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Идёт набор NCT05450978

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

— Наблюдательное Epilepsy Pregnancy Related

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lamotrigine, Levetiracetam, Oxcarbazepine.
Кому может быть актуально
Состояния в реестре: Epilepsy, Pregnancy Related. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

  • Anti-Seizure Medication (ASM) Clearance [Срок оценки: Through study completion, an average of 18 months.]
Вторичные конечные точки (3)
  • Seizure Frequency [Срок оценки: Through study completion, an average of 18 months.]
  • Anti-seizure Medication (ASM) Side Effects [Срок оценки: Through study completion, an average of 18 months]
  • Placental passage of Anti-Seizure Medications (ASM) [Срок оценки: Through study completion, an average of 18 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Pittsburgh — Pittsburgh

Публикации

  • 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

Идентификаторы

NCT: NCT05450978 · STUDY21090138 · R01HD105305

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗