Clinical trial NCT04174365: Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritability Associated With Autism Spectrum Disorder (ASD)
Keywords: Autism
Irritability
Autism Spectrum Disorder
ASD
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2019-11-22
Enrollment: 119
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Key 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

Key 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

Primary outcomes:
measure: The mean change from baseline to Week 8 in the Aberrant Behavior Checklist- Irritability subscale score (ABC-I)
timeFrame: From baseline to Week 8 visit
Secondary outcomes:
measure: The mean change from baseline to Week 8 in the Clinical Global Impression- Severity of Illness Scale (CGI-S) score pertaining to irritability
timeFrame: From baseline to Week 8 visit
Other outcomes:
Locations:
city: Princeton
country: United States
facility: For additional information regarding sites
state: New Jersey
Study officials:
References: