CTRI/2024/06/068495尚未招募不适用
Treatment of Focal Seizures Patients with Brivaracetam through a Multicenter, Real-World Study: Case Cohort Analysis
Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 2,100 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
- 2,100
- 试验地点
- 1
- 主要终点
- Change in Seizure Frequency
研究概览
简要总结
- This study is planned to evaluate the safety and effectiveness of brivaracetam in Indian patients with focal epilepsy.
- Study design**:**Post Approval Observational Studies (PAOS).
- Duration of Observation**:** 12 weeks (At least)
- Study drug and dose: Brivaracetam 25 mg, 50 mg, 100 mg, 200 mg tablets.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients with partial onset seizures with or without secondary generalization in patients 18 years of age and older with epilepsy.
- •Known cases brivaracetam receiving therapy for more than equal to 2 weeks.
排除标准
- •Patients allergic to brivaracetam or any of the ingredients in medicine.
结局指标
主要结局
Change in Seizure Frequency
时间窗: 4 weeks and 12 weeks
次要结局
- Responders Rate(4 weeks and 12 weeks)
- Seizure Freedom(4 weeks and 12 weeks)
- Clinicians Global Impression – Efficacy Index (CGI-EI)(4 weeks and 12 weeks)
- Quality of life(4 weeks and 12 weeks)
- Patient’s treatment acceptability(4 weeks and 12 weeks)
- Demographic pattern(Baseline)
- Prevalence of other co-morbid conditions along with Focal Epilepsy(Baseline)
- Other Anti-epileptic drugs (AEDs) used along with BRV.(Baseline, 4 weeks and 12 weeks)
- Safety assessments in terms of AEs(4 weeks and 12 weeks)
研究者
Dr Nikunj R Godhani
Karunesh Neuro and Spine SUrgical Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
4 期
“A study to find out which medicine—brivaracetam or levetiracetam—is better when given through a vein to stop repeated or cluster seizures.”CTRI/2025/10/096485All India Institute of Medical Sciences60
尚未招募
不适用
Clinical study of Brivaracetam in managing seizuresCTRI/2024/06/068394Torrent Pharmaceuticals Ltd.4,530
尚未招募
2 期
Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG MonitoringNCT07318870Fondation Ophtalmologique Adolphe de Rothschild600
已完成
不适用
Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hospital.NCT07401433Hayat Abad Medical Complex, Peshawar260
尚未招募
Phase 3 4
A randomised controlled trial to study efficacy of intermittent seizure prophylaxis with Clobazam in patients of complex febrile seizures already on continuous sodium valproate prophylaxis.CTRI/2024/03/063676Armed forces medical college50