Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

(-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired skeletal muscle function in Becker Muscular Dystrophy (BMD) patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Craig McDonald, MD
• Collaborator: Cardero Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Male

• Age 18 years to 60 years

• Average to low daily physical activity

• Ability to ambulate for 75 meters without assistive devices

• Diagnosis of BMD confirmed by at least one the following:

• Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical BMD, or

• Gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'in-frame', and clinical picture consistent with typical BMD, or

• Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with BMD, with a typical clinical picture of BMD, or

• Positive family history of BMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of BMD.

• Nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility have been discontinued at least 2 weeks prior to screening (daily multivitamin use is acceptable).

• Hematology profile within normal range

• Baseline laboratory safety chemistry profile within normal range

• No plan to change exercise regimen during study participation

Exclusion Criteria:

• Currently enrolled in another treatment clinical trial.

• History of significant concomitant illness or significant impairment of renal or hepatic function.

• Use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication.

• Regular participation in vigorous exercise.

• Symptomatic heart failure with cardiac ejection fraction <25%