Understanding medication effects during pregnancy and breastfeeding for women with epilepsy
Official title: Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding
Run by University of Pittsburgh · NCT05450978 · Data updated 2026-11-12
This study is trying to see how anti-seizure medications work in pregnant women with epilepsy to help find the right doses that keep both moms and their babies safe.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | July 20, 2022 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT05450978 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-45 with epilepsy who are planning pregnancy or are in the early first trimester.
✕Probably not a fit
Patients with a history of functional seizures or significant medical illnesses may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to analyze how anti-seizure medications (ASMs) like lamotrigine and levetiracetam are processed in the bodies of pregnant women with epilepsy. By developing pharmacokinetic models, the study seeks to predict changes in drug clearance throughout pregnancy and postpartum, allowing for better dose adjustments without frequent lab visits. The research will also assess the exposure of these medications to unborn children and nursing infants, aiming to protect mothers from increased seizures and minimize potential toxicity to their babies.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective management of epilepsy in pregnant women, improving outcomes for both mothers and their infants.
How similar studies have gone: Other studies have shown promise in understanding pharmacokinetics during pregnancy, but this specific approach is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Page B Pennell, MD — The University of Pittsburgh
- Study coordinator: Tonge Ebai, PhD
- Email: ebait@upmc.edu
- Phone: 4126160730
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.