(-)- Epicatechin Becker Muscular Dystrophy | DuchenneXchange

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completed

(-)- Epicatechin Becker Muscular Dystrophy

key information

study id #: NCT03236662

condition: Becker Muscular Dystrophy

status: completed

purpose:

This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in patients with Becker muscular dystrophy who participated in the earlier trial. This single center study will enroll up to 10 adults who will receive the purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the study if they meet all inclusion criteria. They will be evaluated at screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the study will be presence of one or more biologic or strength and performance outcome measures that yield a response magnitude that allows for sufficient power in a Phase II B study with a sample size of 30 individuals.

intervention: (-)-Epicatechin

mechanism of action: Antioxidant to support health

results: https://clinicaltrials.gov/ct2/show/results/NCT03236662

last updated: November 22, 2018

study details

start date: November 2016

estimated completion: November 2017

phase of development: Phase 2

size / enrollment: 10

primary outcomes:

  • Plasma Follistatin [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Myostatin [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Nitrates/ SNO [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma BNP [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Creatine Kinase [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma MMP-9 [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma TNF-Alpha [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma TGF-Beta [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Follistatin:Myostain Ratio [ Time Frame: 48 weeks ]
    Ratio of plasma follistatin to plasma myostatin

secondary outcomes:

  • Graded exercise test using a recumbent cycle ergometer [ Time Frame: baseline and at 2-minute intervals ]
    blood lactate measured
  • 6-minute walk test [ Time Frame: 48 weeks ]
    Measurements recorded will include 25-meter split times and total distance traveled.

inclusion criteria:
• Age 18 years to 70 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.
• Hematology profile within normal range
• Baseline laboratory safety chemistry profile within normal range
• No plan to change exercise regimen during study participation
• 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).

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%

study contacts

sponsor: Craig McDonald, MD

locations: United States