NCT06716801招募中不适用
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
Aziende Chimiche Riunite Angelini Francesco S.p.A1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年12月19日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Responder rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients affected by epilepsy with focal-onset seizures with or without secondary generalization
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 (ASMs).
干预措施: Cenobamate (Drug)
结局指标
主要结局
Responder rate
时间窗: At 6 and at 12 months of maintenance treatment
To describe the ≥50% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pretreatment baseline.
次要结局
- Responder rate(At 6 and at 12 months of maintenance-dosing treatment)
- Safety evaluation(0 -12 months of maintenance-dosing treatment)
- Health-Related Quality of Life evaluation (QOLIE-31-P)(At 6 and at 12 months maintenance-dosing treatment)
- Health-Related Quality of Life evaluation (SF-6Dv2 )(At 6 and at 12 months maintenance-dosing treatment)
- Sleepiness status evaluation(At 6 and at 12 months of maintenance-dosing treatment)
- Healthcare resource evaluation(0-12 months of maintenance-dosing treatment)
研究者
研究点 (1)
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