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Clinical trials for Idebenone

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    20 result(s) found for: Idebenone. Displaying page 1 of 1.
    EudraCT Number: 2006-002679-42 Sponsor Protocol Number: SNT-II-003 Start Date*: 2006-11-22
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: A double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of patients with Leber's Hereditary Optic Neuropathy
    Medical condition: Leber's Hereditary Optic Neuropathy
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-002520-33 Sponsor Protocol Number: SNT-II-1 Start Date*: 2005-09-06
    Sponsor Name:Santhera Pharmaceuticals LLC
    Full Title: 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...
    Medical condition: Duchenne Muscular Dystrophy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023388-16 Sponsor Protocol Number: SNT-III-004 Start Date*: 2011-06-07
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich’s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)
    Medical condition: Friedreich`s Ataxia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10017374 Friedreich's ataxia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) FR (Ongoing) DE (Completed) AT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-004083-22 Sponsor Protocol Number: SNT-III-001 Start Date*: 2006-04-25
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Ltd
    Full Title: A Phase III double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of Friedreich's Ataxia patients.
    Medical condition: Friedreich's Ataxia
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004279-30 Sponsor Protocol Number: SNT-III-012-E Start Date*: 2018-06-14
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: 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
    Medical condition: Duchenne Muscular Dystrophy (DMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: BE (Completed) GB (Prematurely Ended) FR (Ongoing) SE (Prematurely Ended) NL (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000602-10 Sponsor Protocol Number: SNT-III-012 Start Date*: 2016-11-17
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: 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 Ste...
    Medical condition: Duchenne Muscular Dystrophy (DMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Prematurely Ended) BE (Completed) NL (Prematurely Ended) SE (Prematurely Ended) GB (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended) FR (Completed) IT (Prematurely Ended) IE (Completed) HU (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-012037-30 Sponsor Protocol Number: SNT-III-003 Start Date*: 2009-07-14
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: 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
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) NL (Completed) SE (Completed) AT (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001646-40 Sponsor Protocol Number: SNT-III-001-E Start Date*: 2007-06-11
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: A Phase III Open-Label, Single-Group Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients
    Medical condition: Friedrich's Ataxia
    Disease: Version SOC Term Classification Code Term Level
    12.0 10017374 Friedreich's ataxia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Completed) FR (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-007752-34 Sponsor Protocol Number: SNT-II-001-E Start Date*: 2008-08-14
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Ltd
    Full Title: 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
    Medical condition: Duchennes Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    12.0 10013801 Duchenne muscular dystrophy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001493-28 Sponsor Protocol Number: OPA1 Start Date*: 2020-09-24
    Sponsor Name:Medizinische Universität Graz, Univ.-Augenklinik
    Full Title: Raxone® treatment for patients with dominant optic atrophy due to OPA1 gene mutation
    Medical condition: Autosomal dominant optic atrophy (ADOA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019895 Hereditary optic atrophy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003315-63 Sponsor Protocol Number: ARPA-AMANTADINA-2012 Start Date*: 2012-10-24
    Sponsor Name:FIBHULP
    Full Title: RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, STUDY OF EFFECTIVENESS, TOLERABILITY AND SAFETY OF THERAPY WITH AMANTADINE IN DEGENERATIVE ATAXIAS
    Medical condition: Degenerative ataxias
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004405-16 Sponsor Protocol Number: SNT-IV-005 Start Date*: 2016-03-16
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: External Natural History Controlled, open-Label Intervention Study to Assess the Efficacy and Safety of Long-Term Treatment with Raxone® in Leber’s Hereditary Optic Neuropathy (LHON)
    Medical condition: Leber’s Hereditary Optic Neuropathy / LHON is a maternally inherited loss of vision due to atrophy of the optic nerve. It typically presents in young adults, mostly men, as painless acute or subacu...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10062951 Leber's hereditary optic atrophy neuropathy LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) BE (Completed) PT (Completed) ES (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-001034-42 Sponsor Protocol Number: SNT-II-003-OFU Start Date*: 2011-08-25
    Sponsor Name:Santhera Pharmaceuticals (Switzerland) Limited
    Full Title: A single visit, observational, follow-up study of Patients with Leber’s Hereditary Optic Neuropathy following participation in SNT-II-003 trial
    Medical condition: Leber’s Hereditary Optic Neuropathy
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10062951 Leber's hereditary optic atrophy neuropathy LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-014263-40 Sponsor Protocol Number: MEL01 Start Date*: 2009-12-14
    Sponsor Name:Penwest Pharmaceuticals Co.
    Full Title: A Phase 2a, Double Blind, Randomized, Placebo-controlled, 28 day, Two-arm, Parallel Group Study of A0001 in Patients with the A3243G Mitochondrial DNA Point Mutation and Evidence of Impaired Mitoch...
    Medical condition: A3243G mitochondrial DNA point mutation and evidence of impaired mitochondrial function
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-005938-12 Sponsor Protocol Number: 29-09-1963 Start Date*: 2006-06-08
    Sponsor Name:Dr. Sylvia Boesch
    Full Title: Eine offene, nicht randomisierte, einarmige Pilotstudie zur Beurteilung der Wirksamkeit von Erythropoetin bei Friedreich Ataxie.
    Medical condition: Die Friedreich Ataxie (FRDA) ist eine autosomal-rezessiv vererbte, progressive neurodegenerative Erkrankung, die mit einer Inzidenz von rund 1:50.000 auftritt. Es handelt sich dabei um die am häufi...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005021-76 Sponsor Protocol Number: OPBGC&RS_12_003 Start Date*: 2013-01-31
    Sponsor Name:EDISON PHARMACEUTICALS INC.
    Full Title: A Phase 2A Randomized, Placebo Controlled Trial of EPI-743 in Children with Rett Syndrome
    Medical condition: Rett Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10021605 Inborn errors of metabolism HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003360-19 Sponsor Protocol Number: P070123 Start Date*: 2008-11-17
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Etude de l'effet de la pioglitazone dans l'ataxie de Friedreich : étude "preuve de concept"
    Medical condition: Ataxie de Friedreich
    Disease: Version SOC Term Classification Code Term Level
    8.1 10017374 Friedreich's ataxia PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003028-19 Sponsor Protocol Number: PS_KSS_001_2019 Start Date*: 2019-10-30
    Sponsor Name:IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
    Full Title: Clinical-instrumental definition of the phenotypic spectrum, response to treatment and natural history in Pearson and Kearns-Sayre syndrome
    Medical condition: Pearson and Kearns-Sayre syndrome.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10058799 Mitochondrial encephalomyopathy PT
    20.1 10010331 - Congenital, familial and genetic disorders 10058799 Mitochondrial encephalomyopathy PT
    20.1 10010331 - Congenital, familial and genetic disorders 10051403 Mitochondrial DNA deletion PT
    20.1 10010331 - Congenital, familial and genetic disorders 10051403 Mitochondrial DNA deletion PT
    20.0 10010331 - Congenital, familial and genetic disorders 10074070 Mitochondrial encephalopathy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002846-33 Sponsor Protocol Number: KL13332020-104A Start Date*: 2022-10-13
    Sponsor Name:Abliva AB
    Full Title: An interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose, adaptive study of the efficacy of KL1333 in adult patients with primary mitochondrial disease
    Medical condition: Adult patients with primary mitochondrial disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052637 Genetic mitochondrial abnormalities NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003331-23 Sponsor Protocol Number: LA29-0207 Start Date*: 2008-11-20
    Sponsor Name:ApoPharma Inc.
    Full Title: A six-month double-blind, randomized, placebo-controlled study investigating the safety and tolerability of deferiprone in participants with Friedreich's ataxia
    Medical condition: Friedreich's Ataxia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017374 Friedreich's ataxia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) FR (Completed) IT (Completed) ES (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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