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NCT04386304 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Becker Muscular Dystrophy, sponsored by Epirium Bio.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
3
Study locations

NCT04386304: Completed Phase 1 study of Becker Muscular Dystrophy, sponsored by Epirium Bio.

NCT04386304 is a Phase 1 study of Becker Muscular Dystrophy that has completed, run by Epirium Bio. The registered enrollment target is 22 participants, below the 1,394-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04386304, a Phase 1 study of Becker Muscular Dystrophy, has completed, sponsored by Epirium Bio.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
3
Study locations

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).

Primary Outcome

The TEAEs will be graded using the adult National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

Conditions Studied

Interventions

  • DRUG (+)-Epicatechin

Study Locations (3)

California

  • UCLA Dept of Human Genetics - Los Angeles
  • University of California - Davis Department of Physical Medicine and Rehabilitation - Sacramento

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2020-07-13
Est. Completion 2022-03-01
Phase Phase 1
Epirium Bio

2 total trials

What the finished NCT04386304 record still lists

NCT04386304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,394-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Becker Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which (+)-Epicatechin is the first listed.

NCT04386304 reports a single indexed study location in California, Missouri.

Frequently Asked Questions

What is clinical trial NCT04386304 about?

NCT04386304 is a clinical study titled "Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy". 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).

What is the current status of trial NCT04386304?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2020-07-13. Estimated completion is 2022-03-01.

What conditions does trial NCT04386304 study?

This clinical trial studies the following conditions: Becker Muscular Dystrophy.

What interventions are being tested in trial NCT04386304?

The interventions under investigation include: (+)-Epicatechin (DRUG).

Who is sponsoring clinical trial NCT04386304?

This trial is sponsored by Epirium Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04386304 being conducted?

This trial has 3 study locations across California, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Becker Muscular Dystrophy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04386304's enrollment target sits among peer trials

22 10th of 12 higher than 3 of 12 other Becker Muscular Dystrophy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Becker Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04386304, the US trial registry maintained by the National Library of Medicine. NCT04386304 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.