A Multi-center, Real-world Clinical Study of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- 50% response rate of Perampanel
研究概览
简要总结
This study is a multi-center, real-word clinical trial. The purpose of this study is to evaluate the safety and effectiveness of perampanel as an add-on treatment for epileptic seizure, and to find the effective maintenance and maximum dose in Chinese children. The enrolled subjects were epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.
详细描述
This is a multi-center, prospective, observational study. Subjects who meet all of the inclusion and none of the exclusion criteria will be received perampanel. Baseline seizure counts (frequency) data is collected by subjects or guardian/legally authorized representative, retrospectively.
It is expected to enroll 1000 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from July 2021 to November 2021. The initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation. The patients were followed up for 6 months and recorded the frequency of seizures and self-assessment of improvement. Safety will be assessed by monitoring and recording of all of AEs and serious adverse events (SAEs), discontinuation during 6 months treatment (patient spontaneous reporting).
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥2y, ≤12y;
- •Within 3 months before taking perampanel, the frequency of epileptic seizures was ≥1 time/month on average;
- •1-3 kinds of AEDs have been used, and the optimal dose and course of treatment have been reached, but the effect is not good. Perampanel is used as an additional treatment.
排除标准
- •Patients who have participated in other researches on antiepileptic drugs or medical devices;
- •Inaccurate or unreliable clinical records according to the judgment of participating doctors;
- •When the database is closed, the expected follow-up time is less than 6 months.
研究组 & 干预措施
Perampanel
Epilepsy patients who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed perampanel additional treatment.
干预措施: Perampanel (Drug)
结局指标
主要结局
50% response rate of Perampanel
时间窗: 6 months
Proportion of subjects who have at least 50% reduction in total seizure frequency during the Maintenance Period relative to the Baseline
次要结局
- Seizure-free rate of Perampanel(6 months)
- Incidence of AEs and discontinuation [Safety and Tolerability](6 months)
- Retention rate of Perampanel(6 months)
研究者
Xiaodan Li, MD
Principal Investigator
Beijing Children's Hospital