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Autism irritability drug trial ends early: what happened?

NCT ID NCT05555615

Symptom relief Sponsor: ACADIA Pharmaceuticals Inc. 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at the long-term safety of pimavanserin for treating irritability in children and teens (ages 5-17) with autism. It was an extension of an earlier 6-week study, lasting 52 weeks. The trial was terminated early, and results are not yet fully available.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

209 people

The number who actually took part.

Started

Nov 2022

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

5 to 18 years

Sex

Anyone

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: * Has completed the treatment period of study ACP-103-069 * Informed consent prior to the conduct of any study procedures * Continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property * Continues to be medically stable at enrollment * For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test EXCLUSION CRITERIA: * Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study * Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate), medications that prolong the QT interval; and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers * At a significant risk of suicide, or is a danger to self or others * At risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others * Positive urine drug test * Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies * Any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results * Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities * Weight \<15 kg * Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

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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.

Irritability associated with autism spectrum disorder

Contacts and locations

Locations

  • 1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers

    Centennial, Colorado, 80112, United States

  • AIM Trials, LLC

    Plano, Texas, 75093, United States

  • AMR Baber Research Incorporated

    Naperville, Illinois, 60563, United States

  • APG Research, LLC

    Orlando, Florida, 32803-3809, United States

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Integrata di Verona (AOUI)

    Verona, 37126, Italy

  • Békés Megyei Központi Kórház

    Gyula, H-5700, Hungary

  • CHU de Nantes

    Nantes, 44093, France

  • Centre Hospitalier Charles Perrens

    Bordeaux, 33076, France

  • Centre de Ressources Autisme Rhône-Alpes - Center Hospitalier le Vinatier

    Bron, 69678, France

  • Centrum Badań Klinicznych PI-House Sp. z o.o.

    Gdansk, 80-546, Poland

  • Centrum Neuropsychiatrii Neuromed SP ZOZ

    Wroclaw, 54-238, Poland

  • Children's Health Queensland Hospital and Health Service

    South Brisbane, Queensland, 4101, Australia

  • Children's Research Institute

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Clinical Center of Vojvodina, Clinic for Psychiatry

    Novi Sad, 21000, Serbia

  • Clinical Research of Southern Nevada, LLC

    Las Vegas, Nevada, 89128, United States

  • Cortica Inc.

    San Rafael, California, 94903, United States

  • Cortica Inc. (Glendale)

    Glendale, California, 91361, United States

  • ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington, 98201, United States

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS

    Pavia, 27100, Italy

  • Fondazione PTV - Policlinico Tor Vergata

    Rome, 00133, Italy

  • Gdańskie Centrum Zdrowia Sp. z o.o.

    Gdansk, 80-542, Poland

  • Ginemedica Sp. Zoo, S. K.

    Wroclaw, 50-414, Poland

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General de Alicante

    Alicante, 03010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Institut Global d´Atenció Integral del Neurodesenvolupament (IGAIN)

    Barcelona, 08007, Spain

  • Institute of Mental Health

    Belgrade, 11000, Serbia

  • L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot

    Paris, 75019, France

  • La Nostra Famiglia - Scientifica IRCCS Eugenio Medea

    Bosisio Parini, LC, 23842, Italy

  • Magyarországi Református Egyház Bethesda Gyermekkórháza

    Budapest, H-1146, Hungary

  • MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-Boguslawska

    Wroclaw, 54-617, Poland

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Murdoch Children's Research Institute

    Parkville, Victoria, 3052, Australia

  • NAVICULA - Centrum Diagnozy i Terapii Autyzmu

    Lodz, 91-129, Poland

  • Policlinico Riuniti - Azienda Ospedaliero Universitaria

    Foggia, 71122, Italy

  • Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC

    Avon Lake, Ohio, 44012, United States

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090, United States

  • Relaro Medical Trials, LLC

    Dallas, Texas, 75243, United States

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006, United States

  • Szegedi Tudományegyetem

    Szeged, H-6725, Hungary

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146, United States

  • The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials

    Gainesville, Florida, 32607, United States

  • University Clinical Center Kragujevac, Clinic for Psychiatry

    Kragujevac, 34000, Serbia

  • University Clinical Center Nis, Center for Mental Health

    Niš, 18000, Serbia

More trials for these conditions

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