drugset / Trial / NCT00308113

CoQ10 and Prednisone in Non-Ambulatory DMD

NCT00308113 ↗

RandomizedParallel-groupOpen-labelTreatment

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 DMD. Participants who are enrolled in this study should not have taken any corticosteroids within the last six months. This is a 13-month, prospective, randomized study comparing a daily prednisone arm (0.75mg/kg/day), a CoQ10 arm (serum of greater than 2.5 ug/mL) and a combination arm (prednisone and CoQ10) with an enhanced standard of care arm in wheelchair confined males age 10 to 18 years with an established DMD diagnosis.

Timeline

Start
2007-04
Primary completion
2010-11
Completion
2010-11

Outcome

Outcome not reported

Stopped (Enrollment): “New enrollment has been suspended, currently following previously enrolled participants”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prednisone Other / unclassified 0.75 mg/kg Oral