Valbenazine for Tardive Dyskinesia


Title: KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia

Hauser, Robert A. et al.


 

What You Need to Know:

The use of valbenazine, a highly selective vesicular monoamine transporter 2 inhibitor, led to significant improvement of tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, or mood disorder.

Trial Design:

  • Phase 3, randomized, double-blind, placebo-controlled, 6-week trial evaluated efficacy, safety, and tolerability of once-daily valbenazine as a treatment for tardive dyskinesia
  • Included patients had schizophrenia, schizoaffective disorder, or a mood disorder with moderate or severe tardive dyskinesia
  • 225 patients were randomized 1:1:1 to once-daily placebo, valbenazine 40mg daily, or valbenazine 80mg daily; 205 patients completed the study
  • Primary efficacy endpoint: change from baseline at Week 6 in the 80mg daily group vs. placebo group on the Abnormal Involuntary Movement Scale (AIMS) dyskinesia score
  • Safety assessments: adverse event monitoring, lab tests, ECG, psychiatric measures

Key Outcomes:

  • ~65% of patients had schizophrenia or schizoaffective disorder
  • 85.5% of patients were taking concomitant antipsychotics
  • A significant difference in the change from baseline to Week 6 in AIMS dyskinesia score was seen in the valbenazine 80mg daily group vs. placebo (least squares mean change: -3.2 vs. -0.1)
  • AIMS dyskinesia score was also reduced in the valbenazine 40mg daily group vs. placebo (-1.9 vs. -0.1)
  • Valbenazine was generally well tolerated; psychiatric status remained stable