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Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1

NCT01406873 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-06-19

Study results available
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Summary

The purpose of this study is to investigate the effects of mexiletine treatment for 6 months on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning, cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).

Conditions

  • Myotonic Dystrophy

Interventions

DRUG

Mexiletine

150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months

DRUG

Placebo

150 mg/kg placebo capsules taken by mouth, three times daily for 6 months

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Richard T. Moxley, III, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2017-02-28
Completion
2017-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01406873 on ClinicalTrials.gov