NCT00448539终止3 期
An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Eisai Inc.
- 入组人数
- 286
- 试验地点
- 27
- 主要终点
- Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
研究概览
简要总结
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rufinamide (Rufinamide During Core Study)
Experimental
干预措施: Rufinamide (Drug)
Rufinamide (Placebo During Core Study)
Experimental
干预措施: Rufinamide (Drug)
结局指标
主要结局
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
时间窗: Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
Seizure data was collected via patient diaries. "OL" refers to "open-label."
次要结局
未报告次要终点
研究者
研究点 (27)
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