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

Sponsor ID
331-201-00148
Clinicaltrials.gov ID
NCT04174365
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-201-00148
Trial Details
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Age
5 - 17 Years
Therapeutic Area
  • Autism
    • Sex
    Female & Male
    Trial Dates
    Oct 2019 - Aug 2022
    Healthy Volunteers
    No
    • 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
    • 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

    Study 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.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    119
    Additional Study Details

    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

    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
    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

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    For additional information regarding sites
    Princeton, New Jersey, United States, 08540
    Status
    N/A

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