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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004646
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

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 Intervention Phase
Duchenne Muscular Dystrophy Drug: prednisone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 20
Study Start Date: April 1995
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Investigators
Study Chair: Robert Griggs University of Rochester
  More Information

ClinicalTrials.gov Identifier: NCT00004646     History of Changes
Other Study ID Numbers: 199/11695
URMC-2251
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
Last Verified: December 2001

Keywords provided by Office of Rare Diseases (ORD):
Duchenne muscular dystrophy
genetic diseases and dysmorphic syndromes
muscular dystrophy
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents