A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Eculizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGAIN
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 21 Aug 2017 According to an Alexion Pharmaceuticals media release, European Commission (EC) has approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
    • 27 Jun 2017 Results of spectrum of disease based on correlation between Neuro-QOL With MG-ADL, QMG, and MG-QOL15 presented at the 3rd Congress of the European Academy of Neurology
    • 27 Jun 2017 Results assessing correlation between subjective and objective measures of Myasthenia Gravis related impairment presented at the 3rd Congress of the European Academy of Neurology
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