Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Pittsburgh
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Lamotrigine
- Levetiracetam
- Oxcarbazepine
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Pittsburgh
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov