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Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies

This study is currently recruiting participants.
Verified January 2013 by Cooperative International Neuromuscular Research Group
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Cooperative International Neuromuscular Research Group
ClinicalTrials.gov Identifier:
NCT01126697
First received: May 18, 2010
Last updated: January 11, 2013
Last verified: January 2013
History of Changes

May 18, 2010
January 11, 2013
February 2010
December 2013   (final data collection date for primary outcome measure)
myocardial performance index (MPI) [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
The MPI is a sensitive, quantifiable, noninvasive measure of global ventricular function that is independent of cardiac geometry and heart rate. MPI is collected through standard echocardiogram assessment. MPI is a ratio of the total time spent in isovolumic activity (isovolumic contraction time and isovolumic relaxation time) to the time spent in ventricular ejection.
Same as current
Complete list of historical versions of study NCT01126697 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies
PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies

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, 3, 6, 9, 12, 18 and 24.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Duchenne Muscular Dystrophy
  • Becker Muscular Dystrophy
  • Limb Girdle Muscular Dystrophy
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).
  • No Intervention: Enhanced standard of care
  • Active Comparator: Lisinopril
    Intervention: Drug: Coenzyme Q10 and Lisinopril
  • Active Comparator: Coenzyme Q10
    Intervention: Drug: Coenzyme Q10 and Lisinopril
  • Active Comparator: Coenzyme Q10 and Lisinopril
    Intervention: Drug: Coenzyme Q10 and Lisinopril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 8 years of age or older
  • Confirmed genetic diagnosis of Duchenne, Becker, or Limb Girdle muscular dystrophy
  • Beta-blocker naïve
  • Screening Doppler echocardiographic MPI measurement greater than 0.40
  • Normal left ventricular fractional shortening (≥28%) and no clinical cardiac symptoms
  • Has not participated in other therapeutic research protocol within the last 6 months prior to screening
  • Ability to swallow tablets

Exclusion Criteria:

  • Spine curvature greater than 30% (based on the x-ray performed at screening)
  • History of significant concomitant illness or significant impairment of renal or hepatic function
  • History of hypersensitivity to ACE inhibitors
  • History of idiopathic or hereditary angioedema or a history of angioedema with prior ACE inhibitor use
  • Use of carnitine, creatine, glutamine, or any herbal medicines (this would not include herbal teas unless they are consumed daily with intended medicinal effect) in the 3-months prior to enrollment
  • CoQ10 and/or ACE inhibitor use for a duration greater than 6 months
  • CoQ10 and/or ACE inhibitor use in the 3-months prior to enrollment
  • CoQ10 serum level of 2.5 ug/ml or higher
  • Investigator assessment of inability to comply with protocol
Both
8 Years and older
No
Contact: Lauren Hache, MS, CGC 206-451-4496 lhache@childrensnational.org
United States,   Canada
 
NCT01126697
PITT0908
Yes
Cooperative International Neuromuscular Research Group
Cooperative International Neuromuscular Research Group
Department of Defense
Not Provided
Cooperative International Neuromuscular Research Group
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP