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
Completed · Phase 3 · NCT05439616
Conditions: Autism Spectrum Disorder
At a glance
- Research payments reported, 2025
- $76,858
- U.S. investigators named
- 11
- Sites paid
- 11
- Planned or actual enrollment
- 161
About the trial
- Sponsor
- AbbVie
- Tested
- Cariprazine (drug), Placebo (drug)
- Dates
- Started 2022-07-07; completion 2024-10-04
- Results posted
- Not yet
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 th…
From ClinicalTrials.gov, last updated 2025-04-04. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $76,858 in research payments for this study in 2025 (21 payments).
Products named: Vraylar
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Ezekiel Fink, MD Pain Medicine · Beverly Hills, CA
- Jonathan T. Megerian, M.D., PH.D. Child Neurology · Orange, CA
- Salma H. Elfaki, MD Pediatrics · Orlando, FL
- Imad Jandali, MD Pediatrics · Spring Hill, FL
- Yael R. Elfassy, M.D. Pediatrics · Savannah, GA
- Rennan M. Quijano, M.D. Pediatrics · Madisonville, KY
- Waqar A. Siddiqui, MD Psychiatry · Staten Island, NY
- Diab Almhana, MD Psychiatry · Avon Lake, OH
- Sejal Patel, M.D. Military Health Care Provider · Columbia, SC
- Seema A. Gupta, M.D. Psychiatry · Dallas, TX
- James A. Knutson, M.D. Prescribing Psychologist · Kirkland, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Eastside Therapeutic Resource Inc $16,250
- Cedar Health Research LLC $14,074
- Haidar Almhana Nieding LLC $9,472
- Relaro Medical Trials LLC $8,913
- Erg Clinical Research-New York PLLC $7,520
- Cenexel Iresearch LLC $7,255
- Univ Clinical Research-Deland LLC $4,119
- Advanced Research Center Inc $3,906
- Children's Hospital of Orange County, CA $2,835
- Asclepes Research Centers PC $1,750
- K2 Medical Research $765
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.