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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Arms & Interventions
Crossover population
All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing
Intervention: SB-649868 (Drug)
Crossover population
All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording.
Time Frame: 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 Outcomes
- 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)
- 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)
- Spectral analysis of EEG(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.(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).(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.(9 weeks)