--- title: Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia nct_id: NCT00280423 overall_status: COMPLETED phase: PHASE2 sponsor: GlaxoSmithKline study_type: INTERVENTIONAL primary_condition: Sleep Initiation and Maintenance Disorders countries: United States, Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00280423.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00280423" ct_last_update_post_date: 2015-04-15 last_seen_at: "2026-05-12T06:57:17.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia **Official Title:** A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial. **NCT ID:** [NCT00280423](https://clinicaltrials.gov/study/NCT00280423) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 342 - **Lead Sponsor:** GlaxoSmithKline - **Conditions:** Sleep Initiation and Maintenance Disorders, Insomnia - **Start Date:** 2006-01 - **Completion Date:** 2007-02 - **CT.gov Last Update:** 2015-04-15 ## Brief Summary This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 64 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Difficulty going to sleep and/or staying asleep for at least the past 3 months. * Insomnia must result in significant distress or impairment in functioning at home, socially or at work. * Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis. Exclusion Criteria: * History of other sleep disorders such as sleep apnea or restless leg syndrome. * Regular sleep habits, including bedtime between 9 PM and midnight. * No nightshift/rotating shift work, frequent napping or planned travel across \>2 time zones. * Use of nicotine, caffeine and alcoholic products. ``` ## Interventions - **GW679769** (DRUG) ## Primary Outcomes - **Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep.** _(time frame: 28 Days)_ ## Secondary Outcomes - **Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.** _(time frame: 28 Days)_ ## Locations (71) - GSK Investigational Site, Birmingham, Alabama, United States - GSK Investigational Site, Phoenix, Arizona, United States - GSK Investigational Site, Tucson, Arizona, United States - GSK Investigational Site, Little Rock, Arkansas, United States - GSK Investigational Site, Burbank, California, United States - GSK Investigational Site, Huntington Beach, California, United States - GSK Investigational Site, Irvine, California, United States - GSK Investigational Site, Los Angeles, California, United States - GSK Investigational Site, National City, California, United States - GSK Investigational Site, San Diego, California, United States - GSK Investigational Site, San Diego, California, United States - GSK Investigational Site, San Diego, California, United States - GSK Investigational Site, San Francisco, California, United States - GSK Investigational Site, Santa Rosa, California, United States - GSK Investigational Site, Norwalk, Connecticut, United States - GSK Investigational Site, DeLand, Florida, United States - GSK Investigational Site, Delray Beach, Florida, United States - GSK Investigational Site, Hallandale, Florida, United States - GSK Investigational Site, Largo, Florida, United States - GSK Investigational Site, Miami, Florida, United States - GSK Investigational Site, Miami, Florida, United States - GSK Investigational Site, Miami, Florida, United States - GSK Investigational Site, Pembroke Pines, Florida, United States - GSK Investigational Site, Atlanta, Georgia, United States - GSK Investigational Site, Atlanta, Georgia, United States - GSK Investigational Site, Gainesville, Georgia, United States - GSK Investigational Site, Hinesville, Georgia, United States - GSK Investigational Site, Macon, Georgia, United States - GSK Investigational Site, Stockbridge, Georgia, United States - GSK Investigational Site, Chicago, Illinois, United States - GSK Investigational Site, Chicago, Illinois, United States - GSK Investigational Site, Chicago, Illinois, United States - GSK Investigational Site, Overland Park, Kansas, United States - GSK Investigational Site, Crestview Hills, Kentucky, United States - GSK Investigational Site, Rockville, Maryland, United States - GSK Investigational Site, Newton, Massachusetts, United States - GSK Investigational Site, Troy, Michigan, United States - GSK Investigational Site, Hattiesburg, Mississippi, United States - GSK Investigational Site, Las Vegas, Nevada, United States - GSK Investigational Site, Clementon, New Jersey, United States - GSK Investigational Site, West Seneca, New York, United States - GSK Investigational Site, Durham, North Carolina, United States - GSK Investigational Site, Salisbury, North Carolina, United States - GSK Investigational Site, Winston-Salem, North Carolina, United States - GSK Investigational Site, Beachwood, Ohio, United States - GSK Investigational Site, Cincinnati, Ohio, United States - GSK Investigational Site, Cincinnati, Ohio, United States - GSK Investigational Site, Cleveland, Ohio, United States - GSK Investigational Site, Gallipolis, Ohio, United States - GSK Investigational Site, Oklahoma City, Oklahoma, United States - GSK Investigational Site, Gresham, Oregon, United States - GSK Investigational Site, Clarks Summit, Pennsylvania, United States - GSK Investigational Site, Duncansville, Pennsylvania, United States - GSK Investigational Site, Warwick, Rhode Island, United States - GSK Investigational Site, Columbia, South Carolina, United States - GSK Investigational Site, Austin, Texas, United States - GSK Investigational Site, Bellaire, Texas, United States - GSK Investigational Site, Dallas, Texas, United States - GSK Investigational Site, Houston, Texas, United States - GSK Investigational Site, Plano, Texas, United States - GSK Investigational Site, Salt Lake City, Utah, United States - GSK Investigational Site, Calgary, Alberta, Canada - GSK Investigational Site, Mississauga, Ontario, Canada - GSK Investigational Site, Niagara Falls, Ontario, Canada - GSK Investigational Site, Parrry Sound, Ontario, Canada - GSK Investigational Site, Toronto, Ontario, Canada - GSK Investigational Site, Toronto, Ontario, Canada - GSK Investigational Site, Toronto, Ontario, Canada - GSK Investigational Site, Toronto, Ontario, Canada - GSK Investigational Site, Montreal, Quebec, Canada - GSK Investigational Site, Sainte-Foy, Quebec, Canada ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.gsk investigational site|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|burbank|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|huntington beach|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|irvine|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|los angeles|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|national city|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|san diego|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|san francisco|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|santa rosa|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|norwalk|connecticut|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|deland|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|delray beach|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|hallandale|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|largo|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|miami|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|pembroke pines|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|gainesville|georgia|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|hinesville|georgia|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|macon|georgia|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|stockbridge|georgia|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|overland park|kansas|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|crestview hills|kentucky|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|rockville|maryland|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|newton|massachusetts|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|troy|michigan|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|hattiesburg|mississippi|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|clementon|new jersey|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|west seneca|new york|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|durham|north carolina|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00280423.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00280423* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*