NCT00143130已完成3 期
Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Reduction in seizure frequency.
研究概览
简要总结
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.
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
- •met the inclusion/exclusion criteria for A0081005
- •have completed the 21-week study and have shown a significant clinical response and wish to continue treatment
排除标准
- •Having a treatable cause of seizure.
- •Having a progressive neurological or systemic disorder
研究组 & 干预措施
Single Arm
Experimental
干预措施: Pregabalin (Drug)
结局指标
主要结局
Reduction in seizure frequency.
时间窗: 18 months
次要结局
- Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).(18 Months)
- Seizure-free patients during each 3-month period(18 Months)
- Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).(18 Months)
研究者
研究点 (1)
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