drugset / Trial / NCT04174365
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Phase 3
Completed
119 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-10-30
- Primary completion
- 2022-08-08
- Completion
- 2022-09-09
Outcome
Missed primary endpoint
registry analysis (superiority test); Brexpiprazole vs Placebo; p = 0.4597; Least squares (LS) mean difference -1.22 (95% CI -4.49 to 2.05) NCT04174365 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 1.5 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |