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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00679900
First received: May 7, 2008
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: eplivanserin (SR46349)
Drug: lormetazepam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Subjective sleep parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: eplivanserin (SR46349)
5 mg/day
Active Comparator: 2 Drug: lormetazepam
1 mg/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679900

Locations
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD Sanofi
  More Information

No publications provided

Responsible Party: ICD study director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00679900     History of Changes
Other Study ID Numbers: EFC10480, EudraCT 2007-003822-28
Study First Received: May 7, 2008
Last Updated: November 29, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Primary Insomnia
Sleep Maintenance Difficulties

Additional relevant MeSH terms:
Sleep Disorders, Intrinsic
Sleep Initiation and Maintenance Disorders
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Lormetazepam
Lorazepam
SR 46349B
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014