Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:47 PM
Study NCT ID:
NCT00774306
Status:
TERMINATED
Last Update Posted:
2017-12-18
First Post:
2008-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antiepileptic Drugs and Vascular Risk Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010672', 'term': 'Phenytoin'}, {'id': 'C043114', 'term': 'fosphenytoin'}, {'id': 'D014635', 'term': 'Valproic Acid'}, {'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scott.mintzer@jefferson.edu', 'phone': '215-955-1222', 'title': 'Dr. Scott Mintzer', 'organization': 'Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study terminated due to 1) change in clinical practice; 2) inadequate recruitment and follow-up.\n\nNumber of pts providing full data was \\<15% of goal. Because of this, any analysis of data was considered futile, and no analyses were performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Phenytoin', 'description': 'Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.\n\nphenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.\n\nx\n\nx', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Valproate', 'description': 'Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.\n\nvalproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Levetiracetam', 'description': 'Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.\n\nlevetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'No Anticonvulsant', 'description': 'Participants randomized to Group 4 will receive no drug intervention.', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'deep venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'drug fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenytoin', 'description': 'Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.\n\nphenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.\n\nx\n\nx'}, {'id': 'OG001', 'title': 'Valproate', 'description': 'Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.\n\nvalproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.'}, {'id': 'OG002', 'title': 'Levetiracetam', 'description': 'Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.\n\nlevetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.'}, {'id': 'OG003', 'title': 'No Anticonvulsant', 'description': 'Participants randomized to Group 4 will receive no drug intervention.'}], 'timeFrame': '8 weeks, 16 weeks', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)', 'timeFrame': '8 weeks, 16 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phenytoin', 'description': 'Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.\n\nphenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.\n\nx\n\nx'}, {'id': 'FG001', 'title': 'Valproate', 'description': 'Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.\n\nvalproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.'}, {'id': 'FG002', 'title': 'Levetiracetam', 'description': 'Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.\n\nlevetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.'}, {'id': 'FG003', 'title': 'No Anticonvulsant', 'description': 'Participants randomized to Group 4 will receive no drug intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Phenytoin', 'description': 'Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.\n\nphenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.'}, {'id': 'BG001', 'title': 'Valproate', 'description': 'Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.\n\nvalproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.'}, {'id': 'BG002', 'title': 'Levetiracetam', 'description': 'Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.\n\nlevetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.'}, {'id': 'BG003', 'title': 'No Anticonvulsant', 'description': 'Participants randomized to Group 4 will receive no drug intervention.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '71'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '62'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '71'}, {'value': '49', 'groupId': 'BG003', 'lowerLimit': '44', 'upperLimit': '75'}, {'value': '48', 'groupId': 'BG004', 'lowerLimit': '26', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'study no longer consistent with current clinical practice', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2008-10-16', 'resultsFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2008-10-16', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-19', 'studyFirstPostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms', 'timeFrame': '8 weeks, 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)', 'timeFrame': '8 weeks, 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vascular risk', 'lipid fractions', 'lipoprotein(a)', 'C-reactive protein', 'subarachnoid hemorrhage', 'antiepileptic drug', 'randomized', 'seizure', 'cholesterol'], 'conditions': ['Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if certain seizure medications raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes.', 'detailedDescription': 'There is some evidence that certain seizure medicines may raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes, however, more research is needed. Individuals with acute subarachnoid hemorrhage traditionally are treated with seizure medicines, but it is not clear which one is best, or if any such medication is necessary at all.\n\nThis study is intended to find out if certain seizure medications raise levels of cholesterol and other blood components which could lead to an increased risk of heart attacks and strokes.\n\nIn this study, 200 people with acute subarachnoid hemorrhage will be randomized to treatment with one of three different seizure medicines-phenytoin, valproate, or levetiracetam-or to receive no seizure medication at all. In each participant, cholesterol and other blood markers that relate to heart attack and stroke risk will be measured shortly after hospital admission and again 8 weeks later. At the 8-week point most participants will have their seizure medication discontinued, and the same blood tests will be repeated.\n\nInformation from this study could lead to changes in how seizure medications are prescribed both in the subarachnoid hemorrhage population and in other people who are prone to seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute subarachnoid hemorrhage, Hunt-Hess Grades I-IV\n* Within 48 hours of admission\n\nExclusion Criteria:\n\n* Grade V subarachnoid hemorrhage\n* Being treated with a lipid-lowering agent\n* Contraindication to phenytoin, valproate, or levetiracetam (e.g. history of allergy to one of these agents)\n* Contraindication to receiving no antiepileptic drug treatment (e.g. history of pre-existing epilepsy, seizure activity on admission EEG)'}, 'identificationModule': {'nctId': 'NCT00774306', 'briefTitle': 'Antiepileptic Drugs and Vascular Risk Markers', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'K23NS058669', 'link': 'https://reporter.nih.gov/quickSearch/K23NS058669', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1K23NS058669', 'link': 'https://reporter.nih.gov/quickSearch/1K23NS058669', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.', 'interventionNames': ['Drug: phenytoin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.', 'interventionNames': ['Drug: valproate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.', 'interventionNames': ['Drug: levetiracetam']}, {'type': 'NO_INTERVENTION', 'label': '4', 'description': 'Participants randomized to Group 4 will receive no drug intervention.'}], 'interventions': [{'name': 'phenytoin', 'type': 'DRUG', 'otherNames': ['Dilantin, Cerebyx (a phenytoin pro-drug)'], 'description': 'Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.', 'armGroupLabels': ['1']}, {'name': 'valproate', 'type': 'DRUG', 'otherNames': ['Depakote, Depacon'], 'description': 'Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.', 'armGroupLabels': ['2']}, {'name': 'levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Scott Mintzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}