Epilepsy, Pregnancy Related
Conditions
Brief 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.
Detailed description
The goal of this study is to develop modeling of pharmacokinetic changes for Antiseizure medications (ASMs), lamotrigine (LTG), and levetiracetam (LEV) during pregnancy and postpartum that can be used to: 1. Adjust doses in practice without obtaining frequent visits to the lab for therapeutic drug monitoring. 2. Predict exposure of ASMs in mothers and their infants in order to maintain the individualized target concentrations, thus protecting mothers from seizure worsening and minimizing fetal toxicity. Hypotheses: 1. Drug concentrations obtained in preconception and early pregnancy predict clearance changes throughout the remainder of pregnancy for individual pregnant women with epilepsy. 2. Validated model allows the prediction of drug concentration changes at all stages throughout and after pregnancy, which will more accurately predict increased seizures and medication side effects. Additionally, pilot data will be obtained for oxcarbazepine (OXC) in a small number of participants and contribute to data for ASMs that undergo glucuronidation (LTG).
Interventions
DRUGLamotrigine
Anti-seizure concentrations
DRUGLevetiracetam
Anti-seizure concentrations
DRUGOxcarbazepine
Anti-seizure concentrations
Sponsors
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Seizure Medication (ASM) Clearance | Through study completion, an average of 18 months. | ASM Clearance will be calculated from measurements of lamotrigine, oxcarbazepine, and levetiracetam blood concentrations, serum creatinine and 24-hour urine collection (for levetiracetam), glucuronidated metabolite (for lamotrigine), steroid hormones, medication formulation and doses, time since recent doses, and participant weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure Frequency | Through study completion, an average of 18 months. | Participants will keep a daily seizure diary throughout their participation in the study. The diary will be reviewed at each study visit. |
| Anti-seizure Medication (ASM) Side Effects | Through study completion, an average of 18 months | An ASM Side Effect Questionnaire will be administered and a neurologic examination will be performed at each study visit. |
| Placental passage of Anti-Seizure Medications (ASM) | Through study completion, an average of 18 months | Maternal blood will be drawn and umbilical cord blood will be collected, for measurements of ASM concentrations for lamotrigine, oxcarbazepine, and levetiracetam. |
Countries
United States
Contacts
CONTACTTonge Ebai, PhD
CONTACTErica Kemp, PA
PRINCIPAL_INVESTIGATORPage B Pennell, MD
The University of Pittsburgh
Outcome results
None listed