Comparing device closure for migraine relief in patients with PFO
Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)
This study is testing if closing a small hole in the heart can help people with migraines feel better and have fewer headaches.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05561660 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of percutaneous closure of patent foramen ovale (PFO) in alleviating migraine symptoms in patients diagnosed with both conditions. It is a prospective, double-blind, multi-center, and randomized trial that aims to determine if closing the PFO can reduce the frequency and severity of migraine attacks. Participants will undergo the procedure and receive aspirin as part of their treatment regimen, with follow-up assessments to evaluate outcomes. The study addresses conflicting results from previous research regarding the efficacy of PFO occlusion for migraine relief.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a history of migraine for over a year and diagnosed with PFO.
Not a fit: Patients whose migraines are caused by other factors or who have a history of TIA/stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from migraines associated with PFO.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of PFO closure for migraine relief, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-65 ； 2. Diagnosed migraine by ICHD-3 3. History of migraine longer than 1 year 4. TCD/TTE/TEE diagnosed patent foramen ovale 5. Willing to participant and agree to follow-ups 6. Undertook medication therapy for three months without a responder rate higher or equal to 50% Exclusion Criteria: 1. Migraine caused by other reason 2. Had TIA/stroke history 3. Hypersensitive or hyposensitive to the study drug
Where this trial is running
Beijing, Beijing
- Fuwai Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiangbin Pan, MD
- Email: panxiangbin@fuwaihospital.org
- Phone: 88396666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.