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

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Suvorexant
Dose-matched Placebo to Suvorexant
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Suvorexant 10 mg → Placebo

    Placebo → Suvorexant 10 mg

    Suvorexant 20 mg → Placebo

    Placebo → Suvorexant 20 mg

    Suvorexant 40 mg → Placebo

    Placebo → Suvorexant 40 mg

    Suvorexant 80 mg → Placebo

    Placebo → Suvorexant 80 mg

    Arm Description

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    November 10, 2008
    Last Updated
    October 8, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00792298
    Brief Title
    Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 5, 2008 (Actual)
    Primary Completion Date
    December 26, 2009 (Actual)
    Study Completion Date
    December 26, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    254 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Suvorexant 10 mg → Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo → Suvorexant 10 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Suvorexant 20 mg → Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo → Suvorexant 20 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Suvorexant 40 mg → Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo → Suvorexant 40 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Suvorexant 80 mg → Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo → Suvorexant 80 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Suvorexant
    Other Intervention Name(s)
    MK-4305
    Intervention Description
    oral tablet taken before bedtime
    Intervention Type
    Drug
    Intervention Name(s)
    Dose-matched Placebo to Suvorexant
    Intervention Description
    Dose-matched placebo to suvorexant taken before bedtime (oral tablet)
    Primary Outcome Measure Information:
    Title
    LS Mean Sleep Efficiency (SE) During Periods 1 and 2
    Description
    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
    Time Frame
    Night 1 and end of Week 4
    Secondary Outcome Measure Information:
    Title
    LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2
    Description
    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.
    Time Frame
    Night 1 and end of Week 4
    Title
    LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2
    Description
    LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.
    Time Frame
    Night 1 and end of Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23197752
    Citation
    Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=4305-006&kw=4305-006&tab=access

    Learn more about this trial

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

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