Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT04623203
Status:
UNKNOWN
Last Update Posted:
2020-11-10
First Post:
2020-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D018781', 'term': 'Tension-Type Headache'}, {'id': 'D006261', 'term': 'Headache'}], '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': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache diagnosis according to the ICHD-3 criteria', 'timeFrame': '10 years from initial diagnosis', 'description': 'The diagnosis of headache episodes at follow-up according to the ICHD-3 criteria; either Migraine or TTH.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Headache', 'Migraine', 'Tension Type Headache', 'Adolescents', 'Outcome'], 'conditions': ['Children, Only', 'Headache, Migraine', 'Headache, Tension']}, 'descriptionModule': {'briefSummary': "Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010 were reevaluated. We used a structured headache questionnaire through a phone interview with the patients and their caregivers. Data regarding demographics, the patients' and families' medical history, and headache history, past and current (age at onset, location, quality, frequency, duration of episodes, aura, associated symptoms and treatment) were collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of migraine or TTH headache according to the ICHD-3 criteria.\n* Can describe the current headache status.\n\nExclusion Criteria:\n\n\\* Secondary headaches.'}, 'identificationModule': {'nctId': 'NCT04623203', 'briefTitle': 'The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents', 'orgStudyIdInfo': {'id': 'BNZ 109-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with migraine', 'description': 'Children that were diagnosed at the neurology clinic with migraine at the years 2007-2010. A follow up visit at 2020 of their current headache condition.', 'interventionNames': ['Other: No intervention']}, {'label': 'children with TTH', 'description': 'children that were diagnosed at the neurology clinic with TTH at the years 2007-2010. A follow up visit at 2020 of their current headache condition.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['children with TTH', 'children with migraine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3104802', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jacob Genizi, MD', 'role': 'CONTACT', 'email': 'genizij@gmail.com', 'phone': '972-4-8359662'}], 'facility': 'Bnai Zion Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'jacob Genizi, MD', 'role': 'CONTACT', 'email': 'genizij@gmail.com', 'phone': '972-4-8359662'}], 'overallOfficials': [{'name': 'Jacob GENIZI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bnai Zion Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Not yer decided how'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Manager pediatric neurology unit', 'investigatorFullName': 'Jacob.genizi', 'investigatorAffiliation': 'Bnai Zion Medical Center'}}}}