NCT00175929已完成2 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
适应症
干预措施
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
- 157
- 主要终点
- Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
研究概览
简要总结
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- •Subjects with a history of partial onset seizures
- •Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
- •Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
- •Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted
排除标准
- •Seizure type IA non-motor as only seizure type
- •History or presence of seizures occurring only in clustered patterns
- •History of cerebrovascular accident (CVA)
- •Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo tablets administered twice a day
干预措施: Placebo (Other)
Brivaracetam 50 mg/day
Experimental
Brivaracetam 50 mg/day, 25 mg administered twice a day
干预措施: Brivaracetam (Drug)
Brivaracetam 150 mg/day
Experimental
Brivaracetam 150 mg/day, 75 mg administered twice a day
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
时间窗: 7-week maintenance period
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
次要结局
- Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period(During the Maintenance period (approximately 7 weeks))
- Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period(During the Maintenance period (approximately 7 weeks))
- Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period(During the Maintenance period (approximately 7 weeks))
- Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period(During the Maintenance period (approximately 7 weeks))
- Responder rate in partial onset seizures (type I) over the 7-week Maintenance period(During the Maintenance period (approximately 7 weeks))
- Percentage of seizure-free subjects over the 7-week Maintenance period(During the Maintenance period (approximately 7 weeks))
- Time to N-th seizure in the Maintenance period(During the Maintenance period (approximately 7 weeks))
- Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods(Baseline through Maintenance period (approximately 11 weeks))
研究者
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