Could a sleep drug improve social skills in autism?

NCT ID NCT05953389

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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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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