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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Valbenazine |
Valbenazine administered once daily for 24 weeks. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences
