Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy

Completed · Phase 1

Conditions studied: Becker Muscular Dystrophy

In brief

This is a Phase 1, open-label, dose escalation study aimed at evaluating the safety, early efficacy and potential biomarkers of (+)-epicatechin in patients with Becker or Becker-like Muscular Dystrophy (BMD).

Key facts

Study ID

NCT04386304

Run by

Epirium Bio Inc.

People needed

22

Starts

2020-07-13

Expected to finish

2022-03-01

Last updated by the study team

2022-03-23

Who can join

Age: 16 and older, up to 59. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥16 to <60 years of age.
• Genotype confirmation showing a mutation of the dystrophin gene.
• Ambulation - participants must show a history of ambulation past the age of 16 years, with continued ambulation thereafter.
• If on glucocorticoid treatment in the last 12 months, participants must be on a stable dose at screening. Participants cannot start steroids during the study.

You may not qualify if…

• A diagnosis of other neurological diseases or presence of relevant somatic disorders that are not related to Becker muscular dystrophy.
• Participants with a history of migraine headaches requiring medical attention and active treatment within the past 6 months.
• Participants with allergies to chocolate or cocoa.
• Surgery or orthopedic injury that might affect muscle strength or function within 3 months before study entry or planned surgery at any time during the study.
• Presence of a concomitant neurologic disease (e.g., Parkinson's disease) that could negatively impact mobility or balance.
• Symptomatic heart failure (New York Heart Association Class III or IV) or known left ventricular ejection fraction <40% by echocardiogram.
• Presence of documented intrinsic lung disease (e.g., chronic obstructive pulmonary disease, pulmonary fibrosis).
• Evidence of current liver disease or impairment.
• Inadequate renal function.
• Platelet count, WBC count, and hemoglobin at Screening <Lower Limit of Normal (LLN).
• Surgery or orthopedic injury that might affect muscle strength or function within 3 months before study entry or planned surgery at any time during the study

Where it is running

• UCLA Dept of Human Genetics — Los Angeles, California, United States
• University of California - Davis Department of Physical Medicine and Rehabilitation — Sacramento, California, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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