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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

RECRUITINGPhase 4Sponsored by Neurocrine Biosciences
Actively Recruiting
PhasePhase 4
SponsorNeurocrine Biosciences
Started2025-08-29
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions6

Bipolar DisorderDepressionMajor Depressive DisorderSchizoaffective DisorderSchizophreniaTardive Dyskinesia

Locations8 sites

Neurocrine Clinical Site
Bryant, Arkansas, 72022
Neurocrine Clinical Site
Fountain Valley, California, 92708
Neurocrine Clinical Site
Orange, California, 92866
Neurocrine Clinical Site
Bonita Springs, Florida, 34134
Neurocrine Clinical Site
Hialeah, Florida, 33012

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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