A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 322
- 试验地点
- 108
- 主要终点
- Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
研究概览
简要总结
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)
排除标准
- •Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
研究组 & 干预措施
Lacosamide
Lacosamide tablets for dosing 100 -800 mg/day
干预措施: Lacosamide (Drug)
结局指标
主要结局
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
时间窗: From Visit 1 to End of Study (approximately 2 years)
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
时间窗: From Visit 1 to End of Study (approximately 2 years)
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
次要结局
- Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study(From Visit 1 to End of Study (approximately 2 years))
- Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study(From Visit 1 to End of Study (approximately 2 years))