Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
The study will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal
recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no
clinical cardiac symptoms. Participants will be randomized to one of four arms: Arm 1 CoQ10
alone, Arm 2 Lisinopril alone, Arm 3 CoQ10 and Lisinopril or Arm 4 No study medication.
Randomization will be stratified by ambulatory status and corticosteroid use. The primary
outcome for the study is the myocardial performance index (MPI), measured by standard Doppler
echocardiography. The study will last 24 months with visits at Months 0.5,1.5, 6, 12, 18 and
24.
Following completion of the Clinical Trial of Coenzyme Q10 and Lisinopril, participants will
be offered participation in a companion protocol: PITT1215 A Natural History Companion Study
to PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies. The
objective of this study is to evaluate the longitudinal natural history of DMD, BMD, and
LGMD2I and to evaluate the effects of Coenzyme Q10 and/or Lisinopril on prevention of cardiac
dysfunction in these disorders.This will be an 18-month longitudinal natural history study
designed to accompany the Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular
Dystrophies.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Cooperative International Neuromuscular Research Group