Clinical trial NCT05859698: Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Tardive Dyskinesia
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Patient Global Impression of Change (PGI-C) score at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Neurocrine Clinical Site
state: Arizona
city: Bryant
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Orange
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Jose
country: United States
facility: Neurocrine Clinical Site
state: California
city: Torrance
country: United States
facility: Neurocrine Clinical Site
state: California
city: Bonita Springs
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami Lakes
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Okeechobee
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Orlando
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Saint Augustine
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Tampa
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Marietta
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Naperville
country: United States
facility: Neurocrine Clinical Site
state: Illinois
city: South Bend
country: United States
facility: Neurocrine Clinical Site
state: Indiana
city: North Dartmouth
country: United States
facility: Neurocrine Clinical Site
state: Massachusetts
city: Lincoln
country: United States
facility: Neurocrine Clinical Site
state: Nebraska
city: Glen Oaks
country: United States
facility: Neurocrine Clinical Site
state: New York
city: Beechwood
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Neurocrine Clinical Site
state: Oklahoma
city: DeSoto
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: El Paso
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: