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

NCT00679900 | Completed Phase 3

• 2 other identifiers: EFC10480EudraCT 2007-003822-28
• Study Type: interventional
• Target: 283
• Locations: 7 countries
• Sites: 7

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Primary Insomnia; Sleep Maintenance Difficulties

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (3)

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

  4 weeks

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

  4 weeks

• Subjective sleep parameters

  4 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: eplivanserin (SR46349)

2

ACTIVE COMPARATOR

Drug: lormetazepam

Interventions

eplivanserin (SR46349) DRUG

5 mg/day

1

lormetazepam DRUG

1 mg/day

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
• Disturbances of sleep maintenance criteria based on the patient's sleep questionnaire during the run-in period

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Sanofi-Aventis Administrative Office

Santiago, Chile

Location

Sanofi-Aventis Administrative Office

Tallinn, Estonia

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Gouda, Netherlands

Location

Sanofi-Aventis Administrative Office

Lysaker, Norway

Location

Sanofi-Aventis Administrative Office

Porto Salvo, Portugal

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

SR 46349B; lormetazepam

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• ICD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 19, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 30, 2010

Record last verified: 2010-11

Locations

FI (1); ES (1); PT (1); CL (1); FR (1); NL (1); NO (1)