Efficacy and Safety of DHEA for Myotonic Dystrophy

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Versailles
• Collaborators: Assistance Publique - Hôpitaux de Paris; Association Française contre les Myopathies (AFM), Paris
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion Criteria:

• Myotonic dystrophy (genetically proven)

• MDRS score of 3 or 4

Exclusion Criteria:

• 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)

• Chronic renal failure

• Chronic liver disease

• Long term mechanical ventilation

• Any ongoing cancer

• Any underlying endocrine disorders

• Impaired swallowing

• Previous treatment with DHEA