Irritability Associated With Autism Spectrum Disorder
Conditions
Interventions
Trade Name: Rexulti
Product Name: Rexulti
Pharmaceutical Form: Tablet
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study Autism Spectrum Disorder Completion of 331-201-00148 trial Investigator assessment Are the trial subjects under 18? yes Number of subjects for this age range: 95 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose Female with positive pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the long-term safety and tolerability 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 frequency and severity of adverse events (AEs), serious AEs (SAEs), and discontinuation from the trial due to AEs. change from baseline to post-baseline time points in 1) vital sign measurements, 2) electrocardiogram (ECG) parameters, 3) clinical laboratory tests (including prolactin) and urinalysis, and 4) physical examination findings. Analysis of potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS). Changes from baseline to post-baseline time points in results from EPS scales (Simpson Angus Scale [SAS], Abnormal Involuntary Movement Scale [AIMS], and Barnes Akathisia Rating Scale [BARS]). Percentage of subjects with clinically significant changes in weight (gain or loss) from baseline to specified time points. Time to discontinuation.;Timepoint(s) of evaluation of this end point: Pending | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to Week 26 in the Aberrant Behavior Checklist - Irritability (ABC-I) subscale score. Change from baseline to Week 26 in Clinical Global Impression - Severity (CGI S) scale score targeted on irritabbility.;Timepoint(s) of evaluation of this end point: Pending | — |
Countries
United States
Contacts
Public ContactKrista Martinko
Otsuka Pharmaceutical Development & Commercialization, Inc.
Outcome results
None listed