Clinical trial NCT01021852: Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-6096 in Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insomnia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-30
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment
timeFrame: Night 1 and end of Week 4
measure: Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2
timeFrame: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)
measure: Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2
timeFrame: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)
Secondary outcomes:
measure: Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment
timeFrame: Night 1 and end of Week 4
measure: Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment
timeFrame: Night 1 and end of Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Connor KM, Mahoney E, Jackson S, Hutzelmann J, Zhao X, Jia N, Snyder E, Snavely D, Michelson D, Roth T, Herring WJ. A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia. Int J Neuropsychopharmacol. 2016 Aug 12;19(8):pyw022. doi: 10.1093/ijnp/pyw022. Print 2016 Aug.