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Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

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Trial Profile

Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 09 Apr 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

    • 03 Apr 2024 Results published in the AB Science media release Media Release
    • 03 Apr 2024 According to an AB Science media release, that Health Canada has granted eligibility for reconsideration request for masitinib in amyotrophic lateral sclerosis (ALS). The reconsideration process will re examine, with new assessors, the decision based on information that was included in the original submission. A Notice of Deficiency-Withdrawal (NOD/w) was issued on February 19, 2024 by Health Canada regarding the New Drug Submission (NDS) for masitinib in the treatment of ALS. The intention to s
    • 26 Feb 2024 According to an AB Science media release, the company intends to submit a Request for Reconsideration based on information that was included in the original submission.
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