Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study - GEMS
- Conditions
- Sleep maintenance insomnia
- Registration Number
- EUCTR2005-003080-23-DE
- Lead Sponsor
- SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 948
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess efficacy of eplivanserin 5mg/day in comparison to placebo after 6 and 12 weeks of treatment on sleep maintenance insomnia using patient sleep questionnaires (pr-WASO);Primary end point(s): Wake time after sleep onset using patient's sleep questionnaire (pr-WASO);Secondary Objective: - To evaluate patient's daytime functionning using the Funtional Outcomes Sleep Questionnaire (FOSQ) with eplivanserin 5mg/day as compared to placebo after 6 and 12 weeks of treatment.<br>- To evaluate residual effects (using patient's morning questionnaire) that may be associated with eplivanserin 5mg/day as compared to placebo during double-blind treatment period.<br>- To compare the effect on sleep following abrupt discontinuation (after 12 weeks) between eplivanserin 5mg/day and placebo. <br>- To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo<br>- To document eplivanserin and the main metabolite SR141342 plasma concentrations.
- Secondary Outcome Measures
Name Time Method