Trial record 8 of 15 for:
"Muscular Dystrophies, Limb-Girdle"
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:
Cooperative International Neuromuscular Research Group
Collaborator:
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Duchenne Muscular Dystrophy Becker Muscular Dystrophy Limb Girdle Muscular Dystrophy |
Drug: Coenzyme Q10 and Lisinopril |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies |
Resource links provided by NLM:
Genetics Home Reference related topics:
Duchenne and Becker muscular dystrophy
limb-girdle muscular dystrophy
MedlinePlus related topics:
Muscular Dystrophy
U.S. FDA Resources
Further study details as provided by Cooperative International Neuromuscular Research Group:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Enhanced standard of care | |
| Active Comparator: Lisinopril |
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).
|
| Active Comparator: Coenzyme Q10 |
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).
|
| Active Comparator: Coenzyme Q10 and Lisinopril |
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).
|
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126697
Contacts
| Contact: Lauren Hache, MS, CGC | 206-451-4496 | lhache@childrensnational.org |
Locations
| United States, California | |
| University of California, Davis | Recruiting |
| Sacramento, California, United States | |
| Contact: Evan Debie, BS 916-734-6843 evan.debie@ucdmc.ucdavis.edu | |
| Principal Investigator: Craig McDonald, MD | |
| Sub-Investigator: Erik Henricson, MPH | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Carolina Tesi-Rocha, MD | |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States | |
| Contact: Lauren Webb 773-880-6927 lwebb@childrensmemorial.org | |
| Principal Investigator: Nancy Kuntz, MD | |
| United States, North Carolina | |
| Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States | |
| Contact: Susan Sparks, MD 704-446-6253 | |
| Principal Investigator: Susan Sparks, MD, PhD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Kate Hughes, MS, CGC 412-383-7207 hughessc@upmc.edu | |
| Principal Investigator: Paula Clemens, MD | |
| Canada, Alberta | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: Caitlin Wright, B.Sc. 403-955-3192 caitlin.wright@albertahealthservices.ca | |
| Principal Investigator: Jean Mah, MD | |
Sponsors and Collaborators
Cooperative International Neuromuscular Research Group
More Information
Additional Information:
No publications provided
| Responsible Party: | Cooperative International Neuromuscular Research Group |
| ClinicalTrials.gov Identifier: | NCT01126697 History of Changes |
| Other Study ID Numbers: | PITT0908 |
| Study First Received: | May 18, 2010 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Cooperative International Neuromuscular Research Group:
|
Cardiac Muscular Dystrophy Randomized |
Additional relevant MeSH terms:
|
Muscular Dystrophies, Limb-Girdle Muscular Dystrophy, Duchenne Muscular Dystrophies Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Coenzyme Q10 Ubiquinone Lisinopril Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vitamins Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Cardiotonic Agents Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013