[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486131":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":43,"locations":52,"responsibleParty":130,"collaborators":133,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":26,"maxAge":154,"enrollmentInfo":155,"targetDuration":26,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":26,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation with LEV","EXPERIMENTAL","Additional LEV at a higher dose (90 mg\u002Fkg, 120 mg\u002Fkg, or 180 mg\u002Fkg in increments depending on the stage of the study).",[13],"Drug: Levetiracetam Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care Phenobarbital","ACTIVE_COMPARATOR","Treatment with Phenobarbital 20mg\u002Fkg IV and if needed a further 20mg\u002Fkg totalling 40mg\u002Fkg",[19],"Drug: Phenobarbital Sodium Injection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Levetiracetam Injection","Neonates will be treated with intravenous levetiracetam 60mg\u002Fkg for first line management of seizures, and if seizures persist will be randomized to receive higher dose Levetiracetam or standard of care phenobarbital",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Phenobarbital Sodium Injection","Standard of care for neonatal seizures",[15],[32,36,39,41],{"name":33,"affiliation":34,"role":35},"Sonya G Wang, M.D.","University of Minnesota","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Cynthia M Sharpe, M.D.","Auckland City Hospital",{"name":40,"affiliation":5,"role":35},"Jeff J Gold, M.D. PhD",{"name":42,"affiliation":5,"role":35},"Richard H Haas, MBBChir",[44,48],{"name":33,"role":45,"phone":46,"phoneExt":26,"email":47},"CONTACT","612-301-1454","sgwang@umn.edu",{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},"Brittany Faanes, MPH","612-625-5929","grego318@umn.edu",[53,70,84,99,113],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","San Diego","California","92093","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-117.16472,32.71571,{"lat":64,"lon":63},[67],{"name":68,"role":45,"phone":26,"phoneExt":26,"email":69},"Jeff Gold, M.D.","jjgold@health.ucsd.edu",{"facility":34,"status":54,"city":71,"state":72,"zip":73,"country":58,"countryCode":59,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Minneapolis","Minnesota","55455",{"type":61,"coordinates":75},[76,77],-93.26384,44.97997,{"lat":77,"lon":76},[80,81],{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},{"name":82,"role":45,"phone":26,"phoneExt":26,"email":83},"Elizabeth Ramey, MS","eramey@umn.edu",{"facility":38,"status":54,"city":85,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Auckland","1023","New Zealand","NZ",{"type":61,"coordinates":90},[91,92],174.76349,-36.84853,{"lat":92,"lon":91},[95],{"name":96,"role":45,"phone":97,"phoneExt":26,"email":98},"Cynthia Sharpe, MBChB","021924015","cynthias@adhb.govt.nz",{"facility":100,"status":54,"city":85,"state":85,"zip":101,"country":87,"countryCode":88,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Middlemore Hospital","1050",{"type":61,"coordinates":103},[91,92],{"lat":92,"lon":91},[106,110],{"name":107,"role":45,"phone":108,"phoneExt":26,"email":109},"Chris McKinlay, MBChB","+64274725099","c.mckinlay@auckland.ac.nz",{"name":96,"role":45,"phone":111,"phoneExt":26,"email":112},"+6421924015","ciasharpe@gmail.com",{"facility":114,"status":54,"city":115,"state":116,"zip":117,"country":87,"countryCode":88,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand","Wellington","Wellington Region","6021",{"type":61,"coordinates":119},[120,121],174.77557,-41.28664,{"lat":121,"lon":120},[124,128],{"name":125,"role":45,"phone":126,"phoneExt":26,"email":127},"Krishna Raghu, MBBS, DCH, FRACP","+64 22 309 8900","krishna.raghu@ccdhb.org.nz",{"name":96,"role":129,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Richard H. Haas","Professor",[134,135,137,139,141,143],{"name":34,"class":6},{"name":136,"class":6},"Rady Children's Hospital, San Diego",{"name":38,"class":138},"OTHER_GOV",{"name":140,"class":6},"University of Auckland, New Zealand",{"name":142,"class":6},"Middlemore Hospital, New Zealand",{"name":144,"class":6},"Waikato Hospital","100486131","phase-2-a-dose-escalation-study-of-levetiracetam-in-the-treatment-of-neonatal-seizures-100486131",false,"NCT05610085","A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures","A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures","NEOLEV3","Inclusion Criteria:\n\n* at risk for seizures or suspected to be having seizures;\n* all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia;\n* Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days);\n* weight \\> 2200g.\n* Parental ability to comprehend and provide written informed consent\n\nExclusion Criteria:\n\n* Cumulative seizure burden of 8 minutes\u002F hour or more in phases 1 and 2, Cumulative seizure burden of 20 minutes\u002Fhour or more in phase 3;\n* Renal failure defined as anuria in the first 24 hours of life;\n* Subjects in whom death seems imminent;\n* Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.","ALL","1 Month",{"count":156,"type":157},133,"ESTIMATED","INTERVENTIONAL",[160],"PHASE2","The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg\u002Fkg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 20 minute seizure burden\u002Fhour. This will make the final results of study more generalizable.\n\nIf seizures are confirmed, enrolled subjects will receive 60mg\u002Fkg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site.\n\nFunding Source- FDA OOPD",[163,164,165,166],"Neonatal Seizure","Neonatal Encephalopathy","Hypoxic-Ischemic Encephalopathy","Seizure Newborn","2026-06-11",{"date":169,"type":170},"2026-06-15","ACTUAL",{"date":172,"type":170},"2023-03-24",{"date":174,"type":157},"2027-12-31",{"name":5,"class":6},5]