Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• 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)
Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Tonge Ebai, PhD
ebait@upmc.edu
4126160730
Backup
Erica Kemp, PA
kempe2@upmc.edu
Time Frame
Start Date: 2022-07-20
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 60
Treatments
Lamotrigine (LTG)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with lamotrigine (LTG)
Levetiracetam (LEV)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with Levetiracetam (LEV)
Oxcarbazepine (OXC)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with with Oxcarbazepine (OXC)
Related Therapeutic Areas
Sponsors
Leads: University of Pittsburgh
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)