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

Phase 4

Completed

• Conditions: Schizoaffective Disorder; Major Depressive Disorder; Tardive Dyskinesia; Schizophrenia; Bipolar Disorder
• Interventions: Drug: Valbenazine

• Registration Number: NCT05859698
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-05-25
• Primary Completion: 2024-12-27
• Study Completion: 2024-12-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valbenazine	Valbenazine	Valbenazine administered once daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
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 Tardive Dyskinesia Impact Scale (TDIS) total score 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

Name	Time	Method
Patient Global Impression of Change (PGI-C) 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
Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24	Baseline, Week 24

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇺🇸 Houston, Texas, United States