To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia

Study Overview
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Brief Summary
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This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia

Official Title
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A Multi-centre, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of SB-649868 (10, 30 mg and 60 mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects With Primary Insomnia

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: SB-649868
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18-64 years of age (inclusive), Diagnosis of primary insomnia who have had symptoms for at least three months. Exclusion Criteria: Any clinically significant unstable medical or surgical condition (treated or untreated). Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crossover population<br>All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing | Drug: SB-649868<br>* Active compound at doses of 10mg, 30mg and 60mg<br>Drug: Placebo<br>* Placebo to match SB-649868<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording. | Statistical paramaters of sleep measured by analysis of Polysomnography during night section of subject visit. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective PSG measures of sleep continuity including: wake during sleep (WDS), wake after sleep (WAS), and number of awakenings during sleep. Objective PSG measures of sleep structure | Real time Polysomnography technique using combination of EEG, ECG, EOG and EMG to collect data on physiological cleep activity. Data/graphs are collected and analysed post sleep. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. | 9 weeks | 
| Objective PSG measures of sleep structure: Non-REM sleep time, Slow-Wave Sleep (SWS) time (stage 3 and 4), Stage 2 non-REM sleep time; REM sleep time, REM activity, REM density. | Real time Polysomnography technique using combination of EEG, ECG, EOG and EMG to collect data on physiological cleep activity. Data/graphs are collected and analysed post sleep. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. | 9 weeks | 
| Spectral analysis of EEG | Collected as part of PSG. Graph spectra can be quantitatively analysed to assess electrical activity in the brain. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. | 9 weeks | 
| Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording. | Subject answers sleep quality questionnaires after night of sleep during the visit. Measured for each morning after each 4 study night visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. | 9 weeks | 
| Daytime cognitive function data on the morning following dosing, including tests of alertness, memory, attention and fine motor control (i.e. Romberg, VAS for sleepiness/alertness, DSST, and immediate and delayed word recall). | Measurements of insomnia effects on daytime regular functions | 9 weeks | 
| HVLT-R (verbal memory tests), TST, SOL, SQ, WAS and number of awakenings measured with the Post-Sleep Questionnaire score collected on specified mornings at home during the 3-day period following each 2-night PSG sessions. | Further questionnaires answered after each visit regarding sleep quality. Measured during night and day sections at each visit depending on the outcome. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary insomnia, PSG sleep recordings, daytime cognitive function, Insomnia, SB-649868