At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 59 enrolled
Drug / intervention
Valbenazinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Valbenazine for Schizophrenia and 4 related conditions. Completed, enrolled 59 participants across 18 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
202420252026
Enrollment StartMay 2023
First PostedMay 2023
Primary CompletionDec 2024
TodayJul 2026
First PostedMay 16, 2023
Enrollment StartMay 9, 2023
Primary CompletionDec 27, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.1 years ago
Interventions
Valbenazinedrug
Valbenazine capsules for oral administration