NCT05450978 · University of Pittsburgh
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
(PBPK)
What this study 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.
View original scientific 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.
Interventions
DRUG
Lamotrigine
Anti-seizure concentrations
DRUG
Levetiracetam
Anti-seizure concentrations
DRUG
Oxcarbazepine
Anti-seizure concentrations
Primary outcome measures
Anti-Seizure Medication (ASM) Clearance
Time frame: Through 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pittsburgh, Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations