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

Plain Language Summary

Simplified for easier understanding

This study is testing whether valbenazine — an FDA-approved drug for movement disorder symptoms — can help people with tardive dyskinesia (uncontrolled, repetitive movements caused by long-term use of psychiatric medications) who still have symptoms despite being on or after stopping another VMAT2 inhibitor. **You may be eligible if...** - You are 18 or older - You have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depression for at least 3 months - You have tardive dyskinesia (at least mild) that has been present for at least 3 months - You are currently taking another VMAT2 inhibitor or recently stopped one and still have movement symptoms **You may NOT be eligible if...** - You have Parkinsonism or other movement disorders that are more prominent than your tardive dyskinesia - You have a history of heart rhythm problems (long QT syndrome) or severe liver disease - You have a serious substance use disorder in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGValbenazine

Valbenazine capsules for oral administration.

Locations(19)

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Chino, California, United States

Neurocrine Clinical Site

Fountain Valley, California, United States

Neurocrine Clinical Site

Long Beach, California, United States

Neurocrine Clinical Site

Orange, California, United States

Neurocrine Clinical Site

Redlands, California, United States

Neurocrine Clinical Site

San Diego, California, United States

Neurocrine Clinical Site

Bonita Springs, Florida, United States

Neurocrine Clinical Site

Hialeah, Florida, United States

Neurocrine Clinical Site

Hialeah, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Orange City, Florida, United States

Neurocrine Clinical Site

Port Charlotte, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Marietta, Georgia, United States

Neurocrine Clinical Site

Naperville, Illinois, United States

Neurocrine Clinical Site

Omaha, Nebraska, United States

Neurocrine Clinical Site

Independence, Ohio, United States

Neurocrine Clinical Site

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07105111

Related Trials

Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

NCT074679937 locations

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

NCT000180571 location

NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder

NCT056697031 location

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913103 locations

Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

NCT0737982745 locations