RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08-29
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07105111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
  3. * Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening
  1. * Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD
  2. * Diagnosis of moderate or severe substance use disorder in the last 6 months
  3. * History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment

Contacts and Locations

Study Contact

Neurocrine Medical Information Call Center
CONTACT
1-877-641-3461
medinfo@neurocrine.com

Principal Investigator

Clinical Development Lead
STUDY_DIRECTOR
Neurocrine Biosciences

Study Locations (Sites)

Neurocrine Clinical Site
Bryant, Arkansas, 72022
United States
Neurocrine Clinical Site
Orange, California, 92866
United States
Neurocrine Clinical Site
Bonita Springs, Florida, 34134
United States
Neurocrine Clinical Site
Hialeah, Florida, 33012
United States
Neurocrine Clinical Site
Miami, Florida, 33176
United States

Collaborators and Investigators

Sponsor: Neurocrine Biosciences

  • Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-29
Study Completion Date2027-04

Study Record Updates

Study Start Date2025-08-29
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Valbenazine

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
  • Major Depressive Disorder
  • Tardive Dyskinesia