Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease
This trial is active, not recruiting.
|Condition||charcot marie tooth disease|
|Sponsor||University of Rochester|
|Start date||September 2015|
|End date||December 2016|
|Trial size||4 participants|
|Trial identifier||NCT02561702, RSRB00057653|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
occurrence of muscle cramps
time frame: 120 minutes
occurrence of muscle cramps
time frame: 5-7 days
Male or female participants at least 18 years old.
- • • The subject has known CMT, previously diagnosed by a neurologist with subspeciality expertise in neuromuscular disorders/peripheral neuropathy. The diagnosis of CMT relies on a combination of clinical history (including family history), neurological examination electrophysiological features, and prior genetic testing results.
- The subject is at least 18 years old, and has signed the Informed Consent Form.
- The subject is ambulatory (cane, walker, orthoses allowed).
- The subject has experienced muscle cramps and has known provocable hamstring or calf muscle cramps on MVC.
- The subject has a reliable method of birth control (if a female subject of child bearing potential). Reliable birth control is defined as Hormonal contraception Intrauterine contraception/device Any two barrier methods (combination of male or female condom with diaphragm sponge or cervical cap) together with spermicidal foam/gel/film/cream/suppository True abstinence
- • The subject has a known neuropathy from another source (e.g., diabetes, drug induced, alcohol, etc.).
- The subject has an untreated medical disorder known to predispose to muscle cramps
- The subject is pregnant or nursing, has a known mexiletine allergy or has taken mexiletine in the past 12 weeks.
- The subject is participating in another therapeutic trial.
- The subject has second or 3rd degree heart block, atrial flutter/fibrillation, ventricular arrhythmias, or is receiving treatment of a cardiac arrhythmia.
- The subject is currently taking another agent for muscle cramps or a muscle relaxant (e.g., benzodiazepine, baclofen, tizanidine, soma, meprobromate).
- The subject is on another sodium channel blocker or medication that precludes administration of mexiletine.
- The subject has known diabetes mellitus, liver or kidney disease requiring ongoing treatment, untreated thyroid dysfunction, symptomatic cardiomyopathy, or symptomatic coronary artery disease.
- The subject, in the opinion of the investigator, is unsuitable for enrollment for any other reason
|Official title||Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease|
|Principal investigator||David Herrmann, MD|
|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.|
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