Last updated: 11/04/2018 10:08:58
To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Latency to Persistent Sleep (LPS) derived from polysomongraphic (PSG) recording
Timeframe: 9 weeks
Total Sleep Time (TST) derived from PSG recording
Timeframe: 9 weeks
Wake time after sleep onset (WASO) derived from PSG recording
Timeframe: 9 weeks
Secondary outcomes:
Objective PSG measures of sleep continuity including wake during sleep (WDS) and wake after sleep (WAS)
Timeframe: 9 weeks
Objective PSG measures of sleep continuity including number of awakenings (NAW) during sleep
Timeframe: 9 weeks
Objective PSG measures of sleep structure: Non-Rapid Eye Movement (REM) sleep time, Slow-Wave Sleep (SWS) time, REM sleep time and REM activity
Timeframe: 9 weeks
Objective PSG Measures of Sleep Structure: REM Density
Timeframe: 9 weeks
Spectral analysis of Electroencephalogram (EEG)
Timeframe: 9 weeks
Subjective Post-Sleep Questionnaire including TST, WASO and sleep onset latency (SOL) to be applied on each morning following PSG recording
Timeframe: 9 weeks
Number of participants passing the Romberg and Heel-to-Toe test (RHT)
Timeframe: 9 weeks
Leeds Sleep Evaluation Questionnaire (LSEQ) score over time
Timeframe: 9 weeks
Stanford Sleepiness Scale score over time
Timeframe: 9 weeks
Digit Symbol Substitution Test (DSST) score over time
Timeframe: 9 weeks
Verbal Learning Memory Test (VLMT) score over time
Timeframe: Day 2
Plasma pharmacokinetics of SB-649868 by assessment of Area under the curve from time zero to 24 hour (AUC[0-24])
Timeframe: Night 1 (at pre-dose, 1, 1.5 and 10 hours post-dose) and on night 2 (at pre-dose, 1, 1.5 and 10 hours post dose) of each treatment period
Plasma pharmacokinetics of SB-649868 by assessment of maximum plasma concentration (Cmax)
Timeframe: Night 1 (at pre-dose, 1, 1.5 and 10 hours post-dose) and on night 2 (at pre-dose, 1, 1.5 and 10 hours post dose) of each treatment period
Plasma pharmacokinetics of SB-649868 by assessment of Time to maximum plasma concentration (T-max)
Timeframe: Night 1 (at pre-dose, 1, 1.5 and 10 hours post-dose) and on night 2 (at pre-dose, 1, 1.5 and 10 hours post dose) of each treatment period
Subjective Post-Sleep Questionnaire including number of awakenings to be applied on each morning following PSG recording
Timeframe: 9 weeks
Subjective Post-Sleep Questionnaire including sleep quality to be applied on each morning following PSG recording
Timeframe: 9 weeks
Interventions:
Drug: Placebo
Drug: SB649868 10 mg
Drug: SB649868 30 mg
Drug: SB649868 60 mg
Enrollment:
52
Observational study model:
Not applicable
Primary completion date:
2007-07-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sleep Initiation and Maintenance Disorders
Product
SB649868
Collaborators
Not applicable
Study date(s)
December 2006 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Male
Age
18 - 64 years
Accepts healthy volunteers
No
- Male
- 18-64 years of age (inclusive),
- 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).
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44263
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
Hennigsdorf, Brandenburg, Germany, 16761
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68159
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-07-05
Actual study completion date
2007-07-05
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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