Could a sleep drug improve social skills in autism?

NCT ID NCT05953389

Ongoing Symptom relief Sponsor: Bioprojet Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called pitolisant in 62 boys and teens aged 6 to 17 with autism. The goal is to see if it improves social skills and behavior. Participants are randomly assigned to receive the drug or a placebo, and neither they nor the researchers know who gets which. The study is in Phase 2, meaning it's still early and mainly checks for safety and effectiveness.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AUTISM SPECTRUM DISORDER

Contacts and locations

Locations

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

Foggia, 71122, Italy
Azienda ospedaliero-universitaria Senese

Siena, 53100, Italy
CH le Rouvray

Sotteville-lès-Rouen, 76300, France
Centre Hospitalier Charles Perrens

Bordeaux, 33076, France
Clinica Di Neuropsichiatria Infantile

Cagliari, 09121, Italy
Cognition Health

London, W1G 9JF, United Kingdom
Hospital Universitari Vall d'Hebron

Barcelona, 08030, Spain
Hospital Universitario de Burgos

Burgos, 09006, Spain
IRCCS Centro Neurolesi Bonino Pulejo

Messina, 98124, Italy
IRCCS Fondazione Stella Maris

Calambrone, 56128, Italy
IRCCS Instituto Neurologico Casimiro Mondino

Pavia, 27100, Italy
IRCCS-Istituto delle Scienze Neurologiche di Bologna

Bologna, 40139, Italy
Istituto Scientifico IRCCS E. Medea

Bosisio Parini, 23842, Italy
Nantes University Hospital

Nantes, 44093, France
Universita degli Studi di Napoli Federico II

Naples, 80131, Italy

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