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Open-label, Non-controlled, Multicenter Long-term Study to Investigate the Safety and Efficacy of Xeomin (Incobotulinumtoxin A, NT 201) for the Treatment of Spasticity of the Lower Limb(s) or of Combined Spasticity of Upper and Lower Limb in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

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Trial Profile

Open-label, Non-controlled, Multicenter Long-term Study to Investigate the Safety and Efficacy of Xeomin (Incobotulinumtoxin A, NT 201) for the Treatment of Spasticity of the Lower Limb(s) or of Combined Spasticity of Upper and Lower Limb in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2021

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Adverse reactions; Registrational
  • Acronyms TIMO
  • Sponsors Merz Pharmaceuticals GmbH

Most Recent Events

  • 22 Sep 2021 Results of a pooled analysis assessing the neutralizing antibody (NAb) formation in three large Phase 3 studies ( NCT01905683, NCT01893411 and NCT02002884) 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.
  • 22 Apr 2021 Results of two phase III studies TIM and TIMO assessing efficacy and safety of incobotulinumtoxinA in lower-limb (LL) or combined LL/upper-limb (LL/UL) spasticity in children and adolescents with cerebral palsy presented at the 73rd Annual Meeting of the American Academy of Neurology

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