NCT07455383招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 42
- 主要终点
- Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
研究概览
简要总结
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
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
- •Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).
排除标准
- •Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
- •Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.
- •Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit
- •Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.
- •Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
研究组 & 干预措施
ALKS 2680 Dose 1
Experimental
Oral tablet containing ALKS 2680
干预措施: ALKS 2680 Dose 1 (Drug)
ALKS 2680 Dose 2
Experimental
Oral tablet containing ALKS 2680
干预措施: ALKS 2680 Dose 2 (Drug)
Placebo
Placebo Comparator
Placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
时间窗: Baseline to Week 12
次要结局
- Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level(Baseline to Week 12)
- Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level(Baseline to Week 12)
- Weekly cataplexy rate (WCR) at Week 12 by dose level(Week 12)
- Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale (general disease) at Week 12 by dose level(Week 12)
- Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level(Baseline to Week 12)
- Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baseline to Week 12 by dose level(Baseline to Week 12)
- Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level(Week 12)
- Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level(Baseline to Week 12)
- Incidence of treatment emergent adverse events(Up to 14 weeks)
研究者
研究点 (42)
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