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.
Age range
5 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs
Timeframe: From the first dose of study drug (in current study) up to 21 days after the last dose of study drug (up to approximately 29 weeks)
Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs
Timeframe: Baseline (current study) up to Week 26
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities
Timeframe: Baseline (current study) up to Week 26
Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities
Timeframe: Baseline (current study) up to Week 26
Number of Participants With Potentially Clinically Relevant Abnormal Physical Examination Values
Timeframe: Baseline (current study) up to Week 26
Number of Participants With Suicidality as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: Baseline (current study) up to Week 26
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Week 2
Timeframe: Baseline and Week 2
Change From Baseline in SAS Total Score at Week 14
Timeframe: Baseline and Week 14
Change From Baseline in SAS Total Score at Week 26
Timeframe: Baseline and Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Week 2
Timeframe: Baseline and Week 2
Change From Baseline in AIMS Total Score at Week 14
Timeframe: Baseline and Week 14
Change From Baseline in AIMS Total Score at Week 26
Timeframe: Baseline and Week 26
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 2
Timeframe: Baseline and Week 2
Change From Baseline in BARS Score at Week 14
Timeframe: Baseline and Week 14
Change From Baseline in BARS Score at Week 26
Timeframe: Baseline and Week 26
Percentage of Participants With Potentially Clinically Relevant Changes in Weight up to Week 14
Timeframe: Baseline up to Week 14
Percentage of Participants With Potentially Clinically Relevant Changes in Weight up to Week 26
Timeframe: Baseline up to Week 26
Time to Discontinuation Due to AE
Timeframe: Baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)