Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)

NCT00620659 ↗

Phase 2 Terminated 125 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.

Timeline

Start: 2008-02
Primary completion: 2009-02
Completion: 2009-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs MK0249 Mode Dose; p = 0.615; Mixed Models Analysis NCT00620659 ↗

paper MK-0249 did not significantly affect MWT sleep latency. PMID 23920422 ↗

Publications

Results Herring WJ, Liu K, Hutzelmann J, Snavely D, Snyder E, Ceesay P, Lines C, Michelson D, Roth T. Alertness and psychomotor performance effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized adaptive crossover study. Sleep Med. 2013 Oct;14(10):955-63. doi: 10.1016/j.sleep.2013.04.010. Epub 2013 Aug 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MK-0249	Small molecule	3 mg	Oral
Subject	MK-0249	Small molecule	5 mg	Oral
Subject	MK-0249	Small molecule	8 mg	Oral
Subject	MK-0249	Small molecule	10 mg	Oral
Subject	MK-0249	Small molecule	12 mg	Oral
Subject	Modafinil	Small molecule	200 mg	Oral