(-)- Epicatechin Becker Muscular Dystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 6 December 2021
• Main ID: NCT03236662
• Date of registration: 07/11/2016
• Prospective Registration: No
• Primary sponsor: Craig McDonald, MD
• Public title: (-)- Epicatechin Becker Muscular Dystrophy
• Scientific title: UCD0115B: An Open-label Extension Study of Purified Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy
• Date of first enrolment: November 2016
• Target sample size: 2
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03236662
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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%



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Becker Muscular Dystrophy

Intervention(s)

Drug: (-)-Epicatechin

Primary Outcome(s)

Plasma MMP-9 [Time Frame: 48 weeks]

Plasma BNP [Time Frame: 48 weeks]

Plasma Follistatin [Time Frame: 48 weeks]

Plasma Nitrates/ SNO [Time Frame: 48 weeks]

Plasma TNF-Alpha [Time Frame: 48 weeks]

Plasma Follistatin:Myostain Ratio [Time Frame: 48 weeks]

Plasma TGF-Beta [Time Frame: 48 weeks]

Plasma Creatine Kinase [Time Frame: 48 weeks]

Plasma Myostatin [Time Frame: 48 weeks]

Secondary Outcome(s)

Graded Exercise Test Using a Recumbent Cycle Ergometer [Time Frame: baseline and at 2-minute intervals]

6-minute Walk Test [Time Frame: 48 weeks]

Secondary ID(s)

767161

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cardero Therapeutics, Inc.

Results

• Results available: Yes
• Date Posted: 26/07/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03236662