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NCT07105111PHASE4Recruiting

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Neurocrine Biosciences

Start Date

8/29/2025

Completion Date

1/1/2027

Summary

This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * 18 years of age or older * Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder * Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening Key Exclusion Criteria: * Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD * Diagnosis of moderate or severe substance use disorder in the last 6 months * History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment

Interventions

DRUG

Valbenazine

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Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderTardive Dyskinesia

Locations

Neurocrine Clinical Site

Bryant, Arkansas 72022

United States

Neurocrine Clinical Site

Chino, California 91710

United States

Neurocrine Clinical Site

Fountain Valley, California 92708

United States

Neurocrine Clinical Site

Fresno, California 93701

United States

Neurocrine Clinical Site

Long Beach, California 90807

United States

Neurocrine Clinical Site

Orange, California 92866

United States

Neurocrine Clinical Site

Redlands, California 92373

United States

Neurocrine Clinical Site

San Diego, California 92123

United States

Neurocrine Clinical Site

Bonita Springs, Florida 34134

United States

Neurocrine Clinical Site

Hialeah, Florida 33012

United States

Neurocrine Clinical Site

Miami, Florida 33144

United States

Neurocrine Clinical Site

Miami, Florida 33176

United States

Neurocrine Clinical Site

Orange City, Florida 32763

United States

Neurocrine Clinical Site

Port Charlotte, Florida 33980

United States

Neurocrine Clinical Site

Tampa, Florida 33629

United States

Neurocrine Clinical Site

Augusta, Georgia 30912

United States

Neurocrine Clinical Site

Marietta, Georgia 30060

United States

Neurocrine Clinical Site

Naperville, Illinois 60563

United States

Neurocrine Clinical Site

Omaha, Nebraska 68124

United States

Neurocrine Clinical Site

Independence, Ohio 44131

United States

Neurocrine Clinical Site

Austin, Texas 78754

United States

Neurocrine Clinical Site

Richmond, Virginia 23226

United States