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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
UC Davis Medical Center
Sacramento, California, United States
Plasma Follistatin
blood biomarker concentration
Time frame: 48 weeks
Plasma Myostatin
blood biomarker concentration
Time frame: 48 weeks
Plasma Nitrates/ SNO
blood biomarker concentration
Time frame: 48 weeks
Plasma BNP
blood biomarker concentration
Time frame: 48 weeks
Plasma Creatine Kinase
blood biomarker concentration
Time frame: 48 weeks
Plasma MMP-9
blood biomarker concentration
Time frame: 48 weeks
Plasma TNF-Alpha
blood biomarker concentration
Time frame: 48 weeks
Plasma TGF-Beta
blood biomarker concentration
Time frame: 48 weeks
Plasma Follistatin:Myostain Ratio
Ratio of plasma follistatin to plasma myostatin
Time frame: 48 weeks
Graded Exercise Test Using a Recumbent Cycle Ergometer
blood lactate measured
Time frame: baseline and at 2-minute intervals
6-minute Walk Test
Measurements recorded will include 25-meter split times and total distance traveled.
Time frame: 48 weeks
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