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Mexiletine and Non Dystrophic Myotonias

NCT02336477 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-01-13

No results posted yet for this study

Summary

Treatment strategies in non-dystrophic myotonias are based on selective case reports, clinical experience and theoretical benefit. Presently, the most promising antimyotonic medication is mexiletine (MEX) but its manufacturing was stopped. The proposed randomized, double-blind, placebo-controlled, crossover trial is designed to:

1. study the safety and efficacy of mexiletine for the treatment of non-dystrophic myotonias
2. validate electromyographic tests as a standardized outcome measure of myotonia
3. assess the reliability and validity of a new clinical rating scale for myotonia

Conditions

  • Non-dystrophic Myotonias
  • Paramyotonia Congenita
  • Myotonia Congenita

Interventions

DRUG

Mexiletine

* Blisters of 10 capsules of 200 mg mexiletine hydrochloride. * Patients will receive gradual dose of the treatment as it would be done in clinical practice. * Mexiletine will be started at 200 mg / day (1 capsule to be taken at the beginning of the meal) and will be increased by 200mg every 3 days to reach a maximum of 600mg / day in 3 taken in 1 week. * The duration of each treatment period is 18 days minimum (maximum 22 days).

DRUG

placebo

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bertrand Fontaine, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Savine Vicart, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT02336477 on ClinicalTrials.gov