Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Phase 2 Completed 254 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverDouble-blindTreatment

Summary

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.

Timeline

Start: 2008-11-05
Primary completion: 2009-12-26
Completion: 2009-12-26

Publications

Results Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Suvorexant	Small molecule	10 mg	Oral
Subject	Suvorexant	Small molecule	20 mg	Oral
Subject	Suvorexant	Small molecule	40 mg	Oral
Subject	Suvorexant	Small molecule	80 mg	Oral

Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Summary

Timeline

Publications

Drugs

Indications