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

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ClinicalTrials.gov Identifier: NCT00792298
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : November 14, 2014
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 10, 2008
First Posted Date  ICMJE November 17, 2008
Results First Submitted Date  ICMJE August 19, 2014
Results First Posted Date  ICMJE November 14, 2014
Last Update Posted Date November 6, 2018
Actual Study Start Date  ICMJE November 5, 2008
Actual Primary Completion Date December 26, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
LS Mean Sleep Efficiency (SE) During Periods 1 and 2 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
Improvement in sleep efficiency (100 x time asleep divided by time in bed) as measured by polysomnography. [ Time Frame: Polysomnography on Night 1 and after 4 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
Evaluate the efficacy of MK4305 compared with placebo in improving wake after sleep onset and latency to persistent sleep. [ Time Frame: Polysomnography on Night 1 and after 4 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Insomnia
Intervention  ICMJE
  • Drug: Suvorexant
    oral tablet taken before bedtime
    Other Name: MK-4305
  • Drug: Dose-matched Placebo to Suvorexant
    Dose-matched placebo to suvorexant taken before bedtime (oral tablet)
Study Arms  ICMJE
  • Experimental: Suvorexant 10 mg → Placebo
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
  • Experimental: Placebo → Suvorexant 10 mg
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
  • Experimental: Suvorexant 20 mg → Placebo
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
  • Experimental: Placebo → Suvorexant 20 mg
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
  • Experimental: Suvorexant 40 mg → Placebo
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
  • Experimental: Placebo → Suvorexant 40 mg
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
  • Experimental: Suvorexant 80 mg → Placebo
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
  • Experimental: Placebo → Suvorexant 80 mg
    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.
    Interventions:
    • Drug: Suvorexant
    • Drug: Dose-matched Placebo to Suvorexant
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2010)
254
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2008)
250
Actual Study Completion Date  ICMJE December 26, 2009
Actual Primary Completion Date December 26, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan,   United States
 
Administrative Information
NCT Number  ICMJE NCT00792298
Other Study ID Numbers  ICMJE 4305-006
2008_583 ( Other Identifier: Merck Registration Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP