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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Valbenazine
Valbenazine administered once daily for 24 weeks.
  • Drug: Valbenazine
    Valbenazine capsules for oral administration.
    Other names:
    • NBI-98854

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

Neurocrine Medical Information Call Center
1-877-641-3461
medinfo@neurocrine.com