NCT01126697

Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies

PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Cooperative International Neuromuscular Research Group · Network
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Duchenne Muscular Dystrophy
• Becker Muscular Dystrophy
• Limb Girdle Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	Coenzyme Q10 and Lisinopril	Arm 1. Coenzyme Q10: taken once a day each morning by mouth OR Arm 2. Lisinopril: taken once a day each morning by mouth OR Arm 3. Coenzyme Q10 and lisinopril: each taken once a day in the morning by mouth OR Arm 4. Enhanced Standard Care (more doctor visits, muscle and breathing testing, and x-rays for monitoring, but no study medication).

Timeline

• Start date: 2010-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2010-05-20
• Last updated: 2018-06-15

Locations

7 sites across 3 countries: United States, Canada, Japan