This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the effect of MK-7288 after single dose administration on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).

Start Date26 May 2010

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with MK-7288

100 Translational Medicine associated with MK-7288

100 Patents (Medical) associated with MK-7288

Literatures (Medical) associated with MK-7288

01 Aug 2024·Sleep Medicine Reviews

Evaluating pharmacological treatments for excessive daytime sleepiness in obstructive sleep apnea: A comprehensive network meta-analysis and systematic review

Review

Author: Heidari, Afshin ; Labarca, Gonzalo ; Lee Mateus, Alejandra Yu ; Arunthari, Vichaya ; Cheung, Joseph ; Colaco, Brendon ; Neshat, Seyed Sina ; Henriquez-Beltran, Mario ; Patel, Kripa

Obstructive sleep apnea (OSA) is associated with excessive daytime sleepiness (EDS). Pharmacotherapy offers a potential treatment approach for EDS in OSA patients. This systematic review and meta-analysis aimed to assess the efficacy and safety of pharmacological interventions for alleviating EDS in patients with OSA. Following PRISMA guidelines, we included randomized controlled trials investigating pharmacological treatments for EDS in adult OSA until August 2023. We conducted meta-analysis, subgroup, and meta-regression analyses using a random effects model. Finally, a network meta-analysis synthesized direct and indirect evidence, followed by a comprehensive safety analysis. We included 32 articles in the meta-analysis (n = 3357). Pharmacotherapy showed a significant improvement in the Epworth Sleepiness Scale (ESS) score (Mean Difference (MD) -2.73, (95 % Confidence Interval (CI) [-3.25, -2.20], p < 0.01) and Maintenance of Wakefulness Test (MWT) score (MD 6.00 (95 % CI [2.66, 9.33] p < 0.01). Solriamfetol, followed by Pitolisant and modafinil, exhibited the greatest ESS reduction, while Danavorexton, followed by Solriamfetol and MK-7288, had the strongest impact on MWT. MK-7288 had the most total adverse events (AEs), followed by Danavorexton and armodafinil. Pharmacological Interventions significantly alleviate EDS in OSA patients but with heterogeneity across medications. Treatment decisions should involve a personalized assessment of patient factors and desired outcomes.

01 Dec 2013·The Journal of Clinical PharmacologyQ3 · MEDICINE

Early-stage comparative effectiveness: Randomized controlled trial with histamine inverse agonist MK-7288 in excessive daytime sleepiness patients

Q3 · MEDICINE

Article

Author: Schulz, Valerie ; Brown, Kevin R. ; MacLeod, Catherine ; Rosen, Laura B. ; Murphy, M. Gail ; Sun, Hong ; Han, Lingling ; Mostoller, Kate ; Renger, John J. ; Herring, W. Joseph ; Mahon, Chantal ; Lines, Christopher ; Ma, Junshui ; Wagner, John A. ; Kay, Gary G.

Histaminergic neurons are regulators of the sleep-wake cycle. We evaluated the alerting effects of MK-7288 (10, 20 mg), a novel histamine-3 receptor inverse agonist (H3RIA), along with modafinil (200 mg), a standard treatment, in a randomized, double-blind, placebo controlled, crossover study of 56 patients with excessive daytime sleepiness (EDS). Efficacy was assessed using maintenance of wakefulness tests (MWT) and car driving simulation tests. MK-7288 and modafinil significantly prolonged MWT sleep latency (improvements vs. placebo of 8.1 to 8.2 min for MK-7288 and 10.2 min for modafinil), and improved car driving simulation standard deviation of lane position (reduction vs. placebo of -0.1 m for each treatment). MK-7288 was associated with more insomnia (29%) than modafinil (9%) and placebo (6%). The study demonstrated the potential of the H3RIA mechanism for treating EDS, but did not show efficacy differentiation from modafinil. Early-stage comparative effectiveness can help prevent late-stage failure and increase the cost-effectiveness of drug development.

100 Deals associated with MK-7288

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Apnea Syndromes	Phase 1	US	Merck GmbH	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01092780 (Pubmed \| J Clin Pharmacol)	Phase 1	Excessive Daytime Sleepiness	56	MK-7288 10mg	efbbxpvnxw(xdwvznlspg) = dfmbtftwro dwhdjuxwss (icsdqsdhnj ) View more	-	01 Dec 2013
				MK-7288 20mg	efbbxpvnxw(xdwvznlspg) = tieozkcqww dwhdjuxwss (icsdqsdhnj ) View more

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