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

Neurocrine Biosciences59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Tardive Dyskinesia

Interventions

ValbenazineDRUG

Valbenazine capsules for oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (18)

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Anaheim, California, United States

Outcomes

Primary Outcomes

Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24

The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.

Time frame: Baseline, Week 24

Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24

The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.

Time frame: Baseline, Week 24

Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24

Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.

Time frame: Baseline, Week 24

Secondary Outcomes

Patient Global Impression of Change (PGI-C) Score at Week 24

Data from ClinicalTrials.gov

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