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

Purpose

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

Condition	Intervention	Phase
Sleep Initiation and Maintenance Disorders	Drug: SB-649868 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Insomnia

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 Outcome Measures:

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 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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.
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. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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.
Spectral analysis of EEG [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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.
Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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.
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). [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Measurements of insomnia effects on daytime regular functions
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. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Further questionnaires answered after each visit regarding sleep quality. Measured during night and day sections at each visit depending on the outcome.

Enrollment:	48
Study Start Date:	December 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: SB-649868 Drug: Placebo Placebo to match SB-649868

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426816

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00426816 History of Changes
Other Study ID Numbers:	OXS107714
Study First Received:	January 23, 2007
Last Updated:	August 9, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

primary insomnia
PSG sleep recordings
daytime cognitive function
Insomnia
SB-649868

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013