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

Conditions: SLEEP MAINTENANCE INSOMNIA

Registration Number: EUCTR2005-003082-16-CZ

Lead Sponsor: Sanofi-aventis recherche et développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1120

Inclusion Criteria

- 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.

(1) 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.

(2) 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,
b)TST < 7 hours and > 3 hours on 3-worst screening nights.
c) Mean SOL during the screening period have to be = 30mn.
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

Exclusion Criteria

- 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, with clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, with history of serious head injury or stroke
- Patients with clinically significant and abnormal ECG
- 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.