Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 7:12 PM
Study NCT ID:
NCT05561660
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2022-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D054092', 'term': 'Foramen Ovale, Patent'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder rate', 'timeFrame': 'From baseline period to 12-month treatment period', '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.'}, {'measure': 'Treatment safety', 'timeFrame': 'From baseline period to 12-month treatment period', 'description': 'Adverse events after medication treatment\n\nAdverse events after medication treatment\n\nAdverse events after medication treatment\n\nAdverse events after medication treatment\n\nAdverse events after medication treatment'}], 'secondaryOutcomes': [{'measure': 'Migraine days change per month', 'timeFrame': 'From baseline period to 12-month treatment period', 'description': 'Change in the mean number of migraine days from baseline to treatment phase.'}, {'measure': 'Number of migraine attacks change per month', 'timeFrame': 'From baseline period to 12-month treatment period', 'description': 'Change in the mean number of migraine attacks from baseline to treatment phase.'}, {'measure': 'Percentage of migraine change', 'timeFrame': 'From baseline period to 12-month treatment period', 'description': 'Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine', 'Patent Foramen Ovale']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 ；\n2. Diagnosed migraine by ICHD-3\n3. History of migraine longer than 1 year\n4. TCD/TTE/TEE diagnosed patent foramen ovale\n5. Willing to participant and agree to follow-ups\n6. Undertook medication therapy for three months without a responder rate higher or equal to 50%\n\nExclusion Criteria:\n\n1. Migraine caused by other reason\n2. Had TIA/stroke history\n3. Hypersensitive or hyposensitive to the study drug'}, 'identificationModule': {'nctId': 'NCT05561660', 'briefTitle': 'COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)', 'orgStudyIdInfo': {'id': '2022-1748'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PFO closure', 'interventionNames': ['Device: PFO device closure']}, {'type': 'SHAM_COMPARATOR', 'label': 'Shame procedure', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'PFO device closure', 'type': 'DEVICE', 'description': 'Participants randomized into this group will take PFO device closure.', 'armGroupLabels': ['PFO closure']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'Participants randomized into this group will take aspirin 200mg qd for 6 months.', 'armGroupLabels': ['Shame procedure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangbin Pan, MD', 'role': 'CONTACT', 'email': 'panxiangbin@fuwaihospital.org', 'phone': '88396666'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiangbin Pan, MD', 'role': 'CONTACT', 'email': 'panxiangbin@fuwaihospital.org', 'phone': '88396666'}, {'name': 'Fengwen Zhang, MD', 'role': 'CONTACT', 'email': 'zhangfengwen08@126.com', 'phone': '88396666'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Manager', 'investigatorFullName': 'Pan Xiangbin', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}