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

J Neural Transm (Vienna). 2006 Mar;113(3):303-12. doi: 10.1007/s00702-005-0323-3. Epub 2005 Jun 15.


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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Blepharospasm / drug therapy*
  • Blepharospasm / physiopathology
  • Botulinum Toxins, Type A / administration & dosage*
  • Botulinum Toxins, Type A / adverse effects
  • Botulinum Toxins, Type A / chemical synthesis
  • Botulinum Toxins, Type A / chemistry
  • Double-Blind Method
  • Eyelids / drug effects*
  • Eyelids / physiopathology
  • Female
  • Hemagglutinins / adverse effects
  • Hemagglutinins / chemistry
  • Humans
  • Male
  • Middle Aged
  • Muscle, Skeletal / drug effects*
  • Muscle, Skeletal / physiopathology
  • Neuromuscular Agents / administration & dosage
  • Neuromuscular Agents / adverse effects
  • Neuromuscular Agents / chemistry
  • Treatment Outcome


  • Hemagglutinins
  • Neuromuscular Agents
  • Botulinum Toxins, Type A
  • incobotulinumtoxinA