Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia

This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Tardive Dyskinesia; Major Depressive Disorder
• Intervention / Treatment: Drug: Valbenazine

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Neurocrine Clinical Site
  • California
    • Anaheim, California, United States, 92805
      • Neurocrine Clinical Site
    • Orange, California, United States, 92868
      • Neurocrine Clinical Site
    • Torrance, California, United States, 90504
      • Neurocrine Clinical Site
  • Florida
    • Bonita Springs, Florida, United States, 34134
      • Neurocrine Clinical Site
    • Miami, Florida, United States, 33176
      • Neurocrine Clinical Site
    • Miami Lakes, Florida, United States, 33016
      • Neurocrine Clinical Site
    • Okeechobee, Florida, United States, 34972
      • Neurocrine Clinical Site
    • Tampa, Florida, United States, 33629
      • Neurocrine Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Neurocrine Clinical Site
    • Augusta, Georgia, United States, 30912
      • Neurocrine Clinical Site
    • Marietta, Georgia, United States, 30060
      • Neurocrine Clinical Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Neurocrine Clinical Site
  • Ohio
    • Beechwood, Ohio, United States, 44122
      • Neurocrine Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Neurocrine Clinical Site
  • Texas
    • DeSoto, Texas, United States, 75115
      • Neurocrine Clinical Site
    • El Paso, Texas, United States, 79902
      • Neurocrine Clinical Site
    • Houston, Texas, United States, 77030
      • Neurocrine Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• At least 18 years of age
• Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
• Have a clinical diagnosis of neuroleptic-induced TD
• Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study
• Participants must be outpatients and have a stable psychiatric status

Key Exclusion Criteria:

• Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD
• Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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	Measure Description	Time Frame
Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24	The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.	Baseline, Week 24
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24	The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.	Baseline, Week 24
Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24	Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGI-C) Score at Week 24	Participants rated the change in their TD symptoms from the initiation of study treatment dosing by choosing one of 7 responses (1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, and 7=very much worse). Number of participants with PGI-C score responses are reported.	Week 24
Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24	The CGI-TD-S is based on a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patients), was used to rate the overall global severity of TD.	Baseline, Week 24
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24	The AIMS dyskinesia total score was defined as the sum of the scores of AIMS items 1 through 7. The scores for each item ranged from 0 (no dyskinesia) to 4 (severe dyskinesia). If any of the seven items had a missing value, the total score for that participant/visit was set equal to missing. The AIMS dyskinesia total score can therefore range from 0 to 28, with higher scores indicating greater severity.	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Neurocrine Biosciences
• Investigators: Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): December 27, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Mood Disorders; Movement Disorders; Dyskinesias; Dyskinesia, Drug-Induced; Depressive Disorder; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tardive Dyskinesia; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major; valbenazine
• Other Study ID Numbers: NBI-98854-TD4020

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