CoQ10 and Prednisone in Non-Ambulatory DMD

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00308113
• Date of registration: 27/03/2006
• Prospective Registration: Yes
• Primary sponsor: Cooperative International Neuromuscular Research Group
• Public title: CoQ10 and Prednisone in Non-Ambulatory DMD
• Scientific title: PITT0503: Clinical Trial of Coenzyme Q10 and Prednisone in Duchenne Muscular Dystrophy
• Date of first enrolment: April 2007
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00308113
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Puerto Rico, United States

Contacts

• Name: Paula R Clemens, M.D.
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 10 Years
Age maximum: 18 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy

Intervention(s)

Drug: Prednisone

Dietary Supplement: Coenzyme Q10

Primary Outcome(s)

One Year Change in Pulmonary Function (Forced Expiratory Volume, FEV1 and Forced Vital Capacity, FVC) [Time Frame: 12 months]

One Year Change of Left Ventricular Mean Systolic Wall Stress/Rate-corrected Velocity of Fiber Shortening Relation. [Time Frame: 12 months]

Secondary Outcome(s)

Compare Side Effect Profiles of the Three Study Groups [Time Frame: 12 months]

Secondary ID(s)

PITT0503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United States Department of Defense

Results

• Results available: Yes
• Date Posted: 11/10/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00308113