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Recruiting NCT05450978

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

— Observational Epilepsy Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lamotrigine, Levetiracetam, Oxcarbazepine.
Who it may be relevant to
Registry conditions: Epilepsy, Pregnancy Related. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding

Overview

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

  • Drug Lamotrigine
    Anti-seizure concentrations
  • Drug Levetiracetam
    Anti-seizure concentrations
  • Drug Oxcarbazepine
    Anti-seizure concentrations

Primary outcome measures

  • Anti-Seizure Medication (ASM) Clearance [Time frame: Through study completion, an average of 18 months.]
Secondary outcome measures (3)
  • Seizure Frequency [Time frame: Through study completion, an average of 18 months.]
  • Anti-seizure Medication (ASM) Side Effects [Time frame: Through study completion, an average of 18 months]
  • Placental passage of Anti-Seizure Medications (ASM) [Time frame: Through study completion, an average of 18 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Publications

  • Pennell PB, French JA, May RC, Gerard E, Kalayjian L, Penovich P, Gedzelman E, Cavitt J, Hwang S, Pack AM, Sam M, Miller JW, Wilson SH, Brown C, Birnbaum AK, Meador KJ; MONEAD Study Group. Changes in Seizure Frequency and Antiepileptic Therapy during Pregnancy. N Engl J Med. 2020 Dec 24;383(26):2547-2556. doi: 10.1056/NEJMoa2008663. PMID 33369356
  • Birnbaum AK, Meador KJ, Karanam A, Brown C, May RC, Gerard EE, Gedzelman ER, Penovich PE, Kalayjian LA, Cavitt J, Pack AM, Miller JW, Stowe ZN, Pennell PB; MONEAD Investigator Group. Antiepileptic Drug Exposure in Infants of Breastfeeding Mothers With Epilepsy. JAMA Neurol. 2020 Apr 1;77(4):441-450. doi: 10.1001/jamaneurol.2019.4443. PMID 31886825
  • Pennell PB, Karanam A, Meador KJ, Gerard E, Kalayjian L, Penovich P, Matthews A, McElrath TM, Birnbaum AK; MONEAD Study Group. Antiseizure Medication Concentrations During Pregnancy: Results From the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) Study. JAMA Neurol. 2022 Apr 1;79(4):370-379. doi: 10.1001/jamaneurol.2021.5487. PMID 35157004

Identifiers

NCT: NCT05450978 · STUDY21090138 · R01HD105305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗