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NCT Number: NCT07105111

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neurocrine Clinical Site, Bryant, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 18 years of age or older
  • Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
  • Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening

Key Exclusion Criteria:

  • Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD
  • Diagnosis of moderate or severe substance use disorder in the last 6 months
  • History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment

Treatment and study plan

Valbenazine

Drug

Valbenazine capsules for oral administration.

Other names: NBI-98854

Primary outcomes

  1. Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24

    Time frame: Baseline, Week 24

Secondary outcomes

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

    Time frame: Baseline, Week 24

  2. Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24

    Time frame: Baseline, Week 24

  3. Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24

    Time frame: Baseline, Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Neurocrine Medical Information Call Center

CONTACT

[email protected]

1-877-641-3461

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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