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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

rk and a leading botulinum neurotoxin researcher.

The NT-201 data will be presented at the AAN's annual meeting. The data include poster p07.088, Efficacy and safety of NT-201 (Botulinum neurotoxin free from complexing proteins) in cervical dystonia, poster p07.081, Clinical efficacy in focal dystonia and overall tolerability of NT-201 (botulinum neurotoxin free from complexing proteins) and poster p07.091, Efficacy and safety of NT-201 (Botulinum neurotoxin free from complexing proteins) in Blepharospasm.

Joseph Jankovic, M.D. Professor of Neurology, Distinguished Chair in Movement Disorders, and Director of the Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine in Houston and a lead investigator of the blepharospasm study noted that "these promising data indicate that following approval, Xeomin will become an important treatment option for movement disorders."

About the Studies

Efficacy and safety of NT-201 (Botulinum neurotoxin free from complexing proteins) in cervical dystonia. Presented by Cynthia Comella of Rush University in Chicago.

Method

This prospective, double-blind, placebo-controlled, multi-center study evaluated the safety and efficacy of NT-201 [Botulinum neurotoxin A (BoNT A) free from complexing proteins], compared to placebo in subjects with cervical dystonia (CD). There were 233 CD patients (66% women, age 52.8 years, CD duration 51.9 months), 39% not previously treated with BoNT. Patients were randomized to placebo (N= 74), 120 U NT-201 (N= 78), and 240U NT-201 (N= 81). Following injection, patients were evaluated at 4 weeks using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS); adverse events (AEs) were also collected. The primary outcome was the change from Baseline to week 4 for the TWSTRS-
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