Actively Recruiting
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Led by University of Pittsburgh · Updated on 2026-05-06
60
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman with epilepsy between the ages of 18-45 planning pregnancy or in the early first trimester of pregnancy.
- Ability to maintain a daily medical diary.
- Ability to answer side effect questionnaires.
- Currently treated with lamotrigine, levetiracetam, or oxcarbazepine.
You will not qualify if you...
- History of functional seizures.
- History of major medical illnesses including renal or hepatic disease or progressive cerebral disease.
- Inability to maintain a seizure and medication daily diary.
- Present or recent history of drug or alcohol abuse.
- Use of medications that interact with lamotrigine, levetiracetam, or oxcarbazepine.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
T
Tonge Ebai, PhD
CONTACT
E
Erica Kemp, PA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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