Status:
COMPLETED
Effectiveness of Mexiletine for Treating People With Non-Dystrophic Myotonia
Lead Sponsor:
Richard Barohn, MD
Conditions:
Myotonia
Non-Dystrophic Myotonia
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
Nondystrophic myotonias (NDM) are neuromuscular disorders caused by genetic abnormalities in certain muscle cell membrane proteins. The proteins affect muscle contraction. Individuals with NDM experie...
Detailed Description
NDM are neuromuscular disorders that are caused by mutations in skeletal muscle ion channels, usually voltage-dependent sodium and chloride channels. The poorly functioning channels result in impaired...
Eligibility Criteria
Inclusion
- Clinical symptoms or signs suggestive of myotonic disorders
- Presence of myotonic potentials on electromyography (EMG)
- Participant in the Non-Dystrophic Natural History study (RDCRN 5303) or a new patient with confirmed non-dystrophic myotonia
Exclusion
- Other neurological condition that might affect the assessment of the study measurements
- Genetic confirmation of DM1 (more than 50 repeats of CTG) or DM2
- Existing cardiac conduction defects, as evidenced on EKG, including but not limited to the following conditions: malignant arrhythmia or cardiac conduction disturbances (e.g., second degree AV block, third degree AV block, or prolonged QT interval)
- Existing permanent pacemaker
- Current use of any of the following antiarrhythmic medications for a cardiac disorder: flecainide acetate, encainide, disopyramide, procainamide, quinidine, propafenone, or mexiletine
- Use of medications for myotonia, such as phenytoin and flecainide acetate, within 5 days of study entry; carbamazepine and mexiletine within 3 days of study entry; or propafenone, procainamide, disopyramide, quinidine, and encainide within 2 days of study entry
- Use of medications that produce myotonia, which may include fibrate acid derivatives, hydroxymethylglutaryl CoA reductase inhibitors, chloroquine, and colchicines
- Kidney or liver disease
- Heart failure
- Seizure disorder
- Pregnant or breastfeeding
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00832000
Start Date
December 1 2008
End Date
March 1 2011
Last Update
August 23 2013
Active Locations (7)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
University of Rochester School of Medicine & Dentistry
Rochester, New York, United States, 14642
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390