--- title: 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 nct_id: NCT05439616 overall_status: COMPLETED phase: PHASE3 sponsor: AbbVie study_type: INTERVENTIONAL primary_condition: Autism Spectrum Disorder countries: United States, Puerto Rico canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05439616.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05439616" ct_last_update_post_date: 2025-04-04 last_seen_at: "2026-05-12T07:27:30.284Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **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 **NCT ID:** [NCT05439616](https://clinicaltrials.gov/study/NCT05439616) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 161 - **Lead Sponsor:** AbbVie - **Conditions:** Autism Spectrum Disorder - **Start Date:** 2022-07-07 - **Completion Date:** 2024-10-04 - **CT.gov Last Update:** 2025-04-04 ## Brief 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. 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. ## Eligibility - **Minimum age:** 5 Years - **Maximum age:** 17 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * 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). Exclusion Criteria: * 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. ``` ## Arms - **Cariprazine** (EXPERIMENTAL) — Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks. - **Placebo** (PLACEBO_COMPARATOR) — Participants will receive placebo once daily for 8-weeks. ## Interventions - **Cariprazine** (DRUG) — Oral Capsules or Oral Solution - **Placebo** (DRUG) — Oral capsules or Oral Solution ## Primary Outcomes - **Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score** _(time frame: Baseline (Week 0) to Week 8)_ — 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. ## Secondary Outcomes - **Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale** _(time frame: Week 8)_ - **Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score** _(time frame: Baseline (Week 0) to Week 8)_ - **Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score** _(time frame: Baseline (Week 0) to Week 8)_ ## Locations (36) - Advanced Research Center /ID# 245049, Anaheim, California, United States - Sun Valley Research Center /ID# 243133, Imperial, California, United States - CHOC Children's Hospital /ID# 245577, Orange, California, United States - Pacific Clinical Research Management Group /ID# 243019, Upland, California, United States - D&H Doral Research Center-Doral /ID# 255457, Doral, Florida, United States - Sarkis Clinical Trials /ID# 242868, Gainesville, Florida, United States - Advanced Research Institute of Miami /ID# 243179, Homestead, Florida, United States - Sandhill Research LLC /ID# 245079, Lake Mary, Florida, United States - Axcess Medical Research /ID# 244952, Loxahatchee Groves, Florida, United States - G+C Research Group, LLC /ID# 252016, Miami, Florida, United States - Medical Research Group of Central Florida /ID# 243170, Orange City, Florida, United States - K2 Medical Research - Orlando - South Orlando Avenue /ID# 248694, Orlando, Florida, United States - APG Research, LLC /ID# 243130, Orlando, Florida, United States - Nona Pediatric Center /ID# 245078, Orlando, Florida, United States - Asclepes Research Centers - Spring Hill /ID# 248682, Spring Hill, Florida, United States - D&H Tamarac Research Center /ID# 250436, Tamarac, Florida, United States - Atlanta Center for Medical Research /ID# 243124, Atlanta, Georgia, United States - Atlanta Behavioral Research, LLC /ID# 243082, Dunwoody, Georgia, United States - iResearch Savannah /ID# 254582, Savannah, Georgia, United States - Alivation Research /ID# 242915, Lincoln, Nebraska, United States - Dr. Hosneara, M.D. LLC /ID# 252129, Jackson Heights, New York, United States - Richmond Behavioral Associates An Evolution Research Group Portfolio Company /ID# 259578, Staten Island, New York, United States - New Dawn Psychiatric Services PLLC /ID# 243697, Kinston, North Carolina, United States - Quest Therapeutics of Avon Lake /ID# 252013, Avon Lake, Ohio, United States - Cincinnati Children's Hospital /ID# 243968, Cincinnati, Ohio, United States - CincyScience /ID# 242993, West Chester, Ohio, United States - BioBehavioral Research of Austin /ID# 255460, Austin, Texas, United States - Relaro Medical Trials /ID# 243126, Dallas, Texas, United States - Cedar Health Research /ID# 248683, Dallas, Texas, United States - AIM Trials /ID# 243120, Plano, Texas, United States - Family Psychiatry of The Woodlands /ID# 242867, The Woodlands, Texas, United States - Advanced Research Institute /ID# 243098, Ogden, Utah, United States - Northwest Clinical Research Center /ID# 243083, Bellevue, Washington, United States - Core Clinical Research /ID# 243084, Everett, Washington, United States - Dr. Samuel Sanchez PSC /ID# 245739, Caguas, Puerto Rico - GCM Medical Group PSC /ID# 245735, San Juan, Puerto Rico ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.advanced research center /id# 245049|anaheim|california|united states` — added _(2026-05-12)_ - `locations.sun valley research center /id# 243133|imperial|california|united states` — added _(2026-05-12)_ - `locations.choc children's hospital /id# 245577|orange|california|united states` — added _(2026-05-12)_ - `locations.pacific clinical research management group /id# 243019|upland|california|united states` — added _(2026-05-12)_ - `locations.d&h doral research center-doral /id# 255457|doral|florida|united states` — added _(2026-05-12)_ - `locations.sarkis clinical trials /id# 242868|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.advanced research institute of miami /id# 243179|homestead|florida|united states` — added _(2026-05-12)_ - `locations.sandhill research llc /id# 245079|lake mary|florida|united states` — added _(2026-05-12)_ - `locations.axcess medical research /id# 244952|loxahatchee groves|florida|united states` — added _(2026-05-12)_ - `locations.g+c research group, llc /id# 252016|miami|florida|united states` — added _(2026-05-12)_ - `locations.medical research group of central florida /id# 243170|orange city|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research - orlando - south orlando avenue /id# 248694|orlando|florida|united states` — added _(2026-05-12)_ - `locations.apg research, llc /id# 243130|orlando|florida|united states` — added _(2026-05-12)_ - `locations.nona pediatric center /id# 245078|orlando|florida|united states` — added _(2026-05-12)_ - `locations.asclepes research centers - spring hill /id# 248682|spring hill|florida|united states` — added _(2026-05-12)_ - `locations.d&h tamarac research center /id# 250436|tamarac|florida|united states` — added _(2026-05-12)_ - `locations.atlanta center for medical research /id# 243124|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.atlanta behavioral research, llc /id# 243082|dunwoody|georgia|united states` — added _(2026-05-12)_ - `locations.iresearch savannah /id# 254582|savannah|georgia|united states` — added _(2026-05-12)_ - `locations.alivation research /id# 242915|lincoln|nebraska|united states` — added _(2026-05-12)_ - `locations.dr. hosneara, m.d. llc /id# 252129|jackson heights|new york|united states` — added _(2026-05-12)_ - `locations.richmond behavioral associates an evolution research group portfolio company /id# 259578|staten island|new york|united states` — added _(2026-05-12)_ - `locations.new dawn psychiatric services pllc /id# 243697|kinston|north carolina|united states` — added _(2026-05-12)_ - `locations.quest therapeutics of avon lake /id# 252013|avon lake|ohio|united states` — added _(2026-05-12)_ - `locations.cincinnati children's hospital /id# 243968|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.cincyscience /id# 242993|west chester|ohio|united states` — added _(2026-05-12)_ - `locations.biobehavioral research of austin /id# 255460|austin|texas|united states` — added _(2026-05-12)_ - `locations.relaro medical trials /id# 243126|dallas|texas|united states` — added _(2026-05-12)_ - `locations.cedar health research /id# 248683|dallas|texas|united states` — added _(2026-05-12)_ - `locations.aim trials /id# 243120|plano|texas|united states` — added _(2026-05-12)_ - `locations.family psychiatry of the woodlands /id# 242867|the woodlands|texas|united states` — added _(2026-05-12)_ - `locations.advanced research institute /id# 243098|ogden|utah|united states` — added _(2026-05-12)_ - `locations.northwest clinical research center /id# 243083|bellevue|washington|united states` — added _(2026-05-12)_ - `locations.core clinical research /id# 243084|everett|washington|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05439616.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05439616* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*