MigrainePhase 4NCT05561660
COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)
A Phase 4 study testing PFO device closure and Aspirin in people with Migraine and Patent Foramen Ovale, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Patent Foramen Ovale
- What is being tested?
- PFO device closure and Aspirin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Migraine caused by other reason
- Had TIA/stroke history
- Hypersensitive or hyposensitive to the study drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality
Xiangbin Pan, MD, 88396666, panxiangbin@fuwaihospital.org
About this study
Official title: Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)
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.
- Conditions
- Migraine, Patent Foramen Ovale
- Being tested
- PFO device closure, Aspirin
- Medical subject headings
- Migraine Disorders, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO device closureDevice
Participants randomized into this group will take PFO device closure.
AspirinDrug
Participants randomized into this group will take aspirin 200mg qd for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| PFO closure | Experimental | Not described Receives: Device: PFO device closure |
| Shame procedure | Sham comparator | Not described Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From baseline period to 12-month treatment period
Secondary outcomes (3)
Migraine days change per month
Change in the mean number of migraine days from baseline to treatment phase.
Measured: From baseline period to 12-month treatment period
Number of migraine attacks change per month
Change in the mean number of migraine attacks from baseline to treatment phase.
Measured: From baseline period to 12-month treatment period
Percentage of migraine change
Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.
Measured: From baseline period to 12-month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561660
- Sponsor's protocol ID
- 2022-1748
- Status last verified
- Jan 2023
- First submitted
- 28 Sep 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)
- ClinicalTrials.gov ID
- NCT05561660
- Acronym / sponsor ID
- 2022-1748
- Conditions
- Migraine, Patent Foramen Ovale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFO closure | Experimental | Device: PFO device closure |
| Shame procedure | Sham comparator | Drug: Aspirin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Migraine caused by other reason
- Had TIA/stroke history
- Hypersensitive or hyposensitive to the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFO device closureParticipants randomized into this group will take PFO device closure. | Device | PFO closure |
| AspirinParticipants randomized into this group will take aspirin 200mg qd for 6 months. | Drug | Shame procedure |
Primary outcome
Responder rate
Time frame: 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
Time frame: 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
3 secondary outcomes
Migraine days change per month
Time frame: From baseline period to 12-month treatment period
Number of migraine attacks change per month
Time frame: From baseline period to 12-month treatment period
Percentage of migraine change
Time frame: From baseline period to 12-month treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PFO device closure and Aspirin in people with Migraine and Patent Foramen Ovale, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Pan, MD (88396666, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate (time frame: From baseline period to 12-month treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.