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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover population | Experimental | All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-649868 | Drug | Active compound at doses of 10mg, 30mg and 60mg |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68159 | Germany | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 18, 2017 | |
| Reset | Jan 29, 2018 | |
| Release | Mar 6, 2018 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 18, 2017 | Jan 29, 2018 | |||
| Mar 6, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C557781 | N-((1-((5-(4-fluorophenyl)-2-methyl-4-thiazolyl)carbonyl)-2-piperidinyl)methyl)-4-benzofurancarboxamide |
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| Placebo |
| Drug |
Placebo to match SB-649868 |
|
| 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 |
| Cottbus |
| Brandenburg |
| 03050 |
| Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20249 | Germany |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44263 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13125 | Germany |
| D001523 |
| Mental Disorders |