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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

Who can join

Ages 18 to 45 · Women

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 with epilepsy who have inability to maintain a seizure and medication daily diary
* 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).

About the study

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.

What is being tested

• Lamotrigine (drug)
• Levetiracetam (drug)
• Oxcarbazepine (drug)

Sponsor: University of Pittsburgh · Participants: 60 · Started: Jul 20, 2022

Contact the study team

• Tonge Ebai, PhD · Phone: 4126160730

Official record on ClinicalTrials.gov — NCT05450978

Locations in the U.S.

Conditions

• Epilepsy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.