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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