Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00679900

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 III

Drug Information available for: Lormetazepam Eplivanserin SR 46349B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	266
Study Start Date:	April 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: eplivanserin (SR46349) 5 mg/day
2: Active Comparator	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

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

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

Chile
Sanofi-Aventis Administrative Office	Recruiting
Santiago, Chile
Contact GV-Contact-us@sanofi-aventis.com
Estonia
Sanofi-Aventis Administrative Office	Recruiting
Tallinn, Estonia
Contact GV-Contact-us@sanofi-aventis.com
Finland
Sanofi-Aventis Administrative Office	Recruiting
Helsinki, Finland
Contact GV-Contact-us@sanofi-aventis.com
France
Sanofi-Aventis Administrative Office	Recruiting
Paris, France
Contact GV-Contact-us@sanofi-aventis.com
Netherlands
Sanofi-Aventis Administrative Office	Recruiting
Gouda, Netherlands
Contact GV-Contact-us@sanofi-aventis.com
Norway
Sanofi-Aventis Administrative Office	Recruiting
Lysaker, Norway
Contact GV-Contact-us@sanofi-aventis.com
Portugal
Sanofi-Aventis Administrative Office	Recruiting
Porto Salvo, Portugal
Contact GV-Contact-us@sanofi-aventis.com
Spain
Sanofi-Aventis Administrative Office	Recruiting
Barcelona, Spain
Contact GV-Contact-us@sanofi-aventis.com
Turkey
Sanofi-Aventis Administrative Office	Recruiting
Istanbul, Turkey
Contact GV-Contact-us@sanofi-aventis.com

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD study director )
Study ID Numbers:	EFC10480, EudraCT 2007-003822-28
Study First Received:	May 7, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00679900
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Primary Insomnia
Sleep Maintenance Difficulties

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
SR 46349B
Dyssomnias

Sleep Disorders
Serotonin
Lormetazepam
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Hematologic Agents
Central Nervous System Depressants
Fibrinolytic Agents
Cardiovascular Agents

Pharmacologic Actions
Serotonin Antagonists
Fibrin Modulating Agents
Serotonin Agents
Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009