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Clinical trials for Myopathies

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   44364   clinical trials with a EudraCT protocol, of which   7388   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 ).  
     
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    38 result(s) found for: Myopathies. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-003856-32 Sponsor Protocol Number: CL3-90652-004 Start Date*: 2008-12-05
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Evaluation de l’effet de la prise orale de perindopril orodispersible à la dose de 0,150 mg/kg/jour sur la fonction musculaire et myocardique dans la dystrophie musculaire de Duchenne à un stade pr...
    Medical condition: dystrophie musculaire de Duchenne
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028354 Muscular dystrophies and other myopathies LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-005942-35 Sponsor Protocol Number: 1413 Start Date*: 2007-03-14
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Simvastatin therapy in IBM
    Medical condition: inclusion body myositis
    Disease: Version SOC Term Classification Code Term Level
    6.1 10028641 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002692-34 Sponsor Protocol Number: MitoFibrateCT1-2012 Start Date*: 2013-06-26
    Sponsor Name:Univ.-Klinik für Kinder- und Jugendheilkunde
    Full Title: Clinical study for the assessment of safety and efficacy of Bezafibrate as a drug therapy for patients with mitochondrial myopathies
    Medical condition: mitochondrial disorder
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005900-15 Sponsor Protocol Number: P051204 Start Date*: 2007-07-26
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: FORCE : rituximab (anticorps monoclonal anti-CD20 dépléteur des lymphocytes B) pour le traitement des myopathies inflammatoires réfractaires avec auto-anticorps spécifiques et des myasthénies génér...
    Medical condition: Myopathies inflammatoires réfractaires associés à des auto-AC spécifiques Myasthénies généralisées
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028641 Myopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004089-33 Sponsor Protocol Number: DYN101-C101 Start Date*: 2019-08-27
    Sponsor Name:Dynacure SAS
    Full Title: A Phase 1/2 trial on the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of DYN101 in patients ≥ 16 years of age with centronuclear myopathies caused by mutations ...
    Medical condition: Centronuclear myopathies (CNMs) in patients ≥ 16 years of age with mutations in DNM2 or MTM1
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DK (Prematurely Ended) BE (Prematurely Ended) NL (Ongoing) DE (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2020-004608-32 Sponsor Protocol Number: DYN101-C102 Start Date*: Information not available in EudraCT
    Sponsor Name:Dynacure
    Full Title: A Phase 1/2, multicenter, open-label, dose-confirmation trial to evaluate the safety and preliminary efficacy of DYN101 in subjects 2 to 17 years of age with centronuclear myopathy caused by mutati...
    Medical condition: Centronuclear myopathy (CNM), in subjects 2 to 17 years of age (all ages inclusive)caused by mutations in the myotubularin1 (MTM1) or dynamin 2 (DNM2) gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10028640 Myopathies HLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005202-98 Sponsor Protocol Number: 80202135IIM2001 Start Date*: 2022-11-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myo...
    Medical condition: Active Idiopathic Inflammatory Myopathies (IIM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10028640 Myopathies HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003359-33 Sponsor Protocol Number: MABS06 Start Date*: 2023-06-21
    Sponsor Name:MUMC
    Full Title: Assess efficacy of intra-arterial autologous myogenic stem cell therapy for m.3243A>G mutation carriers
    Medical condition: Mitochondrial myopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002855-40 Sponsor Protocol Number: REN001-201 Start Date*: 2021-04-15
    Sponsor Name:Reneo Pharma Ltd.
    Full Title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)
    Medical condition: Primary Mitochondrial Myopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) CZ (Completed) DK (Completed) HU (Completed) BE (Completed) IT (Completed) ES (Ongoing) NL (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2007-005274-31 Sponsor Protocol Number: 2380/2007 Start Date*: 2008-12-02
    Sponsor Name:AZIENDA OSPEDALIERA PISANA
    Full Title: Efficacy assessment of tetracycline in patients with progressive external ophthalmoplegia.
    Medical condition: Progressive external ophthalmoplegia.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036802 Progressive external ophthalmoplegia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020521-40 Sponsor Protocol Number: DG-EF 01/09 Start Date*: 2010-06-21
    Sponsor Name:EPIFARMA S.R.L.
    Full Title: Evaluation of therapeutic equivalence of diclofenac gel 1% formulation compared to Voltaren emulGel 1% gel in subjects with traumatic pathology: a double blind, randomized, phase III multicentre st...
    Medical condition: Painful and traumatic inflammation of the joints, muscles, tendons and ligaments.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028393 HLGT
    9.1 10023213 HLGT
    9.1 10043237 HLGT
    9.1 10028302 HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004410-13 Sponsor Protocol Number: 3401 Start Date*: 2008-03-12
    Sponsor Name:Institute od Rheumatology Prague
    Full Title: A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITI...
    Medical condition: active polymyositis, dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012503 Dermatomyositis LLT
    9.1 10036102 Polymyositis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003501-15 Sponsor Protocol Number: 408-C-1403 Start Date*: 2015-03-05
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: A PHASE 2 STUDY OF THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF RTA 408 IN THE TREATMENT OF MITOCHONDRIAL MYOPATHY
    Medical condition: Mitochondrial myopathy as evidenced by the following 2 criteria (must meet both): a. Have a history of exercise intolerance with or without weakness and/or progressive exercise intolerance (in whi...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-004766-26 Sponsor Protocol Number: NL58747 Start Date*: 2017-03-08
    Sponsor Name:Academic Medical Center
    Full Title: Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.
    Medical condition: idiopathic inflammatory myopathies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003471-34 Sponsor Protocol Number: REN001-202 Start Date*: 2022-04-19
    Sponsor Name:Reneo Pharma Ltd.
    Full Title: AN OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF REN001 IN SUBJECTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)
    Medical condition: Primary Mitochondrial Myopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Prematurely Ended) DK (Prematurely Ended) BE (Completed) HU (Prematurely Ended) NL (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001205-27 Sponsor Protocol Number: ABR35884 Start Date*: 2011-08-04
    Sponsor Name:
    Full Title: The effect of fibrate therapy in two patients with neutral lipid storage disease with myopathy (NLSDM).
    Medical condition: Neutral lipid storage disease with myopathy
    Disease: Version SOC Term Classification Code Term Level
    13.1 10007541 - Cardiac disorders 10007636 Cardiomyopathy PT
    13.1 10027433 - Metabolism and nutrition disorders 10013317 Lipid metabolism disorders HLGT
    13.1 10028395 - Musculoskeletal and connective tissue disorders 10028641 Myopathy PT
    Population Age: Gender:
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000508-24 Sponsor Protocol Number: 7406 Start Date*: 2015-06-12
    Sponsor Name:Newcastle Upon Tyne Hospitals NHS Trust
    Full Title: A Feasibility Study of Bezafibrate in Mitochondrial Myopathy
    Medical condition: Mitochondrial myopathy due to mt.3243A>G mutation
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-003907-16 Sponsor Protocol Number: SPIMD-301 Start Date*: 2022-03-02
    Sponsor Name:Stealth BioTherapeutics Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondr...
    Medical condition: Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    20.0 10010331 - Congenital, familial and genetic disorders 10052635 Cytoplasmic disorders congenital HLGT
    20.0 10010331 - Congenital, familial and genetic disorders 10052637 Genetic mitochondrial abnormalities NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) NO (Completed) ES (Completed) IT (Completed) NL (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002447-15 Sponsor Protocol Number: SPIMM-301 Start Date*: 2018-06-22
    Sponsor Name:Stealth BioTherapeutics Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondr...
    Medical condition: Primary Mitochondrial Myopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DK (Prematurely Ended) DE (Completed) HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000391-15 Sponsor Protocol Number: AIFA-2016-02364869 Start Date*: 2018-06-05
    Sponsor Name:Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
    Full Title: Multicentric, open-label, prospective study of subcutaneous tocilizumab in adult patients with refractory myositis
    Medical condition: Myositis (dermatomyositis [DM] or polymyositis [PM])
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10028653 Myositis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10036102 Polymyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
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