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Trial record 7 of 260 for:    "Charcot-Marie-Tooth disease"

Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

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ClinicalTrials.gov Identifier: NCT02561702
Recruitment Status : Completed
First Posted : September 28, 2015
Results First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
David Herrmann, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Charcot Marie Tooth Disease Other: Placebo Drug: Mexiletine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease
Study Start Date : September 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016


Arm Intervention/treatment
Experimental: Mexiletine first/placebo second
Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily
Other: Placebo
240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days
Other Name: lactose powder

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

Experimental: placebo first/mexiletine second
Participants will receive placebo (240 mg of lactose powder) taken by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of 150 mg of mexiletine by mouth 3 times daily
Other: Placebo
240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days
Other Name: lactose powder

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




Primary Outcome Measures :
  1. Number of Participants With a Decrease in Cramp Duration [ Time Frame: 120 minutes ]
    Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp duration in seconds of the right hamstring was used.

  2. Number of Participants With a Decrease in Cramp Intensity [ Time Frame: 120 minutes ]
    Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp intensity of the right hamstring was reported by the subject on a scale of 1-10 with 1 being weak and 10 being severe.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 provokable 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561702


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: David Herrmann, MD University of Rochester

Responsible Party: David Herrmann, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02561702     History of Changes
Other Study ID Numbers: RSRB00057653
First Posted: September 28, 2015    Key Record Dates
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Tooth Diseases
Muscle Cramp
Spasm
Stomatognathic Diseases
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Mexiletine
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action