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

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.

Conditions

Epilepsy, Pregnancy Related

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding

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

Condition
Epilepsy
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Kaufmann Medical Building, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Women planning pregnancy within the next 6 months.
  • * Women currently being treated with lamotrigine (LTG) or levetiracetam (LEV) for a diagnosis of epilepsy
  • * History of psychogenic non-epileptic spells
  • * History of other major medical illnesses including renal or hepatic disease, progressive cerebral disease,
  • * Inability to maintain a seizure and medication daily diary
  • * 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 or levetiracetam).

Ages Eligible for Study

14 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Page B. Pennell, MD,

Page B Pennell, MD, PRINCIPAL_INVESTIGATOR, The University of Pittsburgh

Study Record Dates

2026-05-21