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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Neurocrine Biosciences |
United States,
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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