Study of experimental medicine, (-)-Epicatechin, in the treatment of Becker Muscular Dystrophy

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"Does experimental medicine, (-)-Epicatechin, improve progressive muscle loss and impaired skeletal muscle function in Muscular Dystrophy?"
Age:
18 to 60 years old
Gender:
Male
Healthy Volunteers:
No
Keywords:
muscular dystrophy
Type:
Drug study, Phase I/II
Investigator:
Description
This research study will look at an experimental medicine called (-)-Epicatechin. (-)-Epicatechin is purified from tea as a nutritional extract. (-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired skeletal muscle function in Becker Muscular Dystrophy (BMD) patients. (-)-Epicatechin has been shown to improve muscle structure and function in previous studies of animals and humans.
This study requires
History and physical
Blood and urine tests
ECGs
Exercise tests
DEXAs
Multifrequency Bioimpedence Assessment (MFBIA)s
Muscle Biopsies
Study medication administration
Who can participate?
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%
Resources
Schedule
Study duration and period
8 weeks (6 visits)
Recruitment period
From May 20, 2013
Location
UC Davis Dept of Physical Medicine & Rehabilitation
4860 Y Street
Lawrence J. Ellison Ambulatory Care Center
Sacramento, CA 95817
Research Topic
Conditions:
  • Becker Muscular Dystrophy

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