CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Mexiletine +1 moredrug
Likely dose
Mexiletine 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00832000
NCT00832000Phase 2Completed
CompareCT.gov

Phase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia

Richard Barohn, MD·interventional·Posted Jan 29, 2009·Updated Aug 23, 2013

In Brief

A Phase 2 clinical trial evaluating Mexiletine and Placebo for Myotonia and Non-Dystrophic Myotonia. Completed, enrolled 59 participants across 7 sites in 4 countries.

Detailed Summary

Nondystrophic myotonias (NDM) are neuromuscular disorders caused by genetic abnormalities in certain muscle cell membrane proteins. The proteins affect muscle contraction. Individuals with NDM experience limited muscle relaxation, which then can cause pain, weakness, incoordination, and impaired physical activity and function. Because NDM is very rare, information on the best way to treat people with the disorders is lacking, and there are no FDA-approved therapies. The purpose of this study is to determine the effectiveness of the medication mexiletine in treating people with NDM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyotonia, Non-Dystrophic Myotonia
CountriesCanada, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2009
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.4 years ago

Interventions

Mexiletinedrug

200 mg three times a day; in pill form

Placebodrug

Placebo three times a day; in pill form