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NCT00004646 Clinical Trial

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

Duchenne Muscular Dystrophy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004646
Other study ID # 199/11695
Secondary ID URMC-2251
Status Completed
Phase Phase 3
First received February 24, 2000
Last updated June 23, 2005
Start date April 1995

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 5 Years to 15 Years
Eligibility PROTOCOL ENTRY CRITERIA:

- Ambulatory males with Duchenne muscular dystrophy

- No medical/psychiatric contraindication to protocol therapy

- No requirement for regular use of prescription medication

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• prednisone

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester
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