EUCTR2005-003080-23-NL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 - GEMS
SANOFI SYNTHELABO RECHERCHE0 个研究点目标入组 948 人开始时间: 2006年7月5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
- 948
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
- 性别
- All
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) 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, one night with WASO < 45min during screening period is acceptable. In addition, one lowest WASO value 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
- •Related to study methodology:
- •1) Lactating or pregnant women
- •2) Woman of childbearing potential (less than two years post-menopausal or not
- •surgically sterile), with a positive serum beta-human chorionic gonadotropin (ßHCG) pregnancy test at screening and not using an acceptable form of contraception (e.g, birth control pill, intra-uterine device, injection of Depo-ProveraTM, double-barrier method, abstinence),
- •3) Patients presenting with acute or chronic pain resulting in insomnia
- •4) Patients with current psychiatric disturbances according to DSM-IV-TR- Axis I
- •criteria including but not limited to psychosis and /or bipolar disorder, obsessive
- •compulsive disorder, major depression, anxiety disorders, panic disorders, eating
- •disorder, alcohol or substance abuse or dependence –except nicotine-, or a history
- •of lifetime psychosis and /or bipolar disorder,
- •5) Body mass index >32 calculated from patient’s height (m) and weight (kg); weight
- •(kg)/height (m2),
- •6) Patients with mental retardation or dementia,
- •7) Patients with a history of epilepsy or seizures (not including benign neonatal and
- •childhood convulsions),
- •8) 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,
- •9) Clinically significant and abnormal ECG (including QTc= 500ms),
- •10) A positive test for hepatitis B (HBs antigens) or C (HCV antibodies),
- •11) Serious head injury or stroke within the past year,
- •12) Positive qualitative urine drug screen (opiates, cocaine, amphetamine,
- •cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone,
- •propoxyphene), at screening,
- •13) Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day,
- •14) Use of any over-the-counter including tryptophan, valerian root (Valeriana
- •officinalis), kava (Piper methysticum Forst), melatonin, St John’s Wort
- •(Hypericum perforatum), Alluna (herbal sleep supplement with valerian root) or
- •prescription sleep medication, including hypnotics and sedatives (N05C), and
- •anxiolytics (N05B), within one week or five half-lives (whichever is longer), prior to screening.
- •15) Use of any substance with psychotropic effects or properties known to affect
- •sleep/wake, including, but not limited to: neuroleptics (N05A), morphine/opioid
- •derivatives (N02A), sedative antihistamines (R06A), stimulants (N06B)
- •antidepressants (N06A), clonidine, within one week or five half-lives (whichever is
- •longer), prior to screening,
- •Related to sleep disorders:
- •1) Night shift workers, and individuals who nap 3 or more times per week over the
- •preceding month,
- •2) 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.
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