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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: 04 Nov 2019

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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

    • 01 Nov 2019 This trial has been withdrawn prior to enrolment in Slovakia , according to European Clinical Trials Database.
    • 08 Jul 2019 Primary endpoint (Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised: Masitinib at 4.5 mg/kg/day in combination with riluzole compared with the active riluzole control at week 48) has been met, according to an AB Science media release.
    • 08 Jul 2019 According to an AB Science media release, full, peer-reviewed results from this study have been published in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration (ALSFD).
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