Valbenazine for adults with tardive dyskinesia who remain symptomatic on or after a VMAT2 inhibitor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial gives valbenazine to adults with tardive dyskinesia who remain symptomatic while receiving or after stopping a VMAT2 inhibitor and measures clinician- and patient-reported outcomes. Eligible participants are ≥18 years old with a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder for at least three months and TD of at least three months' duration. Key exclusions include prominent Parkinsonism, moderate-to-severe substance use disorder within six months, history of long QT syndrome or cardiac arrhythmia, and severe hepatic impairment. The study is run at Neurocrine Clinical Sites in Arkansas and California with repeated clinical and patient-reported assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• Neurocrine Clinical Site
  Bryant, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Chino, California, United States Recruiting
• Neurocrine Clinical Site
  Fresno, California, United States Recruiting
• Neurocrine Clinical Site
  Long Beach, California, United States Recruiting
• Neurocrine Clinical Site
  Orange, California, United States Recruiting
• Neurocrine Clinical Site
  Redlands, California, United States Recruiting

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center
• Email: medinfo@neurocrine.com
• Phone: 1-877-641-3461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.