Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- LS mean difference of LPS from placebo
研究概览
简要总结
Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1
- •Other protocol defined inclusion criteria could apply
排除标准
- •Patients with a history of any of the following diseases according to the DSM-5 criteria:
- •Hypersomnolence disorder
- •Breathing-related sleep disorders
- •Circadian rhythm sleep-wake disorder
- •Parasomnias
- •Restless legs syndrome
- •Substance/medication-induced sleep disorder
- •Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
- •Patients with a history of poorly controlled diabetes mellitus (HbA1c >8%)
- •Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
5 mg
Period in which participants received single-dose of 5 mg TS-142 prior to bedtime
干预措施: TS-142 (Drug)
10 mg
Period in which participants received single-dose of 10 mg TS-142 prior to bedtime
干预措施: TS-142 (Drug)
30 mg
Period in which participants received single-dose of 30 mg TS-142 prior to bedtime
干预措施: TS-142 (Drug)
Placebo
Period in which participants received single placebo prior to bedtime
干预措施: Dose-matched Placebo to TS-142 (Drug)
结局指标
主要结局
LS mean difference of LPS from placebo
时间窗: Day 1
LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG.
LS mean difference of WASO from placebo
时间窗: Day 1
WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG.
次要结局
- LS mean difference of TST from placebo(Day 1)