Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents

Inclusion Criteria

• •Male
• •Age 8 years to 17 years
• •Non-Ambulatory (unable to complete 10m run/walk under 10s)
• •Weight \</=100Kg
• •Diagnosis of DMD confirmed by at least one the following:
• •* Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, or
• •* Gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'out-of-frame', and clinical picture consistent with typical DMD, 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 DMD, with a typical clinical picture of DMD, or
• •* Positive family history of DMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of DMD.
• •Cardiac ejection fraction \>55% on echocardiogram
• •Use of nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility has been discontinued at least 4 weeks prior to screening (daily multivitamin use is acceptable).
• •Glucocorticoid therapy, if used, must have a stable weight-based dose for at least 3 months prior to enrollment
• •Cardiac therapy, if used, includes prophylactic ACE inhibitors, aldosterone receptor antagonists (e.g.
• •spironolactone, eplerenone, etc.), and/or beta-blocker therapy, and must be stable for 3 months prior to enrollment.
• •Hematology profile within normal range.
• •Baseline laboratory safety chemistry profile within typical range for DMD (elevated ALT / AST acceptable in the absence of elevated GGT, elevated CK acceptable).