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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy Of Eculizumab In Patients With Relapsing Neuromyelitis Optica (NMO)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy Of Eculizumab In Patients With Relapsing Neuromyelitis Optica (NMO)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Oct 2019

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At a glance

  • Drugs Eculizumab (Primary)
  • Indications Neuromyelitis optica
  • Focus Registrational; Therapeutic Use
  • Acronyms PREVENT
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 28 Aug 2019 According to an Alexion Pharmaceuticals media release, data from this trial will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, September 11 to 13, 2019.
    • 27 Aug 2019 According to an Alexion Pharmaceuticals media release, the European Commission (EC) has approved the extension of the current marketing authorization of SOLIRIS(eculizumab) to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease, based on comprehensive results of this trial and a long-term extension study (ECU-NMO-302).
    • 24 Jul 2019 According to an Alexion Pharmaceuticals media release, the European Medicines Agency Committee for Medicinal Products for Human Use has issued a positive opinion to extend the current marketing authorization of SOLIRIS to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients. The European Commission will review the CHMP opinion and the final decision is anticipated within 2 months.
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