Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm
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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.
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- Allergan Pharmaceuticals (Ireland) Ltd (2004) BOTOX® (Botulinum Toxin Type A). Purified Neurotoxin Complex (Package Insert). July 2004Google Scholar
- Costa J, Espirito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, Sampaio C (2004) Botulinum toxin type A therapy for blepharospasm. The Cochrane Database of Systematic Reviews Issue 2 (Art No: CD004900pub2; DOI:101002/14651858CD004900pub2 2004)Google Scholar
- Epidemiologic Study of Dystonia in Europe1999Sex-related influences on the frequency and age of onset of primary dystonia.Neurology5318711873Google Scholar
- Goertelmeyer, R, Brinkmann, S, Comes, G, Delcker, A 2002The Blepharospasm Disability Index (BSDI) for the assessment of functional health in focal dystonia.Clin Neurophysiol113S77S78Google Scholar
- Jankovic J (2002) Dystonia: medical therapy and botulinum toxin. Paper, 4th International dystonia symposium, Atlanta, GA, USA, June 2002 (not specified 119–123)Google Scholar
- NIH (1990) Clinical use of Botulinum Toxin. NIH Consens Statement Online 8(8): 1–20 (November 12, 1990)Google Scholar
- Subcommittee of the American Academy of Neurology1994Training guidelines for the use of botulinum toxin for the treatment of neurologic disorders. Report of the Therapeutics and Technology Assessment.Neurology4424012403Google Scholar
- Wohlfarth, K, Mueller, C 2005Safety efficacy and duration of effect of a new botulinum neurotoxin type A preparation free of complexing proteins.Mov Disord20S11Google Scholar