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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05450978
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Lamotrigine — DRUG
    Anti-seizure concentrations
  • Levetiracetam — DRUG
    Anti-seizure concentrations
  • Oxcarbazepine — DRUG
    Anti-seizure concentrations

Study Details

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.

Key Dates

Start date
Jul 20, 2022
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Lamotrigine (LTG)
    Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with lamotrigine (LTG)
  • Arm: Levetiracetam (LEV)
    Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with Levetiracetam (LEV)
  • Arm: Oxcarbazepine (OXC)
    Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with with Oxcarbazepine (OXC)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Tonge Ebai, PhD
[email protected]
412-592-4018
Erica Kemp, P.A.
[email protected]
Page B Pennell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
University of Pittsburgh· Pittsburgh, PA

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