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-NL
- Lead Sponsor
- SANOFI-SYNTHELABO RECHERCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1120
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, 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
- 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 (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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method