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 | EUCTR2016-000602-10-BG (EUCTR) | 10/03/2020 | 07/01/2020 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2017-004279-30-NL (EUCTR) | 23/01/2020 | 16/05/2018 | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden | ||
| 3 | EUCTR2017-004279-30-AT (EUCTR) | 15/02/2019 | 04/01/2019 | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 4 | EUCTR2017-004279-30-ES (EUCTR) | 21/12/2018 | 16/11/2018 | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Belgium;Spain;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 5 | EUCTR2016-000602-10-HU (EUCTR) | 18/12/2018 | 05/11/2018 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2017-004279-30-GB (EUCTR) | 26/10/2018 | 09/05/2018 | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden | ||
| 7 | EUCTR2017-004279-30-IT (EUCTR) | 29/08/2018 | 22/01/2021 | A 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 PHARMACEUTICALS | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 8 | EUCTR2017-004279-30-BE (EUCTR) | 14/06/2018 | 04/05/2018 | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 9 | EUCTR2016-000602-10-NL (EUCTR) | 26/04/2017 | 20/09/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 10 | EUCTR2016-000602-10-GB (EUCTR) | 28/12/2016 | 23/09/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 11 | EUCTR2016-000602-10-AT (EUCTR) | 21/12/2016 | 01/12/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 12 | EUCTR2016-000602-10-ES (EUCTR) | 20/12/2016 | 18/11/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 13 | EUCTR2016-000602-10-FR (EUCTR) | 25/11/2016 | 12/01/2017 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 14 | EUCTR2016-000602-10-DE (EUCTR) | 17/11/2016 | 30/05/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 15 | EUCTR2016-000602-10-IT (EUCTR) | 20/10/2016 | 06/02/2018 | A clinical study to assess how effective and safe is idebenone treatment inpatients with Duchenne Muscular Dystrophy (DMD) who are currentlyreceiving Glucocorticoid steroids | A 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 PHARMACEUTICALS | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 16 | EUCTR2016-000602-10-BE (EUCTR) | 02/09/2016 | 19/07/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 17 | EUCTR2017-004279-30-SE (EUCTR) | 15/05/2018 | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 18 | EUCTR2017-004279-30-FR (EUCTR) | 14/05/2018 | A 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) Limited | NULL | NA | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 19 | EUCTR2016-000602-10-SE (EUCTR) | 22/09/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | |||
| 20 | EUCTR2016-000602-10-IE (EUCTR) | 06/02/2018 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | |||
| 21 | EUCTR2017-004279-30-DE (EUCTR) | 11/06/2018 | A 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden |