A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 76
- 主要终点
- Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
- •Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
- •Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
- •Minimum Body Weight of 40 kg
排除标准
- •Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
- •Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
- •Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
- •Subject has a history of Primary Generalized Seizures
- •Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
- •Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
- •Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
研究组 & 干预措施
Placebo
Matching placebo for 16 weeks.
干预措施: Placebo (Drug)
Lacosamide 200 mg/day
Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
干预措施: Lacosamide 50 mg (Drug)
Lacosamide 200 mg/day
Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
干预措施: Lacosamide 100 mg (Drug)
Lacosamide 400 mg/day
Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
干预措施: Lacosamide 50 mg (Drug)
Lacosamide 400 mg/day
Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
干预措施: Lacosamide 100 mg (Drug)
结局指标
主要结局
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
时间窗: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)
Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.
次要结局
- The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)(8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8))
- Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period(8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8))
- Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)(8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8))