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

Sleep Initiation and Maintenance Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679900
• Other study ID #: EFC10480
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: November 29, 2010
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• eplivanserin (SR46349)
5 mg/day
• lormetazepam
1 mg/day

Locations

Country	Name	City	State
Chile	Sanofi-Aventis Administrative Office	Santiago
Estonia	Sanofi-Aventis Administrative Office	Tallinn
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Norway	Sanofi-Aventis Administrative Office	Lysaker
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Chile,  Estonia,  Finland,  France,  Netherlands,  Norway,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire		4 weeks	Yes
Secondary	Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire)		4 weeks	Yes
Secondary	Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period		4 weeks	Yes
Secondary	Subjective sleep parameters		4 weeks	No