NCT00308503已完成3 期
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 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
- 608
- 试验地点
- 1
- 主要终点
- Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
研究概览
简要总结
The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.
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
- •Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for at least one month preceding the study visit.
- •Disturbance of sleep maintenance:
- •Based on patient' s information:
- •Patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,
- •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 on daytime functioning associated with sleep maintenance insomnia
- •Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the sleep laboratory during the two screening nights.
排除标准
- •Females who are lactating or who are pregnant, or of childbearing potential not using an acceptable form of contraception
- •Patients presenting with acute or chronic pain resulting in insomnia
- •Patients with current psychiatric disturbances
- •Body mass index > 32
- •Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety
- •Clinically significant and abnormal electrocardiogram (ECG) (including QTc B > 500ms),
- •A positive test for hepatitis B (hepatitis B surface [HBs] antigens) or C (hepatitis C virus [HCV] antibodies)
- •Positive qualitative urine drug screen at screening
- •Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day
- •Use of any over-the-counter or prescription sleep medication, or of any substance with psychotropic effects or properties known to affect sleep/wake, within one week or five half-lives (whichever is longer), prior to screening
- •Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- •Based on medical history and/or NPSG:
- •primary hypersomnia
- •narcolepsy
- •breathing-related sleep disorder (apnea-hypopnea index > 10/hour of sleep)
- •circadian rhythm sleep disorder
- •parasomnia (e.g. somnambulism)
研究组 & 干预措施
1
Experimental
5 mg/day
干预措施: eplivanserin (SR46349) (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
时间窗: week 6
次要结局
- Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire)(week 6)
- Change from baseline in patient reported wake after sleep onset (pr-WASO)(week 6)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance InsomniaSleep Initiation and Maintenance DisordersInsomniaNCT00253968Sanofi967
已完成
3 期
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 YearSleep Initiation and Maintenance DisordersInsomniaNCT00253903Sanofi1,155
进行中（未招募）
1 期
Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study - GEMSSleep maintenance insomniaEUCTR2005-003080-23-NLSANOFI SYNTHELABO RECHERCHE948
进行中（未招募）
不适用
Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study - GEMSSleep maintenance insomniaEUCTR2005-003080-23-CZSanofi-aventis recherche et développement948
进行中（未招募）
1 期
Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study - GEMSSleep maintenance insomniaEUCTR2005-003080-23-GBSANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT948