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Prostaglandin Inhibitor

Oral Ifetroban for Duchenne Muscular Dystrophy (DMD Trial)

Phase 2

Recruiting

Led By Larry Markham, MD

Research Sponsored by Cumberland Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males 7 years of age and older with the diagnosis of DMD, defined as phenotype consistent with DMD and either positive genotype, first degree relative with positive genotype, or confirmatory muscle biopsy

Stable dose of oral corticosteroids for at least 8 weeks or has not received corticosteroids for at least 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 12 months

Awards & highlights

DMD Trial Summary

This trial is testing a new therapeutic strategy for Duchenne muscular dystrophy (DMD), which is a devastating disease that leads to loss of ambulation, respiratory failure, and cardiomyopathy (CM). There is currently no cure for DMD, and this new therapeutic strategy aims to address this unmet medical need.

Who is the study for?

This trial is for males aged 7 and older with Duchenne Muscular Dystrophy (DMD). Participants must have stable heart function, be on certain heart medications for a set time without changes, and can't have had recent major surgery or other clinical trials. They need to be able to undergo MRI scans and not require specific heart failure treatments recently.Check my eligibility

What is being tested?

The study tests Ifetroban, a potential new treatment for the cardiomyopathy associated with DMD. It's compared against a placebo in boys and men who meet strict health criteria. The goal is to find out if Ifetroban can help improve cardiac outcomes in DMD patients.See study design

What are the potential side effects?

While the side effects of Ifetroban are not detailed here, common considerations may include risks related to bleeding disorders due to its effect on blood cells or interactions with current medications. Regular monitoring will likely assess any potential organ-specific reactions.

DMD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a male, 7 or older, diagnosed with DMD based on symptoms, genetic tests, or muscle biopsy.

Select...

I haven't taken corticosteroids for the last 30 days or have been on a stable dose for 8 weeks.

DMD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events (safety & tolerability)

Secondary outcome measures

Change from baseline in left ventricular ejection fraction

Change from baseline in pulmonary function

Change from baseline in quality-of-life

+4 more

Side effects data

From 2023 Phase 2 trial • 38 Patients • NCT03326063

17%

Systemic reaction to aspirin challenge with extrapulmonary symptoms

11%

Wheezing, Grade 1

Lung Infection (influenza B-related pneumonia), Grade 2

Otitis Media, Grade 2

Sinus disorder (bloody nose), Grade 1

Constipation, Grade 1

Eye disorder- Stye, Grade 1

Vomiting, Grade 1

Bruising, Grade 1

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Ifetroban

DMD Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral Ifetroban - Low DoseExperimental Treatment1 Intervention

Weight based, once daily oral ifetroban

Group II: Oral Ifetroban - High DoseExperimental Treatment1 Intervention

Weight based, once daily oral ifetroban

Group III: PlacebosPlacebo Group1 Intervention

Matching Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifetroban

2017

Completed Phase 2

~70

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cumberland PharmaceuticalsLead Sponsor

62 Previous Clinical Trials

9,415 Total Patients Enrolled

Vanderbilt University Medical CenterOTHER

857 Previous Clinical Trials

672,145 Total Patients Enrolled

Larry Markham, MDPrincipal InvestigatorRiley Children's Hospital

Media Library

Ifetroban (Prostaglandin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03340675 — Phase 2

Dilated Cardiomyopathy Research Study Groups: Oral Ifetroban - Low Dose, Oral Ifetroban - High Dose, Placebos

Dilated Cardiomyopathy Clinical Trial 2023: Ifetroban Highlights & Side Effects. Trial Name: NCT03340675 — Phase 2

Ifetroban (Prostaglandin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03340675 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the precedent for Ifetroban studies?

"As of right now, 5 clinical trials are underway for Ifetroban. Out of those 5 active studies, 0 have reached Phase 3. Most of the trials taking place for Ifetroban are based in Boston, Massachusetts; however, there are a total of 46 locations running these tests."

Answered by AI

Is this research novel in its approach?

"Research on Ifetroban began in 2017 with a study of 34 patients that was conducted by Cumberland Pharmaceuticals. Phase 2 approval was received after the first successful trial and, as of today, there are 5 ongoing trials in 33 cities across 2 nations."

Answered by AI

Are there many different sites where this research is taking place?

"So far, this study has recruited 10 patients from locations such as Monroe Carrell Jr. Children's Hospital at Vanderbilt in Nashville, Arkansas Children's Hospital in Little Rock, and Lurie Children's Hospital in Chicago."

Answered by AI

Are there any available positions for test subjects in this experiment?

"Yes, this information can be found on the website clinicaltrials.gov. The trial was originally posted on October 19th, 2020 and has had one update since then on November 16th, 2020."

Answered by AI

How many test subjects are needed for this experiment?

"This study requires the participation of 48 patients that meet specific inclusion criteria. Children's hospitals in Nashville, Tennessee and Little Rock, Arkansas are two participating locations where patients can enroll."

Answered by AI

Is Ifetroban known to cause any adverse effects in people?

"Ifetroban's safety is not as well understood as other drugs because it only received a score of 2. This is due to the fact that Ifetroban is still in Phase 2 clinical trials, meaning that while there are some data supporting its safety, none supports its efficacy."

Answered by AI

Recent research and studies

American Journal of Physiology-Heart and Circulatory PhysiologyJournal

Ifetroban Reduces Coronary Artery Dysfunction in a Mouse Model of Duchenne Muscular Dystrophy

Mitchell, R., N. E. Frederick, E. R. Holzman, F. Agobe, H. C. M Allaway, and P. Bagher. 2021. “Ifetroban Reduces Coronary Artery Dysfunction in a Mouse Model of Duchenne Muscular Dystrophy”. American Journal of Physiology-heart and Circulatory Physiology. American Physiological Society. doi:10.1152/ajpheart.00180.2021.

clinicaltrials.govStudy

Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy

2020. "Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03340675.

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