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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 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.

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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).

Conditions Studied

Becker Muscular Dystrophy

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

Sponsor

Epirium Bio

2 total trials

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What the Registry Record Tells You About NCT04386304

The ClinicalTrials.gov registry entry for NCT04386304 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,394-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (98% lower). The listed sponsor is Epirium Bio, which has 2 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.