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How Seizure Medicines Reach Babies During Pregnancy and Breastfeeding

Studies how antiseizure medicines move into unborn babies and nursing infants in women with epilepsy.

Plain-language title generated from the registry record
Registry title: Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Key facts

Where
Pittsburgh, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 45 years old?

Source: NCT05450978, who can take part

Where in United States

  • University of PittsburghPittsburgh, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Pittsburgh
Trial code
NCT05450978
Record updated
6 May 2026
Original description
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.Read full original descriptionShow less

Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding

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.

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 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); 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.

ClinicalTrials.gov NCT05450978