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

to 20 weeks or until the next injection. The change from Baseline to week 4 for the TWSTRS scores was analyzed using an ANCOVA model.

Results

There were 143 CD patients (65% women, mean age 53.9 years, mean CD duration 83.3 months), Patients were randomized to placebo (N= 46), 120 U NT 201 (N= 47), and 240U NT 201 (N= 50). The change in total TWSTRS from baseline to week 4 was -2.4 plus or minus 8.1 points (placebo group); -8.5 plus or minus 9.7 points (120 U group) and -11.4 plus or minus 13.1 points ( 240 U group) (p < 0.002 compared to placebo). Improvement in TWSTRS-Severity score from baseline to week 4 was -1.9 plus or minus 3.7 points (placebo group); -3.7 plus or minus 4.4 points (120 U group) and -5.6 plus or minus 6.4 points ( 240 U group) . AEs occurred in 34.8% of patients of the placebo group, 55.3% of the 120 U group and 46.0% of the 240 U group. AEs reported most frequently were dysphagia (4.3% vs 8.5% vs 16.0%), neck pain (4.3% vs 8.5%, vs 10.0%), and injection site pain (2.2% vs 8.5% vs 2.0%) for each group, respectively.

Second Study - Title

Efficacy and safety of NT-201 (Xeomin(R); Botulinum neurotoxin type A free from complexing proteins) in treatment-naive cervical dystonia patients authored by Susanne Grafe, Cynthia Comella, Joseph Jankovic, Daniel Truong, and Angelika Hanschman.

Method

CD patients not previously treated with BoNT were randomized to placebo, 120 U NT 201, or 240 U NT-201. Following injection, patients were evaluated at 4 weeks using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). Adverse events (AEs) were also collected up to 20 weeks or until the next injection. The change from Baseline to week 4 for the TWSTRS scores was analyzed using an ANCOVA model.

Results

There were 90 CD patients (67.8% women, mean age 51.1 years, mean CD duration 13.5 months), Patients were randomi
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