[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473906":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":76,"collaborators":79,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":97,"studyType":98,"phases":10,"briefSummary":99,"conditions":100,"keywords":10,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Lamotrigine (LTG)",null,"Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with lamotrigine (LTG)",[13],"Drug: Lamotrigine",{"label":15,"type":10,"description":16,"interventionNames":17},"Levetiracetam (LEV)","Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with Levetiracetam (LEV)",[18],"Drug: Levetiracetam",{"label":20,"type":10,"description":21,"interventionNames":22},"Oxcarbazepine (OXC)","Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with with Oxcarbazepine (OXC)",[23],"Drug: Oxcarbazepine",[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Lamotrigine","Anti-seizure concentrations",[9],[31],"Anti-seizure medication: Lamotrigine (LTG)",{"type":26,"name":33,"description":28,"armGroupLabels":34,"otherNames":35},"Levetiracetam",[15],[36],"Anti-seizure medication: Levetiracetam (LEV)",{"type":26,"name":38,"description":28,"armGroupLabels":39,"otherNames":40},"Oxcarbazepine",[20],[41],"Anti-seizure medication: Oxcarbazepine (OXC)",[43],{"name":44,"affiliation":45,"role":46},"Page B Pennell, MD","The University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":10,"email":52},"Tonge Ebai, PhD","CONTACT","4126160730","ebait@upmc.edu",{"name":54,"role":50,"phone":10,"phoneExt":10,"email":55},"Erica Kemp, PA","kempe2@upmc.edu",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-79.99589,40.44062,{"lat":68,"lon":67},[71,73,75],{"name":49,"role":50,"phone":72,"phoneExt":10,"email":52},"412-592-4018",{"name":74,"role":50,"phone":10,"phoneExt":10,"email":55},"Erica Kemp, P.A.",{"name":44,"role":46,"phone":10,"phoneExt":10,"email":10},{"type":46,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Page B. Pennell, MD","Professor",[80],{"name":81,"class":82},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100473906","physiological-based-pharmacokinetics-approach-to-medication-exposure-during-pregnancy-and-breastfeeding-100473906",false,"NCT05450978","Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding","Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding","PBPK","Inclusion Criteria:\n\n* Woman with epilepsy between the ages of 18-45 planning pregnancy or in the early first trimester of pregnancy.\n* Women with epilepsy ability to maintain a daily medical diary\n* Women with epilepsy ability to answer side effect questionnaires\n* Women with epilepsy currently being treated with lamotrigine (LTG) or levetiracetam (LEV) or oxcarbazepine (OXC)\n\nExclusion Criteria:\n\n* Women with epilepsy having history of functional seizures.\n* Women with epilepsy history of other major medical illnesses including renal or hepatic disease, progressive cerebral disease,\n* Women with epilepsy who have inability to maintain a seizure and medication daily diary\n* Women with epilepsy with present or recent history of drug or alcohol abuse, or the use of any concomitant medications that interact with the ASM they are taking (lamotrigine, levetiracetam, oxcarbazepine).","FEMALE","18 Years","45 Years",{"count":95,"type":96},60,"ESTIMATED","2 Years","OBSERVATIONAL","This project focuses on anti-seizure medication (ASM) clearance and physiological factors determining blood concentrations in pregnant adult women with epilepsy and amounts of exposure to their unborn children and nursing infants.",[101,102],"Epilepsy","Pregnancy Related","2026-05-01",{"date":105,"type":106},"2026-05-06","ACTUAL",{"date":108,"type":106},"2022-07-20",{"date":110,"type":96},"2028-04-01",{"name":5,"class":6},1]