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

This study has been terminated.
(Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00788515
First received: November 10, 2008
Last updated: August 27, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: Volinanserin (M100907)
Drug: Lormetazepam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Safety and Efficacy of Volinanserin 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:

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: 33
Study Start Date: November 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Volinanserin (M100907)
2 mg tablets QD
Active Comparator: 2 Drug: Lormetazepam
1 mg tablets (overencapsulated) QD

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

  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: NCT00788515

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00788515     History of Changes
Other Study ID Numbers: EFC10550, EudraCT: 2008-001492-30
Study First Received: November 10, 2008
Last Updated: August 27, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
insomnia
sleep maintenance

Additional relevant MeSH terms:
Lormetazepam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014