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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00792298
First received: November 10, 2008
Last updated: November 12, 2014
Last verified: November 2014

November 10, 2008
November 12, 2014
November 2008
December 2009   (final data collection date for primary outcome measure)
LS Mean Sleep Efficiency (SE) During Periods 1 and 2 [ Time Frame: Night 1 and end of Week 4 ] [ Designated as safety issue: No ]
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
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00792298 on ClinicalTrials.gov Archive Site
  • LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2 [ Time Frame: Night 1 and end of Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Primary Insomnia
  • 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)
  • 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
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.
 
Completed
254
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00792298
4305-006, 2008_583
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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