A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2017

At a glance

  • Drugs SA 237 (Primary)
  • Indications Neuromyelitis optica
  • Focus Registrational; Therapeutic Use
  • Sponsors Chugai Pharmaceutical
  • Most Recent Events

    • 26 Jan 2017 Time frame of primary endpoint has been changed from up to approximately 27 months to up to approximately 38 months.
    • 07 Jul 2016 Planned primary completion date changed from 1 Nov 2016 to 1 Oct 2017.
    • 07 Jul 2016 Planned number of patients changed from 70 to 90.
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