We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00004646
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
First Submitted Date  ICMJE February 24, 2000
First Posted Date  ICMJE February 25, 2000
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE April 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
Official Title  ICMJE Not Provided
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE Drug: prednisone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

PROTOCOL ENTRY CRITERIA:

  • Ambulatory males with Duchenne muscular dystrophy
  • No medical/psychiatric contraindication to protocol therapy
  • No requirement for regular use of prescription medication
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 5 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004646
Other Study ID Numbers  ICMJE 199/11695
URMC-2251
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Center for Research Resources (NCRR)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Rochester
Investigators  ICMJE
Study Chair: Robert Griggs University of Rochester
PRS Account Office of Rare Diseases (ORD)
Verification Date December 2001

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