Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
NCT ID: NCT04258839
Last Updated: 2024-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
95 participants
INTERVENTIONAL
2020-01-23
2023-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brexpiprazole
Participants received brexpiprazole based on the body weight for 26 weeks in this study.
Participants with body weight \< 50 kilograms (kg), received brexpiprazole tablets orally, once daily (QD) at dose of 0.25 mg on Days 1 to 3 followed by 0.5 mg on Days 4 to 7 and 1 mg on Days 8 to 14. Based on the investigator's judgment, the dose was increased to 1 or 1.5 mg starting from Day 15 until week 26.
Participants with body weight ≥ 50 kg received brexpiprazole tablet orally, QD at dose of 0.5 mg on Days 1 to 3, followed by 1.5 mg on Days 4 to 7, and 2 mg on Days 8 to 14. Based on the investigator's judgment the dose was increased to 1.5, 2, or 3 mg starting from Day 15 until week 26.
Brexpiprazole
Oral tablet; taken once daily
Interventions
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Brexpiprazole
Oral tablet; taken once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Autism Spectrum Disorder
* Completion of 331-201-00148 trial
* Investigator assessment
Exclusion Criteria
* 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
5 Years
17 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Family Psychiatry of the Woodlands
The Woodlands, Texas, United States
Woodstock Research Center
Woodstock, Vermont, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004899-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
331-201-00191
Identifier Type: -
Identifier Source: org_study_id
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