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Prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label lead-in tolerability period and an open-label extension period to investigate the efficacy and safety of two different doses of NT 201 in the treatment of post-stroke spasticity of the upper limb

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Prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label lead-in tolerability period and an open-label extension period to investigate the efficacy and safety of two different doses of NT 201 in the treatment of post-stroke spasticity of the upper limb

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2023

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At a glance

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

    • Most Recent Events

    • 07 Jun 2023 According to a Merz Therapeutics media release, the company received from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the use of XEOMIN for the treatment of focal spasticity of the lower limb affecting the ankle joint.
    • 23 Jun 2021 According to a Merz Therapeutics, Teijin Pharma Limited media release, based on the phase-III clinical trials conducted by Merz in Japan, Teijin Pharma has been granted additional approval with partial changes in the obtained approval by Japan's Ministry of Health, Labor and Welfare (MHLW) to market Xeomin (incobotulinumtoxinA) for intramuscular injection in 50, 100 or 200 units for the treatment of lower limb spasticity.
    • 29 Jun 2020 According to a Merz Pharmaceuticals media release, the company has been granted approval by Japan's Ministry of Health, Labor and Welfare (MHLW) to market Xeomin (incobotulinumtoxinA) for intramuscular injection in 50, 100 or 200 units for the treatment of upper limb spasticity.

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