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

NCT05859698 | Completed Phase 4 Results FDA Drug

• 1 other identifier: NBI-98854-TD4020
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Tardive Dyskinesia; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient Global Impression of Change (PGI-C) Score at Week 24

  Week 24

• Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24

  Baseline, Week 24

• Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24

  Baseline, Week 24

Study Arms (1)

Valbenazine

EXPERIMENTAL

Valbenazine administered once daily for 24 weeks.

Drug: Valbenazine

Interventions

Valbenazine DRUG

Valbenazine capsules for oral administration

Also known as: NBI-98854

Valbenazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (18)

Neurocrine Clinical Site

Bryant, Arkansas, 72022, United States

Location

Neurocrine Clinical Site

Anaheim, California, 92805, United States

Location

Neurocrine Clinical Site

Orange, California, 92868, United States

Location

Neurocrine Clinical Site

Torrance, California, 90504, United States

Location

Neurocrine Clinical Site

Bonita Springs, Florida, 34134, United States

Location

Neurocrine Clinical Site

Miami, Florida, 33176, United States

Location

Neurocrine Clinical Site

Miami Lakes, Florida, 33016, United States

Location

Neurocrine Clinical Site

Okeechobee, Florida, 34972, United States

Location

Neurocrine Clinical Site

Tampa, Florida, 33629, United States

Location

Neurocrine Clinical Site

Atlanta, Georgia, 30328, United States

Location

Neurocrine Clinical Site

Augusta, Georgia, 30912, United States

Location

Neurocrine Clinical Site

Marietta, Georgia, 30060, United States

Location

Neurocrine Clinical Site

Lincoln, Nebraska, 68526, United States

Location

Neurocrine Clinical Site

Beechwood, Ohio, 44122, United States

Location

Neurocrine Clinical Site

Oklahoma City, Oklahoma, 73112, United States

Location

Neurocrine Clinical Site

DeSoto, Texas, 75115, United States

Location

Neurocrine Clinical Site

El Paso, Texas, 79902, United States

Location

Neurocrine Clinical Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major; Tardive Dyskinesia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Neurocrine Medical Information
• Organization: Neurocrine Biosciences

medinfo@neurocrine.com

+1 877-641-3461

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: May 9, 2023
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)