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Valbenazine for adults with tardive dyskinesia who remain symptomatic on or after a 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

Phase 4 Interventional Neurocrine Biosciences · NCT07105111

This trial will test whether valbenazine reduces involuntary movements in adults with tardive dyskinesia who still have symptoms while taking or after stopping a VMAT2 inhibitor.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations21 sites (Bryant, Arkansas and 20 other locations)
Trial IDNCT07105111 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional trial gives valbenazine to adults with tardive dyskinesia who remain symptomatic while receiving or after stopping a VMAT2 inhibitor and measures clinician- and patient-reported outcomes. Eligible participants are ≥18 years old with a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder for at least three months and TD of at least three months' duration. Key exclusions include prominent Parkinsonism, moderate-to-severe substance use disorder within six months, history of long QT syndrome or cardiac arrhythmia, and severe hepatic impairment. The study is run at Neurocrine Clinical Sites in Arkansas and California with repeated clinical and patient-reported assessments.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder who have had at least mild TD for three months and remain symptomatic while taking or after stopping a VMAT2 inhibitor.

Not a fit: People whose abnormal movements are due to Parkinsonism rather than TD, those with recent moderate-to-severe substance use disorder, or those with significant cardiac or liver disease are unlikely to be suitable or to benefit from this treatment.

Why it matters

Potential benefit: If effective, valbenazine could reduce involuntary movements and improve daily functioning and quality of life for people with persistent TD despite prior VMAT2 inhibitor use.

How similar studies have performed: Previous randomized trials of valbenazine and other VMAT2 inhibitors have shown benefit for reducing TD, but this trial specifically targets people who remain symptomatic while on or after another VMAT2 inhibitor.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Bryant, Arkansas and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderTardive DyskinesiaValbenazine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.