114. 非ジストロフィー性ミオトニー症候群 Non-dystrophic myotonia syndrome Clinical trials / Disease details


臨床試験数 : 12 薬物数 : 19 - (DrugBank : 5) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 10

  
8 trials found
No.TrialIDDate_
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1EUCTR2021-003784-94-DK
(EUCTR)
20/01/202230/11/2021Which treatment are the best to reduce myotonia?Treatment of Myotonia - Lamotrigine versus Namuscla Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, and Hyperkalemic periodic paralysis
MedDRA version: 20.1;Level: LLT;Classification code 10049841;Term: Myotonia congenital;System Organ Class: 100000004850
MedDRA version: 20.1;Classification code 10076440;Term: Hyperkalemic periodic paralysis;System Organ Class: 100000004850;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Namuscla
INN or Proposed INN: Mexiletine
Trade Name: Lamotrigin ”Nordic Prime 25 mg
INN or Proposed INN: LAMOTRIGINE
Trade Name: Lamotrigin ”Nordic Prime 50 mg
INN or Proposed INN: LAMOTRIGINE
Trade Name: Lamotrigin ”Nordic Prime 100 mg
INN or Proposed INN: LAMOTRIGINE
Rigshospitalet, department of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 3Denmark
2NCT05017155
(ClinicalTrials.gov)
August 12, 202111/8/2021MExiletine Versus Lamotrigine in Non-Dystrophic MyotoniasA Phase III, Randomised, Double Blinded, Head-to-head, Single-site, Cross-over Trial of Lamotrigine Versus Mexiletine for Non-dystrophic MyotoniasNon-Dystrophic MyotoniaDrug: Mexiletine;Drug: Lamotrigine 25Mg Oral Tablet, Extended ReleaseUniversity College, LondonNULLRecruiting18 Years90 YearsAll60Phase 3United Kingdom
3EUCTR2014-002627-10-IT
(EUCTR)
03/11/201505/11/2020Pivotal study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A orCLCN1 genes.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 SCN4A or CLCN1 genes. - RILUMEX NDM patients with mutations in SCN4A or CLCN1 gene
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: RILUZOLO TEVA - 50 MG COMPRESSE RIVESTITE CON FILM 90 COMPRESSE IN BLISTER AL/PVC
Product Name: RILUZOLO
INN or Proposed INN: RILUZOLO
INN or Proposed INN: MEXILETINA CLORIDRATO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2Italy
4NCT02045667
(ClinicalTrials.gov)
January 201418/11/2013Combined N-of-1 Trials Mexiletine vs Placebo in Patients With Non-Dystrophic Myotonia (NDM)Combining N-of-1 Trials to Estimate Population Clinical and Cost-effectiveness of Drugs Using Bayesian Hierarchical Modeling. The Case of Mexiletine for Patients With Non- Dystrophic Myotonia.Non Dystrophic MyotoniaDrug: Mexiletine;Drug: PlaceboRadboud UniversityZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted18 YearsN/ABoth30Phase 2Netherlands
5EUCTR2010-024026-38-NL
(EUCTR)
10/01/201209/02/2011Combining 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. - Mex vs. placebo in NDMsCombining 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. - Mex vs. placebo in NDMs 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 patients with NDMs with a genetically confirmed mutation in the SCN4A-gene or the CLCN1-gene as registred in the Netherlands database of NDMs will be included. Trade Name: Mexitil
Product Name: mexitil
INN or Proposed INN: MEXILETINE
Other descriptive name: Mexitil
Radboud University Nijmegen Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Netherlands
6NCT02336477
(ClinicalTrials.gov)
June 20118/1/2015Mexiletine and Non Dystrophic MyotoniasEfficacy and Safety of Mexiletine in Non-dystrophic MyotoniasNon-dystrophic Myotonias;Paramyotonia Congenita;Myotonia CongenitaDrug: Mexiletine;Drug: placeboAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years65 YearsBoth24Phase 3France
7EUCTR2009-011184-36-IT
(EUCTR)
25/06/201005/09/2011Phase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia (IND #77,021) - NDPhase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia (IND #77,021) - ND Myotonic disorders are divided into dystrophic myotonias (DM1 and DM2) and non-dystrophic myotonias (NDM). The dystrophic myotonias are associated with significant progressive muscular weakness and other systemic organ involvement. On the other hand, NDM usually presents with muscle stiffness as the primary symptom, and severe weakness is not considered a major feature, especially in myotonia congenita.
MedDRA version: 14.0;Level: LLT;Classification code 10032487;Term: Other specific muscle disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MEXITIL*20CPS 200MG
INN or Proposed INN: Mexiletine
Dept. of Neurology - Univ. of Kansas Medical CenterNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom;Italy
8NCT00832000
(ClinicalTrials.gov)
December 200827/1/2009Effectiveness of Mexiletine for Treating People With Non-Dystrophic MyotoniaPhase II Therapeutic Trial of Mexiletine in Non-Dystrophic MyotoniaMyotonia;Non-Dystrophic MyotoniaDrug: Mexiletine;Drug: PlaceboRichard Barohn, MDNULLCompleted16 YearsN/AAll59Phase 2United States;Canada;Italy;United Kingdom