158. 結節性硬化症 Tuberous sclerosis Clinical trials / Disease details
臨床試験数 : 112 / 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118
Showing 1 to 10 of 48 diseases
| 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 | EUCTR2016-002977-37-GB (EUCTR) | 25/08/2017 | 12/01/2017 | Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to b ... | An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis com ... | Refractory seizures associated with tuberous sclerosis complex MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory seizures associated with tuberous sclerosis complex MedDRA version: 20.0;Level: PT;Classi ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France; ... | ||
| 2 | EUCTR2016-002977-37-BE (EUCTR) | 06/07/2017 | 04/04/2017 | Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to b ... | An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis com ... | Refractory seizures associated with tuberous sclerosis complex MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory seizures associated with tuberous sclerosis complex MedDRA version: 20.0;Level: PT;Classi ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 3 | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France; ... | ||
| 3 | EUCTR2016-002977-37-ES (EUCTR) | 12/04/2017 | 10/03/2017 | Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to b ... | An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis com ... | Refractory seizures associated with tuberous sclerosis complex MedDRA version: 19.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory seizures associated with tuberous sclerosis complex MedDRA version: 19.1;Level: PT;Classi ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Farmacéutica S.A | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France; ... | ||
| 4 | EUCTR2016-002977-37-FR (EUCTR) | 24/03/2017 | 16/05/2017 | Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to b ... | An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis com ... | Refractory seizures associated with tuberous sclerosis complex MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory seizures associated with tuberous sclerosis complex MedDRA version: 20.0;Level: PT;Classi ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France; ... | ||
| 5 | EUCTR2016-002977-37-HU (EUCTR) | 24/02/2017 | 18/01/2017 | Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to b ... | An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304. An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis com ... | Refractory seizures associated with tuberous sclerosis complex MedDRA version: 19.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory seizures associated with tuberous sclerosis complex MedDRA version: 19.1;Level: PT;Classi ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 3 | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France; ... | ||
| 6 | EUCTR2013-003795-13-BE (EUCTR) | 10/12/2014 | 17/11/2014 | Long-term monitoring of growth and development of pediatric patients previously treated with everolimus Long-term monitoring of growth and development of pediatric patients previously treated with everoli ... | Long-term follow-up study to monitor the growth and development of pediatric patients previously treated with everolimus in study CRAD001M2301 - EXIST-LT Long-term follow-up study to monitor the growth and development of pediatric patients previously tre ... | Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex (TSC) MedDRA version: 21.0;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex (TSC) MedDRA v ... | Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3;Phase 4 | United States;Canada;Poland;Belgium;Russian Federation | ||
| 7 | EUCTR2011-000860-90-IE (EUCTR) | 05/06/2014 | 10/04/2014 | A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patie ... | A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two tr ... | Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 17.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 1 ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom ... | ||
| 8 | EUCTR2011-000860-90-BE (EUCTR) | 17/09/2013 | 05/06/2013 | A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patie ... | A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two tr ... | Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 17.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 1 ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom ... | ||
| 9 | EUCTR2011-000860-90-GR (EUCTR) | 12/09/2013 | 08/07/2013 | A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patie ... | A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two tr ... | Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 16.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 1 ... | Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: E ... | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom ... | ||
| 10 | EUCTR2011-000860-90-DK (EUCTR) | 09/09/2013 | 09/09/2013 | A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patie ... | A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two tr ... | Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) MedDRA version: 2 ... | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other ... | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | Taiwan;Greece;Spain;Ireland;Turkey;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of Taiwan;Greece;Spain;Ireland;Turkey;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Pol ... |