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 Medicine

Volumn 14, Issue 10, 2013, Pages 955-963

  Herring, W Joseph ^a   Liu, Kenneth ^a   Hutzelmann, Jill ^a   Snavely, Duane ^a   Snyder, Ellen ^a   Ceesay, Paulette ^a   Lines, Christopher ^a   Michelson, David ^a   Roth, Thomas ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b HENRY FORD HOSPITAL   (United States)

Author keywords

Excessive daytime sleepiness; Histamine subtype 3 receptor; MK 0249; Modafinil; Obstructive sleep apnea; Randomized trial

Indexed keywords

HISTAMINE H3 RECEPTOR ANTAGONIST; MK 0249; MODAFINIL; PLACEBO; UNCLASSIFIED DRUG;

ADULT; ALERTNESS; ANXIETY; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DAYTIME SOMNOLENCE; DIAPHORESIS; DIGIT SYMBOL SUBSTITUTION TEST; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; EPWORTH SLEEPINESS SCALE; FEMALE; HOT FLUSH; HUMAN; INSOMNIA; LABORATORY TEST; LOSS OF APPETITE; MAINTENANCE OF WAKEFULNESS TEST; MAJOR CLINICAL STUDY; MALE; NIGHT SWEAT; NIGHTMARE; PANIC; POSITIVE END EXPIRATORY PRESSURE; PRIORITY JOURNAL; PSYCHOMOTOR PERFORMANCE; PSYCHOMOTOR VIGILANCE TASK; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SLEEP; SLEEP DISORDERED BREATHING; THORAX PAIN; TREATMENT DURATION; TREATMENT OUTCOME; VOMITING; WAKEFULNESS;

EXCESSIVE DAYTIME SLEEPINESS; HISTAMINE SUBTYPE-3 RECEPTOR; MK-0249; MODAFINIL; OBSTRUCTIVE SLEEP APNEA; RANDOMIZED TRIAL;

ADOLESCENT; ADULT; BENZHYDRYL COMPOUNDS; COMBINED MODALITY THERAPY; CONTINUOUS POSITIVE AIRWAY PRESSURE; CROSS-OVER STUDIES; DISORDERS OF EXCESSIVE SOMNOLENCE; DOUBLE-BLIND METHOD; FEMALE; HISTAMINE AGONISTS; HUMANS; MALE; MIDDLE AGED; PSYCHOMOTOR PERFORMANCE; QUINAZOLINONES; SLEEP APNEA, OBSTRUCTIVE; TREATMENT OUTCOME; WAKEFULNESS; WAKEFULNESS-PROMOTING AGENTS; YOUNG ADULT;

EID: 84883768395     PISSN: 13899457     EISSN: 18785506     Source Type: Journal    
DOI: 10.1016/j.sleep.2013.04.010     Document Type: Article

References (38)

1. Boulos M.I., Murray B.J. Current evaluation and management of excessive daytime sleepiness. Can J Neurol Sci 2010, 37:167-176.
2. Ohayon M.M. From wakefulness to excessive sleepiness: what we know and still need to know. Sleep Med Rev 2008, 12:129-141.
3. Valentino R.M., Foldvary-Schaefer N. Modafinil in the treatment of excessive daytime sleepiness. Cleve Clin J Med 2007, 74:561-566. 568-71.
4. Lankford D.A. Armodafinil: a new treatment for excessive sleepiness. Expert Opin Investig Drugs 2008, 17:565-573.
5. Schwartz J.C. Histaminergic mechanisms in brain. Ann Rev Pharmacol Toxicol 1977, 17:325-339.
6. Stocking E.M., Letavic M.A. Histamine H3 antagonists as wake-promoting and pro-cognitive agents. Curr Top Med Chem 2008, 8:988-1002.
7. Gemkow M.J., Davenport A.J., Harich S., Ellenbroek B.A., Cesura A., Hallett D. The histamine H3 receptor as a therapeutic drug target for CNS disorders. Drug Discov Today 2009, 14:509-515.
8. Brioni J.D., Esbenshade T.A., Garrison T.R., Bitner S.R., Cowart M.D. Discovery of histamine H3 antagonists for the treatment of cognitive disorders and Alzheimer's disease. J Pharmacol Exp Ther 2011, 336:38-46.
9. Schwartz J.C. The histamine H3 receptor: from discovery to clinical trials withpitolisant. Br J Pharmacol 2011, 163:713-721.
10. Iannone R., Palcza J., Renger J.J., et al. Acute alertness-promoting effects of a novel histamine subtype-3 receptor inverse agonist in healthy sleep-deprived male volunteers. Clin Pharmacol Ther 2010, 88:831-839.
11. James L.M., Iannone R., Palcza J., et al. Effect of a novel histamine subtype-3 receptor inverse agonist and modafinil on EEG power spectra during sleep deprivation and recovery sleep in male volunteers. Psychopharmacology 2011, 215:643-653.
12. Lin J.S., Dauvilliers Y., Arnulf I., et al. An inverse agonist of the histamine H(3) receptor improves wakefulness in narcolepsy: studies in orexin-/- mice and patients. Neurobiol Dis 2008, 30:74-83.
13. Nagase T., Mizutani T., Ishikawa S., et al. Synthesis, structure-activity relationships, and biological profiles of a quinazolinone class of histamine H3 receptor inverse agonists. J Med Chem 2008, 51:4780-4789.
14. Zoethout R.W., Iannone R., Bloem B.R., et al. The effects of a novel histamine-3 receptor inverse agonist on essential tremor in comparison to stable levels of alcohol. J Psychopharmacol 2012, 26:292-302.
15. American Academy of Sleep Medicine International classification of sleep disorders: diagnostic and coding manual 2005, American Academy of Sleep Medicine, Westchester (IL). 2nd ed.
16. Guy W. Clinical global impressions new clinical drug evaluation unit (ECDEU) assessment manual for psychopharmacology 1976, National Institute of Mental Health, Rockville (MD), p. 218-22.
17. Johns M.W. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991, 14:540-545.
18. Ivanova A., Liu K., Snyder E., Snavely D. An adaptive design for identifying the dose with the best efficacy/tolerability profile with application to a crossover dose-finding study. Stat Med 2009, 28:2941-2951.
19. Mitler M., Gujavarty K.S., Browman C.F. Maintenance of wakefulness test: a polysomnographic technique for evaluating treatment efficacy in patients with excessive somnolence. Electroencephalogr Clin Neurophysiol 1982, 53:658-661.
20. Poceta J.S., Timms R.M., Jeong D.-U., Ho S.L., Erman M., Mitler M. Maintenance of wakefulness test in obstructive sleep apnea syndrome. Chest 1992, 101:893-897.
21. Dorrian J., Rogers N.L., Dinges D.F., Kushida C.A. Psychomotor vigilance performance: neurocognitive assay sensitive to sleep loss. Sleep deprivation: clinical issues, pharmacology and sleep loss effects 2005, 39-70. Marcel Dekker, Inc., New York (NY).
22. Wechsler D. WAIS-R manual 1981, The Psychological Corporation, New York (NY).
23. Burgess P.W., Shallice T. Hayling sentence completion test 1997, Thames Valley Test Co. Ltd., Suffolk, England.
24. Mitrushina M., Boone K., Razani J., D' Elia L. Stroop test. Handbook of normative data for neuropsychological assessment 2005, 108-133. Oxford University Press, New York (NY).
25. Veroff A.E., Cutler N.R., Sramek J.J., Prior P.L., Mickelson W., Hartman J.K. A new assessment tool for neuropsychopharmacologic research: the computerized neuropsychological test battery. J Geriatr Psychiatry Neurol 1991, 4:211-217.
26. Egan M., Yaari R., Liu L., Ryan M., Peng Y., Lines C., et al. Pilot randomized controlled study of a histamine receptor inverse agonist in the symptomatic treatment of AD. Curr Alzheimer Res 2012, 9:481-490.
27. Herring W.J., Wilens T.E., Adler L.A., et al. Randomized controlled study of the histamine inverse agonist MK-0249 in adult attention-deficit/hyperactivity disorder. J Clin Psychiatry 2012, 73:e891-e898.
28. Kingshott R.N., Vennelle M., Coleman E.L., Engleman H.M., Mackay T.W., Douglas N.J. Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of residual excessive daytime sleepiness in the sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 2001, 163:918-923.
29. Roth T., White D., Schmidt-Nowara W., et al. Effects of armodafinil in the treatment of residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome: a 12-week, multicenter, double-blind, randomized, placebo-controlled study in nCPAP-adherent adults. Clin Ther 2006, 28:689-706.
30. Dinges D.F., Weaver T.E. Effects of modafinil on sustained attention performance and quality of life in OSA patients with residual sleepiness while being treated with nCPAP. Sleep Med 2003, 4:393-402.
31. Schwartz J.R. Modafinil: new indications for wake promotion. Expert Opin Pharmacother 2005, 6:115-129.
32. Minzenberg M.J., Carter C.S. Modafinil: a review of neurochemical actions and effects on cognition. Neuropsychopharmacology 2008, 33:1477-1502.
33. Arand D., Bonnet M., Hurwitz T., Mitler M., Rosa R., Sangal R.B. The clinical use of the MSLT and MWT. Sleep 2005, 28:123-144.
34. Littner M.R., Kushida C., Wise M., et al. Standards of practice committee of the American academy of sleep medicine. Practice parameters for clinical use of the multiple sleep latency test and the maintenance of Wakefulness test. Sleep 2005, 28:113-121.
35. Doghramji K., Mitler M.M., Sangal R.B., et al. A normative study of the maintenance of wakefulness test (MWT). Electroencephalogr Clin Neurophysiol 1997, 103:554-562.
36. Hirshkowitz M., Black J.E., Wesnes K., Niebler G., Arora S., Roth T. Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome. Respir Med 2007, 101:616-627.
37. Bonnet M.H. ACNS clinical controversy: MSLT and MWT have limited clinical utility. J Clin Neurophysiol 2006, 23:50-58.
38. Sullivan S.S., Kushida C.A. Multiple sleep latency test and maintenance of wakefulness test. Chest 2008, 134:854-861.