A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 主要终点
- Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
研究概览
简要总结
A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:
- •Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
- •Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
- •Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
- •Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks
排除标准
- •The following patients are not eligible for inclusion into the study:
- •Subjects who were diagnosed with status epilepticus within 3 months before screening
- •Subjects with no partial seizures of which frequency was measured during the Baseline Period
- •Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
- •Subjects with a history of oral treatment with Levetiracetam (LEV)
研究组 & 干预措施
Lev 0.5 g
Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Levetiracetam 250 mg (Drug)
Lev 1 g
Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Levetiracetam 250 mg (Drug)
Lev 1 g
Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Levetiracetam 500 mg (Drug)
Lev 2 g
Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Levetiracetam 250 mg (Drug)
Lev 2 g
Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Levetiracetam 500 mg (Drug)
Lev 3 g
Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Levetiracetam 250 mg (Drug)
Lev 3 g
Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Levetiracetam 500 mg (Drug)
Placebo
Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
干预措施: Placebo (Other)
结局指标
主要结局
Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
时间窗: From Baseline to the 12-week Evaluation Period
次要结局
- Partial (Type I) seizure frequency per week over the Evaluation Period(12-week Evaluation Period)
- Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period(From Baseline to the 12-week Evaluation Period)
- Seizure freedom over the Evaluation Period(12-week Evaluation Period)
- Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period(From Baseline to the 12-week Evaluation Period)
- Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period(From Baseline to the 12-week Evaluation Period)