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

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:

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

Investigators

Study Director:

Medical Monitor

Merck

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 May 16, 2013