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Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT05859698•Neurocrine Biosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (18)

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Anaheim, California, United States

Neurocrine Clinical Site

Orange, California, United States

Neurocrine Clinical Site

Torrance, California, United States

Neurocrine Clinical Site

Bonita Springs, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Miami Lakes, Florida, United States

Neurocrine Clinical Site

Okeechobee, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Key Dates

Start Date

May 9, 2023

Primary Completion Date

December 27, 2024

Completion Date

December 27, 2024

Last Updated

January 16, 2026

Enrollment

ACTUAL participants

Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderTardive Dyskinesia

Interventions

Valbenazine

DRUG

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NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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