Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year

Study Overview
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Brief Summary
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The purpose of the study is to assess efficacy and safety of eplivanserin 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 nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Detailed Description
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The study is being conducted worldwide. It consists of 4 segments: Segment A: 7-day run-in (screening) Segment B: 12-week double blind treatment Segment C: 40-week open treatment extension Segment D: 2-week run-out period

Official Title
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Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open Treatment Phase Extension With Eplivanserin for a 40-week Period

Conditions
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Sleep Initiation and Maintenance Disorders, Insomnia

Intervention / Treatment
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* Drug: eplivanserin (SR46349)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out patients Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria Based on patient's information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks. Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit. Exclusion Criteria: Females who are lactating or pregnant Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception Patients presenting with acute or chronic pain resulting in insomnia Patients with history of epilepsy or seizures Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety BMI >32 Acute or chronic pain resulting in insomnia Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia Clinically significant and abnormal EKG (QTc interval >500 msec) Positive for hepatitis B or C Serious head injury or stroke within 1 year Use of OTC medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives Participation in another trial within two month before the screening visit Use of any substance with psychotropic effects or properties known to affect sleep/wake Unable to complete the study questionnaires Night shift workers, and individuals who nap 3 or more times per week over the preceding month History of: Primary hypersomnia Narcolepsy Breathing-related sleep disorder (such as sleep apnea) Circadian rhythm sleep disorder Parasomnia (somnambulism) Dyssomnia (such as periodic leg movements)

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: 1<br>5 mg/day | Drug: eplivanserin (SR46349)<br>* oral administration<br>|
| Placebo Comparator: 2<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 |
| --- | --- | --- |
| Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire) |  | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the mean of the FOSQ items 1 and 2 (concentration/memory) |  | at week 12 | 
| Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work) |  | at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Insomnia, Sleeplessness, Early Awakening, Chronic Insomnia