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Understanding Anti-Seizure Medication Levels During Pregnancy and Breastfeeding

This study is looking at how levels of anti-seizure medications (ASMs) like lamotrigine, levetiracetam, and oxcarbazepine change in pregnant women with epilepsy. The goal is to understand how these medications are cleared from the body and how much reaches an unborn baby or nursing infant. Researchers hope to create models that can help doctors adjust medication doses without frequent lab visits, keeping mothers seizure-free and minimizing potential effects on babies. They are studying women aged 18-45 who are planning pregnancy or are in their early first trimester and are taking one of these medications. The study aims to enroll 60 participants.

Study design
This is an observational study, meaning participants will be monitored without receiving new treatments. It plans to enroll 60 women.
What's involved
Participants will need to maintain a daily medical diary and answer side effect questionnaires. The study will last an average of 18 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, an average of 18 months.

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NCT05450978

Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Recruiting
Not specifiedAges 18–45Observational
University of Pittsburgh
~60 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:LamotrigineLevetiracetamOxcarbazepine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Anti-Seizure Medication (ASM) Clearance
Measured over Through study completion, an average of 18 months.

Conditions

Epilepsy
Pregnancy Related

Explore related trials

PregnancySeizure Disorder

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Page B Pennell, MD · PRINCIPAL_INVESTIGATOR · The University of Pittsburgh

Who to contact

Tonge Ebai, PhD
[email protected]
4126160730
Email the study team

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Anti-Seizure Medication (ASM) ClearanceThrough study completion, an average of 18 months.

    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.