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Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
Study Identifier:
331-201-00191
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
Results Availables
Study Protocol
Available Language: English
Statistical Analysis Plan
Available Language: English
Study Details
Medical Condition
- Autism
Study Drug
- Drug: Brexpiprazole
Date
Jan 2020 - Mar 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5 - 17 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study
- Autism Spectrum Disorder
- Completion of 331-201-00148 trial
- Investigator assessment
Exclusion Criteria
- Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study
- Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose
- Female with positive pregnancy test
Protocol 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.
Study Locations
Location
Status
Location
Dothan Behavioral Medicine Clinic
Dothan, Alabama, United States, 36303
Status
N/A
Location
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
Status
N/A
Location
University of California San Francisco, Nancy Friend Pritzker Psychiatry
San Francisco, California, United States, 94143-3132
Status
N/A
Location
APG Research
Orlando, Florida, United States, 32803
Status
N/A
Location
Autism Assessment, Research, Treatment and Services (AARTS) center
Chicago, Illinois, United States, 60612
Status
N/A
Location
Research site
Lake Charles, Louisiana, United States, 70629
Status
N/A
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© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.
July 2025 01US25EUC0279
Requirements information
Inclusion criteria
- 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study
- Autism Spectrum Disorder
- Completion of 331-201-00148 trial
- Investigator assessment
Exclusion criteria
- Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study
- Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose
- Female with positive pregnancy test