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.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 26 Jul 2018

At a glance

  • Drugs Masitinib (Primary) ; Riluzole
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science
  • Most Recent Events

    • 28 May 2018 According to an AB Science media release, the company plans to submit to the EMA, new sensitivity analyses on the primary analysis of the ALSFRS-R score for patients who stopped the study prematurely, applying recommended methods as per EMA guidelines in order to corroborate the results based on the LOCF method (last observation carried forward) and new preclinical data reinforcing the mechanisms of action of masitinib.
    • 28 May 2018 According to an AB Science media release, the company has decided not to pursue the re-examination procedure that the company initially requested for the marketing authorization application of masitinib in the treatment of ALS. The company determined that the re-examination procedure would not be the most appropriate format to address all the pending concerns raised by the Committee for Human Medicinal Products (CHMP).
    • 30 Apr 2018 According to an AB Science media release, the company is planning to conduct a confirmatory study (see profile 700295486) to confirm the results of this trial even in case of positive opinion by the CHMP, in case of a conditional marketing authorization application.
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