An Open-label, Multi-center, 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
- 入组人数
- 668
- 试验地点
- 100
- 主要终点
- Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
研究概览
简要总结
This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.
详细描述
Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].
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 and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
- •Subjects with epilepsy who have participated in previous brivaracetam trials 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
- •Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
- •Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator
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 the visit schedule or medication intake in the previous brivaracetam study
- •Pregnant or lactating women
- •Participation in any clinical study of another investigational drug or device during the study
研究组 & 干预措施
Brivaracetam
Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.
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) During the Study Period
时间窗: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
时间窗: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
时间窗: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
次要结局
- Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period(From Baseline of the previous study to the Evaluation Period (up to 11 years))
- Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period(From Baseline of the previous study to the Evaluation Period (up to 11 years))
- 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 to the Evaluation Period (up to 11 years))