NCT05450978Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 22 Jun 2022
- Start date
- 20 Jul 2022
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- University of Pittsburgh
- Diseases
- Epilepsy
- NCT number
- NCT05450978
What you commit to
- Study type: Observational
- Planned participants: 60
- From 20 Jul 2022 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.