Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures:a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 815
- 试验地点
- 1
- 主要终点
- The primary efficacy variable will be the proportion of subjects in the PP set who are seizure free for the entire 26-week Evaluation Period at the last received dose level.
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures.
详细描述
Epilepsy affects more than 50 million adults and children worldwide. Prevalence estimates in the total population vary from 4 to 8 per 1000 subjects. Anti-epileptic drugs (AEDs) are the major intervention and approximately 60% of newly diagnosed patients are seizure free on a single AED, but about 40% are not satisfactorily controlled and 25% suffer from significant adverse events (AEs). This lack of seizure control and unsatisfactory tolerability means there is still a need for new, effective AEDs that can be used as monotherapy.
Given the efficacy of ESL in controlling partial onset seizures, the good tolerability and the convenience of QD dosing instead of twice daily (BID) dosing, ESL could offer a beneficial alternative as a first-line therapy in patients newly diagnosed with epilepsy experiencing partial-onset seizures. This study aims to demonstrate the efficacy and safety of ESL as a monotherapy treatment for this patient population proving non-inferiority to a standard therapy, Carbamazepine controlled release (CBZ-CR).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Carbamazepine controlled release
干预措施: Eslicarbazepine acetate (BIA 2-093) (Drug)
Eslicarbazepine acetate
干预措施: Eslicarbazepine acetate (BIA 2-093) (Drug)
结局指标
主要结局
The primary efficacy variable will be the proportion of subjects in the PP set who are seizure free for the entire 26-week Evaluation Period at the last received dose level.
时间窗: 26 weeks
次要结局
- QOLIE-31 and Bond-Lader VAS(26 weeks; up to 183 weeks)
- Time to treatment failure at the first evaluated dose(26 weeks)
- Proportion of subjects in the ITT set without a seizure during the 26-week Evaluation Period at the last evaluated dose.(26 weeks)
- Proportion of seizure-free subjects during 1 year of treatment at the last evaluated dose, where the end of the 1-year period is defined as the same start date as for the 26-week evaluation +365 days.(52 weeks)
- Time to first seizure at the last evaluated dose set.(up to 183 weeks)
- Proportion of subjects without a seizure during the 26-week Evaluation Period at the last evaluated dose.(26 weeks)
- Treatment retention time at the last evaluated dose(26 weeks)
- seizure freedom(26 weeks)
- Adverse Event monitoring(up to 183 weeks)