Journal article

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

Yves Dauvilliers, Claudio Bassetti, Gert Jan Lammers, Isabelle Amulf, Geert Mayer, Andrea Rodenbeck, Philippe Lehert, Claire-Li Ding, Jeanne-Marie Lecomte, Jean-Charles Schwartz

LANCET NEUROLOGY | ELSEVIER SCIENCE INC | Published : 2013

Abstract

BACKGROUND: Narcolepsy is characterised by excessive daytime sleepiness (EDS) and cataplexy. Histamine neurons are crucial to maintain wakefulness. We assessed the safety and efficacy of pitolisant (previously called BF2.649), a selective histamine H3 receptor inverse agonist that activates these neurons, in patients with narcolepsy. METHODS: For this double-blind, randomised, parallel-group controlled trial, we recruited patients with narcolepsy from 32 sleep disorder centres in five European countries. Patients were eligible if they were aged 18 years or older, had not taken psychostimulants for at least 14 days, and had EDS (defined as an Epworth Sleepiness Scale [ESS] score of at least 1..

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