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Atypical Antipsychotic

Arm 1 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 to week 26
Awards & highlights

Study Summary

This trial will study the side effects of a medication called brexpiprazole in children and teens with autism.

Eligible Conditions
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Secondary outcome measures
Aberrant Behavior Checklist (ABC-I)
Clinical Global Impression (CGI-S)

Side effects data

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Brexpiprazole
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
245 Previous Clinical Trials
166,900 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
119 Patients Enrolled for Autism Spectrum Disorder
H. Lundbeck A/SIndustry Sponsor
325 Previous Clinical Trials
77,488 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
119 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
2020. "Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258839.
All > Rexulti
~18 spots leftby Apr 2025
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