Phase 3 N=95 Treatment

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

Irritability Associated With Autism Spectrum Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04258839 ↗

Enrolled (actual)

Serious AEs

3.2%

Results posted

May 2024

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs — 23; 24; 15; 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Brexpiprazole (Drug)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs	23; 24; 15; 19; 11; 12	—
PRIMARY Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs	4; 5; 1; 5; 0; 1	—
PRIMARY Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	1; 2; 1; 0; 1; 2	—
PRIMARY Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities	6; 2; 0; 2; 0; 1	—
PRIMARY Number of Participants With Potentially Clinically Relevant Abnormal Physical Examination Values	6; 4	—
PRIMARY Number of Participants With Suicidality as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)	4; 2	—
PRIMARY Change From Baseline in Simpson Angus Scale (SAS) Total Score at Week 2	-0.0; 0.0	—
PRIMARY Change From Baseline in SAS Total Score at Week 14	-0.1; 0.2	—
PRIMARY Change From Baseline in SAS Total Score at Week 26	-0.1; -0.0	—
PRIMARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Week 2	0.0; 0.14	—
PRIMARY Change From Baseline in AIMS Total Score at Week 14	0.0; 0.16	—
PRIMARY Change From Baseline in AIMS Total Score at Week 26	0.00; -0.04	—
PRIMARY Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 2	0.02; 0.05	—
PRIMARY Change From Baseline in BARS Score at Week 14	-0.05; 0.05	—
PRIMARY Change From Baseline in BARS Score at Week 26	0.00; -0.04	—
PRIMARY Percentage of Participants With Potentially Clinically Relevant Changes in Weight up to Week 14	45.0; 48.6; 0.0; 0.0	—
PRIMARY Percentage of Participants With Potentially Clinically Relevant Changes in Weight up to Week 26	71.8; 76.7; 0.0; 3.3	—
PRIMARY Time to Discontinuation Due to AE	83; 113	—
SECONDARY Mean Change From Baseline to Week 26 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score	-5.47; -7.00	—
SECONDARY Mean Change From Baseline to Week 26 in Clinical Global Impression - Severity (CGI-S) Scale Score	-0.78; -0.68	—

Summary

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.

Eligibility 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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04258839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.