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Completed

NCT Number: NCT00792298

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

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.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suvorexant

Drug

oral tablet taken before bedtime

Other names: MK-4305

Dose-matched Placebo to Suvorexant

Drug

Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2008
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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