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Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

NCT05450978 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lamotrigine

Anti-seizure concentrations

DRUG

Levetiracetam

Anti-seizure concentrations

DRUG

Oxcarbazepine

Anti-seizure concentrations

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Page B Pennell, MD · The University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2027-04-01
Completion
2028-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450978 on ClinicalTrials.gov