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.
- 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
- ~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