Back to resultsPhase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
Primary Purpose
Duchenne Muscular Dystrophy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Duchenne Muscular Dystrophy focused on measuring Duchenne muscular dystrophy, genetic diseases and dysmorphic syndromes, muscular dystrophy, neurologic and psychiatric disorders, rare disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004646
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT00004646
Brief Title
Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
Keywords
Duchenne muscular dystrophy, genetic diseases and dysmorphic syndromes, muscular dystrophy, neurologic and psychiatric disorders, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisone
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Griggs
Organizational Affiliation
University of Rochester
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
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