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

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: 28 Feb 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 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.
    • 26 Feb 2024 According to an AB Science media release, Health Canada has issued a Notice of Non-Compliance-Withdrawal (NON/w) regarding its New Drug Submission (NDS) for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) and a Request for Reconsideration can be filed within 30 days of receiving the NON/w.
    • 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.
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