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Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy

Study acronym: COMFORT-PFO
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Start date: Sep 1, 2026 to Oct 15, 2026 · Primary completion date: Dec 2027 to Dec 31, 2027 · Eligibility criteria expanded, about 26 words · 4 more Show 7 more changesShow less
    • Start date: Sep 1, 2026 to Oct 15, 2026
    • Primary completion date: Dec 2027 to Dec 31, 2027
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised
    • Collaborators: details revised at 1 of 2 entries
    • Publications: details revised at 24 of 24 entries
  2. Minor Study site revisedv2 See this version in full on ClinicalTrials.gov ↗
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
467 trials monitored
See 24 trials at risk
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?
Trial Details
NCT Number NCT07629635
Lead Sponsor Columbia University
Collaborators: Occlutech International AB, W.L.Gore & Associates
Conditions Migraine Disease, Patent Foramen Ovale
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov