NCT00600509已完成2 期
Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 216
- 主要终点
- partial onset seizure frequency per week
研究概览
简要总结
Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with 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
- Double
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
- •simple and/or complex partial seizures with or without secondary generalization, and first partial seizure >= 2 years before selection visit;
- •seizures classifiable according to the ILAE classification;
- •minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
- •exposed to two or more standard AEDs;
- •taking up to three of the standard AEDs, at the initiation of the trial.
排除标准
- •medication influencing the CNS, except for medication taken for antiepileptic treatment;
- •partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
- •history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
- •presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.
结局指标
主要结局
partial onset seizure frequency per week
时间窗: collection of seizure count throughout the whole study (baseline and treatment periods)
次要结局
- safety and tolerability(safety and tolerability data were collected throughout the study period)
研究者
相似试验
已完成
3 期
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)Generalized Tonic-Clonic SeizuresEpilepsyNCT01228747UCB Japan Co. Ltd.361
已完成
3 期
Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed EpilepsyEpilepsyNCT00175903UCB Pharma1,701
已完成
3 期
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset SeizuresEpilepsiesPartialNCT00367432UCB Japan Co. Ltd.398
已完成
3 期
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label MethodEpilepsy, PartialNCT00160615UCB Japan Co. Ltd.154
已完成
3 期
Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary GeneralizationPartial SeizuresEpilepsyNCT01392768Ache Laboratorios Farmaceuticos S.A.126