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

NCT00004646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

prednisone

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Rochester

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Robert Griggs · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004646 on ClinicalTrials.gov