113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details


臨床試験数 : 622 薬物数 : 494 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168

  
37 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000602-10-BG
(EUCTR)
10/03/202007/01/2020A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
2EUCTR2017-004279-30-NL
(EUCTR)
23/01/202016/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
3EUCTR2017-004279-30-AT
(EUCTR)
15/02/201904/01/2019A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
4EUCTR2017-004279-30-ES
(EUCTR)
21/12/201816/11/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Belgium;Spain;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
5EUCTR2016-000602-10-HU
(EUCTR)
18/12/201805/11/2018A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
6EUCTR2017-004279-30-GB
(EUCTR)
26/10/201809/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden
7EUCTR2017-004279-30-IT
(EUCTR)
29/08/201822/01/2021A clinical study to assess the long-term safety and efficacy of idebenonetreatment in patients with Duchenne Muscular Dystrophy (DMD) whocompleted the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safetyand Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy(DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
Product Code: [Idebenone]
INN or Proposed INN: IDEBENONE
SANTHERA PHARMACEUTICALSNULLNot RecruitingFemale: no
Male: yes
266Phase 3France;United States;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
8NCT03603288
(ClinicalTrials.gov)
July 4, 201831/5/2018Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS StudyDuchenne Muscular DystrophyDrug: idebenone 150 mg film-coated tabletsSanthera PharmaceuticalsNULLTerminated11 YearsN/AMale161Phase 3United States;Austria;Belgium;France;Germany;Italy;Spain;Switzerland;United Kingdom
9EUCTR2017-004279-30-BE
(EUCTR)
14/06/201804/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
10EUCTR2016-000602-10-NL
(EUCTR)
26/04/201720/09/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden
11EUCTR2016-000602-10-GB
(EUCTR)
28/12/201623/09/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden
12EUCTR2016-000602-10-AT
(EUCTR)
21/12/201601/12/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
13EUCTR2016-000602-10-ES
(EUCTR)
20/12/201618/11/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
14EUCTR2016-000602-10-FR
(EUCTR)
25/11/201612/01/2017A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS Duchenne Muscular Dystrophy (DMD)
MedDRA version: 19.1;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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
15EUCTR2016-000602-10-DE
(EUCTR)
17/11/201630/05/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
16EUCTR2016-000602-10-IT
(EUCTR)
20/10/201606/02/2018A clinical study to assess how effective and safe is idebenone treatment inpatients with Duchenne Muscular Dystrophy (DMD) who are currentlyreceiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Studyassessing the Efficacy, Safety and Tolerability of Idebenone inPatients with Duchenne Muscular Dystrophy Receiving GlucocorticoidSteroids - SIDEROS 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]
Trade Name: RAXONE - 150 MG- COMPRESSE RIVESTITE CON FILM- USO ORALE- FLACONE (HDPE)- 180 COMPRESSE
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
SANTHERA PHARMACEUTICALSNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
17EUCTR2016-000602-10-BE
(EUCTR)
02/09/201619/07/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
18NCT02814019
(ClinicalTrials.gov)
September 201617/6/2016A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid SteroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid SteroidsDuchenne Muscular Dystrophy (DMD)Drug: Idebenone 150 mg film-coated tablets;Drug: placeboSanthera PharmaceuticalsNULLTerminated10 YearsN/AMale255Phase 3United States;Austria;Belgium;Bulgaria;France;Germany;Hungary;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
19NCT03433807
(ClinicalTrials.gov)
January 29, 20138/2/2018Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)Expanded Access Protocol (EAP) of Idebenone in Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: IdebenoneSanthera PharmaceuticalsNULLTemporarily not available8 YearsN/AAllUnited States
20EUCTR2009-012037-30-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
21EUCTR2009-012037-30-IT
(EUCTR)
27/03/201226/04/2012(DELOS) DuchEnne MD Long-term IdebenOne StudyA 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] - Musculoskeletal Diseases [C05]
Product Name: Idebenone
Product Code: NA
INN or Proposed INN: IDEBENONE
SANTHERA PHARMACEUTICALS (SWITZERLAND) LTDNULLNot RecruitingFemale: no
Male: yes
280Phase 3France;United States;Canada;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
22EUCTR2009-012037-30-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) LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
266Phase 3France;United States;Belgium;Spain;Austria;Germany;Netherlands;Italy;Switzerland;Sweden
23EUCTR2009-012037-30-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
24EUCTR2009-012037-30-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
25EUCTR2009-012037-30-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
26EUCTR2009-012037-30-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
27EUCTR2009-012037-30-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
28NCT01027884
(ClinicalTrials.gov)
July 20098/12/2009Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)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 DystrophyMuscular Dystrophy, Duchenne;Ambulatory CareDrug: Placebo;Drug: IdebenoneSanthera PharmaceuticalsNULLCompleted10 Years18 YearsMale65Phase 3United States;Austria;Belgium;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland
29NCT00758225
(ClinicalTrials.gov)
September 200823/9/2008Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)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 - Extension to Study SNT-II-001Duchenne Muscular DystrophyDrug: IdebenoneSanthera PharmaceuticalsNULLCompletedN/AN/AMale21Phase 2Belgium
30EUCTR2007-007752-34-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
31NCT00654784
(ClinicalTrials.gov)
October 20053/4/2008Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular DystrophyA Phase IIa Double Blind, Randomised, Placebo Controlled, Single Centre Study at the University of Leuven to Assess the Efficacy and Tolerability of Idebenone in 8 - 16 Year Old Males With Cardiac Dysfunction Associated With Duchenne Muscular DystrophyDuchenne Muscular Dystrophy (DMD)Drug: idebenone;Drug: placeboSanthera PharmaceuticalsNULLCompleted8 Years16 YearsMale21Phase 2Belgium
32EUCTR2005-002520-33-BE
(EUCTR)
06/09/200504/10/2005A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular DystrophyA Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular Dystrophy Duchenne Muscular DystrophyProduct Name: idebenoneSanthera Pharmaceuticals LLCNULLNot RecruitingFemale: no
Male: yes
21Phase 2Belgium
33EUCTR2016-000602-10-IE
(EUCTR)
06/02/2018A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
34EUCTR2017-004279-30-SE
(EUCTR)
15/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
35EUCTR2017-004279-30-DE
(EUCTR)
11/06/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
36EUCTR2016-000602-10-SE
(EUCTR)
22/09/2016A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroidsA Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNot RecruitingFemale: no
Male: yes
266Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden
37EUCTR2017-004279-30-FR
(EUCTR)
14/05/2018A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study.A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E 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]
Trade Name: Raxone
Product Name: Idebenone
INN or Proposed INN: IDEBENONE
Other descriptive name: IDEBENONE
Santhera Pharmaceuticals (Switzerland) LimitedNULLNAFemale: no
Male: yes
266Phase 3United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden