Меню
Идёт набор NCT06716801

Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain

— Наблюдательное Focal Epilepsy With and Without Secondary Generalization

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: Cenobamate.
Кому может быть актуально
Состояния в реестре: Focal Epilepsy With and Without Secondary Generalization. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Observational Cohort Study on Adult Patients With Not-adequately Controlled FOcal-onset Seizures Treated With Cenobamate as Early adjUnctive Therapy in a Real-world Setting - FOCUS

Обзор

Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

Вмешательства

  • Препарат Cenobamate
    Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications.

Первичные конечные точки

  • Responder rate [Срок оценки: At 6 and at 12 months of maintenance treatment]
Вторичные конечные точки (6)
  • Responder rate [Срок оценки: At 6 and at 12 months of maintenance-dosing treatment]
  • Safety evaluation [Срок оценки: 0 -12 months of maintenance-dosing treatment]
  • Health-Related Quality of Life evaluation (QOLIE-31-P) [Срок оценки: At 6 and at 12 months maintenance-dosing treatment]
  • Health-Related Quality of Life evaluation (SF-6Dv2 ) [Срок оценки: At 6 and at 12 months maintenance-dosing treatment]
  • Sleepiness status evaluation [Срок оценки: At 6 and at 12 months of maintenance-dosing treatment]
  • Healthcare resource evaluation [Срок оценки: 0-12 months of maintenance-dosing treatment]

Критерии участия

Критерии включения

  • Male and female patients ≥18 years old at the time of cenobamate treatment initiation.
  • Patients with a diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization.
  • Patients under titration phase (i.e., maintenance dose not reached yet according to clinical judgement) with cenobamate as adjunctive therapy in third or fourth line with 1 to maximum 2 (for third line)/3 (for fourth line) concomitant anti-seizure medications (ASMs).
  • Patients who have not been adequately controlled despite treatment with 2 or 3 (maximum) ASMs before cenobamate treatment initiation (including concomitant ASMs started before initiating cenobamate).
  • Patients with available retrospective data in medical charts, seizure diaries or patient's notes, including reliable information about seizure frequency (intended as the number of seizures and the corresponding time period) in the last 3 months before cenobamate treatment initiation.
  • Written informed consent (including consent for the processing of personal data) signed by the patient, or by the legally designated representative in case of patient lacking capacity, prior to entering the study following local regulation.

Критерии исключения

  • Patients who meet any of the contraindications to the administration of cenobamate according to its approved Summary of Product Characteristics (SmPC).
  • Patients with progressive neurodegenerative central nervous system (CNS) diseases or (benign or malignant) brain tumors.
  • Patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania.
  • Patients with known substance abuse or dependence (except for caffeine and nicotine).
  • Patients participating in any interventional study from cenobamate treatment initiation until enrolment visit.
  • Patients with ongoing pregnancy or breast-feeding from cenobamate treatment initiation until enrolment visit.
  • Patients who are seizure-free in the last 3 months before cenobamate treatment initiation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital TARNIER COCHIN — Paris

Идентификаторы

NCT: NCT06716801 · 169(A)MD23324

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗