drugset / Trial / NCT04258839
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
Phase 3
Completed
95 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-01-23
- Primary completion
- 2023-03-16
- Completion
- 2023-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 1 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 1.5 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 2 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |