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

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004462-26-GB
(EUCTR)
16/02/201723/12/2016 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.NULLNot 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): noUnited States;Canada;Australia;Israel;United Kingdom
2EUCTR2016-004262-26-GB
(EUCTR)
16/02/201721/12/2020A 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.NULLNot RecruitingFemale: no
Male: yes
48Phase 2United States;Canada;Australia;Israel;United Kingdom;Sweden
3EUCTR2016-004262-26-SE
(EUCTR)
13/02/201716/12/2016A 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.NULLNot RecruitingFemale: no
Male: yes
48Phase 2United States;Canada;Australia;Israel;United Kingdom;Sweden
4EUCTR2016-004263-38-SE
(EUCTR)
13/02/201716/12/2016An 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.NULLNot RecruitingFemale: no
Male: yes
48Phase 2United States;Canada;Australia;Israel;United Kingdom;Sweden
5EUCTR2016-004263-38-GB
(EUCTR)
10/02/201708/02/2019 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.NULLNot 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): noUnited States;Canada;Australia;Israel;United Kingdom;Sweden