An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 400
- 主要终点
- Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
研究概览
简要总结
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
- •Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- •Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
- •Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1 (V1)
- •Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
- •Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a concomitant AED
排除标准
- •History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
- •History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
研究组 & 干预措施
Placebo
Matching Placebo tablets administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period.
干预措施: Placebo (Other)
Brivaracetam 5 mg/day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment Period.
干预措施: Brivaracetam 2.5 mg (Drug)
BRV 20mg/day
Brivaracetam 20 mg/day, 10 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period.
干预措施: Brivaracetam 10 mg (Drug)
BRV 50mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day, in a double-blinded way for the 12-week Treatment Period.
干预措施: Brivaracetam 25 mg (Drug)
结局指标
主要结局
Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
时间窗: Baseline to 12-week Treatment Period
Partial (Type I) seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)
次要结局
- All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period(Baseline to 12-week Treatment Period)
- Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period(Baseline to 12-week Treatment Period)
- Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period(Baseline to 12-week Treatment Period)
- Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period(Baseline to 12-week Treatment Period)
- Time to Fifth Type I Seizure During the 12-week Treatment Period(Baseline to 12-week Treatment Period)
- Time to Tenth Type I Seizure During the 12-week Treatment Period(Baseline to 12-week Treatment Period)
- Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit(Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(From Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(From Baseline to 12-week Treatment Period)
- Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week(Baseline to 12-week Treatment Period)
- Time to First Type I Seizure During the 12-week Treatment Period(Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 12-week Treatment Period)
- Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period(Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score(Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(From Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Hospital Depression Score(Baseline to 12-week Treatment Period)
- Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit(Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(From Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(From Baseline to 12-week Treatment Period)
- Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(From Baseline to 12-week Treatment Period)