A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis.

Trial Profile

A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Apr 2018

At a glance

  • Drugs Dimethyl fumarate (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions
  • Acronyms ENDORSE
  • Sponsors Biogen
  • Most Recent Events

    • 02 Apr 2018 Planned End Date changed from 6 Feb 2023 to 30 Sep 2020.
    • 02 Apr 2018 Planned primary completion date changed from 6 Feb 2023 to 30 Sep 2020.
    • 28 Oct 2017 Results (Data cut of 1 October 2016; n=2513) of integrated analysis of DEFINE, CONFIRM, ENDORSE and NCT00168701 trials assessing the dynamics and clinical implications of on-DMF absolute lymphocyte count decline and post-DMF absolute lymphocyte count reconstitution presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis
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