A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 28
- 主要终点
- Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment
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
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •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 2 years
- •Nicotine dependence that has an effect on sleep
研究组 & 干预措施
ADX-N05
ADX-N05 to be taken once a day for 12 weeks
干预措施: ADX-N05 (Drug)
Placebo
Placebo to match ADX-N05 to be taken once a day for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment
时间窗: Week 12
The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Improvement was defined as a CGI-rating of 1, 2, or 3.
Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last Assessment.
时间窗: Baseline up to Week 12/Last Assessment post-dose.
The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.
次要结局
- Number of Participants With Improved PGI-C Scores for ADX-N05 vs. Placebo at Last Assessment(Week 12/Last Assessment)
- Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Last Assessment(Baseline up to Week 12/Last Assessment post-dose.)
- Change From Baseline in Epworth Sleepiness Scale (ESS) Scores for ADX-N05 vs. Placebo at Week 4(Baseline up to Week 4 post-dose.)
- Change From Baseline in ESS Scores for ADX-N05 vs. Placebo at Last Assessment(Baseline up to Week 12/Last Assessment post-dose.)
- Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo(Baseline up to Week 4 post-dose.)
- Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Week 4(Baseline up to Week 4 post-dose.)
- Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Week 4(Week 4)
- Number of Participants With Improved Patient Global Impression Change (PGI-C) Scores for ADX-N05 vs. Placebo at Week 4(Week 4)