NCT00141427已完成4 期
Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.57 个研究点 分布在 7 个国家目标入组 540 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 57
- 主要终点
- Reduction in seizure frequency.
研究概览
简要总结
To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with a diagnosis of partial epilepsy.
- •18 years and older.
排除标准
- •Having a treatable cause of seizure.
- •Having a progressive neurological or systemic disorder
结局指标
主要结局
Reduction in seizure frequency.
次要结局
未报告次要终点
研究者
研究点 (57)
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