Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
NCT ID: NCT05859698
Last Updated: 2026-01-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2023-05-09
2024-12-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
NCT05053321
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
NCT05654870
Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
NCT05110157
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
NCT01688037
D-serine and Cognitive Remediation in Schizophrenia
NCT02156908
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Valbenazine
Valbenazine administered once daily for 24 weeks.
Valbenazine
Valbenazine capsules for oral administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Valbenazine
Valbenazine capsules for oral administration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neurocrine Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurocrine Clinical Site
Bryant, Arkansas, United States
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
Orange, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Bonita Springs, Florida, United States
Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
Miami Lakes, Florida, United States
Neurocrine Clinical Site
Okeechobee, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Augusta, Georgia, United States
Neurocrine Clinical Site
Marietta, Georgia, United States
Neurocrine Clinical Site
Lincoln, Nebraska, United States
Neurocrine Clinical Site
Beechwood, Ohio, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
DeSoto, Texas, United States
Neurocrine Clinical Site
El Paso, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NBI-98854-TD4020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.