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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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).

Conditions

• Epilepsy
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Lamotrigine	Anti-seizure concentrations
DRUG	Levetiracetam	Anti-seizure concentrations
DRUG	Oxcarbazepine	Anti-seizure concentrations

Timeline

• Start date: 2022-07-20
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2022-07-11
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study