Trial · NCT04174365

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

NCT04174365, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-08-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder. Trials, record NCT04174365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04174365

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
NCT number: NCT04174365
Status: Completed
Phases: Phase 3
Enrollment: 119 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Irritability Associated With Autism Spectrum Disorder (ASD)
Interventions: Brexpiprazole, Placebo
First posted: 2019-11-22
Last updated: 2025-08-28
Results first posted: 2025-08-28

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline to Week 8 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score	Baseline to Week 8	The ABC is a parent-reported rating scale designed to assess treatment effects on problem behavior in participants with intellectual disabilities. The ABC scale has 58 items, which divide into 5 subscales as follows: (1) Irritability, Agitation; (2) Lethargy, Social Withdrawal; (3) Stereotypic Behavior; (4) Hyperactivity, Noncompliance; and (5) Inappropriate Speech. Each of the 58 ABC items is rated on a 4-point scale (0=not at all a problem; 1=the behavior is a problem, but slight in degree;2=the problem is moderately serious; 3=the problem is severe in degree). ABC-I measures emotional and behavioral symptoms of ASD, including aggression toward others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. ABC-I total score is the sum of the ratings over 15 ABC items. Individual scores were summed, thus the ABC-I total score ranges from 0 to 45. Higher scores represent the worst condition. A negative change from baseline indicates improvement.
Secondary	Mean Change From Baseline to Week 8 in Clinical Global Impression - Severity (CGI-S) Score	Baseline to Week 8	The CGI-S scale is a clinician-rated assessment that evaluates the severity of a participant's condition with a focus on symptoms of irritability on a 7-point scale. The investigator (or rater) answered the following question: "Considering your total clinical experience with this particular population, how ill was the participant at this time with regard to symptoms of irritability?" Response choices were 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. Higher scores indicate more severe illness. A negative change from baseline indicates improvement.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline to Week 8 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score	Baseline to Week 8	Efficacy sample included all randomized participants who took at least 1 dose of brexpiprazole or placebo and had baseline and at least 1 post-baseline assessment of the primary efficacy variable ABC-I subscale score during the double-blind treatment phase. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis at the specified time point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 8 in Clinical Global Impression - Severity (CGI-S) Score	Baseline to Week 8	Efficacy sample included all randomized participants who took at least 1 dose of brexpiprazole or placebo and had baseline and at least 1 post-baseline assessment of the primary efficacy variable ABC-I subscale score during the double-blind treatment phase. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis at the specified time point.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change From Baseline to Week 8 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score	Brexpiprazole	-10.1	Standard Error 1.28	score on a scale
Mean Change From Baseline to Week 8 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score	Placebo	-8.87	Standard Error 1.25	score on a scale
Mean Change From Baseline to Week 8 in Clinical Global Impression - Severity (CGI-S) Score	Brexpiprazole	-1.16	Standard Error 0.15	score on a scale
Mean Change From Baseline to Week 8 in Clinical Global Impression - Severity (CGI-S) Score	Placebo	-1.09	Standard Error 0.15	score on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brexpiprazole	60
Overall Study	STARTED	Placebo	59
Overall Study	Randomized Sample	Brexpiprazole	60
Overall Study	Randomized Sample	Placebo	59
Overall Study	Safety Sample	Brexpiprazole	58
Overall Study	Safety Sample	Placebo	57
Overall Study	Efficacy Sample	Brexpiprazole	58
Overall Study	Efficacy Sample	Placebo	56
Overall Study	COMPLETED	Brexpiprazole	52
Overall Study	COMPLETED	Placebo	52

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vomiting	Gastrointestinal disorders	Brexpiprazole	3	58
other	Vomiting	Gastrointestinal disorders	Placebo	1	57
other	Headache	Nervous system disorders	Brexpiprazole	6	58
other	Headache	Nervous system disorders	Placebo	1	57
other	Somnolence	Nervous system disorders	Brexpiprazole	7	58
other	Somnolence	Nervous system disorders	Placebo	3	57

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brexpiprazole	0	58
Total, all-cause mortality	Placebo	0	57
Total, other adverse events	Brexpiprazole	13	58
Total, other adverse events	Placebo	5	57
Total, serious adverse events	Brexpiprazole	0	58
Total, serious adverse events	Placebo	0	57

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Brexpiprazole vs Placebo: deaths from any cause	Trial comparisons
Brexpiprazole vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04174365

GET https://conductscience.org/api/trials/v1/NCT04174365/registered

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