SNT-MC17 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
113筋ジストロフィー8

113. 筋ジストロフィー


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-012037-30-ES
(EUCTR)
27/06/201229/03/2012Hereditary neuromuscular diseaseA 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) LimitedNULLNot RecruitingFemale: no
Male: yes
280Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden
2EUCTR2009-012037-30-NL
(EUCTR)
03/06/201017/12/2009Hereditary neuromuscular diseaseA 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) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy;Sweden
3EUCTR2009-012037-30-AT
(EUCTR)
10/03/201010/02/2010Hereditary neuromuscular diseaseA 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) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden
4EUCTR2009-012037-30-SE
(EUCTR)
23/02/201028/12/2009Hereditary neuromuscular diseaseA 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) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden
5EUCTR2009-012037-30-FR
(EUCTR)
19/02/201017/12/2009A 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 - DELOSA 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) LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
240Phase 3Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
6EUCTR2009-012037-30-DE
(EUCTR)
08/10/200907/08/2009Hereditary neuromuscular diseaseA 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) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden
7EUCTR2009-012037-30-BE
(EUCTR)
14/07/200927/05/2009Hereditary neuromuscular diseaseA 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) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden
8EUCTR2007-007752-34-BE
(EUCTR)
14/08/200826/06/2008A Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular DystrophyA 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) LtdNULLNot RecruitingFemale: no
Male: yes
Phase 2Belgium