Yves Dauvilliers, Michel Lecendreux, Gert Jan Lammers, Patricia Franco, Mikhail Poluektov, Christian Caussé, Isabelle Lecomte, Jeanne Marie Lecomte, Philippe Lehert, Jean Charles Schwartz, Giuseppe Plazzi
BACKGROUND: Narcolepsy is a life-long disorder characterised by excessive daytime sleepiness and cataplexy, often arising in childhood or adolescence. Pitolisant, a selective histamine H3 receptor inverse agonist, has been approved in Europe and USA for adults with narcolepsy with or without cataplexy, with a favourable safety profile. This phase 3 study aimed to assess the safety and efficacy of pitolisant in children with narcolepsy with or without cataplexy. METHODS: For this double-blind, randomised, placebo-controlled, multisite study, we recruited patients aged 6-17 years with narcolepsy with or without cataplexy in 11 sleep centres in five countries (Italy, France, Netherlands, Russia, and Finland)...
April 2023: Lancet Neurology