Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

Neurocrine Biosciences

Status and phase

Completed

Phase 4

Conditions

Tardive Dyskinesia

Major Depressive Disorder

Schizophrenia

Bipolar Disorder

Schizoaffective Disorder

Treatments

Drug: Valbenazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05859698

NBI-98854-TD4020

Details and patient eligibility

About

This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

At least 18 years of age
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

Key Exclusion Criteria:

Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD
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