Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia

Phase 3

Completed

Brief Summary: A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.
Sleep apnea, or restless legs syndrome.
Daytime napping of more than 1 hour per day.
Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)	From baseline to Day 1&2	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
Change From Baseline to Day 15&16 in WASO	From baseline to Day 15&16	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
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)	From baseline to Week 1&2	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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)	From baseline to Day 1&2	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
Change From Baseline to Day 15&16 in LPS	From baseline to Day 15&16	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
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)	From baseline to Week 1&2	sLSO was the self-reported time to fall asleep as reported in the sleep diary

Locations (90): Sleep Disorders Laboratory, Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Monash Adult Sleep Center, Monash Medical Centre
🇦🇺
Clayton, Victoria, Australia
Western Hospitpal, Private Bag
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Footscray, Victoria, Australia
Institute for Breathing and Sleep (IBAS)
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Heidelburg, Victoria, Australia
The Woolcock Institute of Medical Research
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Glebe, Australia
Australian Clinical Research Organisation
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Kippa Ring, Australia
Melbourne Sleep Disorder Centre
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Melbourne, Australia
Burnside Hospital Clinical Trials Centre
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Toorak Gardens, Australia
Westmead Hospital, Department of Respiratory
🇦🇺
Westmead, Australia
Medical University of Innsbruck, Department of Neurology
🇦🇹
Innsbruck, Austria
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Sleep Disorders Laboratory, Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia