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A prospective, randomized, double-blind, placebo-controlled, two-stage, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity in children and adolescents with cerebral palsy.

Trial Profile

A prospective, randomized, double-blind, placebo-controlled, two-stage, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity in children and adolescents with cerebral palsy.

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2026

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At a glance

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

Most Recent Events

  • 26 Jan 2026 According to a Merz Therapeutics, completed the regulatory submission for XEOMIN (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2-17 years in the European Union (EU) and European Economic Area (EEA).
  • 26 Jan 2026 Results published in the Media Release
  • 08 Dec 2025 According to a Merz Therapeutics, data from this trial will be presented at the TOXINS 2026 8th International Conference, taking place January 14 to 17, 2026, in Madrid, Spain.

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