Understanding medication effects during pregnancy and breastfeeding for women with epilepsy
Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05450978 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with epilepsy who are planning pregnancy or are in the early first trimester.
Not a fit: Patients with a history of functional seizures or significant medical illnesses may not benefit from this study.
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 performed: Other studies have shown promise in understanding pharmacokinetics during pregnancy, but this specific approach is novel and untested.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.