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Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb

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Trial Profile

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2018

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Acronyms PURE
  • Sponsors Merz Pharmaceuticals GmbH

    • Most Recent Events

    • 27 Nov 2018 Results of open label extension (OLEX) assessing efficacy and safety published in the Advances in Therapy.
    • 28 Apr 2017 Pooled analysis results of two phase 3 clinical studies (NCT01392300 and NCT00432666) in upper-limb post-stroke spasticity assessing the duration of treatment effect for incobotulinumtoxinA treatment intervals, presented at the 69th Annual Meeting of the American Academy of Neurology.
    • 16 Aug 2016 Results (n=572) of this and two other phase 3 trials published in the Drugs (2016).

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