Status:
TERMINATED
CoQ10 and Prednisone in Non-Ambulatory DMD
Lead Sponsor:
Cooperative International Neuromuscular Research Group
Collaborating Sponsors:
United States Department of Defense
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
10-18 years
Phase:
PHASE3
Brief Summary
This study will help determine if CoQ10 and prednisone, alone and as a combination decrease the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair confined phase of ...
Detailed Description
Duchenne muscular dystrophy (DMD) is the most common form of muscular dystrophy affecting 1:3500 male births worldwide. Despite an increase in our understanding of the disorder since the discovery and...
Eligibility Criteria
Inclusion
- Age 10-18 years
- Non-ambulatory (primary mode of transportation is via wheelchair for 3 years or less)
- Confirmed DMD diagnosis
- Steroid-naive for the 6 months prior to screening
- Stable dose of b-blocker or ACE inhibitor medication for the 6 months prior to screening, if taking either of these medications
- Ability to provide reproducible repeat QMT grip score within 15% of first assessment score
- Has not participated in other therapeutic research protocol within the last 6 months prior to screening
- Ability to swallow tablets
Exclusion
- Failure to achieve one or more of the diagnostic inclusion criteria cited above
- Symptomatic DMD carrier
- Use of carnitine, other amino acids, creatine, glutamine, CoQ10 or any herbal medicines (this would not include herbal teas unless they are consumed daily with intended medicinal effect) within the last 3 months
- History of significant concomitant illness or significant impairment of renal or hepatic function, or other contraindication to steroid therapy
- Positive PPD
- No prior exposure to chickenpox and no immunization against chicken pox
- Baseline serum CoQ10 level of 5.0mg/ml or greater
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00308113
Start Date
April 1 2007
End Date
November 1 2010
Last Update
November 8 2013
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213