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

May 6, 2026 updated by: Neurocrine Biosciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Recruiting
        • Neurocrine Clinical Site
    • California
      • Chino, California, United States, 91710
        • Recruiting
        • Neurocrine Clinical Site
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Neurocrine Clinical Site
      • Fresno, California, United States, 93720
        • Recruiting
        • Neurocrine Clinical Site
      • Long Beach, California, United States, 90807
        • Recruiting
        • Neurocrine Clinical Site
      • Orange, California, United States, 92866
        • Recruiting
        • Neurocrine Clinical Site
      • Redlands, California, United States, 92373
        • Recruiting
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92123
        • Recruiting
        • Neurocrine Clinical Site
    • Florida
      • Bonita Springs, Florida, United States, 34134
        • Recruiting
        • Neurocrine Clinical Site
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33144
        • Recruiting
        • Neurocrine Clinical Site
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Neurocrine Clinical Site
      • Port Charlotte, Florida, United States, 33980
        • Recruiting
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Neurocrine Clinical Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Neurocrine Clinical Site
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Neurocrine Clinical Site
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Recruiting
        • Neurocrine Clinical Site
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Neurocrine Clinical Site
    • Ohio
      • Independence, Ohio, United States, 44131
        • Recruiting
        • Neurocrine Clinical Site
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Valbenazine
Valbenazine administered once daily for 24 weeks.
Drug: Valbenazine
Valbenazine capsules for oral administration.
Other Names:
  • NBI-98854

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 29, 2025

First Submitted That Met QC Criteria

July 29, 2025

First Posted (Actual)

August 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-98854-TD4027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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