An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 853
- 试验地点
- 153
- 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 trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).
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
- •Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
- •Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
- •Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study
- •Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected
排除标准
- •Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- •Poor compliance with visit schedule or medication intake in previous brivaracetam study
- •Participation in any clinical study of another investigational drug or device during the study
- •Pregnant or lactating woman
研究组 & 干预措施
Brivaracetam
Flexible dosing, can up and down titrate as needed.
干预措施: Brivaracetam (ucb 34714) (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 until Last Visit (up to 162 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 an Adverse Event (AE)
时间窗: From Entry Visit until Last Visit (up to 162 months)
An AE is any untoward medical occurrence in a participant or trial participant 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 until Last Visit (up to 162 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 an 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
- Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period(From Entry Visit until Last Visit (up to 162 months))
- Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period(From Entry Visit until Last Visit (up to 162 months))
- Responder Rate in POS (Type I) Frequency Over the Evaluation Period(From Entry Visit until Last Visit (up to 162 months))