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

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

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 Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Drug: SB-649868; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 13125
    • GSK Investigational Site
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Hamburg, Germany, 20249
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Mannheim, Baden-Wuerttemberg, Germany, 68159
      • GSK Investigational Site
  • Brandenburg
    • Cottbus, Brandenburg, Germany, 03050
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Dortmund, Nordrhein-Westfalen, Germany, 44263
      • GSK Investigational Site
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crossover population; All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing	Drug: SB-649868; Active compound at doses of 10mg, 30mg and 60mg; Drug: Placebo; Placebo to match SB-649868

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	9 weeks
Spectral analysis of EEG	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.	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.	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.	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).	Measurements of insomnia effects on daytime regular functions	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.	Further questionnaires answered after each visit regarding sleep quality. Measured during night and day sections at each visit depending on the outcome.	9 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: January 23, 2007
• First Submitted That Met QC Criteria: January 23, 2007
• First Posted (Estimate): January 25, 2007

Study Record Updates

• Last Update Posted (Estimate): August 13, 2012
• Last Update Submitted That Met QC Criteria: August 9, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Insomnia; primary insomnia; PSG sleep recordings; daytime cognitive function; SB-649868
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: OXS107714