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A confirmatory study of masitinib in the treatment of Amyotrophic Lateral Sclerosis

Trial Profile

A confirmatory study of masitinib in the treatment of Amyotrophic Lateral Sclerosis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2024

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At a glance

  • Drugs Masitinib (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science
  • Most Recent Events

    • 17 Oct 2024 According to an AB science media release, company announces that European Medicines Agency (EMA) confirmed a negative opinion for conditional marketing authorization of masitinib in treatment of amyotrophic lateral sclerosis (ALS), this opinion supports design of this confirmatory study of masitinib in ALS, as the same dichotomization and the same cut-off have been pre-specified for the confirmatory study.
    • 30 Sep 2019 According to an AB science media release, the company expects to initiate this study in Q1 2020.
    • 30 May 2019 According to an AB science media release, the design, optimization and timelines from this trial will be presented in the company webcast on 4 June 2019.

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