A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- Average Change From Baseline - Latency to Persistent Sleep (LPS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
- •Habitual bedtime between 9:00 pm and 1:00 am.
- •No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
- •Patients must sign a written consent form.
排除标准
- •History of drug or alcohol abuse as defined in DSM-IV.
- •History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
- •History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
- •Recent history of shift work or jet lag.
研究组 & 干预措施
VEC-162 20 mg
VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
干预措施: VEC-162 20 mg (Drug)
VEC-162 50 mg
VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
干预措施: VEC-162 50 mg (Drug)
Placebo
Placebo capsules PO daily five weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Average Change From Baseline - Latency to Persistent Sleep (LPS)
时间窗: Baseline, Night 1, and Night 8 measurement
Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.
次要结局
- Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)(Baseline, Night 1, and Night 8 measurements for WASO and TST)