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Atypical Antipsychotic

Brexpiprazole (OPC-34712) for Schizophrenia

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 from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)

Awards & highlights

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of using the drug brexpiprazole to treat teenagers with schizophrenia. Brexpiprazole has been shown to be safe and effective in the treatment of elderly Japanese patients with schizophrenia.

Eligible Conditions

Schizophrenia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 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 to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

Secondary study objectives

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score

Change From Baseline in Simpson Angus Scale (SAS) Total Score

+18 more

Side effects data

From 2023 Phase 3 trial • 316 Patients • NCT03198078

Nausea

Headache

Somnolence

Akathisia

Fatigue

Schizophrenia

100%

80%

60%

40%

20%

Study treatment Arm

Brexpiprazole

Aripiprazole

Placebo

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: BrexpiprazoleExperimental Treatment1 Intervention

Participants were administered with brexpiprazole oral tablets, daily, dose titrated up to 0.5 mg by Day 4, 1 mg by Day 7, 2 mg by Day 14, then between 2-4 mg after Day 21 up to Week 6 with a 1 mg increase or decrease, based on the Investigator's decision.

Group II: AripiprazoleActive Control1 Intervention

Participants were administered with aripiprazole oral tablets, daily, dose titrated up to 2 mg by Day 4, 5 mg by Day 7, 10 mg by Day 14, then 10, 15 or 20 mg after Day 21 up to Week 6 with a 5 mg increase or decrease, based on the Investigator's decision.

Group III: PlaceboPlacebo Group1 Intervention

Participants were administered with brexpiprazole or aripiprazole matching placebo oral tablets, daily up to Week 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brexpiprazole (OPC-34712)

2017

Completed Phase 3

~360

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