NCT00152373已完成3 期
A Double-blind, Placebo-controlled, Randomized Study: 16-week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as add-on Therapy in Adults and Adolescents Older Than 16 Years Suffering From Partial Seizures.
适应症
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
- 192
- 主要终点
- The partial onset (type I) seizure frequency reduction per week over the 16-week treatment period (titration and maintenance)
研究概览
简要总结
clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects with partial seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject suffering from partial onset seizures, whether or not secondarily generalized,
- •presence of the following during the eight weeks of the historical baseline period: at least eight partial seizures (type IA, IB or IC) with or without secondary generalization.
- •subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs).
- •subject who has been exposed to at least one classical AEDs,
- •CT scan or MRI performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease.
排除标准
- •history of status epilepticus within three months prior to the Selection visit,
- •subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries),
- •use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 1 month prior to the Selection visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. Intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the Selection visit. Neuroleptics and Traditional Chinese AEDs are not allowed.,
- •history or presence of pseudoseizures,
结局指标
主要结局
The partial onset (type I) seizure frequency reduction per week over the 16-week treatment period (titration and maintenance)
次要结局
- Safety and tolerability
- Seizure freedom ;
- The partial onset (type I) seizure reduction response rate ;
研究者
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终止
2 期
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