Idebenone (DrugBank: Idebenone)
5 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 2 |
| 13 | 多発性硬化症／視神経脊髄炎 | 2 |
| 18 | 脊髄小脳変性症（多系統萎縮症を除く。） | 3 |
| 113 | 筋ジストロフィー | 36 |
| 302 | レーベル遺伝性視神経症 | 1 |
| 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 | NCT04152655 (ClinicalTrials.gov) | January 1, 2020 | 7/10/2019 | A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease | A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD) | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Idebenone;Drug: Placebo oral tablet | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 2;Phase 3 | China |
| 2 | NCT03727295 (ClinicalTrials.gov) | January 1, 2019 | 30/10/2018 | Idebenone Treatment of Early Parkinson's Diseasesymptoms | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor Symptoms | Oxidative Stress is an Important Cause of Parkinson's Disease | Drug: Idebenone/placebo | Second Affiliated Hospital of Soochow University | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | 30 Years | 80 Years | All | 180 | Phase 4 | NULL |
| 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 | NCT01854359 (ClinicalTrials.gov) | May 11, 2013 | 11/5/2013 | Idebenone for Primary Progressive Multiple Sclerosis | Open Label Extension Trial of Idebenone for Primary Progressive Multiple Sclerosis | Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Idebenone | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Unknown status | 18 Years | N/A | All | 61 | Phase 1;Phase 2 | United States |
| 2 | NCT00950248 (ClinicalTrials.gov) | November 1, 2009 | 30/7/2009 | Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS) | Double Blind Placebo-Controlled Phase I/II Clinical Trial of Idebenone in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: Idebenone;Other: placebo | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 65 Years | All | 85 | Phase 1;Phase 2 | United States |
| 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 | NCT00229632 (ClinicalTrials.gov) | September 27, 2005 | 29/9/2005 | Idebenone to Treat Friedreich's Ataxia | A Six Month Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Determine the Safety and Efficacy of Idebenone Administered to Patients With Friedreich's Ataxia | Friedreich Ataxia | Drug: Idebenone | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 9 Years | 17 Years | All | 51 | Phase 2 | United States |
| 2 | NCT00078481 (ClinicalTrials.gov) | February 2004 | 27/2/2004 | Phase 1 Trial of Idebenone to Treat Patients With Friedreich's Ataxia | Phase 1B Clinical Trial to Establish the Safety and Tolerability of a Multiple-Dose Regimen of Idebenone Administered to Patients With Friedreich's Ataxia | Friedreich Ataxia | Drug: Idebenone | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 16 | Phase 1 | United States |
| 3 | NCT00015808 (ClinicalTrials.gov) | May 2001 | 6/5/2001 | Safety Study of Idebenone to Treat Friedreich's Ataxia | Phase I Clinical Trial to Establish the Maximum Tolerated Dose of Idebenone in Children, Adolescents, and Adults With Friedreich's Ataxia | Friedreich Ataxia | Drug: Idebenone | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 100 | Phase 1 | United States |
| 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] | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland;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] | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland;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 | ||
| 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 |
| 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 | NCT03603288 (ClinicalTrials.gov) | July 4, 2018 | 31/5/2018 | Phase 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 Study | Duchenne Muscular Dystrophy | Drug: idebenone 150 mg film-coated tablets | Santhera Pharmaceuticals | NULL | Recruiting | 11 Years | N/A | Male | 266 | Phase 3 | United States;Austria;Belgium;France;Germany;Italy;Spain;Switzerland;United Kingdom |
| 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 | ||
| 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 |
| 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 | Authorised-recruitment may be ongoing or finished | 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 | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Switzerland;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 | ||
| 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 |
| 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 | NCT02814019 (ClinicalTrials.gov) | September 2016 | 17/6/2016 | A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking 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 | Duchenne Muscular Dystrophy (DMD) | Drug: Idebenone 150 mg film-coated tablets;Drug: placebo | Santhera Pharmaceuticals | NULL | Active, not recruiting | 10 Years | N/A | Male | 255 | Phase 3 | United States;Austria;Belgium;Bulgaria;France;Germany;Hungary;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 18 | NCT03433807 (ClinicalTrials.gov) | January 29, 2013 | 8/2/2018 | Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD) | Expanded Access Protocol (EAP) of Idebenone in Patients With Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Drug: Idebenone | Santhera Pharmaceuticals | NULL | Temporarily not available | 8 Years | N/A | All | United States | ||
| 19 | EUCTR2009-012037-30-ES (EUCTR) | 27/06/2012 | 29/03/2012 | Hereditary neuromuscular disease | 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 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 280 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 20 | EUCTR2009-012037-30-IT (EUCTR) | 27/03/2012 | 26/04/2012 | (DELOS) DuchEnne MD Long-term IdebenOne Study | 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 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) LTD | NULL | Not Recruiting | Female: no Male: yes | 280 | Phase 3 | France;United States;Canada;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 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 |
| 21 | EUCTR2009-012037-30-NL (EUCTR) | 03/06/2010 | 17/12/2009 | Hereditary neuromuscular disease | 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 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) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Germany;Netherlands;Italy;Switzerland;Sweden | ||
| 22 | EUCTR2009-012037-30-AT (EUCTR) | 10/03/2010 | 10/02/2010 | Hereditary neuromuscular disease | 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 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 23 | EUCTR2009-012037-30-SE (EUCTR) | 23/02/2010 | 28/12/2009 | Hereditary neuromuscular disease | 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 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 24 | EUCTR2009-012037-30-FR (EUCTR) | 19/02/2010 | 17/12/2009 | 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 Dystrophy - DELOS | 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 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) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 240 | Phase 3 | Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 25 | EUCTR2009-012037-30-DE (EUCTR) | 08/10/2009 | 07/08/2009 | Hereditary neuromuscular disease | 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 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) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden | ||
| 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 |
| 26 | EUCTR2009-012037-30-BE (EUCTR) | 14/07/2009 | 27/05/2009 | Hereditary neuromuscular disease | 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 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) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 266 | Phase 3 | France;United States;Spain;Belgium;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 27 | NCT01027884 (ClinicalTrials.gov) | July 2009 | 8/12/2009 | Phase 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 Dystrophy | Muscular Dystrophy, Duchenne;Ambulatory Care | Drug: Placebo;Drug: Idebenone | Santhera Pharmaceuticals | NULL | Completed | 10 Years | 18 Years | Male | 65 | Phase 3 | United States;Austria;Belgium;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland |
| 28 | NCT00758225 (ClinicalTrials.gov) | September 2008 | 23/9/2008 | Long-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-001 | Duchenne Muscular Dystrophy | Drug: Idebenone | Santhera Pharmaceuticals | NULL | Completed | N/A | N/A | Male | 21 | Phase 2 | Belgium |
| 29 | EUCTR2007-007752-34-BE (EUCTR) | 14/08/2008 | 26/06/2008 | 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 | 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 | 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) Ltd | NULL | Not Recruiting | Female: no Male: yes | Phase 2 | Belgium | |||
| 30 | NCT00654784 (ClinicalTrials.gov) | October 2005 | 3/4/2008 | Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy | A 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 Dystrophy | Duchenne Muscular Dystrophy (DMD) | Drug: idebenone;Drug: placebo | Santhera Pharmaceuticals | NULL | Completed | 8 Years | 16 Years | Male | 21 | Phase 2 | Belgium |
| 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 |
| 31 | EUCTR2005-002520-33-BE (EUCTR) | 06/09/2005 | 04/10/2005 | A 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 | A 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 Dystrophy | Product Name: idebenone | Santhera Pharmaceuticals LLC | NULL | Not Recruiting | Female: no Male: yes | 21 | Phase 2a | Belgium | ||
| 32 | 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 | |||
| 33 | 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 | |||
| 34 | 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 | |||
| 35 | 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 | |||
| 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 |
| 36 | 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 |
| 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 | JPRN-UMIN000017939 | 2013/10/01 | 20/06/2015 | Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy | Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy - Clinical trial of Idebenone in patients with LHON | Leber hereditary optic neuropathy | 1. Clinical trial medicine: Idebenone 900mg/day 2. Objectives: 50 patients with LHON 3. Exclusion criteria: a) A smoker b) A patient with abnormality of hepatic function c) A patient who present seizures, delirium and hallucination d) Pregnancy or Lactation e) A patient who is associated with agranulocytosis f) A patient with chronic renal failure g) A patient with anaphylactic shock against Idebenone 4. Duration of drug administration: 6 months 5. Examinations schedules: Both subjective and objective examinations are performed as following schedules; a) At the base line: Visual acuity (VA), Critical flicker frequency (CFF), Visual field (VF: Humphry 30-2), central retinal thickness (CRT), functional MRI (f-MRI), searching the mitochondrial mutation b) 8 weeks: VA, CFF, VF, CRT, f-MRI c) 16 weeks: VA, CFF, VF, CRT, f-MRI d) 24 weeks: VA, CFF, VF, CRT, f-MRI e) 32 weeks: VA, CFF, VF, CRT, f-MRI f) 40 weeks: VA, CFF, VF, CRT, f-MRI g) 48 weeks: VA, CFF, VF, CRT, f-MRI | Hyogo College of Medicine | Kitasato UniversityJikei University School of MedicineTokyo Medical University | Complete: follow-up complete | 10years-old | 80years-old | Male and Female | 50 | Phase 1;Phase 2 | Japan |