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

Neurocrine Biosciences

Status and phase: Enrolling; Phase 4

Conditions: Tardive Dyskinesia; Major Depressive Disorder; Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Drug: Valbenazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07105111

NBI-98854-TD4027

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Valbenazine

Experimental group

Description:

Valbenazine administered once daily for 24 weeks.

Treatment:

Drug: Valbenazine