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

This study has been completed.
Sponsor:
Collaborators:
University of Rochester
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004646
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001

February 24, 2000
June 23, 2005
April 1995
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Complete list of historical versions of study NCT00004646 on ClinicalTrials.gov Archive Site
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Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Duchenne Muscular Dystrophy
Drug: prednisone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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PROTOCOL ENTRY CRITERIA:

  • Ambulatory males with Duchenne muscular dystrophy
  • No medical/psychiatric contraindication to protocol therapy
  • No requirement for regular use of prescription medication
Male
5 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004646
199/11695, URMC-2251
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National Center for Research Resources (NCRR)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Rochester
Study Chair: Robert Griggs University of Rochester
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP