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

Sponsor

Neurocrine Biosciences (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05859698

Collaborator

(none)

Enrollment

Arm

19.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Tardive Dyskinesia	Drug: Valbenazine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valbenazine Valbenazine administered once daily for 24 weeks.	Drug: Valbenazine Valbenazine capsules for oral administration Other Names: NBI-98854

Arm

Intervention/Treatment

Experimental: Valbenazine

Valbenazine administered once daily for 24 weeks.

Drug: Valbenazine

Valbenazine capsules for oral administration

Other Names:

NBI-98854

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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