A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Long-term safety as measured by the incidence of treatment-emergent adverse events
研究概览
简要总结
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
详细描述
This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the treatment period of Study AXS-12-301
- •Willing and able to comply with the study requirements
排除标准
- •Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12
研究组 & 干预措施
AXS-12 (reboxetine)
- Up to 24 weeks in open-label period
- Up to 4 weeks in randomized double-blind period
干预措施: AXS-12 (reboxetine) (Drug)
Placebo
Up to 4 weeks in randomized double-blind period
干预措施: Placebo (Drug)
结局指标
主要结局
Long-term safety as measured by the incidence of treatment-emergent adverse events
时间窗: Up to 28 weeks
Efficacy as measured by change in frequency of cataplexy attacks from baseline.
时间窗: Baseline to Week 27
次要结局
未报告次要终点