Recruiting

ValbenazineA 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

Sponsor:

Neurocrine Biosciences

Code:

NCT07105111

Conditions

Schizophrenia

Schizoaffective Disorder

Bipolar Disorder

Major Depressive Disorder

Tardive Dyskinesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Valbenazine

Study Details

Brief 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.

Conditions

Schizophrenia

Schizoaffective Disorder

Bipolar Disorder

Major Depressive Disorder

Tardive Dyskinesia

Study ID

NCT07105111

Start date

Aug 29, 2025

Status verified date

Jun, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Valbenazine

Valbenazine administered once daily for 24 weeks.

Interventions

Valbenazine

Valbenazine capsules for oral administration.

Primary outcome measure

Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24 [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461 medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Bryant, Arkansas, United States, 72022

Neurocrine Clinical Site

Recruiting

Chino, California, United States, 91710

Neurocrine Clinical Site

Recruiting

Fountain Valley, California, United States, 92708

Neurocrine Clinical Site

Recruiting

Fresno, California, United States, 93701

Neurocrine Clinical Site

Recruiting

Long Beach, California, United States, 90807

Neurocrine Clinical Site

Recruiting

Orange, California, United States, 92866

Neurocrine Clinical Site

Recruiting

Redlands, California, United States, 92373

Neurocrine Clinical Site

Recruiting

San Diego, California, United States, 92123

Neurocrine Clinical Site

Recruiting

Bonita Springs, Florida, United States, 34134

Neurocrine Clinical Site

Recruiting

Hialeah, Florida, United States, 33012

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33144

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33176

Neurocrine Clinical Site

Recruiting

Orange City, Florida, United States, 32763

Neurocrine Clinical Site

Recruiting

Port Charlotte, Florida, United States, 33980

Neurocrine Clinical Site

Recruiting

Tampa, Florida, United States, 33629

Neurocrine Clinical Site

Recruiting

Augusta, Georgia, United States, 30912

Neurocrine Clinical Site

Recruiting

Marietta, Georgia, United States, 30060

Neurocrine Clinical Site

Recruiting

Naperville, Illinois, United States, 60563

Neurocrine Clinical Site

Recruiting

Omaha, Nebraska, United States, 68124

Neurocrine Clinical Site

Recruiting

Independence, Ohio, United States, 44131

Neurocrine Clinical Site

Recruiting

Austin, Texas, United States, 78754

Neurocrine Clinical Site

Recruiting

Richmond, Virginia, United States, 23226

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

Valbenazine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-06-16.