Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

December 20, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

November 30, 2025

Conditions
Autism Spectrum Disorder
Interventions
DRUG

Pitolisant

histamine H3 receptor antagonist/inverse agonist

DRUG

Placebo

Matching placebo of pitolisant tablets

Trial Locations (15)

23842

Istituto Scientifico IRCCS E. Medea, Bosisio Parini

27100

IRCCS Instituto Neurologico Casimiro Mondino, Pavia

33076

Centre Hospitalier Charles Perrens, Bordeaux

40139

IRCCS-Istituto delle Scienze Neurologiche di Bologna, Bologna

44093

Nantes University Hospital, Nantes

53100

Azienda ospedaliero-universitaria Senese, Siena

56128

IRCCS Fondazione Stella Maris, Calambrone

71122

A.O.U Ospedali Riuniti di Foggia- Cardiologia (U.O.C), Foggia

76300

CH le Rouvray, Sotteville-lès-Rouen

80131

Universita degli Studi di Napoli Federico II, Napoli

98124

IRCCS Centro Neurolesi Bonino Pulejo, Messina

09121

Clinica Di Neuropsichiatria Infantile, Cagliari

08030

Hospital Universitari Vall d'Hebron, Barcelona

09006

Hospital Universitario de Burgos, Burgos

W1G 9JF

Cognition Health, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bioprojet

OTHER