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

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

Official Title
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Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia

Conditions
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Primary Insomnia

Intervention / Treatment
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* Drug: almorexant
* Drug: almorexant
* Drug: Placebo
* Drug: zolpidem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects (18-64 years) with a diagnosis of primary insomnia. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>almorexant 200 mg | Drug: almorexant<br>* 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem<br>|
| Experimental: 2<br>almorexant 100 mg | Drug: almorexant<br>* 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem<br>|
| Active Comparator: 4<br>zolpidem 10 mg | Drug: zolpidem<br>* 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | From baseline to Week 1&2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | From baseline to Week 1&2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleeplessness, orexin receptor antagonist, almorexant, insomnia