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Autism Spectrum DisorderPhase 3NCT05439616

Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD

A Phase 3 study testing Cariprazine in people with Autism Spectrum Disorder, run by AbbVie at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Cariprazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
36 sitesin 2 countries
Study dates
7 Jul 2022to 4 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants at the time of screening must have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL) administered at screening (Visit 1) by a trained clinician.
  • Participants must have an Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) subscale score ≥ 18 (Visits 1 and 2).
  • Participants must have a Clinical Global Impressions - Severity - Irritability (CGI-S Irritability) score ≥ 4 at screening (Visits 1 and 2).

Who cannot join

  • Participants with diagnosis of intellectual disability (Intelligence quotient < 25).
  • No history of major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition, as excluded by administration of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL).
  • History of ASD that is associated with Rett Disorder, Fragile-X Syndrome, or Childhood Disintegrative Disorder.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States34 sites

  • Advanced Research Center /ID# 245049

    Anaheim, California, 92805

  • Atlanta Center for Medical Research /ID# 243124

    Atlanta, Georgia, 30331

  • BioBehavioral Research of Austin /ID# 255460

    Austin, Texas, 78759

  • Quest Therapeutics of Avon Lake /ID# 252013

    Avon Lake, Ohio, 44012

  • Northwest Clinical Research Center /ID# 243083

    Bellevue, Washington, 98007

  • Cincinnati Children's Hospital /ID# 243968

    Cincinnati, Ohio, 45229

  • Relaro Medical Trials /ID# 243126

    Dallas, Texas, 75243

  • Cedar Health Research /ID# 248683

    Dallas, Texas, 75251-2202

  • D&H Doral Research Center-Doral /ID# 255457

    Doral, Florida, 33122

  • Atlanta Behavioral Research, LLC /ID# 243082

    Dunwoody, Georgia, 30338

  • Core Clinical Research /ID# 243084

    Everett, Washington, 98201

  • Sarkis Clinical Trials /ID# 242868

    Gainesville, Florida, 32607

  • Advanced Research Institute of Miami /ID# 243179

    Homestead, Florida, 33030-4613

  • Sun Valley Research Center /ID# 243133

    Imperial, California, 92251-9401

  • Dr. Hosneara, M.D. LLC /ID# 252129

    Jackson Heights, New York, 11372-3922

  • New Dawn Psychiatric Services PLLC /ID# 243697

    Kinston, North Carolina, 28501-1603

  • Sandhill Research LLC /ID# 245079

    Lake Mary, Florida, 32746

  • Alivation Research /ID# 242915

    Lincoln, Nebraska, 68526-9474

  • Axcess Medical Research /ID# 244952

    Loxahatchee Groves, Florida, 33470

  • G+C Research Group, LLC /ID# 252016

    Miami, Florida, 33126-2018

  • Advanced Research Institute /ID# 243098

    Ogden, Utah, 84405

  • CHOC Children's Hospital /ID# 245577

    Orange, California, 92868-4203

  • Medical Research Group of Central Florida /ID# 243170

    Orange City, Florida, 32763

  • K2 Medical Research - Orlando - South Orlando Avenue /ID# 248694

    Orlando, Florida, 32751

  • APG Research, LLC /ID# 243130

    Orlando, Florida, 32803

  • Nona Pediatric Center /ID# 245078

    Orlando, Florida, 32829-8070

  • AIM Trials /ID# 243120

    Plano, Texas, 75093

  • iResearch Savannah /ID# 254582

    Savannah, Georgia, 31405

  • Asclepes Research Centers - Spring Hill /ID# 248682

    Spring Hill, Florida, 34609-5692

  • Richmond Behavioral Associates An Evolution Research Group Portfolio Company /ID# 259578

    Staten Island, New York, 10314-1607

  • D&H Tamarac Research Center /ID# 250436

    Tamarac, Florida, 33321-2979

  • Family Psychiatry of The Woodlands /ID# 242867

    The Woodlands, Texas, 77381

  • Pacific Clinical Research Management Group /ID# 243019

    Upland, California, 91786

  • CincyScience /ID# 242993

    West Chester, Ohio, 45069

Other trials in United States

Puerto Rico2 sites

  • Dr. Samuel Sanchez PSC /ID# 245739

    Caguas, 00727

  • GCM Medical Group PSC /ID# 245735

    San Juan, 00917-3104

Other trials in Puerto Rico

About this study

Official title: An 8-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Cariprazine in the Treatment of Pediatric Subjects (5 to 17 Years of Age) With Autism Spectrum Disorder

Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Autistic infants tend to avoid eye contact and show little interest in others. This study will assess how safe and effective cariprazine is in treating pediatric participants (5 to 17 years of age) with ASD. Adverse events and change in disease activity will be assessed.

Cariprazine is an investigational drug being developed for the treatment of irritability due to ASD. This study is double-blinded means that neither the participants nor the study doctors will know who will be given cariprazine and who will be given placebo (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 152 participants diagnosed with ASD will be enrolled in approximately 40 sites globally.

Read more

Participants will receive oral capsules or oral solution of cariprazine or placebo once daily for 8-weeks and will undergo a 4-week safety follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Being tested
Cariprazine, Placebo
Keywords
Autism Spectrum Disorder, Cariprazine, VRAYLAR, AGN-241780
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CariprazineDrug

    Also called VRAYLAR, AGN-241780

    Oral Capsules or Oral Solution

  • PlaceboDrug

    Oral capsules or Oral Solution

Study groups in NCT05439616
Study groupRoleWhat they receive
CariprazineExperimentalParticipants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
Receives: Drug: Cariprazine
PlaceboPlacebo comparatorParticipants will receive placebo once daily for 8-weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score

    The Aberrant Behavior Checklist (ABC) - Community version is a 58-item, caregiver-rated scale designed to measure inappropriate and maladaptive behavior of people with developmental disabilities (including intellectual disability and ASD). The ABC has 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity and Inappropriate Speech). The caregiver rates the child's behavior from 0=not at all a problem to 3= the problem is severe in degree. The range for Irritability is 0 to 45. Higher scores indicate greater severity.

    Measured: Baseline (Week 0) to Week 8

Secondary outcomes (3)

  1. Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale

    The Clinical Global Impression - Change-Irritability (CGI-C Irritability) is a single-item rating scale that assesses change in the severity of a participant's irritability from the clinician's perspective. The CGI-C Irritability 7-point graded response scale (1 = "Very much improved," 2 = "Much improved," 3 = "Minimally improved," 4 = "No change," 5 = "Minimally worse," 6 = "Much worse," or 7 = "Very much worse").

    Measured: Week 8

  2. Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score

    PRAS-ASD is a 25-item caregiver-reported measure of anxiety in participants aged 3 to 17 with ASD. All items use a 4-point response scale: 0 = "None (not present);" 1 = "Mild (present sometimes, not a real problem);" 2 = "Moderate (often present and a problem);" 3 = "Severe (very frequent and a major problem)." Total score ranges from 0 to 75, with higher scores indicating greater severity of anxiety.

    Measured: Baseline (Week 0) to Week 8

  3. Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score

    CGSQ SF-7 is a caregiver-reported 7-item measure of self-reported strain that focuses on the impact of caring for a child with emotional and behavioral problems. Responses are scored on a 5-point scale (1 = "Not at all," 2 = "A little;" 3 = "Somewhat;" 4 = "Quite a bit;" and 5 "Very much") with higher scores indicating greater caregiver strain.

    Measured: Baseline (Week 0) to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2022
  2. Study start7 Jul 2022
  3. Primary completion4 Oct 2024
  4. Study completion4 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05439616
Sponsor's protocol ID
M21-465
Status last verified
Apr 2025
First submitted
28 Jun 2022
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Autism Spectrum Disorder, run by AbbVie at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score (time frame: Baseline (Week 0) to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05439616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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