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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neurocrine Medical Information Call Center; Phone Number: 877-641-3461; Email: medinfo@neurocrine.com

Study Locations

• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • Neurocrine Clinical Site
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Recruiting
      • Neurocrine Clinical Site
  • California
    • Anaheim, California, United States, 92805
      • Recruiting
      • Neurocrine Clinical Site
    • Orange, California, United States, 92868
      • Recruiting
      • Neurocrine Clinical Site
    • San Diego, California, United States, 92103
      • Recruiting
      • Neurocrine Clinical Site
    • San Jose, California, United States, 95124
      • Recruiting
      • Neurocrine Clinical Site
    • Torrance, California, United States, 90504
      • Recruiting
      • Neurocrine Clinical Site
  • Florida
    • Bonita Springs, Florida, United States, 34134
      • Recruiting
      • Neurocrine Clinical Site
    • Miami, Florida, United States, 33176
      • Recruiting
      • Neurocrine Clinical Site
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Neurocrine Clinical Site
    • Okeechobee, Florida, United States, 34972
      • Recruiting
      • Neurocrine Clinical Site
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Neurocrine Clinical Site
    • Saint Augustine, Florida, United States, 32086
      • Recruiting
      • Neurocrine Clinical Site
    • Tampa, Florida, United States, 33629
      • Recruiting
      • Neurocrine Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Neurocrine Clinical Site
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Neurocrine Clinical Site
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Recruiting
      • Neurocrine Clinical Site
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Recruiting
      • Neurocrine Clinical Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Recruiting
      • Neurocrine Clinical Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Recruiting
      • Neurocrine Clinical Site
  • New York
    • Glen Oaks, New York, United States, 11004
      • Recruiting
      • Neurocrine Clinical Site
  • Ohio
    • Beechwood, Ohio, United States, 44122
      • Recruiting
      • Neurocrine Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Neurocrine Clinical Site
  • Texas
    • DeSoto, Texas, United States, 75115
      • Recruiting
      • Neurocrine Clinical Site
    • El Paso, Texas, United States, 79902
      • Recruiting
      • Neurocrine Clinical Site
    • Houston, Texas, United States, 77030
      • Recruiting
      • Neurocrine Clinical Site
    • Houston, Texas, United States, 77089
      • Recruiting
      • 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	Time Frame
Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24	Baseline, Week 24
Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24	Baseline, Week 24
Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Global Impression of Change (PGI-C) score at Week 24	Baseline, Week 24
Change from baseline in the Clinical Global Impression of Severity - TD (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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 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 (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Movement Disorders; Bipolar and Related Disorders; Dyskinesia, Drug-Induced; Depressive Disorder; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Dyskinesias; Tardive Dyskinesia; Depressive Disorder, Major
• 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