Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004646

Enrollment

Registered

2000-02-25

Start date

1995-04-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne muscular dystrophy, genetic diseases and dysmorphic syndromes, muscular dystrophy, neurologic and psychiatric disorders, rare disease

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.

Interventions

DRUGprednisone

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

5 Years to 15 Years

Healthy volunteers

Inclusion criteria

PROTOCOL ENTRY CRITERIA: * Ambulatory males with Duchenne muscular dystrophy * No medical/psychiatric contraindication to protocol therapy * No requirement for regular use of prescription medication

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026