RecruitingNCT05450978

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

Sponsor

University of Pittsburgh

Enrollment

60 participants

Start Date

Jul 20, 2022

Study Type

OBSERVATIONAL

Conditions

Epilepsy Pregnancy Related

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

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 Criteria4

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).

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