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Neurocrine Biosciences Inc. Message Board

  • endabaus endabaus Sep 9, 2013 6:04 PM Flag

    Read the PR folks before jumping! This is good news.

    "Although the 50mg dose of NBI-98854 did not reach statistical significance for the primary endpoint at Week 6, the 100mg dose, utilizing the blinded central video AIMS assessment, showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms at Week 2 (the end of the 100mg dose interval). AIMS scores were reduced by 5.5 points in the 100mg per-protocol (PP) group compared to a reduction of 2.7 points in placebo (p=0.008), and the responder rate ( = 50% improvement from baseline) was 48% in the 100mg group compared to 23% in placebo (p=0.034). The 100mg dose was expected to be a maximum tolerated dose based on earlier data; however in this patient population, 100mg was well tolerated. The pre-specified statistical analysis plan included three data sets: safety set (all subjects with at least one dose), ITT set (all randomized subjects with at least one AIMS assessment) and the PP set (all subjects except those with no detectable drug levels at the evaluation time point)."

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