Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Study Overview
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Brief Summary
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A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.

Official Title
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A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period Adaptive Crossover Polysomnography Study to Evaluate Safety and Efficacy of MK-4305 in Patients With Primary Insomnia

Conditions
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Primary Insomnia

Intervention / Treatment
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* Drug: Suvorexant
* Drug: Dose-matched Placebo to Suvorexant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment Must be willing to stay overnight at a sleep laboratory Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory Regular bedtime is between 9 PM and 12 AM (midnight) Exclusion Criteria: Breast feeding, pregnant or planning to become pregnant during the study Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome Currently participating or have participated in a study with an investigational compound or device within the last 30 days Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study Has done shift work within the past 2 weeks Has donated blood products within the last 8 weeks Has difficulty sleeping due to a medical condition

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suvorexant 10 mg → Placebo<br>After an  1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|
| Experimental: Placebo → Suvorexant 10 mg<br>After an  1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|
| Experimental: Suvorexant 20 mg → Placebo<br>After an  1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|
| Experimental: Placebo → Suvorexant 20 mg<br>After an  1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|
| Experimental: Suvorexant 40 mg → Placebo<br>After an  1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|
| Experimental: Placebo → Suvorexant 40 mg<br>After an  1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|
| Experimental: Suvorexant 80 mg → Placebo<br>After an  1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|
| Experimental: Placebo → Suvorexant 80 mg<br>After an  1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2. | Drug: Suvorexant<br>* oral tablet taken before bedtime<br>* Other names: MK-4305;Drug: Dose-matched Placebo to Suvorexant<br>* Dose-matched placebo to suvorexant taken before bedtime (oral tablet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LS Mean Sleep Efficiency (SE) During Periods 1 and 2 | SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100 | Night 1 and end of Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2 | WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. | Night 1 and end of Week 4 | 
| LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2 | LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. | Night 1 and end of Week 4 |