INN or Proposed INN: TRIPTORELIN Other descriptive name: Triptorelin embonate, Triptorelin pamoate | Debiopharm International, S.A. | NULL | NA | Female: yes Male: yes | 44 | United States;Chile;Mexico |
222. 一次性ネフローゼ症候群
臨床試験数 : 285 / 薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191
| 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 | NCT05267262 (ClinicalTrials.gov) | March 15, 2022 | 23/2/2022 | Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental Glomerulosclerosis | A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGC | Alport Syndrome;Focal Segmental Glomerulosclerosis | Drug: R3R01 | River 3 Renal Corp. | IQVIA Biotech | Not yet recruiting | 12 Years | N/A | All | 50 | Phase 2 | NULL |
| 2 | EUCTR2021-000621-27-IT (EUCTR) | 11/01/2022 | 12/10/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: [RE-021] INN or Proposed INN: Sparsentan | TRAVERE THERAPEUTICS, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | NCT04983888 (ClinicalTrials.gov) | November 17, 2021 | 21/7/2021 | Obinutuzumab in Primary FSGS | A Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose Corticosteroids | Primary Focal Segmental Glomerulosclerosis | Drug: Obinutuzumab | Mayo Clinic | Genentech, Inc. | Recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 4 | NCT05162066 (ClinicalTrials.gov) | October 29, 2021 | 26/11/2021 | BCX9930 for the Treatment of C3G, IgAN, and PMN (RENEW) | An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With C3G, IgAN, or PMN | Complement 3 Glomerulopathy;Immunoglobulin A Nephropathy;Membranous Nephropathy | Drug: BCX9930 | BioCryst Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 42 | Phase 2 | Italy;Spain |
| 5 | EUCTR2020-005855-19-ES (EUCTR) | 11/10/2021 | 05/08/2021 | Evaluating oral BCX9930 in renal diseases | An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW | complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride | BioCryst Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | France;Spain;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2021-000621-27-ES (EUCTR) | 08/10/2021 | 27/07/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 57 | Phase 2 | Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States;Poland | ||
| 7 | EUCTR2020-005855-19-IT (EUCTR) | 01/10/2021 | 22/10/2021 | Evaluating oral BCX9930 in renal diseases | An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW | complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: BCX9930 Product Code: [BCX9930] INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Product Name: BCX9930 Product Code: [BCX9930] INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride | BIOCRYST PHARMACEUTICALS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | France;Spain;Germany;United Kingdom;Italy | ||
| 8 | NCT05003986 (ClinicalTrials.gov) | August 12, 2021 | 29/7/2021 | Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular Diseases | Focal Segmental Glomerulosclerosis;Minimal Change Disease;Immunoglobulin A Nephropathy;Immunoglobulin A-Associated Vasculitis;Alport Syndrome | Drug: Sparsentan | Travere Therapeutics, Inc. | NULL | Recruiting | 1 Year | 17 Years | All | 57 | Phase 2 | United States;Poland;Spain |
| 9 | ChiCTR2100048382 | 2021-07-01 | 2021-07-06 | Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial | Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial | Idiopathic membranous nephropathy | Experimental group:On the basis of ACEI/ARB, tripterygium wilfordii polyglycoside tablets were added;Control group:The original dose of ACEI/ARB was used for treatment; | Department of Nephrology, Sichuan Provincial People's Hospital | NULL | Recruiting | 18 | 65 | Both | Experimental group:18;Control group:18; | N/A | China |
| 10 | NCT04629248 (ClinicalTrials.gov) | June 25, 2021 | 27/10/2020 | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy | A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy | Primary Membranous Nephropathy | Drug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 140 | Phase 3 | United States;Argentina;Brazil;China;France;Israel;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine;Peru |
| 11 | EUCTR2020-004176-18-ES (EUCTR) | 21/06/2021 | 09/02/2021 | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - The AFFINITY Study | Proteinuric glomerular diseases, including:Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Spain;Australia;United Kingdom;Korea, Republic of | ||
| 12 | EUCTR2020-002637-15-FR (EUCTR) | 09/06/2021 | 02/02/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy | ||
| 13 | EUCTR2020-004176-18-IT (EUCTR) | 08/06/2021 | 08/06/2021 | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - AFFINITY Study | Proteinuric glomerular diseases, including: Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan Product Code: [atrasentan] INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | CHINOOK THERAPEUTICS, U.S., Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Spain;Australia;United Kingdom;Italy;Korea, Republic of | ||
| 14 | EUCTR2020-003233-38-PL (EUCTR) | 13/04/2021 | 24/02/2021 | A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy | A PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY | Primary Membranous Nephropathy (pMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro Product Name: Obinutuzumab Product Code: RO5072759 INN or Proposed INN: OBINUTUZUMAB Other descriptive name: OBINUTUZUMAB/ GA101 Product Name: Tacrolimus Product Code: RO0485337 INN or Proposed INN: Tacrolimus Product Name: Tacrolimus Product Code: RO0485337 INN or Proposed INN: Tacrolimus | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Peru;China | ||
| 15 | EUCTR2020-002637-15-IT (EUCTR) | 09/04/2021 | 04/06/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: [APL-2] INN or Proposed INN: Pegcetacoplan Trade Name: Prevenar 13 suspension for injection Product Name: Prevenar 13 suspension for injection Product Code: [na] INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg Trade Name: Pneumococcal polysaccharide vaccine Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial Product Code: [na] INN or Proposed INN: Pneumococcal Polysaccharide Vaccine Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide | APELLIS PHARMACEUTCIALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States | ||
| 16 | EUCTR2020-003233-38-IT (EUCTR) | 06/04/2021 | 04/06/2021 | A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy | A PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY - A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropa | Primary Membranous Nephropathy (pMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro Product Name: Obinutuzumab Product Code: [RO5072759] INN or Proposed INN: OBINUTUZUMAB Other descriptive name: OBINUTUZUMAB/ GA101 Trade Name: Prograf Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Prograf Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Adoport Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Prograf Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Adoport Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Brazil;Poland;Peru;China | ||
| 17 | EUCTR2020-002637-15-NL (EUCTR) | 29/03/2021 | 04/01/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy | ||
| 18 | NCT04572854 (ClinicalTrials.gov) | February 23, 2021 | 29/9/2020 | Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN | An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN | C3G;IC-MPGN;Renal Transplant;Complement 3 Glomerulopathy;Complement 3 Glomerulopathy (C3G);Dense Deposit Disease;Membranoproliferative Glomerulonephritis;Membranoproliferative Glomerulonephritis (MPGN);Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | Drug: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 19 | NCT04573920 (ClinicalTrials.gov) | February 1, 2021 | 28/9/2020 | Atrasentan in Patients With Proteinuric Glomerular Diseases | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases | IgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A Nephropathy | Drug: Atrasentan | Chinook Therapeutics U.S., Inc. | NULL | Recruiting | 18 Years | N/A | All | 80 | Phase 2 | United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom |
| 20 | NCT04733040 (ClinicalTrials.gov) | January 20, 2021 | 18/1/2021 | Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) | Glomerulonephritis;Membranous Nephropathy;antiPLA2R Positive | Drug: MOR202 | MorphoSys AG | NULL | Recruiting | 18 Years | 80 Years | All | 22 | Phase 2 | Georgia;Germany;Greece;Korea, Republic of;Russian Federation;Taiwan;United Kingdom |
| 21 | EUCTR2019-000780-24-PL (EUCTR) | 07/01/2021 | 14/09/2020 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Poland;Australia;Netherlands;Italy;Korea, Republic of | ||
| 22 | EUCTR2020-002637-15-GB (EUCTR) | 22/12/2020 | 23/10/2020 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Switzerland;Italy;United Kingdom | ||
| 23 | EUCTR2020-002985-15-DE (EUCTR) | 21/12/2020 | 31/08/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 24 | EUCTR2019-003607-35-CZ (EUCTR) | 26/11/2020 | 26/11/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan | ||
| 25 | EUCTR2019-003607-35-SK (EUCTR) | 12/11/2020 | 09/10/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan | ||
| 26 | EUCTR2019-003607-35-IT (EUCTR) | 03/11/2020 | 02/08/2021 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) - - | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: [PF-06730512] INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Czechia;Slovakia;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan | ||
| 27 | EUCTR2019-003607-35-DE (EUCTR) | 26/10/2020 | 02/10/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan | ||
| 28 | EUCTR2019-003607-35-PL (EUCTR) | 23/10/2020 | 20/10/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan | ||
| 29 | EUCTR2020-002985-15-GR (EUCTR) | 22/10/2020 | 11/09/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 30 | EUCTR2020-002985-15-GB (EUCTR) | 12/10/2020 | 25/08/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | Taiwan;Greece;Australia;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 31 | NCT04183101 (ClinicalTrials.gov) | October 1, 2020 | 14/11/2019 | Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy | Phase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 Glomerulopathy | C3 Glomerulopathy;Membranoproliferative Glomerulonephritis;Complement Abnormality;Dense Deposit Disease;C3 Glomerulonephritis | Drug: Aliskiren;Drug: Enalapril | Region Skane | NULL | Recruiting | 6 Years | N/A | All | 30 | Phase 2 | Sweden |
| 32 | EUCTR2019-001212-29-DK (EUCTR) | 26/08/2020 | 09/06/2020 | Causes and prevention of thrombosis developed due to the kidney disease nephrotic syndrome | Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome | Nephrotic syndrome is defined as severe proteinuria (> 0.5 g / day), edema and hypoalbuminemia. It is conditioned by a defect in the kidney's glomerular filtration barrier, resulting in the loss of a large number of plasma proteins including coagulation factors and consequently a increased risk of thromboembolic complications. The most frequent cause of nephrotic syndrome is the renal disease membranous nephropathy, which is associated with the greatest risk of thromboembolic complications. MedDRA version: 21.1;Level: LLT;Classification code 10029167;Term: Nephrotic syndrome with lesion of membranous glomerulonephritis;System Organ Class: 100000004857 MedDRA version: 20.0;Classification code 10029165;Term: Nephrotic syndrome in diseases classified elsewhere;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Trade Name: Fragmin INN or Proposed INN: Dalteparin Other descriptive name: Dalteparin Trade Name: Eliquis INN or Proposed INN: Apixaban Other descriptive name: Apixaban | Aarhus University Hospital, Henrik Birn | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 1;Phase 2 | Denmark | ||
| 33 | EUCTR2020-000185-42-FR (EUCTR) | 12/06/2020 | 26/05/2020 | Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | APOL1-mediated Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: VX-147 Product Code: VX-147 INN or Proposed INN: VX147 Other descriptive name: VX-147 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;France;United Kingdom | ||
| 34 | NCT04340362 (ClinicalTrials.gov) | June 8, 2020 | 7/4/2020 | Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis | A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis | Glomerulosclerosis, Focal Segmental | Drug: VX-147 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 65 Years | All | 16 | Phase 2 | United States;France;Puerto Rico;United Kingdom |
| 35 | EUCTR2020-000185-42-GB (EUCTR) | 01/06/2020 | 23/03/2020 | Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | APOL1-mediated Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: VX-147 Product Code: VX-147 INN or Proposed INN: VX147 Other descriptive name: VX-147 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | France;United States;United Kingdom | ||
| 36 | EUCTR2019-001734-34-NL (EUCTR) | 07/04/2020 | 22/08/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, open-label, two-arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Netherlands;Germany;China | ||
| 37 | NCT04065438 (ClinicalTrials.gov) | January 1, 2020 | 20/8/2019 | Post Approval Study for Treatment of Drug-resistant Adult Primary FSGS Using the LIPOSORBER® LA-15 System | Treatment of Drug-resistant Adult Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System | Focal Segmental Glomerulosclerosis | Device: LIPOSORBER® LA-15 | Kaneka Medical America LLC | NULL | Recruiting | 22 Years | 75 Years | All | 35 | N/A | United States |
| 38 | NCT04154787 (ClinicalTrials.gov) | November 23, 2019 | 8/10/2019 | Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy | A Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous Nephropathy | Glomerulonephritis, Membranous | Drug: LNP023;Drug: Rituximab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 52 | Phase 2 | United States;Argentina;China;Czechia;France;Germany;India;Netherlands;Singapore;Spain;Taiwan;United Kingdom |
| 39 | EUCTR2019-001734-34-ES (EUCTR) | 12/11/2019 | 04/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Rituximab INN or Proposed INN: RITUXIMAB | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 40 | EUCTR2019-001734-34-DE (EUCTR) | 30/10/2019 | 12/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, open-label, two arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Germany;Netherlands;China | ||
| 41 | EUCTR2019-000780-24-ES (EUCTR) | 25/10/2019 | 26/07/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Netherlands | ||
| 42 | EUCTR2019-001734-34-FR (EUCTR) | 23/10/2019 | 13/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 43 | NCT04145440 (ClinicalTrials.gov) | October 15, 2019 | 18/10/2019 | Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN) | Glomerulonephritis, Membranous;antiPLA2R Positive | Drug: MOR202 | MorphoSys AG | NULL | Active, not recruiting | 18 Years | 80 Years | All | 30 | Phase 1/Phase 2 | United States;Australia;Belgium;France;Italy;Korea, Republic of;Netherlands;Poland;Spain |
| 44 | EUCTR2017-003022-32-PL (EUCTR) | 12/10/2019 | 20/08/2019 | An open, dose escalation study in patients with Primary Focal Segmental Glomerulosclerosis (FSGS - a type of glomerular disease causes scarring in the kidney) and Nephrotic Syndrom (collection of symptoms due to kidney damage) | An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome | Primary Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CCX140-B INN or Proposed INN: not available yet | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 13 | Phase 2 | United Kingdom;Poland;Canada;France;United States | ||
| 45 | EUCTR2019-000780-24-IT (EUCTR) | 08/10/2019 | 22/01/2020 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Netherlands;Italy | ||
| 46 | EUCTR2019-000780-24-NL (EUCTR) | 24/09/2019 | 03/07/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Poland;Spain;Australia;Netherlands;Italy;Korea, Republic of | ||
| 47 | EUCTR2019-001734-34-GB (EUCTR) | 23/09/2019 | 07/08/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 48 | EUCTR2019-000780-24-FR (EUCTR) | 23/09/2019 | 15/10/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;European Union;Spain;Netherlands | ||
| 49 | EUCTR2017-002674-39-NL (EUCTR) | 30/01/2019 | 18/07/2018 | A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2 MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Australia;Netherlands;Italy | ||
| 50 | NCT03448692 (ClinicalTrials.gov) | October 15, 2018 | 22/2/2018 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) | Drug: PF-06730512 | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 44 | Phase 2 | United States;Canada;Czechia;France;Germany;Italy;Japan;Mexico;Poland;Slovakia;Spain;United Kingdom |
| 51 | NCT03703908 (ClinicalTrials.gov) | October 1, 2018 | 24/7/2018 | A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome | An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome | Focal Segmental Glomerulosclerosis | Drug: CCX140-B | ChemoCentryx | NULL | Recruiting | 18 Years | N/A | All | 13 | Phase 2 | United States |
| 52 | EUCTR2017-002674-39-IT (EUCTR) | 03/08/2018 | 08/06/2021 | A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (ICMPGN) | An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 - N/A | C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) MedDRA version: 20.1;Level: PT;Classification code 10018364;Term: Glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ACH-0144471 compresse Product Code: ACH-0144471 INN or Proposed INN: ACH-0144471 Product Name: ACH-0144471 compresse Product Code: ACH-0144471 INN or Proposed INN: ACH-0144471 Product Name: ACH0144471 compresse Product Code: ACH0144471 INN or Proposed INN: ACH-0144471 Trade Name: TETRACT-HIB - 1 SIRINGA PRECARICATA 0.5 ML Product Name: ACT-HIB Product Code: [ACT-HIB] Product Name: Bexsero Product Code: [Bexsero] Product Name: Menveo Product Code: [Menveo] Trade Name: PREVENAR 13 - 0.5 ML SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - FLACONCINO MONODOSE (0,5 ML VETRO TIPO I) - 1 FLACONCINO MONODOSE Product Name: Prevenar 13 Product Code: | ACHILLION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Australia;Netherlands;Italy | ||
| 53 | EUCTR2017-002674-39-BE (EUCTR) | 31/07/2018 | 16/05/2018 | A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2 MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Australia;Netherlands;Italy | ||
| 54 | EUCTR2016-003525-42-NL (EUCTR) | 26/06/2018 | 09/01/2018 | A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Australia;Netherlands | ||
| 55 | NCT03598036 (ClinicalTrials.gov) | June 21, 2018 | 14/6/2018 | Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis | An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental Glomerulosclerosis | Focal Segmental Glomerulosclerosis | Drug: Voclosporin | Aurinia Pharmaceuticals Inc. | NULL | Terminated | 18 Years | 75 Years | All | 5 | Phase 2 | United States;Dominican Republic |
| 56 | NCT03459443 (ClinicalTrials.gov) | June 20, 2018 | 26/2/2018 | A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471 | An Open-Label Phase 2 Proof-of-Concept Study in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated With ACH-0144471 | C3 Glomerulonephritis;C3 Glomerulopathy;Immune Complex Membranoproliferative Glomerulonephritis;IC-MPGN;Dense Deposit Disease | Drug: Danicopan | Alexion Pharmaceuticals | NULL | Completed | 12 Years | N/A | All | 22 | Phase 2 | United States;Australia;Belgium;Italy;Netherlands |
| 57 | NCT03422510 (ClinicalTrials.gov) | April 15, 2018 | 30/1/2018 | FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS) | A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) | Primary Focal Segmental Glomerulosclerosis | Drug: CXA-10 | Complexa, Inc. | Kidney Research Network, formerly NephCure Accelerating Cures Institute;Medpace, Inc.;MicroConstants;Arkana Labs;NephCure Kidney International | Completed | 13 Years | N/A | All | 33 | Phase 2 | United States |
| 58 | NCT03285711 (ClinicalTrials.gov) | October 6, 2017 | 14/9/2017 | Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN) | A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN) | Lupus Membranous Nephropathy | Drug: Filgotinib;Drug: Lanraplenib;Drug: Filgotinib placebo;Drug: Lanraplenib placebo | Gilead Sciences | NULL | Completed | 18 Years | 75 Years | All | 9 | Phase 2 | United States |
| 59 | NCT03095118 (ClinicalTrials.gov) | September 7, 2017 | 20/3/2017 | Daratumumab in Treatment of PGNMID and C3 GN | Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy | Membranoproliferative Glomerulonephritis | Drug: Daratumumab | Fernando Fervenza | NULL | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 60 | NCT03124368 (ClinicalTrials.gov) | August 9, 2017 | 12/4/2017 | A Proof-of-Mechanism Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With C3G or IC-MPGN | A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | C3 Glomerulonephritis;Dense Deposit Disease;Membranoproliferative Glomerulonephritis, Type II;C3 Glomerulopathy;Immune Complex Mediated Membranoproliferative Glomerulonephritis | Drug: ACH-0144471 | Alexion Pharmaceuticals | NULL | Completed | 16 Years | 65 Years | All | 6 | Phase 2 | Australia;Belgium;Netherlands |
| 61 | NCT02921789 (ClinicalTrials.gov) | May 22, 2017 | 30/9/2016 | Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | Kidney Transplantation;Focal Segmental Glomerulosclerosis (FSGS) | Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: Prednisone | Astellas Pharma Global Development, Inc. | Kyowa Kirin Co., Ltd. | Completed | 18 Years | N/A | All | 71 | Phase 2 | United States;Canada |
| 62 | EUCTR2013-000226-55-NL (EUCTR) | 04/03/2015 | 24/06/2014 | SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY | European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN | Primary membranous nephropathy MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Tacrolimus Product Name: TACROLIMUS INN or Proposed INN: TACROLIMUS Other descriptive name: TACROLIMUS Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE ACETATE Trade Name: cyclophosphamide Product Name: cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE | Fundacion Renal Iñigo Alvarez Toledo | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 175 | Spain;Netherlands | |||
| 63 | NCT02235857 (ClinicalTrials.gov) | March 2015 | 6/9/2014 | Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children | Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System | Focal Segmental Glomerulosclerosis | Device: LIPOSORBER® LA-15 System | Kaneka Medical America LLC | NULL | Recruiting | N/A | 21 Years | All | 35 | N/A | United States |
| 64 | NCT01955187 (ClinicalTrials.gov) | January 2014 | 19/9/2013 | Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy | European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) | MEMBRANOUS NEPHROPATHY | Drug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDE | Hospital Universitario 12 de Octubre | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, Aachen | Completed | 18 Years | N/A | All | 86 | Phase 3 | Spain |
| 65 | NCT01791686 (ClinicalTrials.gov) | January 2013 | 29/1/2013 | Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease | A Pilot, Open-label, Multicenter Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease | Dense Deposit Disease;Membranoproliferative Glomerulonephritis Type II;C3 Glomerulonephritis | Drug: CDX-1135 | Celldex Therapeutics | NULL | Terminated | 4 Years | N/A | Both | 1 | Phase 1 | United States |
| 66 | NCT01763580 (ClinicalTrials.gov) | July 16, 2012 | 6/12/2012 | A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome | Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) | MCNS;Minimal Change Nephrotic Syndrome (MCNS) | Drug: Tacrolimus;Drug: Prednisolone | Astellas Pharma Korea, Inc. | NULL | Completed | 16 Years | 78 Years | All | 144 | Phase 4 | Korea, Republic of |
| 67 | NCT01508468 (ClinicalTrials.gov) | January 17, 2012 | 9/12/2011 | Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy | Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin);Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab) | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 80 | Phase 3 | France |
| 68 | NCT01180036 (ClinicalTrials.gov) | November 2011 | 10/8/2010 | MEmbranous Nephropathy Trial Of Rituximab | A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: Rituximab;Drug: Cyclosporine | Mayo Clinic | Columbia University;University of British Columbia;Ohio State University;Stanford University;University of Washington;University of Michigan;University of Alabama at Birmingham;Case Western Reserve University;The Cleveland Clinic;University of Kansas Medical Center;University of Manchester;University Health Network, Toronto;University of Toronto;CHU de Quebec-Universite Laval;Washington University School of Medicine;Florida International University;University of Mississippi Medical Center;NYU Langone Health;Medical College of Wisconsin;University of Arizona;Sunnybrook Health Sciences Centre;Applied Health Research Centre;Fulk Family Foundation | Completed | 18 Years | 80 Years | All | 130 | Phase 2/Phase 3 | United States;Canada |
| 69 | EUCTR2007-005410-39-ES (EUCTR) | 11/06/2008 | 08/04/2008 | Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC | Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC | La nefropatía membranosa idiopática (NMI) es una enfermedad caracterizada histopatológicamente por un engrosamiento uniforme de la pared de los capilares glomerulares, debido al depósito de complejos inmunes a lo largo del espacio subepitelial, en ausencia de inflamación o cambios proliferativos en el resto del glomérulo. El origen exacto de este trastorno se desconoce sin embargo se sabe que la NMI es una causa frecuente de síndrome nefrótico (SN) del adulto. MedDRA version: 9.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy | Trade Name: Advagraf 0,5mg INN or Proposed INN: tacrolimus Trade Name: Genoxal INN or Proposed INN: ciclofosfamida Trade Name: Dacortín 2,5mg INN or Proposed INN: prednisona Trade Name: Advagraf 1mg INN or Proposed INN: tacrolimus Trade Name: Advagraf 5mg INN or Proposed INN: tacrolimus Trade Name: Dacortín 5mg INN or Proposed INN: prednisona Trade Name: Dacortín 30mg INN or Proposed INN: prednisona | Grupo Catalán de Estudio de enfermedades glomerulares. Sociedad Catalana de nefrología. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Spain | |||
| 70 | NCT00782561 (ClinicalTrials.gov) | April 2008 | 27/10/2008 | Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS) | A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis | Focal Segmental Glomerulosclerosis | Drug: FG-3019 | FibroGen | NULL | Terminated | 12 Years | 64 Years | All | 2 | Phase 1 | United States |
| 71 | NCT00464321 (ClinicalTrials.gov) | May 2007 | 20/4/2007 | Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS | A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS) | Focal Segmental Glomerulosclerosis | Biological: GC1008 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | Both | 16 | Phase 1 | United States;Germany;Italy;United Kingdom |
| 72 | NCT00983034 (ClinicalTrials.gov) | March 2006 | 21/9/2009 | The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy | Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy | Nephrotic Syndrome;Glomerulonephritis;Membranous Nephropathy | Drug: lansoprazole, amoxicillin, clarithromycin | Istanbul University | NULL | Completed | 18 Years | 70 Years | Both | 70 | N/A | Turkey |
| 73 | JPRN-C000000369 | 2004/04/01 | 27/03/2006 | Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome | membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome | CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks | Project team for treatment of refractory nephrotic syndrome | The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 300 | Not selected | Japan | |
| 74 | JPRN-C000000368 | 2004/04/01 | 27/03/2006 | Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome | membranous nephropathy with primary steroid resistant nephrotic syndrome | mizoribine once a day per os administration (150mg) after breakfast for 2years. mizoribine 3 times a day per os administration (50mg each) after meals for 2years. | Project team for treatment of refractory nephrotic syndrome | The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 100 | Not selected | Japan | |
| 75 | NCT00404833 (ClinicalTrials.gov) | January 2003 | 27/11/2006 | Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental | A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS) | Glomerulonephritis, Membranous;Glomerulosclerosis, Focal | Drug: prednisolone and mycophenolate mofetil;Drug: prednisolone and chlorambucil | Hospital Authority, Hong Kong | The University of Hong Kong | Completed | 18 Years | 65 Years | Both | 16 | Phase 3 | China |
| 76 | NCT00135967 (ClinicalTrials.gov) | May 2002 | 25/8/2005 | Mycophenolate Mofetil in Membranous Nephropathy | Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study | Glomerulonephritis, Membranous | Drug: mycophenolate mofetil orally 1000 mg twice a day (BID);Drug: prednisone 0,5 mg/kg orally on alternate days;Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9 | Radboud University | Hoffmann-La Roche | Completed | 18 Years | 75 Years | Both | 30 | Phase 2/Phase 3 | Netherlands |
| 77 | NCT00135954 (ClinicalTrials.gov) | July 1997 | 25/8/2005 | Treatment of Patients With Idiopathic Membranous Nephropathy | Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy | Glomerulonephritis, Membranous | Drug: Cyclophosphamide and steroids | Radboud University | NULL | Completed | 18 Years | 75 Years | Both | 29 | Phase 3 | Netherlands |
| 78 | EUCTR2021-000621-27-DE (EUCTR) | 08/09/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 79 | EUCTR2016-003525-42-BE (EUCTR) | 30/10/2017 | A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Australia;Netherlands | |||
| 80 | EUCTR2021-000621-27-PL (EUCTR) | 01/09/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 81 | EUCTR2015-001039-18-Outside-EU/EEA (EUCTR) | 03/07/2015 | Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome | Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study | Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE | Astellas Pharma Korea, Inc. | NULL | NA | Female: yes Male: yes | 152 | Korea, Republic of | ||||
| 82 | EUCTR2021-000621-27-NL (EUCTR) | 14/12/2021 | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Germany;Netherlands;United Kingdom;Italy;Sweden |