A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesi… (NCT07105111) | Clinical Trial Compass
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
United States50 participantsStarted 2025-08-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people who still have tardive dyskinesia symptoms even while taking or after stopping another VMAT2 inhibitor — does my current treatment history and symptom level match what this study is looking for?
2Since this is a Phase 4 trial, valbenazine has already been approved, but this study is measuring whether it works for people who didn't fully respond to other VMAT2 inhibitors — what does that mean for what's already known about its safety and whether it might help someone in my situation?
3The trial tracks involuntary movement scores over 24 weeks, which is a significant time commitment — what would my visit schedule look like, and how might participating affect my current psychiatric medications or care routine?
4Given that I have an underlying diagnosis like schizophrenia or bipolar disorder along with tardive dyskinesia, how would joining this trial interact with the treatments I'm already on for my primary condition?
5Before considering this trial, is there a standard-of-care treatment path I haven't tried yet that might be worth pursuing first, or does my history make this study a more appropriate next step to discuss?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24