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

Sponsored by Neurocrine Biosciences

About this trial

Last updated 2 years ago

Study ID

NBI-98854-TD4020

Status

Recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 months ago

What is this trial 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.

What are the Participation Requirements?

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

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting