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.
The goal of this study is to develop modeling of pharmacokinetic changes for Antiseizure medications (ASMs), lamotrigine (LTG), and levetiracetam (LEV) during pregnancy and postpartum that can be used to: 1. Adjust doses in practice without obtaining frequent visits to the lab for therapeutic drug monitoring. 2. Predict exposure of ASMs in mothers and their infants in order to maintain the individualized target concentrations, thus protecting mothers from seizure worsening and minimizing fetal toxicity. Hypotheses: 1. Drug concentrations obtained in preconception and early pregnancy predict clearance changes throughout the remainder of pregnancy for individual pregnant women with epilepsy. 2. Validated model allows the prediction of drug concentration changes at all stages throughout and after pregnancy, which will more accurately predict increased seizures and medication side effects. Additionally, pilot data will be obtained for oxcarbazepine (OXC) in a small number of participants and contribute to data for ASMs that undergo glucuronidation (LTG).
Study Type
OBSERVATIONAL
Enrollment
60
Anti-seizure concentrations
Anti-seizure concentrations
Anti-seizure concentrations
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITINGAnti-Seizure Medication (ASM) Clearance
ASM Clearance will be calculated from measurements of lamotrigine, oxcarbazepine, and levetiracetam blood concentrations, serum creatinine and 24-hour urine collection (for levetiracetam), glucuronidated metabolite (for lamotrigine), steroid hormones, medication formulation and doses, time since recent doses, and participant weight.
Time frame: Through study completion, an average of 18 months.
Seizure Frequency
Participants will keep a daily seizure diary throughout their participation in the study. The diary will be reviewed at each study visit.
Time frame: Through study completion, an average of 18 months.
Anti-seizure Medication (ASM) Side Effects
An ASM Side Effect Questionnaire will be administered and a neurologic examination will be performed at each study visit.
Time frame: Through study completion, an average of 18 months
Placental passage of Anti-Seizure Medications (ASM)
Maternal blood will be drawn and umbilical cord blood will be collected, for measurements of ASM concentrations for lamotrigine, oxcarbazepine, and levetiracetam.
Time frame: Through study completion, an average of 18 months
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