NCT04386304

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

A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Orally Administered (+)-Epicatechin in Patients With Becker or Becker-like Muscular Dystrophy With Continued Ambulation Past 16 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Epirium Bio Inc. · Industry
• Sex: Male
• Age: 16 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The safety and tolerability of three escalating doses of (+)-epicatechin will be assessed and early effectiveness measured by changes in plasma biomarkers, tissue biomarkers from muscle biopsies, cardiac imaging, and on clinical function assessments of participants' muscle strength. All patients will receive oral (+)-epicatechin for a total duration of approximately 52 weeks. Three doses of (+)-epicatechin will be tested in sequential 2 month periods with total daily doses of 75, 150, and 225 mg/day (+)-epicatechin. Doses will be escalated every 2 months, if tolerated, for the first 6 months of the study. Participants will then continue to receive the highest does they tolerated for an additional 6 months.

Conditions

• Becker Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	(+)-Epicatechin	(+)-Epicatechin is a synthetic flavanol

Timeline

• Start date: 2020-07-13
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2020-05-13
• Last updated: 2022-03-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study