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

Phase 3

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: lormetazepam; Drug: eplivanserin (SR46349)

• Registration Number: NCT00679900
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-29
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	lormetazepam	-
1	eplivanserin (SR46349)	-

Primary Outcome Measures

Name	Time	Method
Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain