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Sponsors and Collaborators: |
University of Versailles Association Française de Lutte contre la Myopathie AP-HP |
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Information provided by: | University of Versailles |
ClinicalTrials.gov Identifier: | NCT00167609 |
To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy
Condition | Intervention | Phase |
---|---|---|
Myotonic Dystrophy |
Drug: dehydroepiandrosterone 100 and 400 mg |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study of Oral Dehydroepiandrosterone (DHEA) in Adults With Myotonic Dystrophy |
Enrollment: | 75 |
Study Start Date: | November 2004 |
Study Completion Date: | December 2006 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Raymond Poincaré Hospital | |
Garches, France, 92380 | |
CHU | |
Angers, France | |
CHU | |
Toulouse, France | |
CHU | |
Nice, France | |
Institut de myologie | |
Paris, France | |
CHU | |
Strasbourg, France | |
CHU Pouget | |
Marseilles, France | |
CHU | |
Lyon, France | |
CHU | |
Grenoble, France | |
CHU | |
Bordeaux, France |
Study Chair: | Djillali annane, MD, PhD | Assistance Publique Hôpitaux de Paris - University of Versailles |
Study Director: | martine devillers, MD | AFM |
Study ID Numbers: | P001108, PS001108 |
Study First Received: | September 10, 2005 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00167609 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
myotonic dystrophy hypersomnia dehydroepiandrosterone |
Immunologic Factors Adjuvants, Immunologic Dehydroepiandrosterone Myotonic Disorders Neurodegenerative Diseases Muscular Dystrophies Muscular Diseases Heredodegenerative Disorders, Nervous System Muscular Disorders, Atrophic |
Musculoskeletal Diseases Neuromuscular Diseases Genetic Diseases, Inborn Myotonic Dystrophy Atrophy Myotonic Dystrophy 1 Myotonia Atrophica Muscular Dystrophy |
Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Dehydroepiandrosterone Myotonic Disorders Neurodegenerative Diseases Pharmacologic Actions |
Muscular Dystrophies Muscular Diseases Heredodegenerative Disorders, Nervous System Muscular Disorders, Atrophic Musculoskeletal Diseases Neuromuscular Diseases Genetic Diseases, Inborn Myotonic Dystrophy |