NCT00525941撤回3 期
An Exploratory Phase IIIb, Single-Blind, Outpatient Study to Assess Next-Day Functioning in Adult Primary Insomnia Patients Following the Administration of NBI-34060 Capsules During the Night
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- Assessments of Next-Day Function
研究概览
简要总结
NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •insomnia (DSM-IV diagnosed; at least one month)
- •Nocturnal awakenings
- •Usual bedtimes between 9:00PM and Midnight.
- •Bedtimes that do not vary by more than 2 hours on 5 or more nights per week.
- •A usual time in bed of 7 to 9 hours.
排除标准
- •no serious concomitant illness
- •no other condition that could interfere with sleep
结局指标
主要结局
Assessments of Next-Day Function
时间窗: daily/six weeks
次要结局
- Quality of Life(biweekly/six weeks)
研究者
研究点 (8)
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