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Merz Pharmaceuticals Announce Three Studies of NT-201 - (Botulinum neurotoxin type A Free From Complexing Proteins)
Date:6/9/2009

zed to placebo (N= 28), 120 U NT 201 (N= 31), and 240U NT 201 (N=31). The change in total TWSTRS from baseline to week 4 was -2.0 plus or minus 6.0 points (placebo group); -11.9 plus or minus 11.1 points (120 U group) and -10.0 plus or minus 9.2 points ( 240 U group) (p < 0.001 compared to placebo). Improvement in TWSTRS-Severity score from baseline to week 4 was -1.9 plus or minus 4.5 points (placebo group); -4.1 plus or minus 4.3 points (120 U group) and -5.4 plus or minus 5.5 points (240 U group). AEs occurred in 53.6% of patients of the placebo group, in 58.1% of the 120 U group and in 71.0% of the 240 U group. AEs reported most frequently were dysphagia (0% vs 19.4% vs 22.6%), muscular weakness (3.6% vs 6.5% vs 22.6%), and neck pain (3.6% vs 3.2%, vs 22.6%) for each group, respectively.

Third Study - Title

Repeated injections of NT-201 (Xeomin(R); botulinum neurotoxin free from complexing proteins) in upper limb post-stroke spasticity patients authored by P. Kanovsky for the NT 201 Study Group, I. Sassin, G. Comes, S. Grafe, T. Platz

Method

Patients who previously participated in the double-blind, placebo-controlled study, entered the OLEX Period, and were treated with NT-201 (up to five injection intervals) over 1 year (48 to 69 weeks). Parameters were the Ashworth Scale, Disability Assessment Scale (DAS), global assessments, and standard safety testing.

Out of 148 patients who participated in the double-blind period of the study, 145 entered the OLEX Period. 120 patients completed the 1-year trial period. Upper limb muscle groups were treated as clinically indicated (median dose: 400 units, maximum dose: 500 units). Changes on the Ashworth Scale score were highly statistically significant (p < 0.0001; Wilcoxon signed rank test) at control visits during all four injection intervals and in all muscle groups. NT 201 was effective in reducing functional impairment as shown
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SOURCE Merz Pharmaceuticals
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