NCT02561702

Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will provide data on the short term efficacy of oral mexiletine in helping to prevent muscle cramps in adults with CMT. The study will also assess the short-term safety and tolerability of low dose mexiletine in adults with CMT.

Conditions

• Charcot Marie Tooth Disease

Interventions

Type	Name	Description
OTHER	Placebo	240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days
DRUG	Mexiletine	150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2015-09-28
• Last updated: 2018-03-26
• Results posted: 2018-03-26

Locations

1 site across 1 country: United States