Back to resultsBrexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
Primary Purpose
Irritability Associated With Autism Spectrum Disorder
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Irritability Associated With Autism Spectrum Disorder focused on measuring Autism, Autism Spectrum Disorder, ASD, Irritability
Eligibility 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
Sites / Locations
- For additional information regarding sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Brexpiprazole
Outcomes
Primary Outcome Measures
Adverse Events
Adverse Events occurring from baseline to Week 26
Secondary Outcome Measures
Aberrant Behavior Checklist (ABC-I)
Aberrant Behavior Checklist- Irritability subscale score (ABC-I)
Clinical Global Impression (CGI-S)
Clinical Global Impression - Severity (CGI-S)
Full Information
NCT ID
NCT04258839
First Posted
February 4, 2020
Last Updated
March 1, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT04258839
Brief Title
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
Official Title
A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent patients, aged 5 to 17, with irritability associated with autism spectrum disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritability Associated With Autism Spectrum Disorder
Keywords
Autism, Autism Spectrum Disorder, ASD, Irritability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Brexpiprazole
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Other Intervention Name(s)
OPC-34712, LuAF41156
Intervention Description
Oral tablet; taken once daily
Primary Outcome Measure Information:
Title
Adverse Events
Description
Adverse Events occurring from baseline to Week 26
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Aberrant Behavior Checklist (ABC-I)
Description
Aberrant Behavior Checklist- Irritability subscale score (ABC-I)
Time Frame
Baseline to Week 26
Title
Clinical Global Impression (CGI-S)
Description
Clinical Global Impression - Severity (CGI-S)
Time Frame
Baseline to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
For additional information regarding sites
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
We'll reach out to this number within 24 hrs