Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
2 other identifiers
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1995
CompletedFirst Submitted
Initial submission to the registry
February 24, 2000
CompletedFirst Posted
Study publicly available on registry
February 25, 2000
CompletedJune 24, 2005
December 1, 2001
February 24, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Griggs
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 24, 2000
First Posted
February 25, 2000
Study Start
April 1, 1995
Last Updated
June 24, 2005
Record last verified: 2001-12