Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
Phase 3
Completed
- Conditions
- Duchenne Muscular Dystrophy
- Registration Number
- NCT00004646
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Brief Summary
OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients with Duchenne muscular dystrophy.
II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth hormone, and insulin.
III. Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin.
IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy.
- Detailed Description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to prednisone or placebo. Therapy is administered daily for 12 weeks; prednisone is then tapered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method