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

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).

Timeline

Start

2009-11-30

Primary completion

2011-02-01

Completion

2011-02-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs MK-6096 2.5 mg; p <0.001; Difference in LS Means 8.4 (95% CI 5.3 to 11.5); Mixed Models Analysis NCT01021852 ↗

paper All filorexant doses (2.5/5/10/20mg) were significantly superior to placebo in improving sleep among patients with insomnia as measured by sleep efficiency PMID 26979830 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filorexant	Small molecule	2.5 mg	Oral
Subject	Filorexant	Small molecule	5 mg	Oral
Subject	Filorexant	Small molecule	10 mg	Oral
Subject	Filorexant	Small molecule	20 mg	Oral

Indications