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
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: 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 August 28, 2014