Phase 2
N=326
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01021852 ↗Enrolled (actual)
326
Serious AEs
0.4%
Results posted
Jun 2016
Primary outcome: Primary: Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment — 74.8; 83.3; 84.8; 85.6 percentage of time in bed spent sleeping — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MK-6096 (Drug); Dose-matched Placebo to MK-6096 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment |
74.8; 83.3; 84.8; 85.6; 88.2; 77.0 | <0.001 sig |
| PRIMARY Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2 |
26.0; 26.6; 25.6; 32.5; 34.6 | — |
| PRIMARY Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2 |
2.2; 5.1; 1.3; 2.5; 0.0 | — |
| SECONDARY Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment |
83.1; 52.3; 50.6; 52.2; 37.3; 76.1 | <0.001 sig |
| SECONDARY Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment |
43.4; 33.2; 27.7; 19.9; 23.0; 39.4 | 0.022 sig |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01021852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.