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NEUROLOGY 2005;64:1949-1951
© 2005 American Academy of Neurology
Brief Communications

A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia

R. Benecke, MD, W. H. Jost, MD, P. Kanovsky, MD, E. Ruzicka, MD, G. Comes, Dipl Stat and S. Grafe, MD

From the Department of Neurology (Dr. Benecke), University of Rostock, Department of Neurology (Dr. Jost), Deutsche Klinik für Diagnostik, Wiesbaden, Department of Neurology (Dr. Kanovsky), Masaryk University Brno, Department of Neurology (Dr. Ruzicka), Charles University Prag, and Merz Pharmaceuticals GmbH (Drs. Comes and Grafe), Frankfurt, Germany.

Address correspondence and reprint requests to Dr. R. Benecke, Department of Neurology, University of Rostock, Gehlsheimer Strasse 20 D-18147, Rostock, Germany; e-mail: reiner.benecke{at}med.uni-rostock.de

A new botulinum toxin type A free of complexing proteins (NT 201) was compared with BOTOX in patients with cervical dystonia by means of a double-blind noninferiority trial. Four hundred sixty-three patients received IM injections of 70 to 300 U of NT 201 or BOTOX and were followed up over 16 weeks. The study clearly shows that NT 201 is at least as effective and safe as BOTOX.

Supported by Merz Pharmaceuticals GmbH (Frankfurt, Germany).

Merz developed the study design in cooperation with Dr. Benecke, who was coordinating investigator for Europe and Israel. The management of the study and the analysis were performed by a contract research organization (Omnicare). The interpretation of the data was done by Dr. Benecke and the other coauthors, two of whom are Merz employees. Merz reviewed the manuscript. Dr. Benecke was responsible for final approval of the manuscript. Dr. Benecke received fees from Merz as coordinating investigator (referred to a third-party account of the University of Rostock) and as a consultant. Drs. Comes and Grafe are full-time employees of Merz Pharmaceuticals.

Received September 16, 2004. Accepted in final form February 9, 2005.


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