An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 370
- 主要终点
- Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 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
- 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
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing
干预措施: lacosamide (Drug)
结局指标
主要结局
Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
时间窗: During the Treatment Period (up to 8 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 (up to 8 Years)
时间窗: During the Treatment Period (up to 8 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 (up to 8 Years)
时间窗: During the Treatment Period (up to 8 years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
次要结局
- Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)(Baseline, End of Treatment Period (up to 8 years))
- Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)(Treatment Period (up to 8 years))