A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 50
- 主要终点
- Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
研究概览
简要总结
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).
详细描述
Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)
- •Provides written informed consent to participate in the study before the conduct of any study procedures.
- •Male or female, aged 18 to 65 inclusive.
排除标准
- •Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
- •Unable to comply with study procedures.
- •Medically inappropriate for study participation in the opinion of the investigator.
研究组 & 干预措施
Solriamfetol 150mg
Up to 12 weeks
干预措施: Solriamfetol 150 mg (Drug)
Solriamfetol 300mg
Up to 12 weeks
干预措施: Solriamfetol 300 mg (Drug)
Placebo
Up to 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
时间窗: 12 weeks
Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.
时间窗: 12 weeks
次要结局
未报告次要终点