NCT07105111

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
8mo left

Started Aug 2025

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Aug 2025Jan 2027

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

August 29, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 16, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

July 29, 2025

Last Update Submit

April 13, 2026

Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderTardive Dyskinesia

Keywords

Valbenazine

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24

    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

    Baseline, Week 24

  • Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24

    Baseline, Week 24

  • Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24

    Baseline, Week 24

Study Arms (1)

Valbenazine

EXPERIMENTAL

Valbenazine administered once daily for 24 weeks.

Drug: Valbenazine

Interventions

ValbenazineDRUG

Valbenazine capsules for oral administration.

Also known as: NBI-98854
Valbenazine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Neurocrine Clinical Site

Bryant, Arkansas, 72022, United States

RECRUITING

Neurocrine Clinical Site

Chino, California, 91710, United States

RECRUITING

Neurocrine Clinical Site

Fountain Valley, California, 92708, United States

RECRUITING

Neurocrine Clinical Site

Long Beach, California, 90807, United States

RECRUITING

Neurocrine Clinical Site

Orange, California, 92866, United States

RECRUITING

Neurocrine Clinical Site

Redlands, California, 92373, United States

RECRUITING

Neurocrine Clinical Site

San Diego, California, 92123, United States

RECRUITING

Neurocrine Clinical Site

Bonita Springs, Florida, 34134, United States

RECRUITING

Neurocrine Clinical Site

Hialeah, Florida, 33012, United States

RECRUITING

Neurocrine Clinical Site

Hialeah, Florida, 33015, United States

RECRUITING

Neurocrine Clinical Site

Miami, Florida, 33176, United States

RECRUITING

Neurocrine Clinical Site

Orange City, Florida, 32763, United States

RECRUITING

Neurocrine Clinical Site

Port Charlotte, Florida, 33980, United States

RECRUITING

Neurocrine Clinical Site

Tampa, Florida, 33629, United States

RECRUITING

Neurocrine Clinical Site

Marietta, Georgia, 30060, United States

RECRUITING

Neurocrine Clinical Site

Naperville, Illinois, 60563, United States

RECRUITING

Neurocrine Clinical Site

Omaha, Nebraska, 68124, United States

RECRUITING

Neurocrine Clinical Site

Independence, Ohio, 44131, United States

RECRUITING

Neurocrine Clinical Site

Richmond, Virginia, 23226, United States

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderDepressive Disorder, MajorTardive Dyskinesia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive DisorderDyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Development Lead

    Neurocrine Biosciences

    STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

1-877-641-3461medinfo@neurocrine.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

August 29, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(19)