EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/day) for the Treatment of Primary Insomnia in Adult Outpatients
Trial description: This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Assessment of objective PSG measure of sleep onset, duration and continuity for wake after persistent sleep onset (WASO1)
Timeframe: Day 27/28
Assessment for wake after sleep onset (WASO) as the mean of PSG recordings obtained on two consecutive nights on Days 27/28
Timeframe: Day 27,28
Secondary outcomes:
Assessment for WASO1 as the mean of PSG recordings obtained on two consecutive nights on Days 1/2.
Timeframe: Day 1/2
Assessment for WASO as the mean of PSG recordings obtained on two consecutive nights on Days 1/2.
Timeframe: Day 1/2
Assessment of objective PSG measure of sleep onset, duration and continuity for latency to persistent sleep (LPS)
Timeframe: Day 1/2 and Day 27/28
Assessment of objective PSG measure of sleep onset, duration and continuity for total sleep time (TST)
Timeframe: Day 1/2 and Day 27/28
Assessment of objective PSG measure of sleep onset, duration and continuity for wake during sleep (WDS)
Timeframe: Day 1/2 and Day 27/28
Assessment of objective PSG measure of sleep onset, duration and continuity for wake after sleep (WAS)
Timeframe: Day 1/2 and Day 27/28
Assessment of objective PSG measure of sleep onset, duration and continuity for number of awakenings during sleep (NAW)
Timeframe: Day 1/2 and Day 27/28
Assessment of subjective sleep assessments as performed by Post-Sleep Questionnaires (PSQs) using Interactive Voice Response System (IVRS) for PSG parameter TST and Sleep onset latency (SOL)
Timeframe: Day 2 (Pre-dose), Day 2 (Inpatient), Day 28 (Post-Dose), Day 35 (Follow-up)
Assessment of subjective sleep assessments as performed by Post-Sleep Questionnaires (PSQs) using Interactive Voice Response System (IVRS) for PSG parameter NAW
Timeframe: Day 2 (Pre-dose), Day 2 (Inpatient), Day 28 (Post-Dose), Day 35 (Follow-up)
Assessment of subjective sleep assessments as performed by participant-rated Insomnia Severity Index (ISI)
Timeframe: Baseline, Day 15, Day 28, Day 42
Number of participants who passed Romberg and Heel-to-toe test for the assessment of motor and cognitive functioning
Timeframe: Day 1 (Visit 2), Day 2 (Visit 3), Day 15 (Visit 6), Day 27 (Visit 7), Day 28 (Visit 8)
Assessment of Motor and cognitive functioning by Digit Symbol Substitution test (DSST)
Timeframe: Day 1 (Visit 2), Day 2 (Visit 3), Day 3 (Visit 4), Day 4 (Visit 5), Day 27 (Visit 7) and Day 28 (Visit 8)
Assessment of Motor and cognitive functioning by Hopkins Verbal Learning Test-Revised (HVLT-R)
Timeframe: Day 2 (Visit 3), Day 4 (Visit 5) and Day 28 (Visit 8)
Interventions:
Drug: GW597599
Drug: Placebo
Enrollment:
161
Observational study model:
Not applicable
Primary completion date:
2009-23-09
Time perspective:
Not applicable
Clinical publications:
Emiliangelo Ratti, David J. Carpenter, Stefano Zamuner, Sofia Fernandes, Lisa Squassante, Heidi Danker-Hopfe, Graeme Archer, Jonathan Robertson, Robert Alexander, David Trist, Emilio Merlo-Pich. Efficacy of vestipitant, a neurokinin-1 receptor antagonist, in primary insomnia. Sleep. 2013;36(12):1823-1830.
Medical condition
Sleep Disorders
Product
vestipitant
Collaborators
GSK
Study date(s)
May 2009 to September 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders –Text Revision (DSM-IV-TR) criteria 307.42
- PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins
- clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);
- nightshift or rotating shift-work;
Inclusion and exclusion criteria
Inclusion criteria:
- Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders –Text Revision (DSM-IV-TR) criteria 307.42
- PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights)
- LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins
- WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins
- Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol
Exclusion criteria:
- clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);
- nightshift or rotating shift-work;
- Lifestyle habits in agreement with Protocol requirement: caffeine
- alcohol intake and smoke
- healthy according to GSK criteria
- laboratory and ECG limits set in the Protocol
Trial location(s)
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
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
2009-23-09
Actual study completion date
2009-23-09
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.
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