A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Tardive Dyskinesia

Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Tardive Dyskinesia

Completed
Phase of Trial: Phase II

Latest Information Update: 14 Aug 2017

At a glance

  • Drugs Valbenazine (Primary)
  • Indications Drug-induced dyskinesia
  • Focus Therapeutic Use
  • Acronyms KINECT-2
  • Sponsors Neurocrine Biosciences
  • Most Recent Events

    • 08 Jun 2017 Results (n=373) of pooled population from KINETIC-1,KINETIC-2,KINETIC-3 studies presented at the 21st International Congress of Parkinson's Disease and Movement Disorders.
    • 11 Apr 2017 According to a Food and Drug Administration media release, on April 11th 2017, the U.S. Food and Drug Administration has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia.
    • 02 Nov 2016 According to a Neurocrine media release, the US FDA has accepted the New Drug Application (NDA) of valbenazine in treating tardive dyskinesia for priority review and provided Prescription Drug User Fee Act (PDUFA) target action date of 11 April 2017.
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