Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

Study Identifier:
331-201-00148
ClinicalTrials.gov Identifier:
NCT04174365
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • Autism
Study Drug
  • Drug: Brexpiprazole
  • Drug: Placebo
Date
Oct 2019 - Aug 2022
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5 - 17 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD
  • Aberrant Behavior checklist - Irritability (ABC-I) subscale score of ≥ 18
  • Clinical Global Impressions - Severity (CGI-S) scale score pertaining to irritability ≥ 4
  • Mental age of ≥ 2 years as determined by Investigator based upon school participation, social history or medical records
  • Ability for parent/caregiver to follow all protocol procedures
  • Able to swallow tablets
  • Able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period
Exclusion Criteria
  • Primary diagnosis of bipolar I disorder, including any DSM-5 current diagnosis of bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode, and post-traumatic stress disorder (PTSD). Attention-deficit/hyperactivity disorder (ADHD) maybe exclusionary if it is the primary disorder, or is not stable or adequately treated.
  • current or historical diagnosis of Fragile-X Syndrome or Rett's Disorder
  • history of neuroleptic malignant syndrome
  • a significant risk of committing violent acts, serious self-harm, or suicide
  • epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions
  • current hypothyroidism or hyperthyroidism
  • uncontrolled Type I or Type II diabetes
  • uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
  • Weight \< 15 kg
  • Previous exposure to brexpiprazole
  • Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study

Protocol Summary

The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.

Study Locations

Location
Status
Location
For additional information regarding sites
Princeton, New Jersey, United States, 08540
Status
N/A
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Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD
  • Aberrant Behavior checklist - Irritability (ABC-I) subscale score of ≥ 18
  • Clinical Global Impressions - Severity (CGI-S) scale score pertaining to irritability ≥ 4
  • Mental age of ≥ 2 years as determined by Investigator based upon school participation, social history or medical records
  • Ability for parent/caregiver to follow all protocol procedures
  • Able to swallow tablets
  • Able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period
Exclusion criteria
  • Primary diagnosis of bipolar I disorder, including any DSM-5 current diagnosis of bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode, and post-traumatic stress disorder (PTSD). Attention-deficit/hyperactivity disorder (ADHD) maybe exclusionary if it is the primary disorder, or is not stable or adequately treated.
  • current or historical diagnosis of Fragile-X Syndrome or Rett's Disorder
  • history of neuroleptic malignant syndrome
  • a significant risk of committing violent acts, serious self-harm, or suicide
  • epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions
  • current hypothyroidism or hyperthyroidism
  • uncontrolled Type I or Type II diabetes
  • uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
  • Weight \< 15 kg
  • Previous exposure to brexpiprazole
  • Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study

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