Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT00777218
Status:
WITHDRAWN
Last Update Posted:
2020-12-17
First Post:
2008-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D011433', 'term': 'Propranolol'}, {'id': 'D000078305', 'term': 'Zonisamide'}, {'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Enrollment criteria was too challenging and Investigators changed Institutions', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2008-10-21', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Record if memory, repetition or recall was impaired by subject during specific time frame on medication.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['migraine'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there are significant differences in the side effects related to memory, repetition and recall among these three drugs when used in a pediatric population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of migraine with and without aura or chronic daily headache as defined by IHS\n* subjects must between the age of 8-17 (inclusive)\n\nExclusion Criteria:\n\n* diagnosis of tension-type headache or cluster headache'}, 'identificationModule': {'nctId': 'NCT00777218', 'briefTitle': 'Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine', 'organization': {'class': 'OTHER', 'fullName': 'University of South Alabama'}, 'officialTitle': 'Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine', 'orgStudyIdInfo': {'id': '07-185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: propranolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: zonisamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: topiramate']}], 'interventions': [{'name': 'propranolol', 'type': 'DRUG', 'otherNames': ['Inderal'], 'description': 'standard pediatric doses, based on body weight', 'armGroupLabels': ['1']}, {'name': 'zonisamide', 'type': 'DRUG', 'otherNames': ['Zonegran'], 'description': 'standard pediatric dosages, based on body weight', 'armGroupLabels': ['2']}, {'name': 'topiramate', 'type': 'DRUG', 'otherNames': ['Topamax'], 'description': 'standard pediatric dosages, based on body weight', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Department of Neurology', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}], 'overallOfficials': [{'name': 'J. I. Lopez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Alabama Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Alabama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}