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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

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE September 28, 2015
Results First Submitted Date  ICMJE January 25, 2018
Results First Posted Date  ICMJE March 26, 2018
Last Update Posted Date March 26, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Charcot Marie Tooth Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: Placebo
    • Drug: Mexiletine
  • 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
    Interventions:
    • Other: Placebo
    • Drug: Mexiletine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2016)
4
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2015)
12
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02561702
Other Study ID Numbers  ICMJE RSRB00057653
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Herrmann, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Herrmann, MD University of Rochester
PRS Account University of Rochester
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP