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

Conditions

• Autism Spectrum Disorder

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine — DRUG
  Oral Capsules or Oral Solution
• Placebo — DRUG
  Oral capsules or Oral Solution

Study Details

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.

Key Dates

Start date

Jul 7, 2022

Status verified

Apr 2025

Primary completion

Oct 4, 2024

Completion

Oct 4, 2024

Study Design

Enrollment

161 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cariprazine
  Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
• Placebo Comparator: Placebo
  Participants will receive placebo once daily for 8-weeks.

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 ]

Locations (34)

Find similar trials in Anaheim, CA

Related Studies

• Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
  PHASE2 · Recruiting · Montefiore Medical Center · New York, New York
• Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy
  Enrolling By Invitation · University of California, Davis · Sacramento, California
• Longitudinal Study of Neurogenetic Disorders
  Recruiting · Columbia University · New York, New York
• Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
  Recruiting · Stanford University · Stanford, California