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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well valbenazine works for adults with tardive dyskinesia (TD), a condition that causes unwanted movements. It is for people who still have TD symptoms while taking or after stopping a type of medicine called a VMAT2 inhibitor. The study will use reports from doctors and patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depression at least 3 months before screening. These conditions affect thoughts or mood.
  • Have at least mild TD caused by antipsychotic medicine, diagnosed at least 3 months before screening.

Who can't join

  • Have Parkinsonism (symptoms such as shaking, stiffness, or slow movement), or other unwanted movements that stand out more than TD.
  • Diagnosed with a moderate or severe substance use disorder in the past 6 months, meaning serious problems related to alcohol or drug use.
  • Have a history of long QT syndrome (a problem with the heart’s electrical signals), an irregular heartbeat, or severe liver problems.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (19)

AR

CA

FL

GA

IL

NE

OH

TX

VA