Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm.
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 (<or=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.
Roggenkämper
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Department of Ophthalmology, University of Bonn, Wiesbaden, Germany. proggenk@uni-bonn.de
Jost
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Bihari
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Comes
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Grafe
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D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001764:Blepharospasm / Q000188:drug therapy* / Q000503:physiopathology; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects / Q000138:chemical synthesis / Q000737:chemistry; D004311:Double-Blind Method; D005143:Eyelids / Q000187:drug effects* / Q000503:physiopathology; D005260:Female; D006388:Hemagglutinins / Q000009:adverse effects / Q000737:chemistry; D006801:Humans; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000187:drug effects* / Q000503:physiopathology; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry; D016896:Treatment Outcome
D006388:Hemagglutinins; D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA