Recruiting

Medication Exposure

Sponsor:

University of Pittsburgh

Code:

NCT05450978

Conditions

Epilepsy

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Lamotrigine

Levetiracetam

Oxcarbazepine

Study Details

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.

Conditions

Epilepsy

Pregnancy Related

Study ID

NCT05450978

Start date

Jul 20, 2022

Status verified date

May, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Lamotrigine (LTG)

Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with lamotrigine (LTG)

Levetiracetam (LEV)

Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with Levetiracetam (LEV)

Oxcarbazepine (OXC)

Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with with Oxcarbazepine (OXC)

Interventions

Lamotrigine

Anti-seizure concentrations

Levetiracetam

Anti-seizure concentrations

Oxcarbazepine

Anti-seizure concentrations

Primary outcome measure

  • Anti-Seizure Medication (ASM) Clearance [ Time Frame: Through study completion, an average of 18 months. ]

Central Contacts and Locations

Central contacts

Tonge Ebai, PhD

4126160730ebait@upmc.edu

Erica Kemp, PA

kempe2@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Tonge Ebai, PhD

412-592-4018ebait@upmc.edu

Erica Kemp, P.A.

kempe2@upmc.edu

Principal Investigator:

Page B Pennell, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-06.