COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)

Phase 4

Recruiting

• Conditions: Migraine; Patent Foramen Ovale
• Interventions: Device: PFO device closure; Drug: Aspirin

• Registration Number: NCT05561660
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-30
• Study Start: 2022-10-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFO closure	PFO device closure	-
Shame procedure	Aspirin	-

Primary Outcome Measures

Name	Time	Method
Responder rate	From baseline period to 12-month treatment period	Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
Treatment safety	From baseline period to 12-month treatment period	Adverse events after medication treatment; Adverse events after medication treatment; Adverse events after medication treatment; Adverse events after medication treatment; Adverse events after medication treatment

Secondary Outcome Measures

Name	Time	Method
Migraine days change per month	From baseline period to 12-month treatment period	Change in the mean number of migraine days from baseline to treatment phase.
Number of migraine attacks change per month	From baseline period to 12-month treatment period	Change in the mean number of migraine attacks from baseline to treatment phase.
Percentage of migraine change	From baseline period to 12-month treatment period	Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China