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

Phase 2

Completed

• Conditions: Primary Insomnia
• Interventions: Drug: Suvorexant; Drug: Dose-matched Placebo to Suvorexant

• Registration Number: NCT00792298
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-05
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Primary Completion: 2009-12-26
• Study Completion: 2009-12-26
• Results First Submitted: 2014-08-19
• Results First Submitted QC: 2014-11-12
• Results First Posted: 2014-11-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Suvorexant 40 mg → Placebo	Suvorexant	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.
Placebo → Suvorexant 40 mg	Suvorexant	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.
Suvorexant 10 mg → Placebo	Suvorexant	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.
Suvorexant 10 mg → Placebo	Dose-matched Placebo to Suvorexant	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.
Placebo → Suvorexant 10 mg	Suvorexant	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.
Placebo → Suvorexant 10 mg	Dose-matched Placebo to Suvorexant	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.
Suvorexant 20 mg → Placebo	Suvorexant	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.
Suvorexant 20 mg → Placebo	Dose-matched Placebo to Suvorexant	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.
Placebo → Suvorexant 20 mg	Suvorexant	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.
Placebo → Suvorexant 20 mg	Dose-matched Placebo to Suvorexant	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.
Suvorexant 40 mg → Placebo	Dose-matched Placebo to Suvorexant	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.
Placebo → Suvorexant 40 mg	Dose-matched Placebo to Suvorexant	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.
Suvorexant 80 mg → Placebo	Suvorexant	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.
Suvorexant 80 mg → Placebo	Dose-matched Placebo to Suvorexant	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.
Placebo → Suvorexant 80 mg	Suvorexant	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.
Placebo → Suvorexant 80 mg	Dose-matched Placebo to Suvorexant	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.

Primary Outcome Measures

Name	Time	Method
LS Mean Sleep Efficiency (SE) During Periods 1 and 2	Night 1 and end of Week 4	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

Secondary Outcome Measures

Name	Time	Method
LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2	Night 1 and end of Week 4	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.
LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2	Night 1 and end of Week 4	LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.