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NCT04258839 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
NCT04258839 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 95 participants.
The verdict
NCT04258839, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
Study 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.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2020-01-23 |
| Est. Completion | 2023-03-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04258839
The ClinicalTrials.gov registry entry for NCT04258839 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT04258839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04258839 about?
NCT04258839 is a clinical study titled "Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148". 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.
What is the current status of trial NCT04258839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2020-01-23. Estimated completion is 2023-03-16.
What interventions are being tested in trial NCT04258839?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT04258839?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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