Health Trials

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

ConditionsSchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderTardive 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

Sponsors and collaborators

Neurocrine Biosciences

Lead sponsor

Source ClinicalTrials.gov