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A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 Trial to compare the efficacy and safety of masitinib in combination with standard of care versus placebo in combination with standard of care in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)

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Trial Profile

A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 Trial to compare the efficacy and safety of masitinib in combination with standard of care versus placebo in combination with standard of care in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Apr 2026

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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

  • 16 Apr 2026 According to an AB science media release, the company secures phase III trial with policy cover of 25 million Euros of trial costs in the event of clinical failure, with zero deductible.
  • 24 Jul 2025 According to an AB science media release, the design has been validated in discussions with European health authorities, particularly with regard to the criteria for the optimal population selected for the confirmatory study: 1. Patients without rapid progression and 2. Patients without complete loss of function.
  • 24 Jul 2025 According to an AB science media release, the authorization follows EMA's validation of the harmonized protocol, approved at the end of Step 1 of the CTIS procedure, and followed the authorization from the FDA. Consequently, AB Science can now initiate this registration study in Europe and the United States.

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