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Atypical Antipsychotic

Brexpiprazole for Autism Spectrum Disorder

Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)
Awards & highlights

Summary

This trial aims to evaluate the safety and tolerability of brexpiprazole in children and adolescents aged 5 to 17 who have irritability associated with autism. The medication helps balance brain chemicals to reduce irritability and improve mood.

Eligible Conditions
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in AIMS Total Score at Week 14
Change From Baseline in AIMS Total Score at Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Week 2
+15 more
Secondary study objectives
Mean Change From Baseline to Week 26 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score
Mean Change From Baseline to Week 26 in Clinical Global Impression - Severity (CGI-S) Scale Score

Side effects data

From 2019 Phase 4 trial • 51 Patients • NCT03149991
16%
Dizziness
16%
Alteration in Taste
12%
Restlessness/Akathisia
8%
Headache
8%
Dissociation/Detachment
8%
Insomnia/Sleep disturbance
8%
Sedation
8%
Constipation
8%
Gastric Distress
4%
Elevated alt
4%
Increased appetite
4%
Hot flashes
4%
Lethargy
4%
Twitching of left side lower lip
4%
Light headedness
4%
Panic episode
4%
Shakiness
4%
Unsteadiness of gait
4%
Irritability
4%
Increased salivation post dose
4%
Weight gain
4%
Bruxism
4%
Nausea
4%
Bi-lateral hand pain
4%
Euphoria
4%
Irregular/Early Menses
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: BrexpiprazoleExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole
FDA approved

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
264 Previous Clinical Trials
169,985 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
119 Patients Enrolled for Autism Spectrum Disorder
H. Lundbeck A/SIndustry Sponsor
329 Previous Clinical Trials
77,614 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
119 Patients Enrolled for Autism Spectrum Disorder
~17 spots leftby Oct 2025