CTRI/2024/06/068394尚未招募不适用
To assess the safety and effectiveness of Brivaracetam in the management of focal and secondary generalized tonic clonic seizures through an observational, multicenter study
Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 4,530 人开始时间: 2024年6月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,530
- 试验地点
- 1
- 主要终点
- Change in Seizure Frequency
研究概览
简要总结
This study is done to evaluate the safety and effectiveness of Brivaracetam sustained release tablets in Indian patients with focal and secondary generalized tonic clonic seizures.
This study is a Post Approval Observational Study (PAOS) that will be performed throughout India across 302 sites.
Study drug is Brivaracetam sustained release available in strengths 50 mg, 100 mg, 200 mg tablets.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients with Partial onset seizures 16 years of age and older with epilepsy.
- •Patients diagnosed with epilepsy and treated with brivaracetam sustained release tablets.
排除标准
- •Patients allergic to brivaracetam sustained release tablets or any of the ingredients in medicine.
结局指标
主要结局
Change in Seizure Frequency
时间窗: 4 weeks
次要结局
- Responders Rate(4 weeks)
- Seizure Freedom(4 weeks)
- Clinicians Global Impression – Efficacy Index (CGI-EI)(4 weeks)
- Demographic pattern(Baseline)
- Prevalence of other co-morbid conditions along with Epilepsy(Baseline)
- Other Anti-epileptic drugs (AEDs) used along with BRV SR(Baseline, 4 weeks)
- Safety assessments in terms of AEs(4 weeks)
研究者
Dr Harshuti Shah
Department of Neurology, 3rd Floor, Rudra Arcade
研究点 (1)
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