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Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

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Trial Profile

Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2024

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At a glance

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

    • Most Recent Events

    • 29 May 2024 According to an AB Science media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a trending toward a negative opinion on the application for conditional marketing authorisation of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), following an oral explanation held at the 28 May meeting of the CHMP. The CHMP is expected to adopt a formal opinion on the MAA at its next meeting, which will be held June 24- 27, 2024.
    • 26 Jan 2024 According to an AB Science media release, the Committee for Medicinal Products for Human Use (CHMP) has proposed that AB Science submit a written response to the List of Outstanding Issues at D195 of the procedure, instead of addressing these issues through the Oral Explanation. AB Science now expects an opinion from the CHMP in the second quarter of 2024.
    • 04 Mar 2022 Planned End Date changed from 1 Dec 2022 to 1 Dec 2023.

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