UC Davis Medical Center
Sacramento, California, 95817, United States
NCT Number: NCT03236662
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.
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Notify Me18 year–70 year
Male
Interventional
Phase 2
Sacramento, California, 95817, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
blood biomarker concentration
Time frame: 48 weeks
Ratio of plasma follistatin to plasma myostatin
Time frame: baseline and at 2-minute intervals
blood lactate measured
Time frame: 48 weeks
Measurements recorded will include 25-meter split times and total distance traveled.
Time frame: 48 weeks
Collection of plasma samples for proteomics analysis.
Craig McDonald, MD
Other
UCD0115B: An Open-label Extension Study of Purified Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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