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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia

Conditions
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Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia

Intervention / Treatment
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* Drug: Valbenazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valbenazine<br>Valbenazine administered once daily for 24 weeks. | Drug: Valbenazine<br>* Valbenazine capsules for oral administration<br>* Other names: NBI-98854;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24 |  | Baseline, Week 24 | 
| Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24 |  | Baseline, Week 24 | 
| Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24 |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change (PGI-C) score at Week 24 |  | Baseline, Week 24 | 
| Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24 |  | Baseline, Week 24 | 
| Change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at Week 24 |  | Baseline, Week 24 |