114. Non-dystrophic myotonia syndrome Clinical trials / Disease details


Clinical trials : 13 Drugs : 19 - (DrugBank : 5) / Drug target genes : 18 - Drug target pathways : 10

  
2 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-024026-38-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
2EUCTR2009-011184-36-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