A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo
研究概览
简要总结
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with 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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of narcolepsy
- •Good general health
- •Willing and able to comply with the study design and schedule and other requirements
排除标准
- •If female, pregnant or lactating
- •Customary bedtime later than midnight
- •History of significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history
- •Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
- •History of significant cardiovascular disease
- •Body mass index >34
- •Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day
- •History of alcohol or drug abuse within the past two years
- •Nicotine dependence that has an affect on sleep
研究组 & 干预措施
Placebo, Then ADX-N05
Participants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They will then receive ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
干预措施: ADX-N05 (Drug)
Placebo, Then ADX-N05
Participants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They will then receive ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
干预措施: Placebo (Drug)
ADX-N05, Then Placebo
Participants first receive ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
干预措施: ADX-N05 (Drug)
ADX-N05, Then Placebo
Participants first receive ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo
时间窗: Baseline up to 2 weeks post-dose.
The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The change from baseline in the mean sleep latency from the MWT was the average of sleep latency from the four trials of the MWT.
次要结局
- Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3(Baseline up to Week 3 post-dose.)
- Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 4(Baseline up to Week 4 post-dose.)
- Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3(Week 1 and Week 3 post-dose.)
- Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4(Week 2 and Week 4 post-dose.)