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Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy

NCT03340675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-17

Study results available
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Summary

Duchenne muscular dystrophy (DMD) is a devastating X-linked disease which leads to loss of ambulation between ages 7 and 13, respiratory failure and cardiomyopathy (CM) at any age, and inevitably premature death of affected young men in their late twenties. DMD is the most common fatal genetic disorder diagnosed in childhood. It affects approximately 1 in every 3,500 live male births across all races and cultures, and results in 20,000 new cases each year worldwide.Significant advances in respiratory care have unmasked CM as the leading cause of death. As there are yet no specific cardiac treatments to extend life, the current study aims to address this unmet medical need using a new therapeutic strategy for patients with DMD.

Funding Source - FDA OOPD

Conditions

  • Duchenne Muscular Dystrophy Cardiomyopathy
  • Cardiomyopathy, Dilated

Interventions

DRUG

Ifetroban

Weight based, once daily oral ifetroban

DRUG

Placebo

Matching oral placebo

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Larry Markham, MD · Riley Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2024-03-06
Completion
2026-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03340675 on ClinicalTrials.gov