Pitolisant versus placebo or modafinil in patients with narcolepsy: A double-blind, randomised trial

The Lancet Neurology

Volumn 12, Issue 11, 2013, Pages 1068-1075

  Dauvilliers, Yves ^a   Bassetti, Claudio ^b   Lammers, Gert Jan ^c   Arnulf, Isabelle ^d   Mayer, Geert ^e   Rodenbeck, Andrea ^f   Lehert, Philippe ^g,h   Ding, Claire Li ⁱ   Lecomte, Jeanne Marie ^j   Schwartz, Jean Charles ^j  

^a GUI DE CHAULIAC HOSPITAL   (France)

^b UNIVERSITY OF BERN   (Switzerland)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d HÔpital la Pitié Salpêtrière   (France)

^e Hephata Clinic for Neurology   (Germany)

^f Studienzentrum Wilhelmshöhe   (Germany)

^g UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^h UNIVERSITY OF MELBOURNE   (Australia)

ⁱ Agence Nationale de Sécurité des Médicaments Saint Denis   (France)

^j Bioprojet   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

LACTOSE; MODAFINIL; PITOLISANT; PLACEBO;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ABNORMAL BEHAVIOR; ADULT; AMPHETAMINE LIKE WITHDRAWAL SYMPTOM; ANXIETY; ARTICLE; BODY HEIGHT; BODY MASS; BODY WEIGHT; CATAPLEXY; CLINICAL GLOBAL IMPRESSION OF CHANGE; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERANCE; EPWORTH SLEEPINESS SCALE; EUROPEAN QUALITY OF LIFE; FEMALE; HEADACHE; HUMAN; HYPNAGOGIC HALLUCINATION; INNER EAR DISEASE; INSOMNIA; INTENTION TO TREAT ANALYSIS; IRRITABILITY; LOW DRUG DOSE; LYMPHADENOPATHY; MAINTENANCE OF WAKEFULNESS TEST; MAJOR CLINICAL STUDY; MALE; MASKING; MEDICAL HISTORY; MICROCAPSULE; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NARCOLEPSY; NAUSEA; NIGHT SLEEP; PARASOMNIA; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SLEEP; SUSTAINED ATTENTION TO RESPONSE TASK; TABLET; TASK PERFORMANCE; TREATMENT DURATION; WEIGHT GAIN; WITHDRAWAL SYNDROME;

ADULT; BENZHYDRYL COMPOUNDS; DOUBLE-BLIND METHOD; FEMALE; HISTAMINE AGONISTS; HUMANS; MALE; MIDDLE AGED; NARCOLEPSY; PIPERIDINES; PLACEBOS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; WAKEFULNESS-PROMOTING AGENTS; YOUNG ADULT;

EID: 84885378478     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(13)70225-4     Document Type: Article

References (28)

1. Dauvilliers Y, Arnulf I, Mignot E Narcolepsy with cataplexy. Lancet 2007, 369:499-511.
2. Baumann CR, Bassetti CL Hypocretins (orexins) and sleep-wake disorders. Lancet Neurol 2005, 4:673-682.
3. Peyron C, Faraco J, Rogers W, et al. A mutation in a case of early onset narcolepsy and a generalized absence of hypocretin peptides in human narcoleptic brains. Nat Med 2000, 6:991-997.
4. Billiard M, Bassetti C, Dauvilliers Y, et al. EFNS Task Force. EFNS guidelines on management of narcolepsy. Eur J Neurol 2006, 13:1035-1048.
5. Morgenthaler TI, Kapur VK, Brown T, et al. Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. Sleep 2007, 30:1705-1711.
6. Pardi D, Black J Gamma-hydroxybutyrate/sodium oxybate: neurobiology, and impact on sleep and wakefulness. CNS Drugs 2006, 20:993-1018.
7. Vignatelli L, D'Alessandro R, Candelise L Antidepressants for narcolepsy. Cochrane Database Syst Rev 2008, 23. CD003724.
8. Schwartz JC Histaminergic mechanisms in brain. Annu Rev Pharmacol Toxicol 1977, 17:325-339.
9. Haas H, Sergeeva O, Selbach O Histamine in the nervous system. Physiol Rev 2008, 88:1183-1241.
10. Nishino S, Sakurai E, Nevsimalova S, et al. Decreased CSF histamine in narcolepsy with and without low CSF hypocretin-1 in comparison to healthy controls. Sleep 2009, 32:175-180.
11. Kanbayashi T, Kodama T, Kondo H, et al. CSF histamine contents in narcolepsy, idiopathic hypersomnia and obstructive sleep apnea syndrome. Sleep 2009, 32:181-187.
12. Dauvilliers Y, Delallée N, Jaussent I, et al. Normal cerebrospinal fluid histamine and tele-methylhistamine levels in hypersomnia conditions. Sleep 2012, 35:1359-1366.
13. Mochizuki T, Arrigoni E, Marcus JN, et al. Orexin receptor 2 expression in the posterior hypothalamus rescues sleepiness in narcoleptic mice. Proc Natl Acad Sci USA 2011, 108:4471-4476.
14. Lin JS, 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.
15. The International Classification of Sleep Disorders-revised: diagnostic and coding manual 2005, American Academy of Sleep Medicine, American Academy of Sleep Medicine, Rochester, MN.
16. Johns MW A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991, 14:540-545.
17. Littner MR, Kushida C, Wise M, et al. 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.
18. Fronczek R, Middelkoop HA, van Dijk JG, Lammers GJ Focusing on vigilance instead of sleepiness in the assessment of narcolepsy: high sensitivity of the Sustained Attention to Response Task (SART). Sleep 2006, 29:187-191.
19. Diagnostic and statistical manual of mental disorders 2000, American Psychiatric Association, The American Psychiatric Association, Washington, DC. fourth edition (DSM-IV-TR).
20. Randomized trial of Modafinil as a treatment for the excessive daytime somnolence of narcolepsy. Neurology 2000, 54:1166-1175. US Modafinil in Narcolepsy Multicenter Study Group.
21. Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. Ann Neurol 1998, 43:88-97. US Modafinil in Narcolepsy Multicenter Study Group.
22. Committee for Medical Products for Human Use. Missing data in confirmatory clinical trials. CPMP/EWP/1776/99, April, 2009.
23. Sander K, Kottke T, Stark H Histamine H3 receptor antagonists go to clinics. Biol Pharm Bull 2008, 31:2163-2181.
24. Schwartz JC The histamine H3 receptor: from discovery to clinical trials with Pitolisant. Br J Pharmacol 2011, 163:713-721.
25. Uguen M, Perrin D, Belliard S, et al. Preclinical evaluation of the abuse potential of Pitolisant, a histamine H3 receptor inverse agonist/antagonist. Br J Pharmacol 2012, 169:632-644.
26. Murillo-Rodríguez E, Haro R, Palomero-Rivero M, Millán-Aldaco D, Drucker-Colín R Modafinil enhances extracellular levels of dopamine in the nucleus accumbens and increases wakefulness in rats. Behav Brain Res 2007, 176:353-357.
27. Volkow ND, Fowler JS, Logan J, et al. Effects of modafinil on dopamine and dopamine transporters in the male human brain: clinical implications. JAMA 2009, 301:1148-1154.
28. Ligneau X, Perrin D, Landais L, et al. Pitolisant [1-{3-[3-(4-Chlorophenyl) propoxy] propyl} piperidine, hydrochloride], a non-imidazole inverse agonist/antagonist at the human histamine H3 receptor: Preclinical pharmacology. J Pharmacol Exp Ther 2007, 320:365-375.