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Recruiting 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

Phase IV Interventional Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Valbenazine.
Who it may be relevant to
Registry conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug Valbenazine
    Valbenazine capsules for oral administration.

Primary outcome measures

  • 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 outcome measures (3)
  • Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24 [Time frame: Baseline, Week 24]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 22 centers
  • Neurocrine Clinical Site — Bryant
  • Neurocrine Clinical Site — Chino
  • Neurocrine Clinical Site — Fountain Valley
  • Neurocrine Clinical Site — Fresno
  • Neurocrine Clinical Site — Long Beach
  • Neurocrine Clinical Site — Orange
  • Neurocrine Clinical Site — Redlands
  • Neurocrine Clinical Site — San Diego
  • … and 14 more centers

Identifiers

NCT: NCT07105111 · NBI-98854-TD4027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗