Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
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|ClinicalTrials.gov Identifier: NCT00004646|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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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.
|Condition or disease||Intervention/treatment||Phase|
|Duchenne Muscular Dystrophy||Drug: prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Study Start Date :||April 1995|
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|Ages Eligible for Study:||5 Years to 15 Years (Child)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
PROTOCOL ENTRY CRITERIA:
- Ambulatory males with Duchenne muscular dystrophy
- No medical/psychiatric contraindication to protocol therapy
- No requirement for regular use of prescription medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004646
|Study Chair:||Robert Griggs||University of Rochester|
|Other Study ID Numbers:||
|First Posted:||February 25, 2000 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||December 2001|
Duchenne muscular dystrophy
genetic diseases and dysmorphic syndromes
neurologic and psychiatric disorders
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal