NCT00160654已完成4 期
A Phase IV, Open-label, Multi-center, Community-based Trial in Asia Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 251
- 试验地点
- 29
- 主要终点
- Number of Patients With Adverse Events (AEs)
研究概览
简要总结
Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.
The optimal dose in daily clinical practice will be used.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
- •Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit
- •Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.
排除标准
- •Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
- •Presence of known pseudoseizures within the last year.
- •Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
- •Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
研究组 & 干预措施
Levetiracetam
Experimental
Subjects received open-label Levetiracetam.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs)
时间窗: From Baseline until Safety visit (two weeks after last dose; up to Week 18)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
次要结局
- Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period(Week 16, compared to Baseline)
- Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period(Week 16, compared to Baseline)
- Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16(Week 16, compared to Baseline)
- Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16(Week 16, compared to Baseline)
- Percentage of Patients With Categorized Change From Baseline in Severity of Illness(Baseline, Week 16)
- Retention Rate at Week 16(Week 16)
研究者
研究点 (29)
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