Trials / Completed
CompletedNCT04258839
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexpiprazole | Oral tablet; taken once daily |
Timeline
- Start date
- 2020-01-23
- Primary completion
- 2023-03-16
- Completion
- 2023-03-16
- First posted
- 2020-02-06
- Last updated
- 2024-05-30
- Results posted
- 2024-05-30
Locations
28 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04258839. Inclusion in this directory is not an endorsement.