At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 42 enrolled
Drug / intervention
Mexiletine +1 moredrug
Likely dose
Mexiletine 150 mg/kgfrom 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.
A Randomized, Placebo Controlled, Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type-1 (DM1)
In Brief
A Phase 2 clinical trial evaluating Mexiletine and Placebo for Myotonic Dystrophy. Completed, enrolled 42 participants across 1 site.
Detailed Summary
The purpose of this study is to investigate the effects of mexiletine treatment for 6 months on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning, cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyotonic Dystrophy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedAug 2011
Primary CompletionFeb 2017
Study CompletionMar 2017
TodayJul 2026
First PostedAug 1, 2011
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2017
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.9 years ago
Interventions
Mexiletinedrug
150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
Placebodrug
150 mg/kg placebo capsules taken by mouth, three times daily for 6 months