An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 29
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
研究概览
简要总结
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).
详细描述
Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.
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
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
- •The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
- •Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg
排除标准
- •The patient has a treatable seizure etiology
- •The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
- •The patient has a history of status Epilepticus during the 3 months prior to Visit 1
- •The patient has a past and present history of pseudo seizures
- •The patient has a current diagnosis of Lennox-Gastaut syndrome
研究组 & 干预措施
Levetiracetam
Open-label, single-arm
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
时间窗: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.
Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
时间窗: From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22
The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as: (B values- T values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
次要结局
- Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period(10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22))
- Number of Seizure-free Subjects Over the 10-weeks Evaluation Period(10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22))
- Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)(During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted))
- Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period(10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22))
- Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period(14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)))
- Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)(From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period))
- Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period(From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22))
- Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period(14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)))
- Number of Seizure-free Subjects Over the 14-weeks Treatment Period(14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)))