Completed

Continuing Valbenazine Treatment for Tardive Dyskinesia

What is being tested

Valbenazine

Drug

Who is being recruted

Tardive Dyskinesia+6

+ Central Nervous System Diseases

+ Dyskinesia, Drug-Induced

From 18 to 85 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 2016

See protocol details

Summary

Principal SponsorNeurocrine Biosciences

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 13, 2016

Actual date on which the first participant was enrolled.

This study focuses on the long-term use of Valbenazine (NBI-98854), a treatment for Tardive Dyskinesia, a condition that causes uncontrollable, repetitive movements. The study aims to continue providing Valbenazine to participants who have previously responded well to it. The importance of this study lies in understanding the long-term effects and safety of Valbenazine, now that it's commercially available. During the study, participants receive Valbenazine and are closely monitored for any side effects. The monitoring includes regular checks of vital signs, lab tests, and heart activity. Any side effects are recorded and categorized according to the Medical Dictionary for Regulatory Activities (MedDRA). The study also tracks the number of participants who experience serious side effects or have to stop taking Valbenazine due to side effects.

Official TitleOpen-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

NCT02736955

Principal SponsorNeurocrine Biosciences

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

161 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Tardive DyskinesiaCentral Nervous System DiseasesDyskinesia, Drug-InducedMovement DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Criteria

5 inclusion criteria required to participate

Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.

If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.

Be in general good health.

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10 exclusion criteria prevent from participating

Have an active, clinically significant unstable medical condition within 1 month prior to screening.

Have a known history of substance dependence, substance (drug) or alcohol abuse.

Have a significant risk of suicidal or violent behavior.

Have a known history of neuroleptic malignant syndrome.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Fixed dose of valbenazine administered once daily for up to 72 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers