A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With 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
- 9
- 试验地点
- 5
- 主要终点
- The Total Number of Subject Withdrawal Due to Adverse Events During the Study
研究概览
简要总结
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks
- •Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024
- •Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024
排除标准
- •Subject has a history of any kind of status epilepticus within 12-month period prior to study entry
- •Subject has actual suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
研究组 & 干预措施
Lacosamide (LCM)
On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).
干预措施: Lacosamide (200 mg/20 mL) (Drug)
结局指标
主要结局
The Total Number of Subject Withdrawal Due to Adverse Events During the Study
时间窗: During the study (Screening through End of Study (Day -1 through Day 6))
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
时间窗: During the study (Screening through End of Study (Day -1 through Day 6))
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
次要结局
- Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1(20 minutes prior infusion at Day 1)
- Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2(20 minutes prior infusion at Day 2)
- Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1(20 minutes prior infusion at Day 1)
- Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5(20 minutes prior infusion at Day 5)
- Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2(20 minutes prior infusion at Day 2)
- Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5(20 minutes prior infusion at Day 5)