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NCT07105111
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
Conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 50
Sponsor: Neurocrine Biosciences
Location: Neurocrine Clinical Site Bryant Arkansas
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 Criteria
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
Source: ClinicalTrials.gov (NCT07105111). StuddyBuddy aggregates publicly available trial information.