SchizophreniaPhase 4NCT07105111
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 study testing Valbenazine in people with Schizophrenia and Schizoaffective Disorder, run by Neurocrine Biosciences at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Valbenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 19 sitesUnited States
- Study dates
- 29 Aug 2025to Jun 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Neurocrine Clinical Site
Augusta, Georgia, 30912
- Recruiting
Neurocrine Clinical Site
Austin, Texas, 78754
- Recruiting
Neurocrine Clinical Site
Bonita Springs, Florida, 34134
- Recruiting
Neurocrine Clinical Site
Bryant, Arkansas, 72022
- Recruiting
Neurocrine Clinical Site
Chino, California, 91710
- Recruiting
Neurocrine Clinical Site
Fresno, California, 93701
- Recruiting
Neurocrine Clinical Site
Hialeah, Florida, 33012
- Recruiting
Neurocrine Clinical Site
Independence, Ohio, 44131
- Recruiting
Neurocrine Clinical Site
Long Beach, California, 90807
- Recruiting
Neurocrine Clinical Site
Miami, Florida, 33176
- Recruiting
Neurocrine Clinical Site
Naperville, Illinois, 60563
- Recruiting
Neurocrine Clinical Site
Omaha, Nebraska, 68124
- Recruiting
Neurocrine Clinical Site
Orange, California, 92866
- Recruiting
Neurocrine Clinical Site
Orange City, Florida, 32763
- Recruiting
Neurocrine Clinical Site
Port Charlotte, Florida, 33980
- Recruiting
Neurocrine Clinical Site
Redlands, California, 92373
- Recruiting
Neurocrine Clinical Site
Richmond, Virginia, 23226
- Recruiting
Neurocrine Clinical Site
San Diego, California, 92123
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33629
About this study
Official title: 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
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia
- Being tested
- Valbenazine
- Keywords
- Valbenazine
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major, Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValbenazineDrug
Also called NBI-98854
Valbenazine capsules for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine | Experimental | Valbenazine administered once daily for 24 weeks. Receives: Drug: Valbenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24
Measured: Baseline, Week 24
Secondary outcomes (3)
Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24
Measured: Baseline, Week 24
Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24
Measured: Baseline, Week 24
Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start29 Aug 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105111
- Sponsor's protocol ID
- NBI-98854-TD4027
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No