A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
709
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16
Time frame: From baseline to Day 1&2
Change From Baseline to Day 15&16 in WASO
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16
Time frame: From baseline to Day 15&16
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1\&2
Time frame: From baseline to Week 1&2
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
Time frame: From baseline to Day 1&2
Change From Baseline to Day 15&16 in LPS
LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
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2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Sleep Disorders Laboratory, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Adult Sleep Center, Monash Medical Centre
Clayton, Victoria, Australia
Western Hospitpal, Private Bag
Footscray, Victoria, Australia
Institute for Breathing and Sleep (IBAS)
Heidelburg, Victoria, Australia
The Woolcock Institute of Medical Research
Glebe, Australia
Australian Clinical Research Organisation
Kippa-Ring, Australia
Melbourne Sleep Disorder Centre
Melbourne, Australia
Burnside Hospital Clinical Trials Centre
Toorak Gardens, Australia
Westmead Hospital, Department of Respiratory
Westmead, Australia
Medical University of Innsbruck, Department of Neurology
Innsbruck, Austria
...and 81 more locations
Time frame: From baseline to Day 15&16
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
sLSO was the self-reported time to fall asleep as reported in the sleep diary
Time frame: From baseline to Week 1&2