Vestipitant 28-day Tolerance Study

Study Overview
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Brief Summary
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This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.

Official Title
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A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients

Conditions
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Sleep Disorders

Intervention / Treatment
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* Drug: GW597599
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42 PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol Exclusion Criteria: clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce); nightshift or rotating shift-work; Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke healthy according to GSK criteria - laboratory and ECG limits set in the Protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Active<br>Vestipitant 15mg once daily | Drug: GW597599<br>* GW597599 15mg tablet<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo to match GW597599 15mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal polysomngraphy |  | 6 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index |  | 4 weeks after start of treatment | 
| Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test) |  | 4 weeks after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polysomnography (PSG), Adults, Primary Insomnia