Clinical trial: Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents (NCT02964377)

Eligibility criteria:
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).

        Exclusion Criteria:

          -  Inability to complete cardiac or strength, range of motion and mobility assessments
             per protocol

          -  Current enrollment 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.

          -  Cardiac symptoms that, in the opinion of the investigator, may be suggestive of
             imminent moderate to severe cardiac events, irrespective of LVEF.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 17 Years

Patient description (medical language): An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD.

Patient description (patient's own words): I brought my  8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy.

Does the patient match the trial criteria? Entailment