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
Recruiting · NCT07105111 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurocrine Biosciences
View the official record on ClinicalTrials.gov →Interventions studied
Valbenazine
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
22 locations listed across 9 US states.
- Neurocrine Clinical Site - Bryant, Arkansas, United States
- Neurocrine Clinical Site - Chino, California, United States
- Neurocrine Clinical Site - Fountain Valley, California, United States
- Neurocrine Clinical Site - Fresno, California, United States
- Neurocrine Clinical Site - Long Beach, California, United States
- Neurocrine Clinical Site - Orange, California, United States
- Neurocrine Clinical Site - Redlands, California, United States
- Neurocrine Clinical Site - San Diego, 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 - Miami, Florida, United States
- Neurocrine Clinical Site - Orange City, Florida, United States
- Neurocrine Clinical Site - Port Charlotte, Florida, United States
- Neurocrine Clinical Site - Tampa, Florida, United States
- Neurocrine Clinical Site - Augusta, Georgia, United States
- Neurocrine Clinical Site - Marietta, Georgia, United States
- Neurocrine Clinical Site - Naperville, Illinois, United States
- Neurocrine Clinical Site - Omaha, Nebraska, United States
- Neurocrine Clinical Site - Independence, Ohio, United States
- Neurocrine Clinical Site - Austin, Texas, United States
- Neurocrine Clinical Site - Richmond, Virginia, United States