Trials / Completed
CompletedNCT00004646
Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- Male
- Age
- 5 Years – 15 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | prednisone |
Timeline
- Start date
- 1995-04-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004646. Inclusion in this directory is not an endorsement.