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

NCT04386304 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-03-23

No results posted yet for this study

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).

Conditions

  • Becker Muscular Dystrophy

Interventions

DRUG

(+)-Epicatechin

(+)-Epicatechin is a synthetic flavanol

Sponsors & Collaborators

  • Epirium Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Epirium Bio Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
59 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04386304 on ClinicalTrials.gov