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临床试验/NCT01146951
NCT01146951已完成3 期

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients

Eisai Limited0 个研究点目标入组 66 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Eisai Limited
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Rufinamide (E2080)

Experimental

干预措施: Rufinamide (E2080) (Drug)

Placebo

Placebo Comparator

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))

研究者

发起方
Eisai Limited
申办方类型
Industry
责任方
Sponsor

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