CTRI/2024/07/070210尚未招募不适用
Post approval observational study for the assessment of effectiveness and safety of once a daily sustained release formulation of BRivarACetam in drug rEsisTance focal onset epilepsy
Torrent Pharmaceuticals Ltd1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2024年7月19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
- 6,000
- 试验地点
- 1
- 主要终点
- 1. Switching pattern amongst ASMs
研究概览
简要总结
Study design: Post Approval Observational Studies (PAOS)
Objective: To assess effectiveness & safety of Brivaracetam -SR Once Daily in partial seizure.
Duration of study: 26 Weeks
Criteria for evaluation: Change in seizure frequency, Responder Rates, Seizure freedom
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients with:
- •Partial onset seizures in patients 16 years of age and older
- •Patients diagnosed with epilepsy and treated with Brivaracetam SR tablets.
排除标准
- •Hypersensitive to Brivaracetam SR tablets or any of the ingredients in medicine.
结局指标
主要结局
1. Switching pattern amongst ASMs
时间窗: Baseline and 12 weeks
2. Reduction in seizure frequency at baseline
时间窗: Baseline and 12 weeks
3. Greater than or equal to 50 percent Responder rate
时间窗: Baseline and 12 weeks
4. Seizure freedom
时间窗: Baseline and 12 weeks
次要结局
- To assess the safety profile of BRV SR in patients with FoS with or without secondary generalized tonic- clonic seizures(At 12 weeks)
研究者
Dr Bhagyadan Patel
Department of Neurology, Brain and nerve Clinic
研究点 (1)
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