US based Neurocrine Biosciences has started a second double-blind, placebo controlled, randomized cross-over Phase II trial to evaluate NBI- 98854.
The company is developing NBI-98854 to address the unmet medical needs of patients suffering from tardive dyskinesia (TD).
The trial aims to evaluate once-daily NBI-98854 (12.5mg and 50mg) over a two week dosing period.The primary endpoint of the study will be a comparison of placebo vs. active scores on the abnormal involuntary movement scale (AIMS).
Neurocrine chief medical officer Christopher O’Brien said the data derived from this study will guide our dosing selection and treatment regimens for our larger Phase IIb studies that they plan to initiate in the first half of 2012.
NBI-98854 may also be useful in other disorders such as Huntington’s chorea, schizophrenia and Tourette’s syndrome.