Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period

PHASE3CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

June 6, 2016

Primary Completion Date

April 3, 2021

Study Completion Date

June 5, 2025

Conditions
Narcolepsy With CataplexyNarcolepsy Without Cataplexy
Interventions
DRUG

pitolisant

Tablet

DRUG

Placebo

Tablet

Trial Locations (11)

Unknown

Terveystalo Helsinki Uniklinikka, Helsinki

Hôpital Femme-Mère-Enfant, Bron

Hôpital Gui de Chauliac, Montpellier

Hôpital Robert Debré, Paris

Università di Bologna, Bologna

Polikliniek Heemstede Neurologist-Somnologist, Heemstede

"Scientific-Research Medical Complex Your Health", Kazan'

I.M. Sechenov First Moscow State Medical University, Moscow

V.M. Behterev National Medical Research Psychiatry and Neurology Center, Saint Petersburg

Samara Regional Clinical Hospital, Samara

N.I. Balaban Crimea Repiblic Clinical Psychiatric Hospital No. 1, Simferopol

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bioprojet

OTHER