At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 135 enrolled
Drug / intervention
Valbenazine +1 moredrug
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, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
In Brief
A Phase 4 clinical trial evaluating Valbenazine and Placebo oral capsule for Tardive Dyskinesia (TD). Completed, enrolled 135 participants across 43 sites in 2 countries.
Detailed Summary
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTardive Dyskinesia (TD)
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
Enrollment StartMar 2019
First PostedMar 2019
Primary CompletionDec 2019
Study CompletionJan 2020
TodayJul 2026
First PostedMar 27, 2019
Enrollment StartMar 18, 2019
Primary CompletionDec 23, 2019
Study CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.3 years ago
Interventions
Valbenazinedrug
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo oral capsuledrug
non-active dosage form