At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 119 enrolled
Drug / intervention
Brexpiprazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 22, 2019·Updated Aug 28, 2025
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole and Placebo for Irritability Associated With Autism Spectrum Disorder (ASD). Completed, enrolled 119 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartOct 2019
First PostedNov 2019
Primary CompletionAug 2022
Study CompletionSep 2022
TodayJul 2026
First PostedNov 22, 2019
Enrollment StartOct 30, 2019
Primary CompletionAug 8, 2022
Study CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.6 years ago
Interventions
Brexpiprazoledrug
Oral tablet; take once daily
Placebodrug
Administered orally daily for up to Week 8.