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临床试验/NCT02876289
NCT02876289已完成不适用

Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Retention rate

研究概览

简要总结

Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy.

The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 86 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with refractory focal epilepsy
  • Initiation of perampanel between 05/2014 and 04/2015

排除标准

  • Exact date of initiation of Perampanel not defined
  • Patients without follow-up data

研究组 & 干预措施

patients treated with Perampanel

干预措施: Perampanel (Drug)

结局指标

主要结局

Retention rate

时间窗: 6 months

Proportion of patient still treated with Perampanel 6 months after its initiation

次要结局

  • Retention rate(12 months)
  • Total withdrawal rate(12 months)
  • Observed adverse effects during the observation period(12 months)
  • Seizure freedom(6 months)
  • Responder rates(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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