Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-27 @ 10:02 AM
Study NCT ID:
NCT02424318
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2015-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topiramate and Cerebrovascular Response in Migraineurs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-06-19', 'releaseDate': '2015-06-03'}], 'estimatedResultsFirstSubmitDate': '2015-06-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-18', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-18', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the Cerebrovascular reactivity', 'timeFrame': 'between baseline and after 2-month treatment of topiramate', 'description': 'Transcranial Doppler sonography (TCD) was performed twice in migraineurs before and after the topiramate treatment during their interictal period of headache.\n\nMeasurements: the mean flow velocity (MFV) of the right middle cerebral artery (MCA) and the left posterior cerebral artery (PCA). After 1 minute of adaptation period to the darkness, flashlights of 10 Hz were presented using a light source of an electroencephalography machine (PS40/R-220, Grass Technologies, West Warwick, USA). Recordings were performed for 10 cycles, and each cycle consisted of 10-second stimulation-on and 10-second stimulation-off.\n\nCalculation: Cerebrovascular reactivity (CVR) CVR = Δ V/Vb or Δ V/(VbxΔT) Where Vb is the baseline MFV, Δ V/Vb is the percentage MFV increase (amplitude), ΔT is the time from the onset of the stimulation to the peak MFV, and Δ V/(VbxΔT) is the slope of the MFV increase.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the mean flow velocities in the middle and posterior cerebral artery', 'timeFrame': 'between baseline and after 2-month treatment of topiramate', 'description': 'Measurements: Same as outcome 1.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of topiramate on cerebrovascular reactivity and mean flow velocity to photic stimulation in migraineurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 to 65 years\n* newly-diagnosed patients with migraine without aura (International Headache Society classification)\n* symptom frequency (at least 2 episodes of migraine attack/month)\n\nExclusion Criteria:\n\n* prior use of preventive medication\n* patients with cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, smoking)\n* patients who take antihypertensive agent or antidepressant\n* patients who were pregnant, breast-feeding or actively smoking\n* patients with neurological or cerebrovascular diseases'}, 'identificationModule': {'nctId': 'NCT02424318', 'briefTitle': 'Topiramate and Cerebrovascular Response in Migraineurs', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs', 'orgStudyIdInfo': {'id': '06-2008-71'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topiramate', 'description': 'topiramate 25mg twice for 1 week -\\> topiramate 50mg twice for 7 weeks', 'interventionNames': ['Drug: Topiramate']}], 'interventions': [{'name': 'Topiramate', 'type': 'DRUG', 'description': 'topiramate 25mg twice 1 week -\\> topiramate 50mg twice 7 weeks', 'armGroupLabels': ['Topiramate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hyunwoo Nam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SMG-SNU Boramae Medical Center', 'investigatorFullName': 'Hyunwoo Nam', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-06-03', 'type': 'RELEASE'}, {'date': '2015-06-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hyunwoo Nam, SMG-SNU Boramae Medical Center, SMG-SNU Boramae Medical Center'}}}}