Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): Two multicentre, randomised, double-masked, placebo-controlled phase 3 trials

The Lancet

Volumn 386, Issue 10005, 2015, Pages 1754-1764

  Lockley, Steven W ^a,b   Dressman, Marlene A ^c   Licamele, Louis ^c   Xiao, Changfu ^c   Fisher, Dennis M ^d   Flynn Evans, Erin E ^b   Hull, Joseph T ^a,b   Torres, Rosarelis ^c   Lavedan, Christian ^c   Polymeropoulos, Mihael H ^c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c Suite 300 E   (United States)

^d P Less Than   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TASIMELTEON; BENZOFURAN DERIVATIVE; CYCLOPROPANE DERIVATIVE; MELATONIN RECEPTOR;

ADULT; AGED; ARTICLE; BLINDNESS; COMPARATIVE STUDY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; HYPERTRANSAMINASEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NIGHTMARE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SLEEP TIME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; AGONISTS; CIRCADIAN RHYTHM; CLINICAL TRIAL; COMPLICATION; DRUG EFFECTS; MIDDLE AGED; SLEEP DISORDERS, CIRCADIAN RHYTHM; TREATMENT OUTCOME;

BENZOFURANS; BLINDNESS; CIRCADIAN RHYTHM; CYCLOPROPANES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; RECEPTORS, MELATONIN; SLEEP DISORDERS, CIRCADIAN RHYTHM; TREATMENT OUTCOME;

EID: 84946491861     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)60031-9     Document Type: Article

References (40)

1. SW Lockley, J Arendt, DJ Skene Visual impairment and circadian rhythm disorders Dialogues Clin Neurosci 9 2007 301 314
2. O Remler Untersuchungen an Blinden ueber die 24-Stunden-Rhythmik Monatsblaetter fuer Augenheilkunde 113 1948 116 137
3. CA Czeisler, JF Duffy, TL Shanahan et al. Stability, precision, and near-24-hour period of the human circadian pacemaker Science 284 1999 2177 2181
4. AJ Lewy, DA Newsome Different types of melatonin circadian secretory rhythms in some blind subjects J Clin Endocrinol Metab 56 1983 1103 1107
5. ME Aldhous, J Arendt Melatonin rhythms and the sleep-wake cycle in blind subjects J Interdiscipl Cycle Res 22 1991 84 85
6. RL Sack, AJ Lewy, ML Blood, LD Keith, H Nakagawa Circadian rhythm abnormalities in totally blind people: incidence and clinical significance J Clin Endocrinol Metab 75 1992 127 134
7. SW Lockley, DJ Skene, H Tabandeh, AC Bird, R Defrance, J Arendt Relationship between napping and melatonin in the blind J Biol Rhythms 12 1997 16 25
8. DJ Skene, SW Lockley, K James, J Arendt Correlation between urinary cortisol and 6-sulphatoxymelatonin rhythms in field studies of blind subjects Clin Endocrinol 50 1999 715 719
9. EE Flynn-Evans, H Tabandeh, DJ Skene, SW Lockley Circadian rhythm disorders and melatonin production in 127 blind women with and without light perception J Biol Rhythms 29 2014 215 224
10. H Tabandeh, SW Lockley, R Buttery et al. Disturbance of sleep in blindness Am J Ophthalmol 126 1998 707 712
11. LEM Miles, DM Raynal, MA Wilson Blind man living in normal society has circadian rhythms of 24·9 hours Science 198 1977 421 423
12. T Klein, H Martens, DJ Dijk, RE Kronauer, EW Seely, CA Czeisler Chronic non-24-hour circadian rhythm sleep disorder in a blind man with a regular 24-hour sleep-wake schedule Sleep 16 1993 333 343
13. SW Lockley, DJ Skene, J Arendt, H Tabandeh, AC Bird, R Defrance Relationship between melatonin rhythms and visual loss in the blind J Clin Endocrinol Metab 82 1997 3763 3770
14. SW Lockley, DJ Skene, LJ Butler, J Arendt Sleep and activity rhythms are related to circadian phase in the blind Sleep 22 1999 616 623
15. American Psychiatric Association Diagnostic and statistical manual of mental disorders 5th edn. 2013 American Psychiatric Publishing Arlington, VA
16. American Academy of Sleep Medicine The International Classification of Sleep Disorders (ICSD-3) 3rd edn. 2014 American Academy of Sleep Medicine Darien, IL
17. SW Lockley, D-J Dijk, O Kosti, DJ Skene, J Arendt Alertness, mood and performance rhythm disturbances associated with circadian sleep disorders in the blind J Sleep Res 17 2008 207 216
18. RL Sack, AJ Lewy Circadian rhythm sleep disorders: lessons from the blind Sleep Med Rev 5 2001 189 206
19. Licamele L, Dressman M, Feeney J, Polymeropoulos MH, Lockley SW. Pleiomorphic expression of Non-24-Hour disorder in the totally blind. 13th meeting of the Society for Research in Biological Rhythms (SRBR); Destin, FL, USA; May 19-23, 2012: p279.
20. SW Lockley, DJ Skene, K James, K Thapan, J Wright, J Arendt Melatonin administration can entrain the free-running circadian system of blind subjects J Endocrinol 164 2000 R1 R6
21. RL Sack, RW Brandes, AR Kendall, AJ Lewy Entrainment of free-running circadian rhythms by melatonin in blind people N Engl J Med 343 2000 1070 1077
22. FDA Highlights of prescribing information. Hetlioz™ (tasimelteon) capsules, for oral use http://www.accessdata.fda.gov/drugsatfda-docs/label/2014/205677s000lbl.pdf (accessed Dec 5, 2014).
23. SM Rajaratnam, MH Polymeropoulos, DM Fisher et al. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials Lancet 373 2009 482 491
24. C Lavedan, M Forsberg, AJ Gentile Tasimelteon: a selective and unique binding profile Neuropharmacology 91 2015 142 147
25. K Posner, GK Brown, B Stanley et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults Am J Psychiatry 168 2011 1266 1277
26. JC Mundt, JH Greist, AJ Gelenberg, DJ Katzelnick, JW Jefferson, JG Modell Feasibility and validation of a computer-automated Columbia-Suicide Severity Rating Scale using interactive voice response technology J Psychiatr Res 44 2010 1224 1228
27. KF Storch, O Lipan, I Leykin et al. Extensive and divergent circadian gene expression in liver and heart Nature 417 2002 78 83
28. GE Duffield DNA microarray analyses of circadian timing: the genomic basis of biological time J Neuroendocrinol 15 2003 991 1002
29. MU Gillette, AJ McArthur Circadian actions of melatonin at the suprachiasmatic nucleus Behav Brain Res 73 1996 135 139
30. J Redman, S Armstrong, KT Ng Free-running activity rhythms in the rat: entrainment by melatonin Science 219 1983 1089 1091
31. SM Rajaratnam, DJ Dijk, B Middleton, BM Stone, J Arendt Melatonin phase-shifts human circadian rhythms with no evidence of changes in the duration of endogenous melatonin secretion or the 24-hour production of reproductive hormones J Clin Endocrinol Metab 88 2003 4303 4309
32. AJ Lewy, S Ahmed, JM Jackson, RL Sack Melatonin shifts human circadian rhythms according to a phase-response curve Chronobiol Int 9 1992 380 392
33. S Deacon, J Arendt Melatonin-induced temperature suppression and its acute phase-shifting effects correlate in a dose-dependent manner in humans Brain Res 688 1995 77 85
34. LM Hack, SW Lockley, J Arendt, DJ Skene The effects of low dose 0·5 mg melatonin on the free-running circadian rhythms of blind subjects J Biol Rhythms 18 2003 420 429
35. AJ Lewy, VK Bauer, BP Hasler, AR Kendall, LN Pires, RL Sack Capturing the circadian rhythms of free-running blind people with 0.5 mg melatonin Brain Res 918 2001 96 100
36. MA St Hilaire, SW Lockley Caffeine does not entrain the circadian clock but improves daytime alertness in blind patients with non-24-hour rhythms Sleep Med 16 2015 800 804
37. H Hahm, J Kujawa, L Augsburger Comparison of melatonin products against USP's nutritional supplements standards and other criteria J Am Pharm Assoc (Wash) 39 1999 27 31
38. N Buscemi, B Vandermeer, N Hooton et al. Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis BMJ 332 2006 385 393
39. SA Ferguson, SM Rajaratnam, D Dawson Melatonin agonists and insomnia Expert Rev Neurother 10 2010 305 318
40. AJ Lewy, JS Emens, RL Sack, BP Hasler, RA Bernert Zeitgeber hierarchy in humans: resetting the circadian phase positions of blind people using melatonin Chronobiol Int 20 2003 837 852