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Could a sleep drug improve social skills in autism?

NCT ID NCT05953389

Symptom relief Sponsor: Bioprojet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Nov 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants and their parent(s)/legal guardian(s) are willing and able to give informed assent and consent for participation in the study. * Male children and adolescents aged from 6 to 17 inclusive for the duration of study participation. * Diagnosis of autism spectrum disorders (ASD) as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria confirmed by the Autism Diagnostic Observation Schedule (ADOS-2) or the Autism Diagnostic Interview-Revised (ADI-R). * Intelligence Quotient (IQ) ≥ 70 using Wechsler Intelligence Scale. * Social Responsiveness Scale Second Edition (SRS-2) total T-score ≥ 66 at screening and baseline. Exclusion Criteria: * Previous genetic diagnosis of ASD-known "syndromic" ASD (e.g., Fragile X syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q syndrome). * History of suicidal behavior or suicidal ideation in the past 12 months, or a positive answer to questions 4 or 5 on the Columbia-Suicide-Severity Rating Scale (C-SSRS) at screening and/or baseline, and/or is a significant risk for suicidal behavior per investigator judgement. * History or current diagnosis of epilepsy or any seizure occurring after the age of 5. * Clinically significant deviation from normal on 12-lead ECG that results in an active medical problem, per investigator judgement or, with a corrected QT interval by Fridericia (QTcF) \> 450ms at screening. * Severe hepatic impairment (Child Pugh C) or with any other hepatic significant abnormality in the physical examination or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 2x Upper Limit of Normal (ULN) for age at laboratory results.

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.