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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2017

At a glance

  • Drugs Botulinum toxin A (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Acronyms PURE
  • Sponsors Merz Pharmaceuticals GmbH
  • Most Recent Events

    • 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).
    • 10 May 2016 Data will be presented at the 9th World Congress for Neurorehabilitation, as per Merz Neurosciences media release.
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