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XenoPort Inc Announces Top-Line Results of Phase 3 Trial of Arbaclofen Placarbil for Spasticity in Multiple Sclerosis Patients


Monday, 20 May 2013 06:30am EDT 

XenoPort Inc announced top-line results from its pivotal Phase 3 clinical trial of arbaclofen placarbil (AP) for the treatment of patients with spasticity due to multiple sclerosis (MS). The trial was unsuccessful in demonstrating that AP provided statistically significant improvement relative to placebo in the co-primary endpoints of the study. The trial was a 13-week, multicenter, randomized, double-blind, placebo-controlled study that enrolled 228 subjects in 30 sites in the United States. There was a one-week placebo run-in period, two weeks of up-titration, eight weeks at the maintenance dose and two weeks of down-titration. Eligible subjects were randomized to one of four arms: 15 mg, 30 mg or 45 mg of AP or placebo dosed twice a day (BID) with food. The first of the co-primary endpoints for the study was the time-matched change from baseline in Maximum Ashworth score (six hours post-dose time point) at the end of the maintenance dose period. The muscle group in the lower limbs with the highest Ashworth score at baseline was followed throughout the trial. Subjects entering the trial were required to have a Maximum Ashworth score of two or greater prior to entering the study and at the end of the placebo run-in period, which served as baseline. The second co-primary endpoint was the score on the 7-point Patient Global Impression of Change scale at the end of the maintenance period. 

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