Recruiting

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

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.

ClinicalTrials.gov IDNCT07105111

PhasePHASE4

Enrollment100

SponsorNeurocrine Biosciences

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia

About this study

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.

Interventions

Drug: Valbenazine — Valbenazine capsules for oral administration.

Primary outcomes

Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24 (Baseline, Week 24)

Eligibility information

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

Study locations

Neurocrine Clinical Site, Bryant, Arkansas 72022 United States
Neurocrine Clinical Site, Chino, California 91710 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 33176 United States

Showing 10 of 19 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.