Supplementary efficacy of Brivaracetam and Levetiracetam on frequency of seizures among epileptic children aged 1 to less-than-18 years- An open labelled, randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To study the percentage of greater than or equal to 50% seizure reduction among children aged 1 to less than 18 years after supplementing Brivaracetam as an add on anti seizure medication compared to supplementing Levetiracetam as an add on anti seizure medication.
研究概览
简要总结
This study is a randomized, open-label, parallel-group study comparing the efficacy of Brivaracetam and Levetiracetam as a second-line drug in the management of epilepsy among children aged 1 to less than 18 years. This study will be conducted in JIPMER, Puducherry in 24 months in 500 patients. The primary outcome measured will be the >/= 50 % seizure reduction rate in children using the drugs. The secondary outcomes will be to study the retention rate and adverse effects of the drugs as well as their efficacy in focal versus generalized seizures, efficacy in children with 2 anti-seizure medications versus more than 2 anti-seizure medications, and time to achieve >/= 50 % seizure reduction rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with epilepsy, not controlled with one or more ASMs aged 1 to less than 18 years.
排除标准
- •Children who are on therapy with Levetiracetam or Brivaracetam or have been in the last 1 month 2) Drug resistant epilepsy, secondary to progressive cerebral disease, tumors, and progressive neurodegenerative disorders.
- •Clinically significant baseline laboratory abnormalities (CBC, RFT, LFT).
结局指标
主要结局
To study the percentage of greater than or equal to 50% seizure reduction among children aged 1 to less than 18 years after supplementing Brivaracetam as an add on anti seizure medication compared to supplementing Levetiracetam as an add on anti seizure medication.
时间窗: The percentage of seizure reduction will be analyzed at 8 weeks after initiating the anti seizure medication.
次要结局
- To study the retention rates and adverse effects of Brivaracetam and Levetiracetam(The retention rates and the adverse effects of the drugs will be studied at 8 weeks after initiating the drugs)
- To compare the percentage of greater than or equal to 50 % seizure reduction in focal vs generalized epilepsy(The percentage of seizure reduction in focal & generalized epilepsy will be studied at 8 weeks after initiating the drugs)
- To compare the percentage of greater than or equal to 50% seizure reduction in children using two anti seizure medication vs more than two anti seizure medication(The comparison of seizure reduction in children using two anti seizure medications versus more than two anti seizure medications will be made at 8 weeks after initiating the drugs)
- To compare the percentage of greater than or equal to 50% seizure reduction at 4 weeks of intervention vs 8 weeks of intervention(The time points are as specified in the outcome)
研究者
Steve Jacob Mathew
JIPMER