Clinical trial NCT00426816: To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: primary insomnia
PSG sleep recordings
daytime cognitive function
Insomnia
SB-649868
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording.
timeFrame: 9 weeks
Secondary outcomes:
measure: 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
timeFrame: 9 weeks
measure: 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.
timeFrame: 9 weeks
measure: Spectral analysis of EEG
timeFrame: 9 weeks
measure: Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording.
timeFrame: 9 weeks
measure: 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).
timeFrame: 9 weeks
measure: 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.
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Cottbus
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: