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

Phase 2

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: SB-649868; Drug: Placebo

• Registration Number: NCT00426816
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-25
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-09
• Last Update Posted: 2012-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Male
• 18-64 years of age (inclusive),
• Diagnosis of primary insomnia who have had symptoms for at least three months.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover population	Placebo	All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing
Crossover population	SB-649868	All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing

Primary Outcome Measures

Name	Time	Method
Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording.	9 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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	9 weeks	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.
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.	9 weeks	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.
Spectral analysis of EEG	9 weeks	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.
Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording.	9 weeks	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.
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).	9 weeks	Measurements of insomnia effects on daytime regular functions
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.	9 weeks	Further questionnaires answered after each visit regarding sleep quality. Measured during night and day sections at each visit depending on the outcome.

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Hamburg, Germany