Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

Completed · Phase 3

Conditions studied: Irritability Associated With Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT04258839

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

95

Starts

2020-01-23

Expected to finish

2023-03-16

Last updated by the study team

2024-05-30

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dothan Behavioral Medicine Clinic — Dothan, Alabama, United States
• Southwest Autism Research and Resource Center — Phoenix, Arizona, United States
• University of California San Francisco, Nancy Friend Pritzker Psychiatry — San Francisco, California, United States
• APG Research — Orlando, Florida, United States
• Autism Assessment, Research, Treatment and Services (AARTS) center — Chicago, Illinois, United States
• Research site — Lake Charles, Louisiana, United States
• The Lurie Center for Autism — Lexington, Massachusetts, United States
• Research site — Bloomfield Hills, Michigan, United States
• Thompson Center for Autism and Neurodevelopment — Columbia, Missouri, United States
• Research site — Saint Charles, Missouri, United States
• Alivation — Lincoln, Nebraska, United States
• Center for Psychiatry and Behavioral Medicine Inc. — Las Vegas, Nevada, United States
• Rutger's-New Jersey Medical Scholl Clinical Research Unit — Newark, New Jersey, United States
• For additional information regarding sites — Princeton, New Jersey, United States
• Bioscience Research — Mount Kisco, New York, United States
• Research site — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Research Site — Avon Lake, Ohio, United States
• The Holloway Group, Inc — Oklahoma City, Oklahoma, United States
• Access Clinical Trials — Nashville, Tennessee, United States
• Research site — Austin, Texas, United States
• Cedar Health Research — Dallas, Texas, United States
• Research site — San Antonio, Texas, United States
• UT Health San Antonio Long School of Medicine, Department of Psychiatry and Behavioral Sciences — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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