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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

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)

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

Headache

Dissociation/Detachment

Insomnia/Sleep disturbance

Sedation

Constipation

Gastric Distress

Elevated alt

Hot flashes

Increased appetite

Unsteadiness of gait

Lethargy

Twitching of left side lower lip

Light headedness

Panic episode

Shakiness

Irritability

Increased salivation post dose

Weight gain

Bruxism

Nausea

Bi-lateral hand pain

Euphoria

Irregular/Early Menses

100%

80%

60%

40%

20%

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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