A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
研究概览
简要总结
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18 and 70 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
Placebo
干预措施: Placebo (Drug)
AXS-12 (reboxetine)
干预措施: AXS-12 (Reboxetine) (Drug)
结局指标
主要结局
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
时间窗: 2 weeks
Presented as LSmeans. A positive change is indicative of improvement.
次要结局
未报告次要终点