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

Launched by NEUROCRINE BIOSCIENCES · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called valbenazine to see how well it helps adults with tardive dyskinesia (TD), a condition that causes involuntary movements, often as a side effect of certain psychiatric medications. The study focuses on people who still have symptoms of TD while taking, or after stopping, another type of treatment called VMAT2 inhibitors. Researchers want to understand how valbenazine affects both the patients’ symptoms and their overall well-being.

Adults 18 years or older who have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder for at least three months may be eligible if they have mild or greater TD symptoms for at least three months. People with certain heart problems, severe liver issues, or recent serious substance use problems cannot join. Participants will work with doctors who will track their symptoms and how they feel during the study. This trial is not yet recruiting, but it aims to find better ways to manage TD for those still struggling despite previous treatments.

Gender

ALL

Eligibility criteria

• 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