NCT05059223已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 51
- 主要终点
- Frequency of cataplexy attacks
研究概览
简要总结
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
详细描述
Eligible subjects must have a diagnosis of narcolepsy per the International Classification of Sleep Disorders (ICSD-3), and exhibit symptoms of both cataplexy and EDS. Subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-12 or placebo for five weeks.
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
- •Male or female subjects between 15 and 75 years of age, inclusive
- •Primary diagnosis of narcolepsy with cataplexy
- •Willing and able to comply with the study requirements
排除标准
- •Other clinically significant conditions potentially causing EDS
- •Clinically significant psychiatric disorders
研究组 & 干预措施
AXS-12 (reboxetine)
Experimental
Up to 5 weeks
干预措施: AXS-12 (reboxetine) (Drug)
Placebo
Placebo Comparator
Up to 5 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of cataplexy attacks
时间窗: Change from Baseline to Week 5
Average number of cataplexy attacks per week
次要结局
未报告次要终点
研究者
研究点 (51)
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