Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Launched by UNIVERSITY OF PITTSBURGH · Jul 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how anti-seizure medications (ASMs) affect pregnant women with epilepsy and how these medications might impact their unborn babies and nursing infants. Specifically, the research looks at how the body processes these medications during pregnancy, which can change due to hormonal and physiological factors. The goal is to better understand the right amounts of these medicines to keep both mothers and babies safe.

To be eligible for this trial, women need to be planning a pregnancy within the next six months and currently taking either lamotrigine or levetiracetam for epilepsy. Unfortunately, those with certain medical conditions, a history of substance abuse, or who can't keep a daily record of their seizures and medications won't be able to participate. If you join the study, you can expect to track your medication and seizure activity while contributing valuable information that could help improve care for other women with epilepsy during pregnancy and breastfeeding.

Gender

FEMALE

Eligibility 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).