A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide
研究概览
简要总结
To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
干预措施: Rufinamide (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide
时间窗: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months
Safety was assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, blood pressure, pulse rate, physical examination, and 12-lead electrocardiogram (ECG). Treatment-emergent adverse events (TEAEs) were defined as AEs that started on or after the date and time of administration of first dose of test drug, but not later than 30 days after discontinuation from the study, or if the AE was present prior to the administration of the first dose of test drug and increased in National Cancer Institute Common Toxicity Criteria (NCI CTC version 3.0) grade during the study or 30 days after discontinuation from the study. AEs were considered serious if it resulted in; death, was life-threatening, hospitalization/prolonged hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
次要结局
- Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days)(Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF)
- Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)(Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF)
- Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures(Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF)
- Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders)(Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF)
- Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency(Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF)