RecruitingPhase 3

Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy

Cessation of Migraine Headaches With Patent Foramen Ovale-Directed Therapy (COMFORT - PFO): An Investigator-Initiated Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks, 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether closing a PFO, a small opening in the heart wall, gives lasting migraine relief after medicine is stopped. It is for adults ages 18–54 with migraines and a PFO whose migraines improve with prasugrel, a medicine that helps prevent blood clots. It compares PFO closure plus 24 weeks of prasugrel with 24 weeks of prasugrel alone.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–54 years old when screened.
  • Your migraines meet the study’s diagnosis rules, with or without aura (warning signs such as changes in vision).
  • You have had migraines for at least 1 year, and symptoms started before age 40.
  • You have averaged more than 1 migraine day per week without preventive medicine or despite taking it, or you have a reason to stop effective treatment.
  • If you take medicine to prevent migraines, your dose has been stable for at least 3 months. You agree to keep that dose during study weeks 1–17.
  • If you can become pregnant, you agree to use two forms of birth control or not have sex during the study.
  • Your migraines must improve with prasugrel to continue in the study.

Who can't join

  • You have a headache disorder other than migraine, or a history of stroke, mini-stroke (TIA), or bleeding inside the skull.
  • You have low platelets (blood cells that help stop bleeding) now or within the past year, severe liver problems, active bleeding or stomach ulcers, or significant bleeding within the past 6 months.
  • You have a pacemaker, a filter in a large vein, a heart-opening or heart-pouch closure device, or another heart history that makes joining unsafe.
  • You have another abnormal blood-flow pathway besides the PFO, an uncontrolled heartbeat problem, failed heartbeat control in the past 90 days, or high resistance in lung blood vessels that makes closure unsafe.
  • You have an infection that cannot be treated, plan surgery during the study, are pregnant, or plan to become pregnant during the study.
  • You have a nickel allergy or sensitivity, or cannot safely take prasugrel-type medicines.
  • You need long-term blood-thinning medicine or daily NSAIDs (pain medicines such as ibuprofen) for something other than migraines.
  • Your history of not following medical care makes participation unsuitable in the study team’s view.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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 Exclusion Due to Medication Restrictions: * 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

Study sites (1)

NY