20 completed, 4 unknown, 2 no longer available, 2 terminated. 11 Phase 3, 10 Phase 2, 7 Phase 1, 4 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 11 | Completed 6, Terminated 2, Withdrawn 2, Recruiting 1 |
| Phase 2 | 10 | Completed 8, Active not recruiting 1, Withdrawn 1 |
| Phase 1 | 7 | Completed 6, Unknown 1 |
| Phase 4 | 4 | Unknown 3, Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy idebenone 30 mg for 14 days, idebenone 30 mg for 3 months - Post Stroke Epilepsy | Phase 4 | Unknown | Xiangya Hospital of Central South University | 2700 | 2023-07-05 | 2023-08-14 |
| Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients Idebenone+ placebo, Idebenone, Placebo - Migraine | Phase 4 | Unknown | Beijing Tiantan Hospital | 900 | 2022-05-09 | 2022-06-23 |
| Idebenone for the Preventive Treatment of Migraine Placebo, 90mg Idebenone, 270mg Idebenone - Migraine Disorders, Headache Disorders | Phase 3 | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 180 | 2021-12-08 | 2025-05-15 |
| Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis Idebenone, Placebo - Non Alcoholic Steatohepatitis, Fibrosis | Phase 1 / Phase 2 | Completed | Stanford University | 53 | 2021-07-30 | 2026-04-24 |
| A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies Idebenone, Placebo - Rapid Eye Movement Sleep Behavior Disorder, Synucleinopathy | Phase 2 | Active not recruiting | Ruijin Hospital | 28 | 2020-08-31 | 2025-11-25 |
| Symptomatic Therapy for Patients With Huntington's Disease Haloperidol 2Mg Tab, Risperidone 1Mg Tab, Zoloft 50Mg Tablet - Huntington Disease | Phase 1 | Unknown | Second Affiliated Hospital, Zhejiang University, School of Medicine | 60 | 2020-03-12 | 2021-04-02 |
| A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease Idebenone, Placebo oral tablet - REM Sleep Behavior Disorder, Parkinson Disease | Phase 2 / Phase 3 | Withdrawn | Second Affiliated Hospital, Zhejiang University, School of Medicine | 2020-01-01 | 2025-01-07 | |
| Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis Idebenone, Naohuan Dan and Idebenone - Mild Cognitive Impairment | Completed | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 64 | 2019-05-01 | 2023-07-05 | |
| Idebenone Treatment of Early Parkinson's Diseasesymptoms Idebenone/placebo - Oxidative Stress is an Important Cause of Parkinson's Disease | Phase 4 | Unknown | Second Affiliated Hospital of Soochow University | 180 | 2019-01-01 | 2018-11-01 |
| Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E) idebenone 150 mg film-coated tablets - Duchenne Muscular Dystrophy | Phase 3 | Terminated | Santhera Pharmaceuticals | 161 | 2018-07-04 | 2021-12-03 |
| A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate Raxone (idebenone 150 mg), Midazolam 2,5 mg - Drug-Drug Interaction | Phase 1 | Completed | Santhera Pharmaceuticals | 32 | 2016-09-01 | 2017-10-05 |
| A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids Idebenone 150 mg film-coated tablets, placebo - Duchenne Muscular Dystrophy (DMD) | Phase 3 | Terminated | Santhera Pharmaceuticals | 255 | 2016-09-01 | 2021-12-03 |
| Post Authorisation Safety Study With Raxone in LHON Patients Idebenone - Leber's Hereditary Optic Neuropathy (LHON) | Completed | Santhera Pharmaceuticals | 229 | 2016-09-01 | 2021-07-16 | |
| Study to Assess the Efficacy and Safety of Raxone in LHON Patients Idebenone - Leber's Hereditary Optic Neuropathy (LHON) | Phase 4 | Completed | Santhera Pharmaceuticals | 199 | 2016-05-01 | 2023-04-21 |
| Idebenone for Primary Progressive Multiple Sclerosis Idebenone - Multiple Sclerosis, Primary Progressive Multiple Sclerosis | Phase 1 / Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 61 | 2013-03-12 | 2021-05-19 |
| Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI) Idebenone, Placebo - Friedreich's Ataxia | Phase 3 | Completed | Santhera Pharmaceuticals | 29 | 2011-04-01 | 2016-03-09 |
| Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS) Idebenone, placebo - Primary Progressive Multiple Sclerosis | Phase 1 / Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 85 | 2009-11-01 | 2019-03-19 |
| Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD) Placebo, Idebenone - Muscular Dystrophy, Duchenne, Ambulatory Care | Phase 3 | Completed | Santhera Pharmaceuticals | 65 | 2009-07-01 | 2015-10-19 |
| Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes Idebenone, Placebo - MELAS Syndrome | Phase 2 | Completed | Michio Hirano | 27 | 2009-05-01 | 2016-10-26 |
| Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) Idebenone - Duchenne Muscular Dystrophy | Phase 2 | Completed | Santhera Pharmaceuticals | 21 | 2008-09-01 | 2011-06-01 |
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Friedreich Ataxia (7) · Muscular Dystrophy, Duchenne (6) · Optic Atrophy, Hereditary, Leber (5) · Migraine Disorders (2) · Mitochondrial Diseases (2) · Multiple Sclerosis (2) · Multiple Sclerosis, Chronic Progressive (2) · Nerve Degeneration (2) · REM Sleep Behavior Disorder (2) · Ataxia (1) · Cognitive Dysfunction (1) · Fibrosis (1) · Headache Disorders (1) · Huntington Disease (1) · MELAS Syndrome (1)
Santhera Pharmaceuticals (17) · National Institute of Neurological Disorders and Stroke (NINDS) (3) · Second Affiliated Hospital, Zhejiang University, School of Medicine (3) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Beijing Tiantan Hospital (1) · Michio Hirano (1) · Ruijin Hospital (1) · Second Affiliated Hospital of Soochow University (1) · Stanford University (1) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (1) · Xiangya Hospital of Central South University (1)
United States (14) · Germany (9) · Austria (8) · Belgium (8) · China (7) · France (7) · Netherlands (6) · United Kingdom (6) · Italy (5) · Spain (4) · Switzerland (3) · Bulgaria (2) · Sweden (2) · Canada (1) · Greece (1)
Bibiana Bielekova, M.D. (2) · David Lynch, MD (2) · Nick Wood, Professor (2) · Susan Perlman, MD (2) · Ana Camacho Salas, MD (1) · Ass. Prof. Jan Verschuuren, MD, PhD (1) · Baorong Zhang, MD (1) · Barry Byrne, MD (1) · Bryan W. Burnette, MD (1) · Craig McDonald, MD (1) · Dr. Pierre-Yves Jeannet, Médecin Associé, MER (1) · Dr. Ulrike Schara, MD, PhD (1) · Ericka Simpson, MD (1) · Gihan Tennekoon, MD (1)
PMID 17562928, PMID 21779958, PMID 21788663, PMID 11972582, PMID 17826341, PMID 19847907, PMID 20065258, PMID 20090835, PMID 20599042, PMID 20697044, PMID 21392622, PMID 21435876, PMID 21586650, PMID 23263355, PMID 25907158, PMID 25916335, PMID 27574516, PMID 28132202, PMID 28189481, PMID 29298622, PMID 36172027, PMID 38428428
R21DK111217 (1)