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

Last updated: January 13, 2026
Sponsor: Neurocrine Biosciences
Overall Status: Completed

Phase

4

Condition

Depression

Dyskinesias

Tardive Dyskinesia

Treatment

Valbenazine

Clinical Study ID

NCT05859698
NBI-98854-TD4020
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Key Inclusion Criteria:

  • At least 18 years of age

  • Have one of the following clinical diagnoses: schizophrenia or schizoaffectivedisorder, bipolar disorder, or major depressive disorder

  • Have a clinical diagnosis of neuroleptic-induced TD

  • Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, ormajor depressive disorder and other protocol-allowed concurrent medications must beat a stable dose and expected to remain stable during the study

  • Participants must be outpatients and have a stable psychiatric status

Exclusion

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 judgementof the investigator, or have any laboratory value outside the normal range that isconsidered by the investigator to be clinically significant at the screening visit

Study Design

Total Participants: 59
Treatment Group(s): 1
Primary Treatment: Valbenazine
Phase: 4
Study Start date:
May 09, 2023
Estimated Completion Date:
December 27, 2024

Connect with a study center

  • Neurocrine Clinical Site

    Bryant 4103448, Arkansas 4099753 72022
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Anaheim 5323810, California 5332921 92805
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Torrance 5403022, California 5332921 90504
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Bonita Springs 4148533, Florida 4155751 34134
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Miami Lakes 4164186, Florida 4155751 33016
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Okeechobee 4166822, Florida 4155751 34972
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Tampa 4174757, Florida 4155751 33629
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Lincoln 5072006, Nebraska 5073708 68526
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Beechwood 4506089, Ohio 5165418 44122
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Oklahoma City 4544349, Oklahoma 4544379 73112
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Neurocrine Clinical Site

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Neurocrine Clinical Site

    El Paso 5520993, Texas 4736286 79902
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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