Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 2:51 PM
Study NCT ID:
NCT00277368
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Prevalence of Headache in Epileptic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 719}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-26', 'studyFirstSubmitDate': '2006-01-13', 'studyFirstSubmitQcDate': '2006-01-13', 'lastUpdatePostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of seizure-related headache among epilepsy patients and its classification', 'timeFrame': 'At first visit (This study is cross-sectional)'}], 'secondaryOutcomes': [{'measure': 'The pain intensity of seizure-related headache', 'timeFrame': 'At 1st visit'}, {'measure': 'The frequency of seizure-related headache', 'timeFrame': 'At 1st visit'}]}, 'conditionsModule': {'keywords': ['Epilepsy', 'Headache', 'Seizure'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.', 'detailedDescription': "Headache is often ignored as a symptom of epileptic seizures. The purpose of this survey is to investigate the prevalence, characteristics and classification of seizure-associated headaches and non-seizure-associated headaches in epileptic patients in Korea, according the criteria of the International Headache Society 2004. In this survey, 577 consecutive patients with a recent diagnosis of epilepsy are interviewed by questionnaire about headaches associated with epileptic seizures. It involves questions about headache in general, localization, severity, duration and frequency, as well as headache associated with seizures, and about patient's family history. This Observational study does not involve the administration of any drugs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a recent diagnosis epilepsy; able to describe their symptoms by themselves; have had at least 2 episodes of seizures during the previous year; have had at least 1 headache during the previous year.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a recent diagnosis epilepsy\n* Able to describe their symptoms by themselves\n* Have had at least 2 episodes of seizures during the previous year\n* Have had at least 1 headache during the previous year\n\nExclusion Criteria:\n\n* Well-controlled epileptic patients taking anti-epileptic medications'}, 'identificationModule': {'nctId': 'NCT00277368', 'briefTitle': 'A Study of the Prevalence of Headache in Epileptic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': 'Headache in Epileptic Patients', 'orgStudyIdInfo': {'id': 'CR003613'}}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'interventionNames': ['Other: A structured questionnaire for seizure-related headache']}], 'interventions': [{'name': 'A structured questionnaire for seizure-related headache', 'type': 'OTHER', 'description': 'A structured questionnaire for seizure-related headache', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen Korea, Ltd. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Research Director', 'oldOrganization': 'Janssen Korea, Ltd., Korea'}}}}