RecruitingNCT05450978
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding
Sponsor
University of Pittsburgh
Enrollment
60 participants
Start Date
Jul 20, 2022
Study Type
OBSERVATIONAL
Conditions
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
Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria4
- 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 Criteria4
- 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).
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Interventions
DRUGLamotrigine
Anti-seizure concentrations
DRUGLevetiracetam
Anti-seizure concentrations
DRUGOxcarbazepine
Anti-seizure concentrations
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05450978
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