(-)- Epicatechin Becker Muscular Dystrophy

Becker Muscular Dystrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236662
• Other study ID #: 767161
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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%

Related Conditions & MeSH terms

• Becker Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Drug:
• (-)-Epicatechin

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Craig McDonald, MD	Cardero Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Proteomics	Collection of plasma samples for proteomics analysis.	48 weeks
Primary	Plasma Follistatin	blood biomarker concentration	48 weeks
Primary	Plasma Myostatin	blood biomarker concentration	48 weeks
Primary	Plasma Nitrates/ SNO	blood biomarker concentration	48 weeks
Primary	Plasma BNP	blood biomarker concentration	48 weeks
Primary	Plasma Creatine Kinase	blood biomarker concentration	48 weeks
Primary	Plasma MMP-9	blood biomarker concentration	48 weeks
Primary	Plasma TNF-Alpha	blood biomarker concentration	48 weeks
Primary	Plasma TGF-Beta	blood biomarker concentration	48 weeks
Primary	Plasma Follistatin:Myostain Ratio	Ratio of plasma follistatin to plasma myostatin	48 weeks
Secondary	Graded Exercise Test Using a Recumbent Cycle Ergometer	blood lactate measured	baseline and at 2-minute intervals
Secondary	6-minute Walk Test	Measurements recorded will include 25-meter split times and total distance traveled.	48 weeks