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Clinical trials for Myotonia

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   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 ).  
     
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    15 result(s) found for: Myotonia. Displaying page 1 of 1.
    EudraCT Number: 2013-003309-24 Sponsor Protocol Number: 2013-562 Start Date*: 2013-10-28
    Sponsor Name:Grete Andersen
    Full Title: Lamotrigine as treatment of Myotonia
    Medical condition: Myotonia is a symptom seen certain inherited muscle dystrophies and pure channelopathies (Dystrophia myotonica type 1 and 2, Myotonia Congenita, Paramyotonia Congenita, Hyperkalæmisk periodic paral...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061533 Myotonia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-003784-94 Sponsor Protocol Number: MexLam Start Date*: 2022-01-20
    Sponsor Name:Rigshospitalet, department of Neurology
    Full Title: Treatment of Myotonia - Lamotrigine versus Namuscla
    Medical condition: Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, and Hyperkalemic periodic paralysis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10049841 Myotonia congenital LLT
    20.1 100000004850 10076440 Hyperkalemic periodic paralysis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-004623-23 Sponsor Protocol Number: AMO-02-MD-2-003 Start Date*: 2018-11-19
    Sponsor Name:AMO Pharma Ltd
    Full Title: A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Tideglusib Versus Placebo for the Treatment of Children and Adolescents with Congenital Myotonic Dystrophy
    Medical condition: Treatment of child and adolescent congenital myotonic dystrophy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068871 Myotonic dystrophy PT
    20.0 10010331 - Congenital, familial and genetic disorders 10068871 Myotonic dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2010-020923-37 Sponsor Protocol Number: P091101 Start Date*: 2010-10-26
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Etude de l'efficacité et de la tolérance de la mexiletine dans les myotonies non dystrophiques
    Medical condition: Patients présentant une myotonie non-dystrophique de type myotonie congénitale (MC) ou paramyotonie congénitale (PM).
    Disease: Version SOC Term Classification Code Term Level
    8.1 10061533 Myotonia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024026-38 Sponsor Protocol Number: mex201011 Start Date*: 2012-01-10
    Sponsor Name:Radboud University Nijmegen Medical Center
    Full Title: Combining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierarchical modeling. The case of Mexilitin for patients with Non-Dystrophic Myotonia.
    Medical condition: Patients with non-dystrophic myotonic syndromes (NDMs). NDMs are caused by mutations in the gene encoding for the skeletal muscle sodium (SCN4A) or chloride (CLCN1) channel. In this study patient...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000067-16 Sponsor Protocol Number: AMO-02-MD-2-001 Start Date*: 2016-04-20
    Sponsor Name:AMO Pharma Ltd.
    Full Title: A Single-Blind, Phase 2 Study To Evaluate The Safety And Efficacy Of Tideglusib 400 mg Or 1000 mg For The Treatment Of Adolescent And Adult Congenital And Juvenile-Onset Myotonic Dystrophy
    Medical condition: Treatment of adolescent and adult congenital and juvenile onset myotonic dystrophy
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10068871 Myotonic dystrophy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-000889-18 Sponsor Protocol Number: DYNE101-DM1-201 Start Date*: 2023-02-08
    Sponsor Name:Dyne Therapeutics
    Full Title: A Randomized, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-101 Administered to Participants with Myoton...
    Medical condition: Myotonic Dystrophy Type 1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068871 Myotonic dystrophy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000601-36 Sponsor Protocol Number: GUP15004 Start Date*: 2016-07-26
    Sponsor Name:FONDAZIONE SERENA ONLUS
    Full Title: CLINICAL EFFICACY OF NIV AND MODAFINIL ON EXCESSIVE DAYTIME SLEEPINESS: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL IN DM1
    Medical condition: Myotonic Dystrophy type 1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068871 Myotonic dystrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-011184-36 Sponsor Protocol Number: 08/0169 Start Date*: 2009-07-14
    Sponsor Name:University College London-Joint UCLH/UCL Biomedical (R&D) Unit
    Full Title: A Phase II Randomised, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Mexiletine in Patients with Non-Dystrophic Myotonia.
    Medical condition: Non-Dystrophic Myotonia (NDM). Non-dystrophic myotonias are a group of rare neuromuscular disorders that cause episodes of muscle stiffness (known as myotonia) and paralysis. Predominantly the musc...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029317 Neuromuscular disorders HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002627-10 Sponsor Protocol Number: RILUMEX Start Date*: 2015-11-03
    Sponsor Name:FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    Full Title: A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN...
    Medical condition: NDM patients with mutations in SCN4A or CLCN1 gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003757-28 Sponsor Protocol Number: MEX-NM-301 Start Date*: 2020-06-24
    Sponsor Name:Lupin Europe GmbH
    Full Title: An Open-label, non-Comparative Study to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of Mexiletine in Adolescents and Children with Myotonic Disorders
    Medical condition: Myotonic disorders: Nondystrophic myotonias (NDM) or myotonic dystrophies (DM, type 1 or type 2); ICD-10 code G71.1
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10028658 Myotonic disorders LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-003758-97 Sponsor Protocol Number: MEX-NM-303 Start Date*: 2020-06-24
    Sponsor Name:Lupin Europe GmbH
    Full Title: Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Mexiletine in Paediatric Patients with Myotonic Disorders Who Have Completed MEX-NM-301 and MEX-NM-302 Studies
    Medical condition: Myotonic disorders: Nondystrophic myotonias (NDM) or myotonic dystrophies (DM, type 1 or type 2); ICD-10 code G71.1
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10028658 Myotonic disorders LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-001732-21 Sponsor Protocol Number: MET001 Start Date*: 2013-09-06
    Sponsor Name:Centre d'Etude des Cellules Souches (CECS)
    Full Title: A randomized, double blind, placebo-controlled phase II study of metformin in myotonic dystrophy type 1 patients
    Medical condition: Myotonic dystrophy type 1 (DM1) also known as Steinert disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-004195-36 Sponsor Protocol Number: 120542 Start Date*: 2014-07-21
    Sponsor Name:University College of London
    Full Title: A randomised, double-blind, placebo-controlled, phase II clinical trial with a cross-over design assessing efficacy of a single dose of bumetamide in reducing focal attack severity in hypokalaemic ...
    Medical condition: Hypokalaemic Periodic Paralysis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10016208 Familial periodic paralysis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-002306-19 Sponsor Protocol Number: Hyp Hop Start Date*: 2010-02-10
    Sponsor Name:University of Rochester
    Full Title: Double-blind, placebo-controlled, parallel group, phase III study comparing dichlorphenamide vs. placebo for the treatment of periodic paralysis
    Medical condition: Patients with hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10016208 Familial periodic paralysis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
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