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NCT05859698 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05859698
Other study ID # NBI-98854-TD4020
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 25, 2023
Est. completion date December 2024

Study information
Verified date April 2024
Source Neurocrine Biosciences
Contact Neurocrine Medical Information Call Center
Phone 877-641-3461
Email medinfo@neurocrine.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valbenazine
Valbenazine capsules for oral administration

Locations
Country Name City State
United States Neurocrine Clinical Site Anaheim California
United States Neurocrine Clinical Site Atlanta Georgia
United States Neurocrine Clinical Site Beechwood Ohio
United States Neurocrine Clinical Site Bonita Springs Florida
United States Neurocrine Clinical Site Bryant Arkansas
United States Neurocrine Clinical Site DeSoto Texas
United States Neurocrine Clinical Site El Paso Texas
United States Neurocrine Clinical Site Glen Oaks New York
United States Neurocrine Clinical Site Houston Texas
United States Neurocrine Clinical Site Houston Texas
United States Neurocrine Clinical Site Lincoln Nebraska
United States Neurocrine Clinical Site Marietta Georgia
United States Neurocrine Clinical Site Miami Florida
United States Neurocrine Clinical Site Miami Lakes Florida
United States Neurocrine Clinical Site Naperville Illinois
United States Neurocrine Clinical Site North Dartmouth Massachusetts
United States Neurocrine Clinical Site Okeechobee Florida
United States Neurocrine Clinical Site Oklahoma City Oklahoma
United States Neurocrine Clinical Site Orange California
United States Neurocrine Clinical Site Orlando Florida
United States Neurocrine Clinical Site Saint Augustine Florida
United States Neurocrine Clinical Site San Diego California
United States Neurocrine Clinical Site San Jose California
United States Neurocrine Clinical Site South Bend Indiana
United States Neurocrine Clinical Site Sun City Arizona
United States Neurocrine Clinical Site Tampa Florida
United States Neurocrine Clinical Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the Tardive Dyskinesia Impact Scale (TDIS) total score at Week 24 Baseline, Week 24
Primary Change from baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 at Week 24 Baseline, Week 24
Primary Change from baseline in the EQ-visual analogue scale (EQ-VAS) score at Week 24 Baseline, Week 24
Secondary Patient Global Impression of Change (PGI-C) score at Week 24 Baseline, Week 24
Secondary Change from baseline in the Clinical Global Impression of Severity - TD (CGI-TD-S) score at Week 24 Baseline, Week 24
Secondary Change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score at Week 24 Baseline, Week 24
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