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Atypical Antipsychotic

Brexpiprazole for Autism Spectrum Disorder (Anchor Trial)

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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial is testing brexpiprazole, a medication, to see if it can help reduce irritability in children and teenagers aged 5 to 17 with autism. The medication works by balancing brain chemicals to improve mood and reduce irritability.

Eligible Conditions
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
Hot flashes
4%
Increased appetite
4%
Unsteadiness of gait
4%
Lethargy
4%
Twitching of left side lower lip
4%
Light headedness
4%
Panic episode
4%
Shakiness
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BrexpiprazoleExperimental Treatment1 Intervention
Participants received flexible doses of brexpiprazole 0.25 to 3 milligram per day (mg/day), orally, once daily (QD) up to Week 8. For participants with body weight \< 50 kilograms (kg) the dose was titrated up from 0.25 mg/day on Days 1 to 3, followed by 0.5 mg on Days 4 to 7, and to 1 mg on Days 8 to 14. Based on the investigator's judgment the dose was increased to 1.5 mg/day after Day 15. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8. For participants with body weight ≥ 50 kg the dose was titrated up from 0.5 mg/day on Days 1 to 3, followed by 1.5 mg on Days 4 to 7, and to 2 mg on Days 8 to 14. Based on the investigator's judgment the dose was increased to 3 mg/day after Day 15. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
Group II: PlaceboPlacebo Group1 Intervention
Participants received brexpiprazole matching placebo orally, QD, in the same way as brexpiprazole up to Week 8.
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
265 Previous Clinical Trials
170,405 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
95 Patients Enrolled for Autism Spectrum Disorder
H. Lundbeck A/SIndustry Sponsor
329 Previous Clinical Trials
77,590 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
95 Patients Enrolled for Autism Spectrum Disorder
~20 spots leftby Nov 2025
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