An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.
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
- •Completed the previous protocol and wish to continue to receive pregabalin.
- •Diagnosis of epilepsy with partial seizures
排除标准
- •Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
研究组 & 干预措施
1
干预措施: pregabalin (Drug)
结局指标
主要结局
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Week 28
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Seizure Frequency
时间窗: Baseline up to Week 28
Number of Participants With Laboratory Test Values of Potential Clinical Importance
时间窗: Baseline up to Week 28
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
次要结局
未报告次要终点