NCT00615615已完成3 期
Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 216
- 主要终点
- Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period
研究概览
简要总结
Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was >= 6 months before the Selection Visit
- •epilepsy was classifiable according to the ILAE Classification
- •>= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have >= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
- •unsatisfactory current AED treatment in terms of efficacy and/or safety
- •stable AED treatment consisting of no more than two AEDs
排除标准
- •treatable seizure etiology
- •epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
- •history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
- •history of or the presence of pseudo seizures
- •current diagnosis of Lennox-Gastaut syndrome
研究组 & 干预措施
Levetiracetam (LEV)
Experimental
LEV dose was titrated to a level of 60 mg/kg/day. The initial dose level was 20 mg/kg/day for the first two weeks, followed by a dose level of 40 mg/kg/day for two weeks. If lower doses were well tolerated, the LEV dose was increased to a dose level of 60 mg/kg/day for the remaining 10 weeks. The dose level could be reduced to 40 mg/kg/day if the patient did not tolerate LEV at a dose level of 60 mg/kg/day.
干预措施: Levetiracetam (Drug)
Placebo
Placebo Comparator
Subjects received Placebo matching to LEV treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period
时间窗: During the 14-weeks Treatment period (Week 8 to Week 22)
Calculated as 7-day partial onset seizure frequency.
次要结局
- 50% responder rate in seizure frequency per week during the Treatment Period(During the 14-weeks Treatment period (Week 8 to Week 22))
- Percent change from baseline in partial onset seizure frequency per week during the Treatment Period(Baseline, During the 14-weeks Treatment period (Week 8 to Week 22))
- Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period(From Baseline to the 14-weeks Treatment period)
- Number of seizure free days during the Treatment Period(During the 14-weeks Treatment period (Week 8 to Week 22))
- Absolute change from baseline in partial onset seizure frequency per week during the Titration Period(Baseline, During the 6-weeks Titration period (Week 8 to Week 14))
- Total seizure frequency per week (Types I + II + III) during the Treatment Period(During the 14-weeks Treatment period (Week 8 to Week 22))
- Total seizure frequency per week (Types I + II + III) during the Titration Period(During the 6-weeks Titration period (Week 8 to Week 14))
- Change from baseline in the average duration of seizure free intervals(From Baseline to the 14-weeks Treatment period)
- Partial onset seizure frequency per week during the Titration Period(During the 6-weeks Titration period (Week 8 to Week 14))
- Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period(Baseline, During the 14-weeks Treatment period (Week 8 to Week 22))
- Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period(Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22))
- Partial onset seizure frequency per week during the Evaluation Period(During the 6-weeks Evaluation period (Week 8 to Week 14))
- Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period(Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22))
- Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period(Beginning of the Evaluation Period (Week 14))
- Percent change from baseline in partial onset seizure frequency per week during the Titration Period(Baseline, During the 6-weeks Titration period (Week 8 to Week 14))
- Total seizure frequency per week (Types I + II + III) during the Evaluation Period(During the 6-weeks Evaluation period (Week 8 to Week 14))
研究者
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