Trials / Completed
CompletedNCT03236662
(-)- Epicatechin Becker Muscular Dystrophy
UCD0115B: An Open-label Extension Study of Purified Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Craig McDonald, MD · Academic / Other
- Sex
- Male
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | (-)-Epicatechin |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-11-01
- Completion
- 2017-12-01
- First posted
- 2017-08-02
- Last updated
- 2021-11-24
- Results posted
- 2021-07-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03236662. Inclusion in this directory is not an endorsement.