WASHINGTON (dpa-AFX) - Neurocrine Biosciences Inc. (NBIX) announced Monday 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.
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.
Copyright RTT News/dpa-AFX
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