A Study to Evaluate the Effectiveness of Valbenazine in A... | NCT07105111

Studies
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

NCT07105111

Sponsor

Neurocrine Biosciences

Status

Recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Tardive Dyskinesia

Interventions

Valbenazine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2025Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Jul 29, 2025

First Submission Date that Met QC Criteria

Jul 29, 2025

First Posted Date

Aug 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Valbenazine	Experimental	Valbenazine administered once daily for 24 weeks.	Drug: Valbenazine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valbenazine	Drug	Valbenazine capsules for oral administration.	Valbenazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24		Baseline, Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24		Baseline, Week 24
Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24		Baseline, Week 24

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neurocrine Medical Information Call Center	Contact	1-877-641-3461		medinfo@neurocrine.com

Overall Officials

Name	Affiliation	Role
Clinical Development Lead	Neurocrine Biosciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurocrine Clinical Site	Recruiting	Bryant	Arkansas	72022	United States
Neurocrine Clinical Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders
D001714	Bipolar Disorder
D003865	Depressive Disorder, Major
D000071057	Tardive Dyskinesia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D003866	Depressive Disorder
D004409	Dyskinesia, Drug-Induced
D020820	Dyskinesias
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms