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
Public ClinicalTrials.gov record NCT05439616. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. 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.
Study identification
- NCT ID
- NCT05439616
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 161 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2022 (Actual)
- Primary completion
- Oct 4, 2024 (Actual)
- Completion
- Oct 4, 2024 (Actual)
- Last update posted
- Apr 4, 2025
2022 – 2024
United States locations
- U.S. sites
- 34
- U.S. states
- 10
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Center /ID# 245049 | Anaheim | California | 92805 | — |
| Sun Valley Research Center /ID# 243133 | Imperial | California | 92251-9401 | — |
| CHOC Children's Hospital /ID# 245577 | Orange | California | 92868-4203 | — |
| Pacific Clinical Research Management Group /ID# 243019 | Upland | California | 91786 | — |
| D&H Doral Research Center-Doral /ID# 255457 | Doral | Florida | 33122 | — |
| Sarkis Clinical Trials /ID# 242868 | Gainesville | Florida | 32607 | — |
| Advanced Research Institute of Miami /ID# 243179 | Homestead | Florida | 33030-4613 | — |
| Sandhill Research LLC /ID# 245079 | Lake Mary | Florida | 32746 | — |
| Axcess Medical Research /ID# 244952 | Loxahatchee Groves | Florida | 33470 | — |
| G+C Research Group, LLC /ID# 252016 | Miami | Florida | 33126-2018 | — |
| 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 | — |
| Asclepes Research Centers - Spring Hill /ID# 248682 | Spring Hill | Florida | 34609-5692 | — |
| D&H Tamarac Research Center /ID# 250436 | Tamarac | Florida | 33321-2979 | — |
| Atlanta Center for Medical Research /ID# 243124 | Atlanta | Georgia | 30331 | — |
| Atlanta Behavioral Research, LLC /ID# 243082 | Dunwoody | Georgia | 30338 | — |
| iResearch Savannah /ID# 254582 | Savannah | Georgia | 31405 | — |
| Alivation Research /ID# 242915 | Lincoln | Nebraska | 68526-9474 | — |
| Dr. Hosneara, M.D. LLC /ID# 252129 | Jackson Heights | New York | 11372-3922 | — |
| Richmond Behavioral Associates An Evolution Research Group Portfolio Company /ID# 259578 | Staten Island | New York | 10314-1607 | — |
| New Dawn Psychiatric Services PLLC /ID# 243697 | Kinston | North Carolina | 28501-1603 | — |
| Quest Therapeutics of Avon Lake /ID# 252013 | Avon Lake | Ohio | 44012 | — |
| Cincinnati Children's Hospital /ID# 243968 | Cincinnati | Ohio | 45229 | — |
| CincyScience /ID# 242993 | West Chester | Ohio | 45069 | — |
| BioBehavioral Research of Austin /ID# 255460 | Austin | Texas | 78759 | — |
| Relaro Medical Trials /ID# 243126 | Dallas | Texas | 75243 | — |
| Cedar Health Research /ID# 248683 | Dallas | Texas | 75251-2202 | — |
| AIM Trials /ID# 243120 | Plano | Texas | 75093 | — |
| Family Psychiatry of The Woodlands /ID# 242867 | The Woodlands | Texas | 77381 | — |
| Advanced Research Institute /ID# 243098 | Ogden | Utah | 84405 | — |
| Northwest Clinical Research Center /ID# 243083 | Bellevue | Washington | 98007 | — |
| Core Clinical Research /ID# 243084 | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05439616, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05439616 live on ClinicalTrials.gov.