113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 622 / 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
| 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 | EUCTR2016-004262-26-GB (EUCTR) | 16/02/2017 | 21/12/2020 | A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy(DMD) | VBP15-002 A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne MuscularDystrophy (DMD) | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone | ReveraGen BioPharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 48 | Phase 2 | United States;Canada;Australia;Israel;United Kingdom;Sweden | ||
| 2 | EUCTR2016-004462-26-GB (EUCTR) | 16/02/2017 | 23/12/2016 | A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) | VBP15-002 A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | Duchenne muscular dystrophy (DMD) MedDRA version: 19.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone | ReveraGen BioPharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Australia;Israel;United Kingdom | ||
| 3 | EUCTR2016-004263-38-SE (EUCTR) | 13/02/2017 | 16/12/2016 | An Extension Study to Assess the Long-term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy(DMD) | A Phase II Open-label, Multicenter Extension Study to Assess the Long-term Safety and Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone | ReveraGen BioPharma Inc. | NULL | Not Recruiting | Female: no Male: yes | 48 | Phase 2 | United States;Canada;Australia;Israel;United Kingdom;Sweden | ||
| 4 | EUCTR2016-004262-26-SE (EUCTR) | 13/02/2017 | 16/12/2016 | A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) | A Phase IIa, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone Product Name: Vamorolone INN or Proposed INN: vamorolone | ReveraGen BioPharma Inc. | NULL | Not Recruiting | Female: no Male: yes | 48 | Phase 2 | United States;Canada;Australia;Israel;United Kingdom;Sweden | ||
| 5 | EUCTR2016-004263-38-GB (EUCTR) | 10/02/2017 | 08/02/2019 | An Extension Study to Assess the Long-term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) | A Phase II Open-label, Multicenter Extension Study to Assess the Longterm Safety and Efficacy of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamarolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: vamorolone | ReveraGen BioPharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Australia;Israel;United Kingdom;Sweden |