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Long-term safety of brexpiprazole in children with ASD irritability
NCT04258839Phase 3Completed
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization
- Start
- Jan 2020
- Primary completion
- Mar 2023
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of brexpiprazole orally disintegrating tablet in Autism Spectrum Disorder (ASD), sponsored by Otsuka Pharmaceutical Development & Commercialization. Primary endpoints: Participants With Treatment-emergent Adverse Events at 29 weeks, Potentially Clinically Relevant Abnormalities in Vital Signs at 26 weeks and 7 more. Started Jan 2020; status: completed.
02
Drugs
brexpiprazole orally disintegrating tablet
03
Conditions
Autism Spectrum Disorder (ASD)
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