RECRUITINGPhase 4INTERVENTIONAL
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
A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
About This Trial
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.
Who May Be Eligible (Plain English)
Key Who May Qualify:
- 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 Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Valbenazine
Valbenazine capsules for oral administration.
Locations (8)
Neurocrine Clinical Site
Bryant, Arkansas, United States
Neurocrine Clinical Site
Fountain Valley, California, United States
Neurocrine Clinical Site
Orange, California, United States
Neurocrine Clinical Site
Bonita Springs, Florida, United States
Neurocrine Clinical Site
Hialeah, Florida, United States
Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
Marietta, Georgia, United States