Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties. The secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.

Official Title
-----------------
Comparison of the Safety and Efficacy of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week, Randomized, Double-blind,Comparative, Parallel-group Study

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Drug: eplivanserin (SR46349)
* Drug: lormetazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria At least 1 hour of wakefulness for at least 3 nights per week during the month preceding inclusion Disturbances of sleep maintenance criteria based on the patient's sleep questionnaire during the run-in period Exclusion Criteria: Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control Night shift workers and individuals who nap 3 or more times per week Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day Insomnia secondary to a general medical condition The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: eplivanserin (SR46349)<br>* 5 mg/day<br>|
| Active Comparator: 2<br> | Drug: lormetazepam<br>* 1 mg/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire) |  | 4 weeks | 
| Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period |  | 4 weeks | 
| Subjective sleep parameters |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Insomnia, Sleep Maintenance Difficulties