113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
| 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 | EUCTR2009-012037-30-ES (EUCTR) | 27/06/2012 | 29/03/2012 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 ? 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 280 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 2 | EUCTR2009-012037-30-NL (EUCTR) | 03/06/2010 | 17/12/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy;Sweden | ||
| 3 | EUCTR2009-012037-30-AT (EUCTR) | 10/03/2010 | 10/02/2010 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 4 | EUCTR2009-012037-30-SE (EUCTR) | 23/02/2010 | 28/12/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 5 | EUCTR2009-012037-30-FR (EUCTR) | 19/02/2010 | 17/12/2009 | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 12.0;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 240 | Phase 3 | Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 6 | EUCTR2009-012037-30-DE (EUCTR) | 08/10/2009 | 07/08/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden | ||
| 7 | EUCTR2009-012037-30-BE (EUCTR) | 14/07/2009 | 27/05/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden | ||
| 8 | EUCTR2007-007752-34-BE (EUCTR) | 14/08/2008 | 26/06/2008 | A Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular Dystrophy | A Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular Dystrophy | Duchennes Muscular Dystrophy MedDRA version: 12.0;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: Idebenone | Santhera Pharmaceuticals (Switzerland) Ltd | NULL | Not Recruiting | Female: no Male: yes | Phase 2 | Belgium |