Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1

Completed · Phase 2 · Has a placebo group

Conditions studied: Myotonic Dystrophy

In brief

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).

Key facts

Study ID

NCT01406873

Run by

University of Rochester

People needed

42

Starts

2011-06-01

Expected to finish

2017-03-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of DM1, confirmed by DM1 genetic mutation
• Ability to walk 30 feet (assistance with cane and/or leg bracing permitted)
• Presence of grip myotonia

You may not qualify if…

• Congenital DM1
• Treatment with Mexiletine within past 8 weeks
• Second or third degree heart block, atrial flutter, atrial fibrillation, ventricular arrhythmias, or is receiving medication for treatment of a cardiac arrhythmia
• Receiving another antimyotonia drug
• Liver or kidney disease requiring ongoing treatment
• Has a seizure disorder
• Is pregnant or lactating
• Had severe depression within 3 months or a history of suicide ideation
• Has any one of the following medical conditions: uncontrolled diabetes mellitus, congestive heart failure, symptomatic cardiomyopathy, symptomatic coronary artery disease, cancer (other than skin cancer) less than five years previously, multiple sclerosis, or other serious medical illness.
• Drug or alcohol abuse within 3 months
• Coexistence of another neuromuscular disease
• Is unable to give informed consent
• Severe arthritis or other medical condition (besides DM1) that would significantly impact ambulation

Where it is running

• University of Rochester Medical Center, Department of Neurology — Rochester, New York, United States

Full record on ClinicalTrials.gov

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