Clinical Trial: Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

Brief 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 Summary: 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.
Sponsor: University of Rochester

Current Primary Outcome:

• occurrence of muscle cramps [ Time Frame: 120 minutes ]
  Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. Cramp occurrences will be evaluated for cramp duration measured in seconds and for participant-reported intensity on a 0-10 scale.
• occurrence of muscle cramps [ Time Frame: 5-7 days ]
  Participant will be evaluated for muscle cramps after a steady state (5-7 days) of oral mexiletine. Cramp occurrence will be evaluated for duration of cramp in seconds and for participant-reported intensity on a 0-10 scale.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Rochester

Dates:
Date Received: September 24, 2015
Date Started: September 2015
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017