EUCTR2005-003082-16-AT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 followed by an open treatment phase extension with eplivanserin for 40 weeks period - EPLILONG
anofi-aventis recherche et développement0 个研究点目标入组 1,120 人开始时间: 2005年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- 性别
- All
入选标准
- •Out-patients aged = 18 years.
- •Diagnosis of 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.
- •Disturbances of sleep maintenance:
- •Based on patient’ s information:
- •- Patient has spent at least 6.5 hours and no 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 daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening and randomization visits.
- •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 < 45 min during screening period is 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 = 30 mn 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. Females who are lactating or who are pregnant,
- •2. Woman of childbearing potential (less than two years post-menopausal or not surgically sterile), with a positive serum beta-human chorionic gonadotropin (bêta HCG) 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 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,
- •16. Participation in another trial within two months before the screening visit,
- •17. Patients unable to complete the study questionnaire,
- •18. Patients who are unable to participate for the entire duration of the study, or in the opinion of the investigator, are likely to be non-compliant with the obligations inherent in the trial participation,
- •19. Written, signed and dated informed consent not obtained from each patient,
- •20. Patient not able to understand and follow the requirements of the study and to comply.
- •21. Lifetime history of diverticulitis or sigmoiditis
- •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 dis
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