A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- Latency To Persistent Sleep (LPS)
研究概览
简要总结
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10 prespecified treatment sequence patterns.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
- •Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:
- •Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
- •Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
- •Participants who meet both of the following based on polysomnogram (PSG) in observation period:
- •Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
- •Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days
排除标准
- •Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
- •Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
- •Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
- •Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
- •Participants with organic mental disorder.
研究组 & 干预措施
Eszopiclone 2 mg
干预措施: Eszopiclone 2 mg (Drug)
Eszopiclone 1 mg
干预措施: Eszopiclone 1 mg (Drug)
Eszopiclone 3 mg
干预措施: Eszopiclone 3 mg (Drug)
Placebo
干预措施: Placebo (Drug)
Zolpidem Tartrate 10 mg
干预措施: Zolpidem Tartrate 10 mg (Drug)
结局指标
主要结局
Latency To Persistent Sleep (LPS)
时间窗: 10 days (5 intervals of two consecutive nights)
The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
Sleep Latency (SL)
时间窗: 10 days (5 intervals of two consecutive nights)
The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
次要结局
- Total Sleep Time (Objective & Subjective)(10 days (5 intervals of two consecutive nights))
- Sleep Efficiency(10 days (5 intervals of two consecutive nights))
- Wake Time After Sleep Onset (WASO)- Objective & Subjective(10 days (5 intervals of two consecutive nights))
- Number of Awakenings (Objective & Subjective)(10 days (5 intervals of two consecutive nights))