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Clinical trials for Mexiletine

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   44345   clinical trials with a EudraCT protocol, of which   7373   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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    13 result(s) found for: Mexiletine. Displaying page 1 of 1.
    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: 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: 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: 2011-001287-22 Sponsor Protocol Number: FLECAINIDE-1 Start Date*: 2011-04-18
    Sponsor Name:FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE
    Full Title: A Prospective Randomized Crossover trial of Oral Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia
    Medical condition: Patients with CPVT and ICD
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10028159 Multiform ventricular tachycardia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-006652-22 Sponsor Protocol Number: AN08/8751 Start Date*: 2009-06-03
    Sponsor Name:Leeds Teaching Hospital NHS Trust
    Full Title: A multicentre, randomised, double blind, evaluative comparison trial of Rapydan® patch and Ametop® gel for topical anaesthesia during venous cannulation in adults admitted to hospital for day-case ...
    Medical condition: ASA 1 and 2 patients admitted for Day case surgery- assessment of cannulation pain after topical anaesthetic applications.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2014-000042-30 Sponsor Protocol Number: GS-US-372-1234 Start Date*: 2015-05-18
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects with Long QT-3 Syndrome
    Medical condition: Subjects with an established diagnosis of LQT3.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10007541 - Cardiac disorders 10024803 Long QT syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) FI (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-004007-19 Sponsor Protocol Number: AV-007-IM Start Date*: 2006-11-16
    Sponsor Name:Nycomed Austria GmbH
    Full Title: A multi-centre, double-blind, placebo-controlled, randomised, parallel group clinical trial to evaluate efficacy and safety of Actovegin® in diabetic type 2 patients with symptomatic diabetic perip...
    Medical condition: Diabetic Polyneuropathy
    Disease: Version SOC Term Classification Code Term Level
    8.1 10012685 Diabetic polyneuropathy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010091-17 Sponsor Protocol Number: KIP112967 Start Date*: 2009-09-15
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A randomised, double blind study to evaluate the safety and efficacy of the p38 kinase inhibitor, GW856553, in subjects with neuropathic pain from peripheral nerve injury. Estudio aleatorizado, do...
    Medical condition: Neuropathic pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10054095 Neuropathic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) DK (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002846-21 Sponsor Protocol Number: PARENTIDE-02 Start Date*: 2017-04-10
    Sponsor Name:BCN Peptides S.A.
    Full Title: CLINICAL TRIAL PHASE IIa PROOF OF CONCEPT, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED IN PATIENTS WITH NEUROPATHIC PAIN DUE TO PERIPHERAL NERVE INJURY
    Medical condition: Patients with neuropathic pain due to peripheral nerve injury
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    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)
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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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