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NCT07629635 · ClinicalTrials.gov registry record · Phase 3
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
A Phase 3 study, sponsored by Columbia University.
- Not yet
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT07629635 is a Phase 3 study that has not yet begun recruiting, run by Columbia University. The registered enrollment target is 32 participants.
The verdict
NCT07629635, a Phase 3 study, has not yet begun recruiting, sponsored by Columbia University.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study 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?
Interventions
- DRUG Prasugrel 5mg
- DEVICE Transcatheter Closure of Patent Foramen Ovale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07629635
The ClinicalTrials.gov registry entry for NCT07629635 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prasugrel 5mg is the first listed.
NCT07629635 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07629635 about?
NCT07629635 is a clinical study titled "Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy". 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 platele...
What is the current status of trial NCT07629635?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2026-09-01. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07629635?
The interventions under investigation include: Prasugrel 5mg (DRUG), Transcatheter Closure of Patent Foramen Ovale (DEVICE).
Who is sponsoring clinical trial NCT07629635?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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