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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: Clinical Trial Phase 3 study, sponsored by Columbia University.
NCT07629635 is a Phase 3 study that has not yet begun recruiting, run by Columbia University. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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?
Primary Outcome
The primary efficacy endpoint is the proportion of randomized subjects maintaining a clinically meaningful migraine response, defined as a ≥50% reduction in Monthly Migraine Days (MMD) in the Post-Therapy monitoring session, compared with the Baseline monitoring session (following discontinuation of prasugrel).
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 |
What is known before NCT07629635 opens enrollment
NCT07629635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Prasugrel 5mg is the first listed.
NCT07629635 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07629635's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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