Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding
University of Pittsburgh
Summary
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.
Description
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…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Woman with epilepsy between the ages of 18-45 planning pregnancy or in the early first trimester of pregnancy. * Women with epilepsy ability to maintain a daily medical diary * Women with epilepsy ability to answer side effect questionnaires * Women with epilepsy currently being treated with lamotrigine (LTG) or levetiracetam (LEV) or oxcarbazepine (OXC) Exclusion Criteria: * Women with epilepsy having history of functional seizures. * Women with epilepsy history of other major medical illnesses including renal or hepatic disease, progressive cerebral disease, * Women…
Interventions
- DrugLamotrigine
Anti-seizure concentrations
- DrugLevetiracetam
Anti-seizure concentrations
- DrugOxcarbazepine
Anti-seizure concentrations
Location
- University of PittsburghPittsburgh, Pennsylvania