Irritability Associated With Autism Spectrum Disorder (ASD)
Conditions
Interventions
Trade Name: Rexulti
Product Name: Rexulti
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 [Time Frame: From baseline to Week 8 visit];Timepoint(s) of evaluation of this end point: Week 8 Visit | — |
Countries
United States
Contacts
Public ContactKrista Martinko
Otsuka Pharmaceutical Development & Commercialization, Inc.
Outcome results
None listed