NCT02687711已完成不适用
A 12-Month Noninterventional, Postmarketing, Multicenter Study to Evaluate the Effectiveness of Briviact® (Brivaracetam) as Adjunctive Therapy in Patients With Epilepsy With Partial-onset Seizures in Daily Clinical Practice
UCB Biopharma S.P.R.L.44 个研究点 分布在 9 个国家目标入组 544 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 544
- 试验地点
- 44
- 主要终点
- Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12
研究概览
简要总结
Study is the first study after commercialization of brivaracetam. It is designed to collect real world information on the effectiveness of brivaracetam in patients with Partial Onset Seizure epislepsy who are treated in standard clinical practice.
详细描述
EP0077 is a 12 months, multicenter, noninterventional study (NIS) conducted at specialized sites in approximately 10 European countries. Patients will be treated according to usual medical diagnostic procedures and therapy; commercially available brivaracetam will be prescribed according to normal clinical practice and the current Summary of Product Characteristics (SmPC) in Europe for brivaracetam (BRV). The prescription of BRV is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients.
The primary objective of this study is to determine BRV retention over a 12 month period as a measure of effectiveness in a real world setting. The secondary objective of this study is to assess seizure control with BRV treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has never been treated with brivaracetam (BRV) prior to enrollment in this Non-Interventional Study (NIS)
- •The decision by the treating physician to prescribe BRV is made independently of the participation in the NIS
- •Patient is a male or female ≥16 years of age
- •Patient has a clinical diagnosis of epilepsy with partial-onset seizures POS with or without secondary generalization
- •Patient uses an epilepsy/seizure diary.
排除标准
- •No specific exclusion criteria
结局指标
主要结局
Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12
时间窗: Month 12 (end of Observation Period)
Participants who remained in the study and were on BRV treatment for at least 1 year (\>=330 days) after their start of BRV were classed as having 12 months of treatment retention.
次要结局
- Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3(Baseline (Day 1) to Month 3)
- Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6(Month 6)
- Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period(From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal))
- Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12(Baseline (Day 1) to Month 12)
- Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6(Month 6)
- Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6(Month 6)
- Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12(From Baseline (Day 1) to Month 12)
- Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6(Baseline (Day 1) to Month 6)
- Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3(From Baseline (Day 1) to Month 3)
- Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6(From Baseline (Day 1) to Month 6)
- Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3(Month 3)
- Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3(Baseline (Day 1) to Month 3)
- Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3(From Baseline (Day 1) to Month 3)
- Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6(From Baseline (Day 1) to Month 6)
- Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period(From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal))
- Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12(From Baseline (Day 1) to Month 12)
- Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period(Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal))
- Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12(Baseline (Day 1) to Month 12)
- Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3(Month 3)
- Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3(Month 3)
- Number of Seizure Free Participants at End of Observation Period(End of Observation Period (up to Month 12/withdrawal))
- Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6(Baseline (Day 1) to Month 6)
- Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period(Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal))
- Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6(Month 6)
- Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12(Month 12)
- Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3(Month 3)
- Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3(Month 3)
- Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6(Month 6)
- Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12(Month 12)
- Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12(Month 12)
- Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12(Month 12)
- Time to First Seizure After First Dose of Brivaracetam(Month 12)
- Percent of Seizure Free Participants at End of Observation Period(End of Observation Period (up to Month 12/withdrawal))
研究者
研究点 (44)
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