Neurocrine Biosciences has commenced a Phase IIb trial of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854, for the treatment of tardive dyskinesia.
The twelve-week Kinect study is a randomised, parallel, double-blind, placebo-controlled trial of 120 subjects with moderate-to-severe tardive dyskinesia and underlying schizophrenia or schizoaffective disorder.
The study is designed to assess two doses of once-daily NBI-98854 over a six-week placebo-controlled dosing period.
Neurocrine Biosciences chief medical officer Christopher O’Brien said the clinical trial is NBI-98854’s next development step.
"The Kinect Study incorporates key refinements to improve the appropriateness of tardive dyskinesia subjects, reduce the variability in AIMS assessments, and expand our dose response database," O’Brien said.
"This study will provide us with the data necessary to develop the Phase III programme for NBI-98854."
The company expects the topline data from the trial in the second quarter of 2013.
According to the study design, the two NBI-98854 dosing groups will consist of a 50mg group for six weeks, and a group that will begin at 100mg for the initial two weeks, then convert to a 50mg for the final four weeks of placebo-controlled dosing.
After the placebo-controlled dosing, all subjects will enter a six-week open label safety extension of 50mg of NBI-98854, administered once-daily with additional Abnormal Involuntary Movement Scale (AIMS) assessments.
A comparison of placebo vs active scores utilising AIMS at the end of week six, is the primary endpoint of the study.
The independent panel will determine if the subject meets the AIMS severity criteria to be eligible for the Kinect Study.