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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: 31 Jan 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

    • 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.
    • 04 Mar 2022 Planned primary completion date changed from 1 Dec 2022 to 1 Dec 2023.
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