NL-OMON35288已完成3 期
A double-blind, placebo-controlled, dose-escalation, parallel-group study to evaluate the efficacy and safety of E2007 (perampanel) given as adjunctive therapy in subjects with refractory partial seizures. - Eisai Epilepsy E2007-G000-305
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Be considered reliable and willing to be available for the study period and is able to record seizures and report AEs them self or have a caregiver who can record seizures and report AEs for them
- •*Male or female and greater than or equal to 18 years of age
- •*Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy*s Classification of Epileptic Seizures (1981).
- •*Have uncontrolled partial seizures despite having been treated with at least 2 different AEDs within approximately the last 2 years;
- •*Are on a stable dose of the same concomitant AED(s) for 1 month (or no less than 21 days) prior to Visit 1;
排除标准
- •* Presence of nonmotor simple partial seizures only;
- •* Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies;
- •* Presence or previous history of Lennox-Gastaut syndrome;
- •* A history of status epilepticus within approximately 12 months prior to Visit 1;
- •* Seizure clusters where individual seizures cannot be counted;
- •* A history of psychogenic seizures;
- •* Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject*s safety or the study conduct;
研究者
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