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

Primary Purpose

Migraine, Patent Foramen Ovale

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PFO device closure
Aspirin
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PFO closure

Shame procedure

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2022
Last Updated
January 5, 2023
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05561660
Brief Title
COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)
Official Title
Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Patent Foramen Ovale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PFO closure
Arm Type
Experimental
Arm Title
Shame procedure
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
PFO device closure
Intervention Description
Participants randomized into this group will take PFO device closure.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Participants randomized into this group will take aspirin 200mg qd for 6 months.
Primary Outcome Measure Information:
Title
Responder rate
Description
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.
Time Frame
From baseline period to 12-month treatment period
Title
Treatment safety
Description
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
Time Frame
From baseline period to 12-month treatment period
Secondary Outcome Measure Information:
Title
Migraine days change per month
Description
Change in the mean number of migraine days from baseline to treatment phase.
Time Frame
From baseline period to 12-month treatment period
Title
Number of migraine attacks change per month
Description
Change in the mean number of migraine attacks from baseline to treatment phase.
Time Frame
From baseline period to 12-month treatment period
Title
Percentage of migraine change
Description
Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.
Time Frame
From baseline period to 12-month treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: Migraine caused by other reason Had TIA/stroke history Hypersensitive or hyposensitive to the study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangbin Pan, MD
Phone
88396666
Email
panxiangbin@fuwaihospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
Fengwen Zhang, MD
Phone
88396666
Email
zhangfengwen08@126.com
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, MD
Phone
88396666
Email
panxiangbin@fuwaihospital.org

12. IPD Sharing Statement

Learn more about this trial

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

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