CoQ10, Lisinopril Trial in DMD, BMD, LGMD2C-2F, LGMD2I

Researchers at five U.S. and one Canadian center are conducting a clinical trial of the medications coenzyme Q10 and lisinopril to determine their possible beneficial effects on heart function in Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD) and five forms of limb-girdle muscular dystrophy (LGMD).

The trial is under the auspices of the Cooperative International Neuromuscular Research Group (CINRG) and has funding from the U.S. Department of Defense.

Coenzyme Q10 (coQ10) is involved in energy production in cells and is also an antioxidant, meaning it combats a cause of cell damage called oxidative stress. It's considered a dietary supplement and is available without a prescription.

Lisinopril (brand names Prinivil, Zestril) is a prescription drug that reduces stress on the cardiovascular system. It belongs to a class of drugs known as angiotensin converting enzyme (ACE) inhibitors.

Criteria for participation in the two-year trial

The study will include 120 participants who are at least 8 years old. They will be randomly assigned to receive either coenzyme Q10 alone, lisinopril alone, a combination of coenzyme Q10 and lisinopril, or no study medication.

Prospective participants must:

• have a confirmed genetic diagnosis of DMD, BMD or LGMD2C, LGMD2D, LGMD2E, LGMD2F or LGMD2I;
• have no clinical cardiac symptoms;
• have never taken cardiac medications known as beta blockers;
• have not taken coenzyme Q10 or an ACE inhibitor at any time for a duration of more than six months;
• have not taken coenzyme Q10 or an ACE inhibitor at all in the three months prior to study enrollment; and
• meet other study criteria.

Coenzyme Q10 and lisinopril trial sites

U.S. study sites are in the District of Columbia; Chicago; St. Louis; Charlotte, N.C.; and Pittsburgh, Pa. The Canadian site is in Calgary, Alberta.

For details and contact information, see Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies; or enter NCT01126697 into the search box at ClinicalTrials.gov.