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:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00788515
First received: November 10, 2008
Last updated: August 27, 2009
Last verified: August 2009
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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. |
Resource links provided by NLM:
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
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:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Lormetazepam Lorazepam MDL 100907 Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Antagonists Serotonin Agents |
ClinicalTrials.gov processed this record on May 22, 2013