NCT00167609

Efficacy and Safety of DHEA for Myotonic Dystrophy

Phase 3 Study of Oral Dehydroepiandrosterone (DHEA) in Adults With Myotonic Dystrophy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Versailles · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy

Detailed description

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.

Conditions

• Myotonic Dystrophy

Interventions

Type	Name	Description
DRUG	dehydroepiandrosterone 100 and 400 mg

Timeline

• Start date: 2004-11-01
• Completion: 2006-12-01
• First posted: 2005-09-14
• Last updated: 2010-04-06

Locations

10 sites across 1 country: France