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

Last updated: February 25, 2025
Sponsor: Neurocrine Biosciences
Overall Status: Completed

Phase

4

Condition

Dyskinesias

Depression

Bipolar Disorder

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 25, 2023
Estimated Completion Date:
December 27, 2024

Connect with a study center

  • Neurocrine Clinical Site

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Anaheim, California 92805
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Orange, California 92868
    United States

    Site Not Available

  • Neurocrine Clinical Site

    San Diego, California 92103
    United States

    Site Not Available

  • Neurocrine Clinical Site

    San Jose, California 95124
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Torrance, California 90504
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Bonita Springs, Florida 34134
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Miami, Florida 33176
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Okeechobee, Florida 34972
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Orlando, Florida 32803
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Tampa, Florida 33629
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Neurocrine Clinical Site

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Neurocrine Clinical Site

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Glen Oaks, New York 11004
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Beechwood, Ohio 44122
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Neurocrine Clinical Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Neurocrine Clinical Site

    El Paso, Texas 79902
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Houston, Texas 77030
    United States

    Site Not Available

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