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

NCT07105111 · tracked via the Priya Life Science USA tracker

Sponsor

Neurocrine Biosciences

Phase

Phase 4

Started

2025-08-29

Last updated

2026-09-18

Condition(s) studied

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderTardive Dyskinesia

Investigational drug(s) / intervention(s)

Valbenazine

Valbenazine: Valbenazine capsules for oral administration.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (19)

Facility	City	Region	Status
Neurocrine Clinical Site	Bryant	Arkansas	Recruiting
Neurocrine Clinical Site	Chino	California	Recruiting
Neurocrine Clinical Site	Fresno	California	Recruiting
Neurocrine Clinical Site	Long Beach	California	Recruiting
Neurocrine Clinical Site	Orange	California	Recruiting
Neurocrine Clinical Site	Redlands	California	Recruiting
Neurocrine Clinical Site	San Diego	California	Recruiting
Neurocrine Clinical Site	Bonita Springs	Florida	Recruiting
Neurocrine Clinical Site	Hialeah	Florida	Recruiting
Neurocrine Clinical Site	Miami	Florida	Recruiting
Neurocrine Clinical Site	Orange City	Florida	Recruiting
Neurocrine Clinical Site	Port Charlotte	Florida	Recruiting
Neurocrine Clinical Site	Tampa	Florida	Recruiting
Neurocrine Clinical Site	Augusta	Georgia	Recruiting
Neurocrine Clinical Site	Naperville	Illinois	Recruiting
Neurocrine Clinical Site	Omaha	Nebraska	Recruiting
Neurocrine Clinical Site	Independence	Ohio	Recruiting
Neurocrine Clinical Site	Austin	Texas	Recruiting
Neurocrine Clinical Site	Richmond	Virginia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07105111 on ClinicalTrials.gov ↗ ← All trials in the USA