Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder ( Anchor )
- Conditions
- Irritability Associated With Autism Spectrum Disorder (ASD)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-000723-40-Outside-EU/EEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 119
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): The mean change from baseline to Week 8 in the Aberrant Behavior Checklist- Irritability subscale score (ABC-I) [Time Frame: From baseline to Week 8 visit];Timepoint(s) of evaluation of this end point: Week 8 visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The mean change from baseline to Week 8 in the Clinical Global Impression- Severity of Illness Scale (CGI-S) score pertaining to irritability<br>[Time Frame: From baseline to Week 8 visit];Timepoint(s) of evaluation of this end point: Week 8 Visit