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Prospective, Multicenter, Randomized, Double-blind, Parallel-group, Dose-response Study of Three Doses Xeomin (incobotulinumtoxinA, NT 201) for the Treatment of Upper Limb Spasticity Alone or Combined Upper and Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

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Trial Profile

Prospective, Multicenter, Randomized, Double-blind, Parallel-group, Dose-response Study of Three Doses Xeomin (incobotulinumtoxinA, NT 201) for the Treatment of Upper Limb Spasticity Alone or Combined Upper and Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Mar 2022

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At a glance

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

    • Most Recent Events

    • 22 Sep 2021 Results presented at the 25th International Congress of Parkinson's Disease and Movement Disorders
    • 22 Sep 2021 Results of pooled analysis of two randomized Phase 3 studies, TIM (NCT01893411) and XARA (NCT02002884) assessing efficacy and safety of incobotulinumtoxinA for lower-limb (LL) and upper-limb (UL) spasticity in children and adolescents with cerebral palsy, presented at the 25th International Congress of Parkinson's Disease and Movement Disorders.
    • 22 Sep 2021 Results assessing effect of incobotulinumtoxinA on spasticity-related pain (SRP) using pooled data from three large Phase 3 pediatric studies (TIM (NCT01893411); TIMO (NCT01905683) & XARA (NCT02002884)) presented at the 25th International Congress of Parkinson's Disease and Movement Disorders.

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