A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
研究概览
简要总结
To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rufinamide (E2080)
干预措施: Rufinamide (E2080) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
时间窗: Baseline (28 day observational period) and End of Treatment (28 day treatment period)
The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.
次要结局
- Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)(Baseline (28 day observational period) and End of Treatment (28 day treatment period))
- Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency(12 weeks)
- Clinical Global Impression of Change (CGIC)(Up to Week 12 of the treatment period)
- Percent Change in Total Seizure Frequency (Per 28 Days)(Baseline (28 day observational period) and End of Treatment (28 day treatment period))
