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

ConditionsSchizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Tardive Dyskinesia

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorNeurocrine Biosciences

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Valbenazine

Treatment groups

50 Participants

are divided into 1 treatment group

Locations

Arkansas

Neurocrine Clinical Site72022, Bryant United States

California

Neurocrine Clinical Site91710, Chino United States

Neurocrine Clinical Site92708, Fountain Valley United States

Neurocrine Clinical Site93701, Fresno United States

Sponsors and collaborators

Neurocrine Biosciences

Lead sponsor

Source ClinicalTrials.gov