Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Recruiting · NCT05450978 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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).
Where it is running
1 location listed across 1 US state.
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States