Polysomnography Study of MK6096 in Patients With Primary Insomnia (6096-011)(COMPLETED)

Official Title: “A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK6096 in Patients With Primary Insomnia”

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of MK6096 in the treatment of patients with primary insomnia.

Intervention(s) in this Clinical Trial

• Drug: MK6096 2.5 mg and placebo
  • MK6096 2.5 mg or placebo taken before bedtime
• Drug: Comparator: MK6096 5 mg and placebo
  • MK6096 5 mg or placebo taken before bedtime
• Drug: Comparator: MK6096 10 mg and placebo
  • MK6096 10 mg or placebo taken before bedtime
• Drug: Comparator: MK6096 20 mg and placebo
  • MK6096 20 mg or placebo taken before bedtime

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • MK6096 2.5 mg and placebo
• Experimental: 2
  • MK6096 5 mg and placebo
• Experimental: 3
  • MK6096 10 mg and placebo
• Experimental: 4
  • MK6096 20 mg and placebo

Primary Measures

• Improvement in sleep efficiency as measured by polysomnography
  • Time Frame: Night 1 and after 4 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Improvement in wake after sleep onset
  • Time Frame: Night 1 and after 4 weeks of treatment
    Safety Issue?: No
• Improvement in latency to persistent sleep
  • Time Frame: Night 1 and after 4 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Patient is willing to stay overnight at a sleep laboratory on 6 separate nights and is willing to stay in bed for at least 8 hours each night while at the sleep laboratory
• Patient's regular bedtime is between 9 PM and 12 AM (midnight)
• Patient is able to read and complete questionnaires and diaries
• Patient is willing to refrain from napping during the study

Exclusion Criteria:

• If female, patient is breast feeding, pregnant, or planning to become pregnant
• Patient is expecting to donate eggs or sperm during the study
• Patient has any history of a neurological disorder
• Patient has a history within the past 6 months of a cardiovascular disorder such as unstable angina, congestive heart failure or acute coronary syndrome.
• Patient has difficulty sleeping due to a medical condition
• Patient has donated blood products within the 8 weeks prior to the study
• Patient plans to travel across 3 or more time zones during the study
• Patient is currently participating or has participated in a study with an investigational compound or device within the last 30 days

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 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01021852

Study ID Number: 2009_699

ClinicalTrials.gov Identifier: NCT01021852

Health Authority: United States: Food and Drug Administration