NCT00175825已完成2 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 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
- 210
- 主要终点
- Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
研究概览
简要总结
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 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
- •Male/female from 16 to 65 years
- •Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- •History of partial onset seizures
- •Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
- •Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.
排除标准
- •Seizure type IA non-motor as only seizure type
- •Seizures occurring only in clusters
- •Status epilepticus during the last 2 years before Visit 1
- •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 5 mg/day
Experimental
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
干预措施: Brivaracetam (Drug)
Brivaracetam 20 mg/day
Experimental
Brivaracetam 20 mg/day, 10 mg administered twice a day
干预措施: Brivaracetam (Drug)
Brivaracetam 50 mg/day
Experimental
Brivaracetam 50 mg/day, 25 mg administered twice a day
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
时间窗: During the 7-week Treatment Period
Calculated as 7-day partial onset seizure frequency.
次要结局
- Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period(During the 7-week Treatment Period)
- Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period(During the 7-week Treatment Period)
- Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period(Baseline, during the 7-week Treatment Period)
- Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period(During the 7-week Treatment Period)
- Number of Seizure-free Days Per 4 Weeks(Baseline, during the 7-week Treatment Period)
- Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period(During the 7-week Treatment Period)
- Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period(During the 7-week Treatment Period)
- Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period(During the 7-week Treatment Period)
- Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period(During the 7-week Treatment Period)
- Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period(During the 7-week Treatment Period)
研究者
相似试验
已完成
2 期
A Study of Brivaracetam in Subjects With Partial Onset SeizuresEpilepsy, FocalNCT00175929UCB Pharma157
已完成
3 期
Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset SeizuresEpilepsyNCT01261325UCB Pharma768
已完成
3 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence EpilepsyJuvenile Absence EpilepsyChildhood Absence EpilepsyNCT04666610UCB Biopharma SRL153
已完成
3 期
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and AdultsUnverricht-Lundborg DiseaseNCT00368251UCB Pharma56
已完成
3 期
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and AdultsUnverricht-Lundborg DiseaseNCT00357669UCB Pharma SA50