Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy

NCT ID
NCT07629635
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Columbia University
Conditions
Migraine Disease, Patent Foramen Ovale

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 32 participants (Estimated).

What is being studied

  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 1-Ring
  • Intervention: Organic Chemicals
  • Intervention: Piperazines
  • Drug: Prasugrel 5mg
  • Intervention: Prasugrel Hydrochloride
  • Intervention: Sulfur Compounds
  • Intervention: Thiophenes
  • Device: Transcatheter Closure of Patent Foramen Ovale

Who may be eligible

Ages
18 Years to 55 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • Columbia University Irving Medical Center - NewYork Presbyterian Hospital (CUIMC/NYP) — New York, New York, 10032, United States — Recruiting

Study details

Start date
October 15, 2026
Primary completion date
December 31, 2027
Completion date
March 1, 2028
First posted
June 5, 2026
Collaborators
Occlutech International AB, W.L.Gore & Associates

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07629635
Registry last updated
October 8, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07629635 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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