CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Mexiletine +1 moredrug
Likely dose
Mexiletine 150 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/NCT02561702
NCT02561702Phase 2Completed
CompareCT.gov

Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

University of Rochester·interventional·Posted Sep 28, 2015·Updated Mar 26, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo and Mexiletine for Charcot Marie Tooth Disease. Completed, enrolled 4 participants across 1 site.

Detailed Summary

Charcot Marie Tooth Disease is a family of inherited peripheral neuropathies, with over 70 causative genes identified to date.1-4 Muscle cramps are frequent in CMT, affecting up to 85% of patients with some subtypes of CMT. These cramps impact quality of life and have been identified as an important therapeutic target for clinical trials in CMT.1-4 There is no FDA approved treatment for muscle cramps.5 Mexiletine is a sodium channel blocker approved for treatment of arrhythmias. As a sodium channel blocker, mexiletine offers the promise of effective therapy for muscle cramps.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCharcot Marie Tooth Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 28, 2015
Enrollment StartSep 1, 2015
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.8 years ago

Interventions

Placeboother

240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletinedrug

150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days