Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1

Myotonic Dystrophy Clinical Trial

Official title: A Randomized, Placebo Controlled, Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type-1 (DM1)

Status Completed

Clinical Trial 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).

Clinical Trial Description

This study will provide data on the long term (6 months) safety and efficacy of mexiletine in:

• improving the distance participants are able to walk in six minutes;

• reducing myotonia;

• improving muscle strength;

• increasing lean muscle mass;

• decreasing musculoskeletal pain;

• improving gastrointestinal function and swallowing);

• improving functional abilities;

• decreasing cardiac arrhythmias; and

• improving disease-specific health related quality-of-life. ;

Related Conditions & MeSH terms

• Myotonic Dystrophy

• NCT number: NCT01406873
• Study type: Interventional
• Source: University of Rochester
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Completion date: March 2017