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Prospective, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of Two Different Doses of NT 201 in Botulinum Toxin Treatment-naive Subjects With Blepharospasm

Trial Profile

Prospective, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of Two Different Doses of NT 201 in Botulinum Toxin Treatment-naive Subjects With Blepharospasm

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 May 2019

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Blepharospasm
  • Focus Registrational; Therapeutic Use
  • Sponsors Merz Pharmaceuticals GmbH
  • Most Recent Events

    • 13 May 2019 According to a Merz North America media relaease, based on the data from this trial, the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XEOMIN(incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients.
    • 27 Apr 2018 Primary endpoint (Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4)) has been met, according to results presented at the 70th Annual Meeting of the American Academy of Neurology.
    • 27 Apr 2018 Results (n=61) assessing the safety and efficacy of incobotulinumtoxinA for treating benign essential blepharospasm in subjects not previously treated with botulinum toxin, were presented at the 70th Annual Meeting of the American Academy of Neurology.
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