EUCTR2005-003082-16-GB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 followed by an open treatment phase extension with eplivanserin for 40 weeks period - EPLILONG
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT0 个研究点目标入组 1,120 人开始时间: 2006年6月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Out- patients,
- •2) Age =18 years old,
- •3) Each patient must have primary insomnia based on criteria (DSM-IV-TR- Axis I) with
- •predominant complaints of difficulty in initiating or maintaining sleep (nocturnal
- •awakenings), or nonrestorative sleep for at least one month preceding the study visit,and having clinically significant distress or impairment in social occupational or other important areas of functioning,
- •4) Based on patient’s information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,
- •5) 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,
- •6) 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. To be included patient’s answer should be either: 2 (=Somewhat interfering), or 3 (=Much), or 4 (=Very Much Interfering),
- •7) Based on the information recorded in the patient’s diary during the screening week preceding the randomization the following criteria must be present:
- •a) Mean WASO per night = 60mn during screening period (7 days) and no period of
- •WASO < 45mn on each screening night. However, two nights with WASO < 45min during screening period are acceptable. In addition, two lowest WASO values will be excluded from the calculation of the mean WASO.
- •b) TST = 7 hours and = 3 hours on 3-worst screening nights.
- •c) Mean SOL per night have to be = 30mn during the screening period. One highest
- •SOL value will be excluded from the calculation of mean SOL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Females who are lactating or who are pregnant,
- •- Woman of childbearing potential with a positive serum beta-human chorionic gonadotropin (bHCG) pregnancy test at screening and not using an acceptable form of contraception,
- •- Patients presenting with acute or chronic pain resulting in insomnia,
- •- Patients with current psychiatric disturbances ,
- •- Patients with a history of epilepsy or seizures,
- •- Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder,
- •- Serious head injury or stroke within the past year,
- •- Body mass index > 32,
- •- Patients with mental retardation or dementia,
- •- Patients with clinically significant and abnormal ECG (including QTc= 500ms),
- •- Use of any prescription or OTC sleep medication,
- •- Use of substances with psychotropic effects or porperties known to affect sleep/awake,
- •- Night shift workers, and individuals who nap 3 or more times per week over the preceding month,
- •- History of (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep disorder, (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e. periodic leg movement syndrome.
研究者
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