NCT00253968已完成3 期
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 967
- 试验地点
- 1
- 主要终点
- Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
研究概览
简要总结
The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
详细描述
12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)
Total Duration of observation: 15 weeks for each patient
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out patients
- •Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I (Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision) criteria
- •Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
- •Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.
排除标准
- •Females who are lactating or pregnant
- •Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
- •Patients presenting with acute or chronic pain resulting in insomnia
- •Patients with history of epilepsy or seizures
- •Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
- •Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
- •Acute or chronic pain resulting in insomnia
- •Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia
- •Clinically significant and abnormal EKG (QTc interval >=500 msec)
- •Positive for hepatitis B or C
- •Serious head injury or stroke within 1 year
- •Use of OTC (over-the-counter) medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
- •Participation in another trial within two month before the screening visit
- •Use of any substance with psychotropic effects or properties known to affect sleep/wake
- •Unable to complete the study questionnaires
- •Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- •History of:
- •Primary hypersomnia
- •Narcolepsy
- •Breathing-related sleep disorder (such as sleep apnea)
- •Circadian rhythm sleep disorder
- •Parasomnia (somnambulism)
- •Dyssomnia (such as periodic leg movements)
研究组 & 干预措施
Eplivanserin
Experimental
Eplivanserin 5 mg/day
干预措施: Eplivanserin (Drug)
Placebo
Placebo Comparator
Placebo of Eplivanserin 5 mg /day
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
时间窗: at week 12
次要结局
- Change from baseline of the mean of the FOSQ (Functional Outcome of Sleep Questionnaire) items 1 and 2 (concentration/memory)(at week 12)
- Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)(at week 12)
研究者
研究点 (1)
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