Oct. 1, 2012
/PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase IIb clinical trial (Kinect Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The design of this twelve-week Phase IIb study is a randomized, parallel, double-blind, placebo-controlled, trial of 120 subjects with moderate to severe tardive dyskinesia and underlying schizophrenia or schizoaffective disorder. Topline data is expected in the second quarter of 2013.
"We are pleased that NBI-98854 is taking the next step in development with this Phase IIb clinical trial," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences. "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. This study will provide us with the data necessary to develop the Phase III program for NBI-98854."
Kinect Study Design
The Kinect Study is a randomized, parallel, double-blind, placebo-controlled, Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia or schizoaffective disorder. This 120 subject study will assess two doses of once-daily NBI-98854 over a six-week placebo-controlled dosing period. Half of the randomized subjects will receive placebo and half will receive one of two doses of NBI-98854. 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 period. Subsequent to the placebo-controlled dosing, all subjects will enter a six-week open label safety extension of 50 mg of NBI-98854 administered once daily with additional AIMS assessments. The primary endpoint of the study is a comparison of placebo vs. active scores utilizing the Abnormal Involuntary Movement Scale (AIMS) at the end of week six.