NCT05561660

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

September 28, 2022

Last Update Submit

January 5, 2023

Conditions

MigrainePatent Foramen Ovale

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Migraine days change per month

    From baseline period to 12-month treatment period

  • Number of migraine attacks change per month

    From baseline period to 12-month treatment period

  • Percentage of migraine change

    From baseline period to 12-month treatment period

Study Arms (2)

PFO closure

EXPERIMENTAL
Device: PFO device closure

Shame procedure

SHAM COMPARATOR
Drug: Aspirin

Interventions

PFO device closureDEVICE

Participants randomized into this group will take PFO device closure.

PFO closure
AspirinDRUG

Participants randomized into this group will take aspirin 200mg qd for 6 months.

Shame procedure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 ；
  • Diagnosed migraine by ICHD-3
  • History of migraine longer than 1 year
  • TCD/TTE/TEE diagnosed patent foramen ovale
  • Willing to participant and agree to follow-ups
  • Undertook medication therapy for three months without a responder rate higher or equal to 50%

You may not qualify if:

  • Migraine caused by other reason
  • Had TIA/stroke history
  • Hypersensitive or hyposensitive to the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Migraine DisordersForamen Ovale, Patent

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Xiangbin Pan, MD

CONTACT

88396666panxiangbin@fuwaihospital.org

Fengwen Zhang, MD

CONTACT

88396666zhangfengwen08@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

September 28, 2022

First Posted

September 30, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations

CN(1)