A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF)
- •Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)
- •Participant is expected to benefit from participation, in the opinion of the Investigator
排除标准
- •Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- •Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
- •Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- •Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious adverse event (SAE)
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
研究组 & 干预措施
Lacosamide
Subjects in this arm will receive various single doses of lacosamide
干预措施: Lacosamide (Drug)
结局指标
主要结局
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
Percentage of Participants Who Withdrew From Study Due to TEAEs
时间窗: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
Percentage of Participants Who Withdrew From Study Due to Serious Adverse Event (SAEs)
时间窗: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
A SAE is defined as results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect, other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. Only participants who discontinued the study due to SAEs are reported.
Modal Daily Dose During the Study
时间窗: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
The modal daily LCM dose in milligram per kilogram (mg/kg/day) is defined as the daily Lacosamide dose the participant received for the longest duration in EP0151.
Maximum Daily Dose During the Study
时间窗: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Maximum daily dose is defined as the highest total daily dose a participant received in EP0151.
次要结局
未报告次要终点