Skip to main content
OpenTrials
Completed

NCT Number: NCT00679900

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eplivanserin (SR46349)

Drug

5 mg/day

Lormetazepam

Drug

1 mg/day

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

  3. Subjective sleep parameters

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: DREAMS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 19, 2008
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.