(-)- Epicatechin Becker Muscular Dystrophy
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ClinicalTrials.gov Identifier: NCT03236662 |
Recruitment Status :
Completed
First Posted : August 2, 2017
Results First Posted : July 26, 2021
Last Update Posted : November 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Becker Muscular Dystrophy | Drug: (-)-Epicatechin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | UCD0115B: An Open-label Extension Study of Purified Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy |
Actual Study Start Date : | November 2016 |
Actual Primary Completion Date : | November 2017 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
(-)-epicatechin 50mg twice per day (100mg per day total dose)
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Drug: (-)-Epicatechin |
- 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
- 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.
- Exploratory Proteomics [ Time Frame: 48 weeks ]Collection of plasma samples for proteomics analysis.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Prior participation in UCD0113 BMD epicatechin pilot study
- Male
- 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%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236662
United States, California | |
UC Davis Medical Center | |
Sacramento, California, United States, 95817 |
Documents provided by Craig McDonald, MD, University of California, Davis:
Responsible Party: | Craig McDonald, MD, Principal Investigator, University of California, Davis |
ClinicalTrials.gov Identifier: | NCT03236662 |
Other Study ID Numbers: |
767161 |
First Posted: | August 2, 2017 Key Record Dates |
Results First Posted: | July 26, 2021 |
Last Update Posted: | November 24, 2021 |
Last Verified: | November 2021 |
BMD Becker muscular dystrophy epicatechin clinical trial neuromuscular disease |
Muscular Dystrophies Muscular Dystrophy, Duchenne Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn Genetic Diseases, X-Linked |