Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of 4 weeks of treatment (Week 4).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Participant 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

• Participant's regular bedtime is between 9 PM and 12 AM (midnight)

• Participant is able to read and complete questionnaires and diaries

• Participant is willing to refrain from napping during the study

Exclusion Criteria:

• If female, participant is breast feeding, pregnant, or planning to become pregnant

• Participant is expecting to donate eggs or sperm during the study

• Participant has any history of a neurological disorder

• Participant has a history within the past 6 months of a cardiovascular disorder such as unstable angina, congestive heart failure or acute coronary syndrome.

• Participant has difficulty sleeping due to a medical condition

• Participant has donated blood products within the 8 weeks prior to the study

• Participant plans to travel across 3 or more time zones during the study

• Participant is currently participating or has participated in a study with an investigational compound or device within the last 30 days