SchizophreniaPhase 4NCT05859698

Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

A Phase 4 study testing Valbenazine in people with Schizophrenia and Schizoaffective Disorder, run by Neurocrine Biosciences at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks. 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: 59 participants
Where: 18 sitesUnited States
Study dates: 9 May 2023to 27 Dec 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

At least 18 years of age
Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
Have a clinical diagnosis of neuroleptic-induced TD
Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study
Participants must be outpatients and have a stable psychiatric status

Who cannot join

Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD
Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Neurocrine Clinical Site
Anaheim, California, 92805
Neurocrine Clinical Site
Atlanta, Georgia, 30328
Neurocrine Clinical Site
Augusta, Georgia, 30912
Neurocrine Clinical Site
Beechwood, Ohio, 44122
Neurocrine Clinical Site
Bonita Springs, Florida, 34134
Neurocrine Clinical Site
Bryant, Arkansas, 72022
Neurocrine Clinical Site
DeSoto, Texas, 75115
Neurocrine Clinical Site
El Paso, Texas, 79902
Neurocrine Clinical Site
Houston, Texas, 77030
Neurocrine Clinical Site
Lincoln, Nebraska, 68526
Neurocrine Clinical Site
Marietta, Georgia, 30060
Neurocrine Clinical Site
Miami, Florida, 33176
Neurocrine Clinical Site
Miami Lakes, Florida, 33016
Neurocrine Clinical Site
Okeechobee, Florida, 34972
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
Neurocrine Clinical Site
Orange, California, 92868
Neurocrine Clinical Site
Tampa, Florida, 33629
Neurocrine Clinical Site
Torrance, California, 90504

Other trials in United States

About this study

Official title: A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia

Conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia
Being tested: 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 groups in NCT05859698
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 Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24
The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.
Measured: Baseline, Week 24
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24
The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.
Measured: Baseline, Week 24
Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24
Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.
Measured: Baseline, Week 24

Secondary outcomes (3)

Patient Global Impression of Change (PGI-C) Score at Week 24
Participants rated the change in their TD symptoms from the initiation of study treatment dosing by choosing one of 7 responses (1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, and 7=very much worse). Number of participants with PGI-C score responses are reported.
Measured: Week 24
Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24
The CGI-TD-S is based on a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patients), was used to rate the overall global severity of TD.
Measured: Baseline, Week 24
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24
The AIMS dyskinesia total score was defined as the sum of the scores of AIMS items 1 through 7. The scores for each item ranged from 0 (no dyskinesia) to 4 (severe dyskinesia). If any of the seven items had a missing value, the total score for that participant/visit was set equal to missing. The AIMS dyskinesia total score can therefore range from 0 to 28, with higher scores indicating greater severity.
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.

9 May 202327 Dec 2024

First posted16 May 2023
Study start9 May 2023
Primary completion27 Dec 2024
Study completion27 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05859698
Sponsor's protocol ID: NBI-98854-TD4020
Status last verified: Nov 2025
First submitted: 5 May 2023
Last updated: 16 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia
ClinicalTrials.gov ID: NCT05859698
Acronym / sponsor ID: NBI-98854-TD4020
Conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Neurocrine BiosciencesIndustry (pharma, biotech, devices)
Study start: 9 May 2023 (actual)
Primary completion: 27 Dec 2024 (actual)
Study completion: 27 Dec 2024 (actual)
First posted: 16 May 2023 (actual)
Results: Posted 16 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Valbenazine	Experimental	Drug: ValbenazineValbenazine administered once daily for 24 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

At least 18 years of age
Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
Have a clinical diagnosis of neuroleptic-induced TD
Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study
Participants must be outpatients and have a stable psychiatric status

Key exclusion criteria (2 listed)

Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD
Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ValbenazineAlso: NBI-98854Valbenazine capsules for oral administration	Drug	Valbenazine

Primary outcome

Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24
Time frame: Baseline, Week 24
The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24
Time frame: Baseline, Week 24
The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.
Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24
Time frame: Baseline, Week 24
Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.

3 secondary outcomes

Patient Global Impression of Change (PGI-C) Score at Week 24
Time frame: Week 24
Change From Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24
Time frame: Baseline, Week 24
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 16 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valbenazine	59	51

Primary outcome: Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24

Time frame: Baseline, Week 24. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Valbenazine n = 45
Value	-8.0 (-10.48 to -5.44)

Population analysed: The Full Analysis Set included all enrolled participants with at least one baseline efficacy data point for any measure and at least one postbaseline efficacy data point for any measure. Here, "Overall Number of Participants Analyzed" = the number of participants evaluable at the timepoint assessed.

Primary outcome: Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24

Time frame: Baseline, Week 24. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Valbenazine n = 45
Item 1: Work/School Impairment	-1.2 (-2.98 to 0.58)
Item 2: Social Life Impairment	-2.3 (-3.23 to -1.43)
Item 3: Family Life/Home Responsibilities	-1.6 (-2.54 to -0.57)

Primary outcome: Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24

Time frame: Baseline, Week 24. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Valbenazine n = 45
Value	13.1 (7.70 to 18.48)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 26 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valbenazine	6 of 59 (10.2%)	6 of 59 (10.2%)	1 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Lead study director

Neurocrine Biosciences

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Valbenazine in people with Schizophrenia and Schizoaffective Disorder, run by Neurocrine Biosciences at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24 (time frame: Baseline, Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05859698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.