Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT02895256
Status:
UNKNOWN
Last Update Posted:
2020-03-20
First Post:
2016-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2016-09-04', 'studyFirstSubmitQcDate': '2016-09-04', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall prognosis', 'timeFrame': 'at least 5 years after the first visit', 'description': 'active disease: at least one bout within the past 5 years Remission: no headache for 5 years and twice of the usual remission period'}, {'measure': 'Changes in the length of active/inactive periods', 'timeFrame': 'at least 5 years after the first visit'}, {'measure': 'Changes in seasonal and diurnal predilections', 'timeFrame': 'at least 5 years after the first visit'}, {'measure': 'Changes in autonomic symptoms', 'timeFrame': 'at least 5 years after the first visit'}, {'measure': 'Changes in treatment responses', 'timeFrame': 'at least 5 years after the first visit'}], 'secondaryOutcomes': [{'measure': 'Any depression', 'timeFrame': 'at least 5 years after the first visit'}, {'measure': 'Any suicidal thoughts (active/passive), plans, and attempts', 'timeFrame': 'at least 5 years after the first vis', 'description': 'ictal vs interictal'}]}, 'conditionsModule': {'conditions': ['Cluster Headache', 'Disease Course']}, 'descriptionModule': {'briefSummary': 'Cluster headache is a syndrome characterized by disabling headache and accompanying autonomic symptoms. Despite cluster headache is called "suicide headache", its natural history has not been well investigated. The investigators aimed to investigate its disease course, overall prognosis, and treatment pattern in retrospective cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cluster headache', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were diagnosed as cluster headache\n* More than 5 years after the first visit\n\nExclusion Criteria:\n\n* Subjects who refused the telephone visit'}, 'identificationModule': {'nctId': 'NCT02895256', 'briefTitle': 'Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'orgStudyIdInfo': {'id': '2016-04-155'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Any treatment for cluster headache', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Mi Ji Lee, MD', 'role': 'CONTACT', 'email': 'mirony.lee@samsung.com', 'phone': '82-2-3410-1895'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Mi Ji Lee, MD', 'role': 'CONTACT', 'email': 'mirony.lee@gmail.com', 'phone': '82-2-3410-1895'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor of neurology', 'investigatorFullName': 'Chin-Sang Chung', 'investigatorAffiliation': 'Samsung Medical Center'}}}}