Status:
COMPLETED
High-dose Prednisone in Duchenne Muscular Dystrophy
Lead Sponsor:
Cooperative International Neuromuscular Research Group
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
4-10 years
Phase:
PHASE3
Brief Summary
This study will help to determine whether a high-dose weekly course of prednisone therapy is safer than and at least as effective as daily dose therapy for people with Duchenne muscular dystrophy (DMD...
Detailed Description
Duchenne muscular dystrophy (DMD) is the most common lethal inherited disorder worldwide. Despite the exponential increase in our understanding of the disorder since the discovery and characterization...
Eligibility Criteria
Inclusion
- 4 to 10 years of age
- Ambulant
- Confirmed DMD Diagnosis
- Steroid naive
- Evidence of muscle weakness by MRC score or clinical functional evaluation
- Ability to provide reproducible QMT bicep score
Exclusion
- History of significant concomitant illness or significant impairment of renal or hepatic function, or other contraindication to steroid therapy
- Symptomatic DMD carrier
- Positive PPD
- Lack of prior exposure to chickenpox or immunization
- Use of carnitine, glutamine, Coenzyme Q10, other amino acids or any herbal medications within the last 3 months
- History of symptomatic cardiomyopathy
- Prior attainment of quota for the age group in which the patient belongs
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00110669
Start Date
January 1 2004
End Date
February 1 2008
Last Update
October 27 2011
Active Locations (1)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010