Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study - GEMS

Sanofi-aventis recherche et développement0 个研究点目标入组 948 人开始时间: 2005年11月7日最近更新: 2012年3月19日

研究概览

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•- Male and female out-patients = 18 years old.
•- Diagnosis of primary insomnia based on criteria (DSM-TR-IV) with predominant complaints of difficulty in initiating or maintaining sleep (nocturnal awakenings), or nonrestorative sleep for at least one month preceding the study visit.
•(1) 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.
•(2) Based on the information recorded in the patient’s diary during the screening week
•a) WASO = 60mn per night during screening period (7 days) and no WASO < 45mn on each screening night
•b) TST < 7 hours and > 3 hours on 3-worst screening nights
•c) mean SOL have to be = 30mn during the screening period
•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

•- Lactating or pregnant women
•- Women of child bearing potential with a positive serum BHCG pregnacy test at screening visit, and not using an acceptable form of contraception
•- Patients presenting with acute or chronic pain resulting in insomnia
•- Patients with current psychiatric disorders
•- Patients with history of epilepsy or seizures, with any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, with history of serious head injury or stroke
•- Clinically significant and abnormal ECG
•- Use of any prescription or OTC sleep medication
•- Use of substance with psychotropic effects or properties 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.

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