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Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 [BG 12] in Subjects With Relapsing-Remitting Multiple Sclerosis

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Trial Profile

Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 [BG 12] in Subjects With Relapsing-Remitting Multiple Sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Aug 2023

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At a glance

  • Drugs Dimethyl fumarate (Primary)
  • Indications Multiple sclerosis
  • Focus Therapeutic Use
  • Sponsors Biogen Idec

Most Recent Events

  • 27 Mar 2019 Results assessing functional changes in lymphocyte repertoire during delayed-release dimethyl fumarate (DMF) treatment in patients with multiple sclerosis published in the Neurology
  • 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
  • 28 Apr 2017 Results of an integrated analysis (n=2470) of phase III (DEFINE, CONFIRM and ENDORSE-extension) and phase IIb Dimethyl Fumarate (DMF) studies reporting long-term absolute lymphocyte count (ALC) and post-DMF ALC data, presented at the 69th Annual Meeting of the American Academy of Neurology.

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