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

NCT00788515 | Terminated Phase 3 DMC

• 2 other identifiers: EFC10550EudraCT: 2008-001492-30
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 3

Brief Summary

The primary objective is to compare the potential for next-day residual effects of volinanserin 2 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. 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

insomnia; sleep maintenance

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: Volinanserin (M100907)

2

ACTIVE COMPARATOR

Drug: Lormetazepam

Interventions

Volinanserin (M100907) DRUG

2 mg tablets QD

1

Lormetazepam DRUG

1 mg tablets (overencapsulated) QD

2

Eligibility Criteria

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

You may qualify if:

• Out-patients with Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria

You may not qualify if:

• Based on patient's information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks
• Based on patient's information, the patient complains of less than one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
• Disturbances of sleep maintenance parameters based on the patient's sleep questionnaire during the run-in period differing from pre-defined 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
• 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 (3)

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

Sanofi-Aventis Administrative Office

Bromma, Sweden

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

volinanserin; lormetazepam

Condition Hierarchy (Ancestors)

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

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 28, 2009

Record last verified: 2009-08

Locations

FR (1); SE (1); ES (1)