Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy

This study is looking at new ways to treat migraine headaches in people who also have a Patent Foramen Ovale (PFO), which is a small opening in the heart wall. Researchers want to see if closing the PFO with a device, or taking a medication called prasugrel, can reduce the number of migraine days you experience. The study will measure how much your monthly migraine days (MMD) are reduced after treatment. You might be able to join if you are between 18 and 55 years old, have had migraines for at least a year, and typically experience more than one migraine headache day per week. The study aims to understand if a PFO plays a role in migraines for some people, especially those who respond to prasugrel.

Study design: This is an interventional study planning to enroll 32 participants. It is designed to compare PFO closure with medical therapy alone.
What's involved: Participants in one group will take prasugrel 5mg daily for six months. Participants in another group will undergo a non-surgical procedure to close their PFO using the GORE Cardioform Septal Occluder.
Compensation: Not stated in the trial record.
Follow-up: Your monthly migraine days will be measured upon completion of a 56-day post-therapy monitoring session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy

Not Yet Recruiting

PHASE3Ages 18–55InterventionalPrevention

Columbia University

~32 participants

Updated 2026-07-29 on ClinicalTrials.gov

What's tested:Prasugrel 5mgTranscatheter Closure of Patent Foramen Ovale

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Reduction in Monthly Migraine Days (MMD)

Measured over upon completion of the 56-day Post-Therapy monitoring session

Conditions

Migraine Disease

Patent Foramen Ovale

Where it's being run

1 sites across 1 states

New York1

Study leadership

Jessica Ailani, MD · PRINCIPAL_INVESTIGATOR · MedStar Georgetown University Hospital
Robert J Sommer, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Robert J Sommer, MD

[email protected]

212-342-0886

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: ≥18 and \<55 at time of screening

Migraine headache with aura, or migraine headache without aura, fulfilling conditions of the Neurology Screening Tool (meeting ICHD-3 criteria)

Diagnosis of migraine for ≥ 1 year; onset of migraine symptoms \< 40 years of age

By history, an average headache burden of greater than one migraine headache day per week:

without current preventative therapy, OR

despite preventative therapy, OR

with reason to come off effective therapy (e.g. cost, aversion to injections, side effects)

If patient is taking preventive migraine medications, dose must be stable for at least 3 months prior to the screening visit. Patient agrees to continue preventive medication at the current dosage throughout the duration of the Baseline and On-treatment monitoring periods (Study Weeks 1 - 17).

Female patients capable of becoming pregnant agree to use two forms of birth control or abstinence during their participation in the study.

Exclusion

Headache disorder other than migraine with aura, or migraine without aura

Patient has history of stroke, TIA, or intracranial hemorrhage.

Patient has a history of thrombocytopenia within one year, or platelet count \<100,000/mm3 identified during the screening laboratory evaluation.

Patient has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT/PTT, or with total bilirubin \>3.0 mg/dL identified during the screening laboratory evaluation.

Patient has previously implanted pacemaker, IVC filter, PFO closure device, ASD closure device, or left atrial appendage closure device or any cardiac history which, in the investigator's opinion, would preclude them from study participation.

Patient has documented right-to-left shunt source in addition to PFO such as atrial septal defect or pulmonary arteriovenous malformation.

Patient has a history of clinically significant bleeding within 6 months of the screening visit, any active bleeding, or active peptic ulcer disease.

Patient has an uncontrolled arrhythmia, or if on therapy, has evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia or atrial fibrillation while under rhythm control).

Patient has elevated PVR which in the opinion of the implanting physician precludes safe PFO closure.

Patient has active infection at the time of screening that cannot be treated.

Patient is planning surgery during the study timeframe.

A female patient is pregnant or is planning pregnancy during the anticipated duration of the study. Urine or blood pregnancy screening will be performed as part of the screening laboratory evaluation.

Patient has documented nickel allergy/sensitivity

Patient has a documented history of non-compliance with medical care, which would preclude them, in the opinion of the study team

Patient has known hypersensitivity or contraindication to thienopyridines

Patient has another medical condition requiring chronic antithrombotic therapy with antiplatelet, oral anticoagulant or injectable agents

Patient has need for daily use of NSAIDs other than for treatment of migraines

What this trial measures

Reduction in Monthly Migraine Days (MMD)upon completion of the 56-day Post-Therapy monitoring session
The primary efficacy endpoint is the proportion of randomized subjects maintaining a clinically meaningful migraine response, defined as a ≥50% reduction in Monthly Migraine Days (MMD) in the Post-Therapy monitoring session, compared with the Baseline monitoring session (following discontinuation of prasugrel).

Trialytics