Status:
COMPLETED
Efficacy and Safety of DHEA for Myotonic Dystrophy
Lead Sponsor:
University of Versailles
Collaborating Sponsors:
Association Française contre les Myopathies (AFM), Paris
Assistance Publique - Hôpitaux de Paris
Conditions:
Myotonic Dystrophy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief 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, ...
Eligibility Criteria
Inclusion
- Myotonic dystrophy (genetically proven)
- MDRS score of 3 or 4
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00167609
Start Date
November 1 2004
End Date
December 1 2006
Last Update
April 6 2010
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU
Angers, France
2
CHU
Bordeaux, France
3
Raymond Poincaré Hospital
Garches, France, 92380
4
CHU
Grenoble, France