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
Neurocrine Biosciences
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugValbenazine
Valbenazine capsules for oral administration.
Locations (21)
- Neurocrine Clinical SiteBryant, Arkansas
- Neurocrine Clinical SiteChino, California
- Neurocrine Clinical SiteFountain Valley, California
- Neurocrine Clinical SiteFresno, California
- Neurocrine Clinical SiteLong Beach, California
- Neurocrine Clinical SiteOrange, California