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

Migraine Clinical Trial

Official title:

Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561660
• Other study ID #: 2022-1748
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiangbin Pan, MD
• Phone: 88396666
• Email: panxiangbin[@]fuwaihospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Migraine
• Migraine Disorders
• Patent Foramen Ovale

Intervention

Device:
• PFO device closure
Participants randomized into this group will take PFO device closure.

Drug:
• Aspirin
Participants randomized into this group will take aspirin 200mg qd for 6 months.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate	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.	From baseline period to 12-month treatment period
Primary	Treatment safety	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	From baseline period to 12-month treatment period
Secondary	Migraine days change per month	Change in the mean number of migraine days from baseline to treatment phase.	From baseline period to 12-month treatment period
Secondary	Number of migraine attacks change per month	Change in the mean number of migraine attacks from baseline to treatment phase.	From baseline period to 12-month treatment period
Secondary	Percentage of migraine change	Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.	From baseline period to 12-month treatment period