Last updated: 11/04/2018 08:00:48

A study to evaluate the effects of GW679769 on sleep and cognitive function in subjects with primary insomnia

GSK study ID
GW679769/903
See study documents
Clinicaltrials.gov ID
NCT00650871
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of GW679769 (30mg and 90mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects with Primary Insomnia
Trial description: A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects participate in a clinical screening visit and a two-night PSG recording session in the sleep laboratory. Eligible subjects then participate in three separate two-night PSG sessions in which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior to bedtime, one treatment for each session in a balanced order. Each treatment session is separated by a two-week drug-free period and occur on the same day of the week. A safety follow-up visit occurs 2 weeks after the last treatment session.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Mean Wake time after sleep onset (WASO) derived from PSG recording

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 Days)

Secondary outcomes:

Mean total sleep time (TST) as objective PSG measures of sleep continuity

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Mean latency to persistent sleep (LPS) as objective PSG measures of sleep continuity

Timeframe: Night 1 and 2 of each treatment period (approximately 31 days)

Mean wake during sleep (WDS) as objective PSG measures of sleep continuity

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Mean wake after sleep (WAS) as objective PSG measures of sleep continuity

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Mean number of 1 minute awakenings during sleep as objective PSG measures of sleep continuity

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Total Time in NREM Stage 1 and stage 2 as objective PSG measures of sleep structure

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Total Time in Slow Wave Sleep (SWS) as objective PSG measures of sleep structure

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Total Time in REM as objective PSG measures of sleep structure

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Latency to REM as objective PSG measures of sleep structure

Timeframe: Night 1 and 2 of each treatment period (Approximately up to 31 days)

Total sleep time (TST) as parameter of subjective post-sleep questionnaire

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

WASO as parameter of subjective post-sleep questionnaire

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Sleep onset latency (SOL) as parameter of subjective post-sleep questionnaire

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Number of awakenings as parameter of subjective post-sleep questionnaire

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Sleep quality (SQ) as parameter of subjective post-sleep questionnaire

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Digit symbol substitution test (DSST) as a measure of daytime cognitive function

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Mean Hopkins Verbal Learning Test-Revised (HVLT-R) score including total recall and delayed recall as a measure of Daytime Cognitive Function

Timeframe: Night 1, Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

HVLT-R (Retention %) as a measure of daytime Cognitive Function

Timeframe: Night 1, Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

HVLT-R (Recognition Discrimination Index [RDI]) as a measure of daytime Cognitive Function

Timeframe: Night 1, Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Leeds Sleep Evaluation Questionnaire as scales for sleepiness/alertness

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Stanford Sleepiness Scale as scales for sleepiness/alertness

Timeframe: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)

Interventions:
  • Drug: GW679769
  • Drug: Placebo
    • Enrollment:
    48
    Primary completion date:
    2005-30-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sleep Initiation and Maintenance Disorders
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    July 2004 to August 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    No
    • Healthy male and female subjects with primary insomnia with normal EG may be eligible for inclusion.
    • clinically significant physical or psychiatric illness or abnormal sleep patterns.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male and female subjects with primary insomnia with normal EG may be eligible for inclusion.
    Exclusion criteria:
    • clinically significant physical or psychiatric illness or abnormal sleep patterns.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27157
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    New York, New York, United States, 10025
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45246
    Status
    Terminated/Withdrawn
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2005-30-08
    Actual study completion date
    2005-30-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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