INGREZZA™ (valbenazine) capsules: an investigational treatment for Tardive Dyskinesia
Valbenazine (NBI-98854) has been investigated in multiple clinical trials, including several in patients with Tardive Dyskinesia.
KINECT 3 Study
The KINECT 3 study (ClinicalTrials.gov Identifier NCT02274558) was a randomized, parallel-group, double-blind, placebo-controlled, Phase 3 clinical trial of valbenazine (NBI-98854) in moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder). The KINECT 3 study randomized 234 subjects to either placebo, once-daily 40mg of valbenazine or once-daily 80mg of valbenazine for six weeks. Subsequent to the completion of the six week placebo-controlled dosing, subjects were eligible to continue treatment through Week 48. The pre-specified primary efficacy endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) total dyskinesia score at Week 6 in the 80mg once-daily dosing group compared to placebo as assessed by central blinded video raters. In addition to the primary efficacy endpoint, the AIMS rating for the 40mg once-daily dose and the Clinical Global Impression of Change (CGI-TD) for both doses were also evaluated.
KINECT 3: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Valbenazine (NBI-98854) for Tardive Dyskinesia (Click Here)