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Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

NCT02561702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-03-26

Study results available
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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.

Conditions

  • Charcot Marie Tooth Disease

Interventions

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

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • David Herrmann, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02561702 on ClinicalTrials.gov