Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-21 @ 10:54 AM
Study NCT ID:
NCT01239212
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2010-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dosing of Levetiracetam (Keppra) in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}], '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'}, {'id': 'D001927', 'term': 'Brain Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.merhar@cchmc.org', 'phone': '513-636-4200', 'title': 'Dr. Stephanie Merhar', 'organization': "Cincinnati Children's Hospital Medical Center"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours after dose', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm, 50 mg/kg of Levetiracetam', 'description': 'Single arm, 50 mg/kg of levetiracetam', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm, 50 mg/kg of Levetiracetam', 'description': 'Single arm, 50 mg/kg of levetiracetam'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)', 'description': '3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.', 'unitOfMeasure': 'ml/min/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants had adequate levels drawn for analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm, 50 mg/kg of Levetiracetam', 'description': 'Single arm, 50 mg/kg of levetiracetam'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Recruitment was from 9/2010 to 8/2011 from the NICU at Cincinnati Children's Hospital."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm, 50 mg/kg of Levetiracetam', 'description': 'Single arm, 50 mg/kg of levetiracetam'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-11', 'studyFirstSubmitDate': '2010-10-28', 'resultsFirstSubmitDate': '2014-02-26', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-27', 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Profile', 'timeFrame': '5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)', 'description': '3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['seizures', 'neonate', 'levetiracetam', 'Epilepsy', 'central nervous system diseases', 'anticonvulsants'], 'conditions': ['Seizures']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Gestational age ≥ 32 weeks\n* Postnatal age ≤ 30 days\n* Birth weight ≥ 2000 grams\n* Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital\n* Clinical or electrographic seizures of any etiology\n* Seizures or seizure prophylaxis requiring treatment with levetiracetam\n* Parental consent obtained\n\nExclusion Criteria:\n\n* Infants with renal insufficiency indicated by serum creatinine \\> 2.0 at any time\n* Infants who have previously received levetiracetam\n* Parents refuse consent\n* Attending physician does not wish the infant to be enrolled in the study\n* Infants who are currently receiving an investigational drug"}, 'identificationModule': {'nctId': 'NCT01239212', 'briefTitle': 'Dosing of Levetiracetam (Keppra) in Neonates', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates', 'orgStudyIdInfo': {'id': '101335'}}, 'armsInterventionsModule': {'interventions': [{'name': 'levetiracetam', 'type': 'DRUG', 'description': '50 mg/kg single loading dose of IV levetiracetam'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Stephanie Merhar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Stephanie Merhar, MD', 'investigatorAffiliation': "Children's Hospital Medical Center, Cincinnati"}}}}