Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus

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 objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.

Official Title
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Efficacy and Safety of 2mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-center, Randomized, Double-blind, Placebo-controlled 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 participant's information related to sleep pattern during the preceding month Sub-study : Participants will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening) 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 participant'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> | Drug: Volinanserin<br>* oral administration<br>* Other names: M100907;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO) |  | at 3 months | 
| Efficacy (sub-study): change from baseline for glycemic measure HbA1c |  | at 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: change from baseline of the pr-WASO |  | at 6 and 12 months | 
| Efficacy: change from baseline of General Productivity domain score of the Functional Outcomes of Sleep Questionnaire |  | at 3 months | 
| Safety: adverse events and laboratory abnormalities |  | during 12 months of treatment | 

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