A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
- 主要终点
- Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)
研究概览
简要总结
The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
详细描述
A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study [NCT00655551] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects who participated in SP925 [NCT00655551] for treatment of partial-onset seizures
排除标准
- •Receiving any study drug or experimental device other than lacosamide
- •Meets withdrawal criteria for parent study SP925 [NCT00655551]
- •Experiencing ongoing serious adverse event
研究组 & 干预措施
Lacosamide
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
干预措施: lacosamide (Drug)
结局指标
主要结局
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)
时间窗: 2 years
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)
时间窗: 2 years
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
次要结局
未报告次要终点