Back to results

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

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

eplivanserin (SR46349)

lormetazepam

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Primary Insomnia, Sleep Maintenance Difficulties

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire

Secondary Outcome Measures

Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire)

Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period

Subjective sleep parameters

Full Information

NCT ID

NCT00679900

First Posted

May 7, 2008

Last Updated

November 29, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00679900

Brief Title

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

Acronym

DREAMS

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Initiation and Maintenance Disorders

Keywords

Primary Insomnia, Sleep Maintenance Difficulties

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

283 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

eplivanserin (SR46349)

Intervention Description

5 mg/day

Intervention Type

Drug

Intervention Name(s)

lormetazepam

Intervention Description

1 mg/day

Primary Outcome Measure Information:

Title

Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire)

Time Frame

4 weeks

Title

Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period

Time Frame

4 weeks

Title

Subjective sleep parameters

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name