Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT01720667
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2012-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}, {'id': 'D010634', 'term': 'Phenobarbital'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001463', 'term': 'Barbiturates'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rhaas@ucsd.edu', 'phone': '(858) 822-6700', 'title': 'Dr. Richard Haas', 'organization': 'University of California San Diego, School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 days after treatment', 'description': 'Data not collected separately for each intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg PHB infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with LEV 40 mg/kg first. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance 1.5 mg/kg PHB mg/kg/dose given IV q8 hours continued for five days.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 13, 'seriousNumAtRisk': 42, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 - 60 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg LEV infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with PHB 20 mg/kg. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance LEV 10 mg/kg/dose given IV q8 hours continued for five days.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 12, 'seriousNumAtRisk': 64, 'deathsNumAffected': 2, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypotension', 'notes': 'Specific finding of hypotension on a day on which an adverse event was indicated.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Rate Abnormailty', 'notes': 'Specific finding of heart rate abnormality on a day on which an adverse event was reported', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Abnormality', 'notes': 'Specific finding of respiratory abnormality documented on a day on which an adverse event was documented', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'notes': 'Specific finding of sedation on a day on which an adverse event was documented', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor Feeding', 'notes': 'Specific finding of poor feeding on a day on which adverse event was documented', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'Specific finding of infection on a day on which adverse event was documented', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Medical Problem', 'notes': 'New Medical Problem reported on a day where an adverse event is documented', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasopressor Requirement', 'notes': 'Hypotension requiring vasopressor support on at least one day', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypotension', 'notes': 'Grade 4 hypotension thought probably or possibly due to study medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Abnormality', 'notes': 'Grade 4 respiratory distress thought probably or possibly due to study medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Rate Abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor Feeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Medications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 - 60 mg/kg loading dose \\& 10 mg/kg 8 hourly maintenance'}, {'id': 'OG001', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 - 40 mg/kg loading dose \\& 1.5 mg/kg 8 hourly maintenance.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Comparison of 24 hour seizure termination rates using a Fisher's exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.\n\nSeizure cessation from 15 minutes after completion of infusion for 24 hours as assessed by continuous EEG reviewed by neurophysiologists.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants with available primary outcome measure- EEG to 24 hours confirming seizure cessation.'}, {'type': 'SECONDARY', 'title': 'Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 - 60 mg/kg loading dose \\& 10 mg/kg 8 hourly maintenance'}, {'id': 'OG001', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 - 40 mg/kg loading dose \\& 1.5 mg/kg 8 hourly maintenance.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Comparison of seizure cessation at 48 hours using Fisher's exact test", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with evaluable data with 48 hours of seizure monitoring'}, {'type': 'SECONDARY', 'title': 'Number of Neonates With Seizure Termination at 1 Hour After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 - 60 mg/kg loading dose \\& 10 mg/kg 8 hourly maintenance'}, {'id': 'OG001', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 - 40 mg/kg loading dose \\& 1.5 mg/kg 8 hourly maintenance.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': 'A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes 1 participant in each arm who did not have data available for the primary end point at 24 hours'}, {'type': 'SECONDARY', 'title': 'LEV Dose Escalation Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 mg/kg loading dose \\& 10 mg/kg 8 hourly maintenance'}, {'id': 'OG001', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 mg/kg loading dose \\& 1.5 mg/kg 8 hourly maintenance.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Number of babies with seizure control at levetiracetam (60 mg/Kg load) who had not responded to 40 mg/kg load and number of babies with seizure control at 40 mg/kg who had not responded to 20 mg/kg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Babies who received any treatment of either phenobarbital or levetiracetam within the modified intent to treat'}, {'type': 'SECONDARY', 'title': 'Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 - 60 mg/kg loading dose \\& 10 mg/kg 8 hourly maintenance'}, {'id': 'OG001', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 - 40 mg/kg loading dose \\& 1.5 mg/kg 8 hourly maintenance.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'HIE participants with hypothermia treatment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetic Data', 'timeFrame': '48 hours', 'description': 'To obtain additional pharmacokinetic data "Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax)" of intravenous levetiracetam to confirm findings from our previous pharmacokinetic study.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Feasibility of Continuous Internet EEG Monitoring', 'timeFrame': 'Subject study duration', 'description': 'Feasibility of centralized remote access to continuous video EEG monitoring in the NICU via the internet', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluation of the Accuracy of Neonatal Seizure Detection Algorithm', 'timeFrame': '48 Hours', 'description': 'A novel neonatal seizure detection algorithm will be compared to the gold standard of two encephalographers reading 48 hours of neonatal video EEG in the measurement of seizure burden.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gather Safety Information on IV Levetiracetam', 'timeFrame': '5 days', 'description': 'Safety information to be collected includes daily recording of any adverse events during the 5 day treatment protocol.\n\nComplete Blood Count and Comprehensive Chemistry panels after 48 hours of treatment collected.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2019-09'}, {'type': 'POST_HOC', 'title': 'Imputation Sensitivity Analysis', 'timeFrame': '48 hours', 'description': 'Analysis of missing data impact on the outcome measures', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 - 60 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg LEV infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with PHB 20 mg/kg. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance LEV 10 mg/kg/dose given IV q8 hours continued for five days.'}, {'id': 'FG001', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg PHB infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with LEV 40 mg/kg first. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance 1.5 mg/kg PHB mg/kg/dose given IV q8 hours continued for five days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Recieved Second Infusion of Same Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Recieved Alternate Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Received 2nd Infusion of Alternate Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Modified ITT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '280 were enrolled to EEG monitoring and of these 106 were randomized to treatment as neonatal seizures were thought to have occurred. 174 excluded as they did not have electrographic seizures; from 6 participants only verbal not written consent obtained.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravenous Levetiracetam', 'description': 'Intravenous levetiracetam 40 to 60 mg/kg loading dose. 10 mg/kg 8 hourly maintenance\n\nIntravenous levetiracetam: Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.'}, {'id': 'BG001', 'title': 'Intravenous Phenobarbital', 'description': 'Intravenous phenobarbital 20 to 40 mg/kg load. 1.5 mg/kg 8 hourly maintenance\n\nIntravenous phenobarbital: Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-14', 'size': 766911, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-14T14:08', 'hasProtocol': False}, {'date': '2018-04-13', 'size': 421809, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-14T14:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2012-10-22', 'resultsFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-12', 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacokinetic Data', 'timeFrame': '48 hours', 'description': 'To obtain additional pharmacokinetic data "Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax)" of intravenous levetiracetam to confirm findings from our previous pharmacokinetic study.'}, {'measure': 'Feasibility of Continuous Internet EEG Monitoring', 'timeFrame': 'Subject study duration', 'description': 'Feasibility of centralized remote access to continuous video EEG monitoring in the NICU via the internet'}, {'measure': 'Evaluation of the Accuracy of Neonatal Seizure Detection Algorithm', 'timeFrame': '48 Hours', 'description': 'A novel neonatal seizure detection algorithm will be compared to the gold standard of two encephalographers reading 48 hours of neonatal video EEG in the measurement of seizure burden.'}, {'measure': 'Gather Safety Information on IV Levetiracetam', 'timeFrame': '5 days', 'description': 'Safety information to be collected includes daily recording of any adverse events during the 5 day treatment protocol.\n\nComplete Blood Count and Comprehensive Chemistry panels after 48 hours of treatment collected.'}], 'primaryOutcomes': [{'measure': 'Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)', 'timeFrame': '24 hours', 'description': 'A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.\n\nSeizure cessation from 15 minutes after completion of infusion for 24 hours as assessed by continuous EEG reviewed by neurophysiologists.'}], 'secondaryOutcomes': [{'measure': 'Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment', 'timeFrame': '48 hours', 'description': 'A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.'}, {'measure': 'Number of Neonates With Seizure Termination at 1 Hour After Treatment', 'timeFrame': '1 hour', 'description': 'A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.'}, {'measure': 'LEV Dose Escalation Component', 'timeFrame': '24 hours', 'description': 'Number of babies with seizure control at levetiracetam (60 mg/Kg load) who had not responded to 40 mg/kg load and number of babies with seizure control at 40 mg/kg who had not responded to 20 mg/kg.'}, {'measure': 'Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Seizures', 'Neonates', 'Anticonvulsants', 'Treatment', 'Levetiracetam', 'Phenobarbital'], 'conditions': ['Neonatal Seizures']}, 'referencesModule': {'references': [{'pmid': '22495532', 'type': 'BACKGROUND', 'citation': 'Sharpe CM, Capparelli EV, Mower A, Farrell MJ, Soldin SJ, Haas RH. A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life. Pediatr Res. 2012 Jul;72(1):43-9. doi: 10.1038/pr.2012.51. Epub 2012 Apr 11.'}, {'pmid': '30289769', 'type': 'RESULT', 'citation': 'Sharpe C, Davis SL, Reiner GE, Lee LI, Gold JJ, Nespeca M, Wang SG, Joe P, Kuperman R, Gardner M, Honold J, Lane B, Knodel E, Rowe D, Battin MR, Bridge R, Goodmar J, Castro B, Rasmussen M, Arnell K, Harbert M, Haas R. Assessing the Feasibility of Providing a Real-Time Response to Seizures Detected With Continuous Long-Term Neonatal Electroencephalography Monitoring. J Clin Neurophysiol. 2019 Jan;36(1):9-13. doi: 10.1097/WNP.0000000000000525.'}, {'pmid': '38902005', 'type': 'DERIVED', 'citation': 'Sharpe C, Yang DZ, Haas RH, Reiner GE, Lee L, Capparelli EV; NEOLEV2 Investigators. Pharmacokinetic and pharmacodynamic data from the NEOLEV1 and NEOLEV2 studies. Arch Dis Child. 2024 Sep 25;109(10):854-860. doi: 10.1136/archdischild-2022-324952.'}]}, 'descriptionModule': {'briefSummary': 'A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory.\n\nMonitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.', 'detailedDescription': 'This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects.\n\nLevetiracetam (LEV) has great potential as a treatment for neonatal seizures but is not approved for use in children less than 2 years of age.\n\nThis study aims to obtain essential data regarding the efficacy and safety of LEV in this vulnerable and under researched population and simultaneously to develop EEG monitoring systems that facilitate seizure detection and research.\n\nSpecific aims are:\n\n1. To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy.\n2. To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.\n3. To obtain additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.\n4. To obtain further safety data of LEV in neonates.\n5. To prove the feasibility of centralized remote monitoring of continuous EEG monitoring in the Neonatal Intensive Care Unit (NICU) via the internet and test a promising automated neonatal seizure detection algorithm.\n\nThe study design is a phase 2b randomized blinded controlled study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '15 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newborns admitted to any of the study sites with electrographic seizures seizures.\n2. Term infants gestational age \\>36 weeks less than 2 weeks of age.\n3. Greater than 2200 grams.\n4. Infants for whom parental consent to participate in the study is obtained.\n\nExclusion Criteria:\n\n1. Infants who are already receiving anticonvulsants\n2. If serum creatinine is greater than 1.6mM\n3. If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia)\n4. Subjects in whom death seems imminent, as assessed by the neonatologist.'}, 'identificationModule': {'nctId': 'NCT01720667', 'acronym': 'NEOLEV2', 'briefTitle': 'Efficacy of Intravenous Levetiracetam in Neonatal Seizures', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Efficacy of Intravenous Levetiracetam in Neonatal Seizures: A Phase 2 Randomized Blinded Controlled Study of the Efficacy of Intravenous Levetiracetam (LEV) as First Line Treatment for Neonatal Seizures', 'orgStudyIdInfo': {'id': 'NoGA - R01 FD004147-01A1 Haas'}, 'secondaryIdInfos': [{'id': '1R01FD004147-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01FD004147-01A1', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous levetiracetam', 'description': 'Intravenous levetiracetam 40 to 60 mg/kg loading dose. 10 mg/kg 8 hourly maintenance', 'interventionNames': ['Drug: Intravenous levetiracetam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous phenobarbital', 'description': 'Intravenous phenobarbital 20 to 40 mg/kg load. 1.5 mg/kg 8 hourly maintenance', 'interventionNames': ['Drug: Intravenous phenobarbital']}], 'interventions': [{'name': 'Intravenous levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.', 'armGroupLabels': ['Intravenous levetiracetam']}, {'name': 'Intravenous phenobarbital', 'type': 'DRUG', 'otherNames': ['phenobarbitone'], 'description': 'Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.', 'armGroupLabels': ['Intravenous phenobarbital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Richard H Haas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Richard H. Haas', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': "Rady Children's Hospital, San Diego", 'class': 'OTHER'}, {'name': 'Auckland City Hospital', 'class': 'OTHER_GOV'}, {'name': 'Sharp Mary Birch Hospital for Women & Newborns', 'class': 'OTHER'}, {'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, {'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Richard H. Haas', 'investigatorAffiliation': 'University of California, San Diego'}}}}