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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01021852
First received: November 25, 2009
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Primary Insomnia
Drug: MK6096 2.5 mg and placebo
Drug: Comparator: MK6096 5 mg and placebo
Drug: Comparator: MK6096 10 mg and placebo
Drug: Comparator: MK6096 20 mg and placebo
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 the Safety and Efficacy of MK6096 in Patients With Primary Insomnia

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

Primary Outcome Measures:
  • Improvement in sleep efficiency as measured by polysomnography [ Time Frame: Night 1 and after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in wake after sleep onset [ Time Frame: Night 1 and after 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Improvement in latency to persistent sleep [ Time Frame: Night 1 and after 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 326
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK6096 2.5 mg and placebo
Drug: MK6096 2.5 mg and placebo
MK6096 2.5 mg or placebo taken before bedtime
Experimental: 2
MK6096 5 mg and placebo
Drug: Comparator: MK6096 5 mg and placebo
MK6096 5 mg or placebo taken before bedtime
Experimental: 3
MK6096 10 mg and placebo
Drug: Comparator: MK6096 10 mg and placebo
MK6096 10 mg or placebo taken before bedtime
Experimental: 4
MK6096 20 mg and placebo
Drug: Comparator: MK6096 20 mg and placebo
MK6096 20 mg or placebo taken before bedtime

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021852

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

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01021852     History of Changes
Other Study ID Numbers: 2009_699, MK6096-011
Study First Received: November 25, 2009
Last Updated: March 25, 2011
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 April 17, 2014