At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 95 enrolled
Drug / intervention
Brexpiprazoledrug
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, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Feb 6, 2020·Updated May 30, 2024
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Irritability Associated With Autism Spectrum Disorder. Completed, enrolled 95 participants across 28 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedFeb 2020
Primary CompletionMar 2023
TodayJul 2026
First PostedFeb 6, 2020
Enrollment StartJan 23, 2020
Primary CompletionMar 16, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.4 years ago
Interventions
Brexpiprazoledrug
Oral tablet; taken once daily