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Journal of Neural Transmission

, Volume 113, Issue 3, pp 303–312 | Cite as

Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm

  • P. Roggenkämper
  • W. H. Jost
  • K. Bihari
  • G. Comes
  • S. Grafe
  • for the NT 201 Blepharospasm Study Team
Article

Summary.

NT 201 is a new development of Botulinum Toxin Type A free of complexing proteins. In this double-blind Phase III trial, we compared the efficacy and safety of NT 201 and BOTOX® in patients suffering from blepharospasm. Of 304 enrolled patients, 300 patients received study medication (intent-to-treat population), and 256 patients completed the study as planned (per-protocol population). At baseline, patients received a single injection of NT 201 or BOTOX® (≤35 units per eye). No significant differences were found between NT 201 and BOTOX® for all efficacy and safety variables three weeks after injection. Both the NT 201 and the BOTOX® group showed a decrease in the Jankovic Rating Scale (JRS) sum score signifying an improvement in the symptoms of blepharospasm during this time period. These data show that NT 201* is an effective and safe treatment for patients suffering from blepharospasm.

Keywords: Botulinum toxin type A, blepharospasm. 

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Copyright information

© Springer-Verlag/Wien 2005

Authors and Affiliations

  • P. Roggenkämper
    • 1
  • W. H. Jost
    • 2
  • K. Bihari
    • 3
  • G. Comes
    • 4
  • S. Grafe
    • 4
  • for the NT 201 Blepharospasm Study Team
  1. 1.Department of OphthalmologyUniversity of BonnWiesbadenGermany
  2. 2.Deutsche Klinik für DiagnostikWiesbadenGermany
  3. 3.Orszagos Idegsebeszeti Tudomanyos IntezetBudapestHungary
  4. 4.Merz PharmaceuticalsFrankfurt/MainGermany

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