RecruitingPhase 4NCT07105111

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

A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Sponsor

Neurocrine Biosciences

Enrollment

50 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Major Depressive Disorder Bipolar Disorder Schizoaffective Disorder Tardive Dyskinesia

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria3

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