Efficacy and Safety of DHEA for Myotonic Dystrophy (NCT00167609) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of DHEA for Myotonic Dystrophy
France75 participantsStarted 2004-11
Plain-language summary
To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Variation in a Muscle Strength Score between randomization and study week 12