An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 767
- 试验地点
- 184
- 主要终点
- Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
详细描述
The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject completed the Treatment Period of N01358 or the evaluation period of N01258
- •Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
- •Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
- •Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible
排除标准
- •Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
- •Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- •Poor compliance with the visit schedule or medication intake in the previous BRV study
- •Planned participation in any other clinical study of another investigational drug or device during this study
- •Pregnant or lactating woman
- •Any medical condition which, in the Investigator's opinion, warrants exclusion
- •Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
研究组 & 干预措施
Brivaracetam
Brivaracetam with a maximum of 200 mg/day
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
时间窗: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants With at Least One Serious Adverse Event (SAE)
时间窗: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
次要结局
- Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period(From Baseline of the previous study until the Last Visit (up to 84 months))
- Responder Rate in POS (Type I) Frequency Over the Evaluation Period(From Baseline of the previous study until the Last Visit (up to 84 months))
- Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period(From Baseline of the previous study until the Last Visit (up to 84 months))