Clinical trial NCT04258839: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritability Associated With Autism Spectrum Disorder
Keywords: Autism
Autism Spectrum Disorder
ASD
Irritability
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2020-02-06
Enrollment: 95
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs
timeFrame: From the first dose of study drug (in current study) up to 21 days after the last dose of study drug (up to approximately 29 weeks)
measure: Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs
timeFrame: Baseline (current study) up to Week 26
measure: Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline (current study) up to Week 26
measure: Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities
timeFrame: Baseline (current study) up to Week 26
measure: Number of Participants With Potentially Clinically Relevant Abnormal Physical Examination Values
timeFrame: Baseline (current study) up to Week 26
measure: Number of Participants With Suicidality as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (current study) up to Week 26
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in SAS Total Score at Week 14
timeFrame: Baseline and Week 14
measure: Change From Baseline in SAS Total Score at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in AIMS Total Score at Week 14
timeFrame: Baseline and Week 14
measure: Change From Baseline in AIMS Total Score at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in BARS Score at Week 14
timeFrame: Baseline and Week 14
measure: Change From Baseline in BARS Score at Week 26
timeFrame: Baseline and Week 26
measure: Percentage of Participants With Potentially Clinically Relevant Changes in Weight up to Week 14
timeFrame: Baseline up to Week 14
measure: Percentage of Participants With Potentially Clinically Relevant Changes in Weight up to Week 26
timeFrame: Baseline up to Week 26
measure: Time to Discontinuation Due to AE
timeFrame: Baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)
Secondary outcomes:
measure: Mean Change From Baseline to Week 26 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score
timeFrame: Baseline (current study), Week 26
measure: Mean Change From Baseline to Week 26 in Clinical Global Impression - Severity (CGI-S) Scale Score
timeFrame: Baseline (current study), Week 26
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Dothan Behavioral Medicine Clinic
state: Alabama
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
city: San Francisco
country: United States
facility: University of California San Francisco, Nancy Friend Pritzker Psychiatry
state: California
city: Orlando
country: United States
facility: APG Research
state: Florida
city: Chicago
country: United States
facility: Autism Assessment, Research, Treatment and Services (AARTS) center
state: Illinois
city: Lake Charles
country: United States
facility: Research site
state: Louisiana
city: Lexington
country: United States
facility: The Lurie Center for Autism
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Research site
state: Michigan
city: Columbia
country: United States
facility: Thompson Center for Autism and Neurodevelopment
state: Missouri
city: Saint Charles
country: United States
facility: Research site
state: Missouri
city: Lincoln
country: United States
facility: Alivation
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine Inc.
state: Nevada
city: Newark
country: United States
facility: Rutger's-New Jersey Medical Scholl Clinical Research Unit
state: New Jersey
city: Princeton
country: United States
facility: For additional information regarding sites
state: New Jersey
city: Mount Kisco
country: United States
facility: Bioscience Research
state: New York
city: New York
country: United States
facility: Research site
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Avon Lake
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: The Holloway Group, Inc
state: Oklahoma
city: Nashville
country: United States
facility: Access Clinical Trials
state: Tennessee
city: Austin
country: United States
facility: Research site
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: San Antonio
country: United States
facility: Research site
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio Long School of Medicine, Department of Psychiatry and Behavioral Sciences
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of the Woodlands
state: Texas
city: Woodstock
country: United States
facility: Woodstock Research Center
state: Vermont
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
Study officials:
References: