Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-25 @ 8:29 AM
Study NCT ID:
NCT02253004
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2014-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Migraine Aura With Cilostazol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020325', 'term': 'Migraine with Aura'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-20', 'studyFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aura', 'timeFrame': '24 hours', 'description': 'Induction of aura reported by an aura diary for 24 hours post medication'}], 'secondaryOutcomes': [{'measure': 'Migraine', 'timeFrame': '24 hours', 'description': 'Induction of headache resembling usual migraine attacks'}, {'measure': 'Endothelial response', 'timeFrame': '3 hours', 'description': 'Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine With Aura', 'Stroke']}, 'descriptionModule': {'briefSummary': 'In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.', 'detailedDescription': 'Migraine with aura is associated to an increased risk of stroke. The mechanism behind such increased risk is not fully understood. Cilostazol induce headache and migraine in migraine patients and is used as secondary prevention of stroke. The effect on aura induction is not known. We investigate the aura inducing potential of cilostazol and associated changes in endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Migraine with aura\n* Minimum of 2 attacks/year\n\nExclusion Criteria:\n\n* Chronic tension type headache\n* Cardiac arrhythmias'}, 'identificationModule': {'nctId': 'NCT02253004', 'briefTitle': 'Induction of Migraine Aura With Cilostazol', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.', 'orgStudyIdInfo': {'id': 'H-3-2013-166'}, 'secondaryIdInfos': [{'id': '2013-004188-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Cilostazol 200 mg single dose', 'interventionNames': ['Drug: Cilostazol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cilostazol', 'type': 'DRUG', 'otherNames': ['Pletal'], 'description': 'Single oral administration of active or placebo one week apart', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital, Dept Neurology', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Christina Kruuse, MD PhD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Neurologist, Dept Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, consultant neurologist', 'investigatorFullName': 'Christina Kruuse', 'investigatorAffiliation': 'Herlev Hospital'}}}}