Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 主要终点
- Reduction in frequency of partial seizures
研究概览
简要总结
To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.
详细描述
A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must weigh greater than or equal to 40kg
- •Patients must have diagnosis of partial seizures
- •At least 3 observable partial seizures a month
- •Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs.
- •Patients on Valproic acid, and Felbamate
排除标准
- 未提供
研究组 & 干预措施
1
Enzyme-inducing placebo TID
干预措施: Placebo (Drug)
2
Enzyme-inducing Talampanel 35 mg TID
干预措施: Talampanel (Drug)
3
Enzyme-inducing TLP 50mg TID
干预措施: Talampanel (Drug)
4
Non-enzyme-inducing placebo TID
干预措施: Placebo (Drug)
5
Non-enzyme-inducing TLP 25mg TID
干预措施: Talampanel (Drug)
6
Non-enzyme-inducing TLP 35mg TID
干预措施: Talampanel (Drug)
结局指标
主要结局
Reduction in frequency of partial seizures
时间窗: 12 weeks
Change in frequency of recognizable seizures as measured by entries in a seizure diary
次要结局
- The number of seizure-free days and percent responders(12 weeks)