An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 308
- 主要终点
- Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
研究概览
简要总结
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
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
- •Completion of parent clinical trial for treatment of partial seizures
排除标准
- •Receiving any study drug or experimental device other than lacosamide
- •Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
研究组 & 干预措施
Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
干预措施: lacosamide (Drug)
结局指标
主要结局
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
时间窗: During the Treatment Period (Maximum 6 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
时间窗: During the Treatment Period (Maximum 6 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
时间窗: During the Treatment Period (Maximum 6 years)
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
次要结局
- Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)(Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years))
- Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)(Treatment Period (Maximum 6 years))