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: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Primary Insomnia
Drug: Suvorexant
Drug: Dose-matched Placebo to Suvorexant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • LS Mean Latency to the onset of Persistent Sleep (LPS) During Period 1 (Without Carryover Effect) [ Time Frame: Night 1 (Period 1 only) and end of Week 4 (Period 1 only) ] [ Designated as safety issue: No ]
    LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. To further evaluate the efficacy of suvorexant on LPS without the influence of carryover, an ad hoc analysis of LPS restricted to Period 1 was also performed.


Enrollment: 254
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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 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.
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: 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.
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 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.
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: 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.
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 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.
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: 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.
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)

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792298

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00792298     History of Changes
Other Study ID Numbers: 4305-006, 2008_583
Study First Received: November 10, 2008
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014