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Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients
Date:4/28/2009

Total score analyzed using an ANCOVA model.

Results

The change in total TWSTRS from baseline to week 4 was -2.2 +/- 7.3 points (placebo group); -9.9 +/- 10.4 points (120 U group) and -10.9 +/- 11.7 points (240 U group) (p < 0.001). AEs occurred in 41.9% of the placebo group, 56.4% of the 120 U group and 55.6% of the 240 U group. AEs reported most frequently for each group respectively were dysphagia (2.7% vs 12.8% vs 18.5%), neck pain (4.1% vs 6.4%, vs 14.8%), and muscular weakness (1.4% vs 6.4% vs 11.1%).

Efficacy and safety of NT-201 (Botulinum neurotoxin free from complexing proteins) in Blepharospasm. Presented by Joseph Jankovic of Baylor College of Medicine in Houston, TX.

Method

This prospective, double-blind, placebo-controlled, randomized, multi-center study investigated the efficacy and safety of NT-201 [Botulinum neurotoxin A (BoNT A) free from complexing proteins], compared to placebo in pre-treated subjects with blepharospasm (BEB). The study investigated individual dose of NT-201 up to 50 units per eye compared to placebo; of the 109 randomized BEB patients 65.1% were female, mean age 61.9 years and a median BEB duration of 84 months. The mean dose was 64.8 U in the NT-201 group. Pre-treated subjects were randomized in a 2:1 ratio to NT-201 or placebo. Subjects were followed-up for up to 20 weeks. The Jankovic Rating Scale (JRS) severity subscore six weeks after injection was the primary outcome assessed by a blinded independent investigator. Confirmatory analysis was based on the intent-to-treat (ITT) population using an ANCOVA model. AEs were collected via direct questioning.

Results

The treatment difference in the JRS severity subscore was statistically significant in favor of NT-201 (p<0.001). These results were confirmed in all secondary endpoint
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SOURCE Merz Pharmaceuticals
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