A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Idiopathic hypersomnia severity scale (IHSS) score
研究概览
简要总结
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.
Patients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Solriamfetol
Solriamfetol will be taken once a day upon awakening during 7-weeks
干预措施: Solriamfetol (Drug)
Placebo
Placebo will be taken once a day upon awakening during 7-weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Idiopathic hypersomnia severity scale (IHSS) score
时间窗: From baseline to week 7
IHSS is a tool used to measure the severity of the symptoms experienced by patients with IH during the previous month. The IHSS includes 2 items (1 and 2) on nighttime sleep duration and quality, 3 items (3, 4, and 5) on sleep inertia and sleep drunkenness after nighttime sleep and 1 (8) after daytime nap, and 3 items (6, 7, and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10-14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and 8 items on a 4-point Likert scale; the Likert scale is a point scale that is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0-50), and higher scores indicate more severe symptoms.
次要结局
- Epworth Sleepiness Scale (ESS) score(From baseline to week 7)
- Maintenance of Wakefulness Test (MWT)(From baseline to week 7)
- Psychomotor vigilance task (PVT)(From baseline to week 7)
- Karolinska Sleepiness Scale (KSS)(From baseline to week 7)
- Sleep inertia questionnaire(From baseline to week 7)
- Clinical Global Impression Scale for Change (CGI-C)(From baseline to week 7)
- Clinical Global Impression Scale for Severity (CGI-S)(From baseline to week 7)
- The EuroQol 5-Dimensional Descriptive System (EQ-5D-3L)(From baseline to week 7)
- Work Productivity and Activity Impairment- General Health (WPAI:GH)(From baseline to week 7)
- Questionnaire on Functional Outcomes of Sleep(From baseline to week 7)
- Logbook for compliance to monitor(From baseline to week 7)
- Percentage of sleep stages(From baseline to week 7)
- Microarousal index(From baseline to 7 weeks)
- Total sleep time(From baseline to 7 weeks)