Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties

Study Overview
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Brief Summary
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Primary objective: - To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW). Secondary objectives: To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS). To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo. To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment. To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire. To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo. To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo. To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey. To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.

Detailed Description
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Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks Duration of observation: 9 weeks

Official Title
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Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties: a 6-week, Randomized, Double-blind, Placebo-controlled, Polysomnography Study.

Conditions
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Primary Insomnia

Intervention / Treatment
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* Drug: Eplivanserin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria Exclusion Criteria: Inpatients. Mean screening PSG-WASO for screening night 1+ screening night 2 < 45 mn, or screening night with PSG-WASO < 30 mn. Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours. Mean screening PSG-LPS for screening night 1+ screening night 2 > 30 mn. 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eplivanserin<br>Eplivanserin 5 mg/day | Drug: Eplivanserin<br>* one 5 mg tablet once a day<br>* Other names: SR46349;|
| Placebo Comparator: Placebo<br>Placebo of Eplivanserin 5 mg/day | Drug: Placebo<br>* Placebo of Eplivanserin one tablet once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of mean PSG-WASO on N41/N42 |  | 6 weeks | 
| Change from baseline of mean PSG-NAW on N41/N42 |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS |  | 6 weeks | 
| Patient-reported sleep parameters |  | 6 weeks | 
| Patient Global impression (PGI) |  | 6 weeks | 
| sleep architecture: percentage of time spent in each sleep stage (1, 2, 3-4/SWS, REM), shift to stage 1, shift to wake, stage 1 + WASO, [stages 3&4]/[stage 1 + WASO]). |  | 6 weeks | 
| Sleep Impact Scale (SIS) |  | 6 weeks | 
| SF-36 Health Survey |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Sleep Maintenance, Polysomnography