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"Overall we were very pleased with the conduct of the study, including the investigators' administration of the Yale Global Tic Severity Scale as well as the safety profile of INGREZZA in adults with Tourette syndrome," said Chris O'Brien, Chief Medical Officer of Neurocrine. "Through this initial placebo-controlled study we gained valuable insights into the conduct of clinical trials in Tourette patients, including patient identification methods and appropriate study inclusion/exclusion criteria. As we have done with our previous early Phase II studies in both endometriosis and tardive dyskinesia, we will apply these new insights to future Tourette studies." "This T-Forward study has provided us with our first experience in applying the Yale Global Tic Severity Scale with adult patients in a placebo-controlled setting. We are pleased with the clinical response observed across the various efficacy assessments," said Kevin Gorman, Chief Executive Officer of Neurocrine. "At present, we are not disclosing specific details of this study in order to avoid the potential introduction of assessment bias in the ongoing Phase II T-Force GREEN study of pediatric Tourette patients. We look forward to the pediatric study readout next quarter and our subsequent discussion with the FDA on our plans for Phase III development of INGREZZA in Tourette syndrome." T-Forward Study Design The T-Forward study was a randomized, double-blind, placebo-controlled, multi-dose, parallel group, Phase II study to evaluate the safety, tolerability and efficacy of valbenazine in adults with moderate to severe Tourette syndrome. Two once-daily fixed doses of valbenazine were evaluated vs. placebo in a 1:1:1 randomization. The three-arm study evaluated 124 patients over eight weeks of dosing followed by two weeks off-drug at32 study centers in the United States. The primary endpoint of this study was a change from baseline of placebo vs. active scores utilizing theYGTSS at the end of Week 8.


For the original version including any supplementary images or video, visit http://www.marketwatch.com/story/neurocrine-announces-completion-of-phase-ii-clinical-study-of-vmat2-inhibitor-ingrezzatm-valbenazine-in-adults-with-tourette-syndrome-2017-01-17



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