Status:
COMPLETED
Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1
Lead Sponsor:
University of Rochester
Conditions:
Myotonic Dystrophy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 conducti...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01406873
Start Date
June 1 2011
End Date
March 1 2017
Last Update
June 19 2018
Active Locations (1)
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1
University of Rochester Medical Center, Department of Neurology
Rochester, New York, United States, 14642