NCT00143143已完成3 期
Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 300
- 试验地点
- 47
- 主要终点
- Safety assessments are performed at quarterly visits up until the study is closed.
研究概览
简要总结
The primary purpose of the protocol is to evaluate the long-term safety of pregabalin 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
- •Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
- •Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
- •Be currently taking 1 to 3 AEDs.
排除标准
- •Have a treatable cause of seizures
- •Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication
结局指标
主要结局
Safety assessments are performed at quarterly visits up until the study is closed.
次要结局
- Seizure frequency is assessed throughout the study until the study is closed.
研究者
研究点 (47)
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