Phase IIB 2-Period Crossover PSG Study in Patients With Primary Insomnia

Official Title: “A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period Crossover Polysomnography Study to Evaluate Safety and Efficacy of MK4305 in Patients With Primary Insomnia”

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of MK4305 in the treatment of patients with primary insomnia.

Intervention(s) in this Clinical Trial

• Drug: MK4305
  • MK4305 10 mg or placebo taken before bedtime
• Drug: Comparator: MK4305.
  • MK4305 20 mg or placebo taken before bedtime
• Drug: Comparator: MK4305,
  • MK4305 40 mg or placebo taken before bedtime
• Drug: Comparator: MK4305..
  • MK4305 80 mg or placebo taken before bedtime

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • MK4305 10 mg and matching placebo
• Experimental: 2
  • MK4305 20 mg and matching placebo
• Experimental: 3
  • MK4305 40 mg and matching placebo
• Experimental: 4
  • MK4305 80 mg and matching placebo

Primary Measures

• Improvement in sleep efficiency as measured by polysomnography
  • Time Frame: polysomnography over 4 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Improvement in wake after sleep onset and latency to persistent sleep.
  • Time Frame: polysomnography over 4 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Between the ages of 18 and 64 years
• 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.
• Have traveled across 3 or more time zones in the last 2 weeks or plan on traveling across 3 or more time zones during the next 2 months.
• Have done shift work within the past 2 weeks
• Have donated blood products within the last 8 weeks
• Have difficulty sleeping due to a medical condition

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00792298

Study ID Number: 2008_583

ClinicalTrials.gov Identifier: NCT00792298

Health Authority: United States: Food and Drug Administration