Not Yet RecruitingPhase 3

Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy

United States32 participantsStarted 2026-09-01

Plain-language summary

Migraine is a common and often disabling condition, but its exact causes are not fully understood. Some people with migraines have a small opening in the heart wall called a patent foramen ovale (PFO). In some of these patients, closing this opening or taking a medication that inhibits blood platelets (prasugrel) has been shown to reduce migraines. However, not everyone benefits, and it is unclear why. This study is being done to better understand whether closing a PFO can provide lasting migraine relief - especially in patients whose migraines improve with prasugrel. The goal of this study is to find out whether, in patients whose migraines improve while taking prasugrel, closing the PFO along with 24 weeks of prasugrel leads to better long-term migraine relief after stopping the medication, than by taking prasugrel for 24 weeks alone. Participants will track their migraines daily using an electronic diary, then take prasugrel and compare their migraines while on the medication. Only patients whose migraines improve on this medication will continue in the study. Eligible participants will be randomly assigned (like flipping a coin) to one of two groups: 1) Medication-only group: Continue prasugrel for 24 weeks. 2) Procedure group: Undergo a minimally invasive procedure to close the PFO and continue prasugrel for 24 weeks. After treatment, the medication will be stopped in both groups, and participants will again track their migraines for about 8 weeks. The main question is: Do patients who have PFO closure continue to have fewer migraines after stopping prasugrel compared with those who did not have the procedure?

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patient Inclusion Criteria: * 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. Patient Exclusion Criteria: Exclusions due to underlying patient medical issues: * 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 t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Monthly Migraine Days (MMD)

Timeframe: upon completion of the 56-day Post-Therapy monitoring session

Trial details

NCT IDNCT07629635

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Robert J Sommer, MD

212-342-0886 rs2463@cumc.columbia.edu

View on ClinicalTrials.gov More Migraine Disease trials