Efficacy and Safety of DHEA for Myotonic Dystrophy
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ClinicalTrials.gov Identifier: NCT00167609
Recruitment Status :
First Posted : September 14, 2005
Last Update Posted : April 6, 2010
University of Versailles
Association Française contre les Myopathies (AFM), Paris
To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy
Condition or disease
Drug: dehydroepiandrosterone 100 and 400 mg
Phase 2Phase 3
Myotonic dystrophy is an inherited disorder that affects 1 per 8000 adults. The disease is characterize by muscular dystrophy, myotonia, cardiac disorders, cognitive function impairment, hypersomnia, hair loss, endocrine disorders. Recent small studies suggested that DHEA treatment may improve muscle strength in adults with myotonic dystrophy. Thus, the current study aims at investigating the safety and efficacy of a prolonged treatment with DHEA in adults with myotonic dystrophy.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Myotonic dystrophy (genetically proven)
MDRS score of 3 or 4
Age <18 years or >70 years
Pregnancy or breastfeeding
Poor compliance to treatment and follow up
Inclusion in any other clinical trial
Severe cardiac disease: acute myocardial infarction in the preceding 6 months, unstable heart failure, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg after 10 minutes of rest in the lying position), severe arteritis, any past history of thrombose or embolic event, any past history of symptomatic arrhythmia)