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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
Must not have
Clinically significant illness other than DMD
Major surgery within six weeks prior to the first dose of study drug, or planned surgery during this study which would interfere with the ability to perform study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 12 months

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any major illnesses besides DMD.
Select...
I haven't had major surgery in the last 6 weeks and don't plan any that would affect this study.
Select...
I am allergic to gadolinium contrast or have kidney problems.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events (safety & tolerability)
Secondary study objectives
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
6%
Eye disorder- Stye, Grade 1
6%
Lung Infection (influenza B-related pneumonia), Grade 2
6%
Sinus disorder (bloody nose), Grade 1
6%
Otitis Media, Grade 2
6%
Constipation, Grade 1
6%
Vomiting, Grade 1
6%
Bruising, Grade 1
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Ifetroban

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

Find a Location

Who is running the clinical trial?

Cumberland PharmaceuticalsLead Sponsor
62 Previous Clinical Trials
9,398 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
908 Previous Clinical Trials
934,539 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
~0 spots leftby Dec 2024
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