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Trial record 1 of 1 for:    NCT01126697
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Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies

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ClinicalTrials.gov Identifier: NCT01126697
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Cooperative International Neuromuscular Research Group

Tracking Information
First Submitted Date  ICMJE May 18, 2010
First Posted Date  ICMJE May 20, 2010
Last Update Posted Date June 15, 2018
Study Start Date  ICMJE February 2010
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2010)
myocardial performance index (MPI) [ Time Frame: every 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies
Official Title  ICMJE PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Duchenne Muscular Dystrophy
  • Becker Muscular Dystrophy
  • Limb Girdle Muscular Dystrophy
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2018)
63
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2010)
120
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 or equal to 0.40 for the highest MPI value (spectral and tissue) or circumferential strain measured by STE that is less negative than or equal to - 23
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01126697
Other Study ID Numbers  ICMJE PITT0908
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cooperative International Neuromuscular Research Group
Study Sponsor  ICMJE Cooperative International Neuromuscular Research Group
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE Not Provided
PRS Account Cooperative International Neuromuscular Research Group
Verification Date June 2018

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