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
NCT04258839, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2024-05-30
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 for Subjects That Have Completed Participation in 331-201-00148. Trials, record NCT04258839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04258839
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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 for Subjects That Have Completed Participation in 331-201-00148
- NCT number
- NCT04258839
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 95 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Irritability Associated With Autism Spectrum Disorder
- Interventions
- Brexpiprazole
- First posted
- 2020-02-06
- Last updated
- 2024-05-30
- Other registries' IDs
- eudract:2018-004899-35
- Results first posted
- 2024-05-30
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | 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) | An AE is any untoward medical occurrence in a clinical trial participant administered a medicinal product that does not necessarily have a causal relationship with the treatment. An SAE: AE that results in the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions i.e. fatal, life-threatening, result in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, and requires inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE that started after trial drug treatment; or if the event was continuous from baseline and was worsening, serious, trial drug-related, or resulted in death, discontinuation, interruption, or reduction of trial therapy. TEAEs were graded as, Mild: Discomfort noticed, but no disruption to daily activity, Moderate: Discomfort sufficient to reduce or affect normal daily activity, and Severe: Inability to work or perform normal daily activity. |
| Primary | Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs | Baseline (current study) up to Week 26 | Vital signs measurements included body weight, body temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Blood pressure (i.e., SBP, DBP) and heart rate were measured in the supine and standing positions after the participant had been in each position for at least 3 minutes. The participants were categorized based on the clinically relevant vital sign values as per protocol-predefined criteria. The categories with at least one participant with clinically significant value outside the normal range for vital signs are reported. |
| Primary | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities | Baseline (current study) up to Week 26 | Twelve-lead ECG recordings were obtained after the participant was supine and at rest for at least 5 minutes. Criteria for identifying ECG measurements of potential clinical relevance included Rate: Tachycardia (Vent ≥110 beats per minute \[bpm\]; increase ≥15bpm), Bradycardia (Vent ≤ 60bpm; decrease ≥15bpm); Rhythm: Sinus tachycardia (≥ 110bpm; an increase of ≥15 bpm), Sinus bradycardia (≤ 60bpm; a decrease of ≥15 bpm), Supraventricular premature beat (not present at baseline and present post-baseline), Conduction: Right bundle branch block (not present at baseline and present post-baseline) and ST/T Morphology: Symmetrical T-Wave Inversion (not present at baseline and present post-baseline). The categories with at least one participant with clinically relevant ECG abnormalities are reported. |
| Primary | Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities | Baseline (current study) up to Week 26 | Laboratory assessments included - serum chemistry including prolactin and thyrotropin, hematology, and urinalysis. Number of participants with potentially clinically relevant laboratory test abnormalities were reported as per criteria defined in SAP. The categories with at least one participant with clinically relevant value outside the normal range for laboratory assessments are reported. |
| Primary | Number of Participants With Potentially Clinically Relevant Abnormal Physical Examination Values | Baseline (current study) up to Week 26 | Physical examination included measurement of height and the examination of the head, ears, eyes, nose, and throat (HEENT); thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae. Participants with abnormal values, as assessed by the investigator were reported. |
| Primary | Number of Participants With Suicidality as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline (current study) up to Week 26 | Suicidality as defined as at least one occurrence of suicidal ideation or suicidal behavior, was assessed using C-SSRS. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) \& suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior. Number of participants with at least one occurrence of suicidal ideation or suicidal behavior was reported. |
| Primary | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Week 2 | Baseline and Week 2 | SAS was used to evaluate extrapyramidal symptoms (EPS). The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Severity of each item was rated on a 5-point Likert scale, with a score of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores of all 10 items, ranging from 0 to 40 where a higher score indicates a severe condition. Negative change from baseline indicates absence of symptoms. |
| Primary | Change From Baseline in SAS Total Score at Week 14 | Baseline and Week 14 | SAS was used to evaluate extrapyramidal symptoms (EPS). The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Severity of each item was rated on a 5-point Likert scale, with a score of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores of all 10 items, ranging from 0 to 40 where a higher score indicates a severe condition. Negative change from baseline indicates absence of symptoms. |
| Primary | Change From Baseline in SAS Total Score at Week 26 | Baseline and Week 26 | SAS was used to evaluate extrapyramidal symptoms (EPS). The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Severity of each item was rated on a 5-point Likert scale, with a score of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores of all 10 items, ranging from 0 to 40 where a higher score indicates a severe condition. Negative change from baseline indicates absence of symptoms. |
| Primary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Week 2 | Baseline and Week 2 | The AIMS is a 12-item scale. The first 10 items are rated on a Likert 5-point scale from 0 to 4 (0 = best, 4 = worst). An item score of 0, depending on specific item, means either "no abnormal Involuntary movement (AIM)" or "no incapacitation due to AIM" or "no awareness of AIM". An item score of 4 means either "severe AIM" or "severe incapacitation due to AIM" or "being aware of, and severe distress caused by AIM". Items 11 and 12 are related to dental status, taking dichotomous response: 0 = no and 1 = yes. AIMS movement score is the sum of the ratings for the first seven items with possible total scores of 0 to 28, where a higher score indicates a severe condition. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | 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) | Safety Sample included all enrolled participants who received at least one dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs | Baseline (current study) up to Week 26 | Safety Sample included all enrolled participants who received at least one dose of IMP. 'Overall number of participants analyzed' indicates the number of participants with data available for this outcome measure. 'Number analyzed' indicates the number of participants with data available for analysis of the specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities | Baseline (current study) up to Week 26 | Safety Sample included all enrolled participants who received at least one dose of IMP. 'Overall number of participants analyzed' indicates the number of participants with data available for this outcome measure. 'Number analyzed' indicates the number of participants with data available for the analysis of the specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Laboratory Test Abnormalities | Baseline (current study) up to Week 26 | Safety Sample included all enrolled participants who received at least one dose of IMP. 'Overall number of participants analyzed' indicates the number of participants with data available for this outcome measure. 'Number analyzed' indicates the number of participants with data available for analysis of the specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Abnormal Physical Examination Values | Baseline (current study) up to Week 26 | Safety Sample included all enrolled participants who received at least one dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Suicidality as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline (current study) up to Week 26 | Safety Sample included all enrolled participants who received at least one dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Week 2 | Baseline and Week 2 | Safety Sample included all enrolled participants who received at least one dose of IMP. 'Overall number of participants analyzed' indicates the number of participants with data available for this outcome measure. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in SAS Total Score at Week 14 | Baseline and Week 14 | Safety Sample included all enrolled participants who received at least one dose of IMP. 'Overall Number of Participants Analyzed' indicates the number of participants with data available for outcome measure analysis at specified time point. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in SAS Total Score at Week 26 | Baseline and Week 26 | Safety Sample included all enrolled participants who received at least one dose of IMP. 'Overall Number of Participants Analyzed' indicates the number of participants with data available for outcome measure analysis at specified time point. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Week 2 | Baseline and Week 2 | Safety Sample included all enrolled participants who received at least one dose of IMP. 'Overall Number of Participants Analyzed' indicates the number of participants with data available for outcome measure analysis at specified time point. | score on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group146
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Brexpiprazole | Participants With TEAEs | 23 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Placebo | Participants With TEAEs | 24 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Brexpiprazole | Participants With Mild TEAEs | 15 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Placebo | Participants With Mild TEAEs | 19 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Brexpiprazole | Participants With Moderate TEAEs | 11 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Placebo | Participants With Moderate TEAEs | 12 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Brexpiprazole | Participants With Severe TEAEs | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Placebo | Participants With Severe TEAEs | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Brexpiprazole | Participants With Serious TEAEs | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Graded By Severity, Serious TEAEs and Trial Discontinuation Due to TEAEs | Prior Placebo | Participants With Serious TEAEs | 1 | Participants |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prior Brexpiprazole | 49 | |
| Overall Study | STARTED | Prior Placebo | 46 | |
| Overall Study | Safety Sample | Prior Brexpiprazole | 49 | |
| Overall Study | Safety Sample | Prior Placebo | 46 | |
| Overall Study | Efficacy Sample | Prior Brexpiprazole | 48 | |
| Overall Study | Efficacy Sample | Prior Placebo | 46 | |
| Overall Study | COMPLETED | Prior Brexpiprazole | 39 | |
| Overall Study | COMPLETED | Prior Placebo | 31 | |
| Overall Study | NOT COMPLETED | Prior Brexpiprazole | 10 | |
| Overall Study | NOT COMPLETED | Prior Placebo | 15 |
Source ClinicalTrials.gov
Adverse events18
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 | Events |
|---|---|---|---|---|---|---|
| other | Gastroenteritis | Infections and infestations | Prior Brexpiprazole | 3 | 49 | |
| other | Gastroenteritis | Infections and infestations | Prior Placebo | 0 | 46 | |
| other | Viral Influenza | Infections and infestations | Prior Brexpiprazole | 4 | 49 | |
| other | Viral Influenza | Infections and infestations | Prior Placebo | 0 | 46 | |
| other | Weight Increased | Investigations | Prior Brexpiprazole | 5 | 49 | |
| other | Weight Increased | Investigations | Prior Placebo | 8 | 46 | |
| other | Increased Appetite | Metabolism and nutrition disorders | Prior Brexpiprazole | 2 | 49 | |
| other | Increased Appetite | Metabolism and nutrition disorders | Prior Placebo | 4 | 46 | |
| other | Somnolence | Nervous system disorders | Prior Brexpiprazole | 5 | 49 | |
| other | Somnolence | Nervous system disorders | Prior Placebo | 1 | 46 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prior Brexpiprazole | 0 | 49 |
| Total, all-cause mortality | Prior Placebo | 0 | 46 |
| Total, other adverse events | Prior Brexpiprazole | 17 | 49 |
| Total, other adverse events | Prior Placebo | 11 | 46 |
| Total, serious adverse events | Prior Brexpiprazole | 2 | 49 |
| Total, serious adverse events | Prior Placebo | 1 | 46 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prior Brexpiprazole vs Prior Placebo: Number of Participants With Suicidality as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) | Trial comparisons |
| Prior Brexpiprazole vs Prior Placebo: deaths from any cause | Trial comparisons |
| Prior Brexpiprazole vs Prior Placebo: Number of Participants With Potentially Clinically Relevant Abnormal Physical Examination Values | Trial comparisons |
| Prior Brexpiprazole vs Prior 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.
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/NCT04258839
GET https://conductscience.org/api/trials/v1/NCT04258839/results?page=2