Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study

Study Overview
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Brief Summary
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The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Official Title
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Efficacy and Safety of 2 mg/Day M100907 on Sleep Maintenance Insomnia: a 6-week, Multicenter, Randomized, Double-blind, Placebo-controlled Polysomnographic Study

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: volinanserin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month Specific criteria based on the NPSG recordings during the screening nights Exclusion Criteria: Females who are lactating or who are pregnant Night shift workers, and individuals who nap 3 or more times per week over the preceding month Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day Participation in another trial having received study medication within 1 month before the screening visit Body Mass Index ≥ 33 Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication Use of any substance with psychotropic effects or properties know to affect sleep/wake History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder Positive qualitative urine drug screen (opiates, cocaine, amphetamine…) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volinanserin<br>2 mg volinanserin tablets orally once daily | Drug: volinanserin<br>* oral administration<br>* Other names: M100907;|
| Placebo Comparator: Placebo<br>tablets orally once daily | Drug: placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO). |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Outcomes of Sleep Questionnaire at 6 weeks |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep problems, Insomnia, Sleeplessness, Polysomnographic