A study to evaluate the safety and efficacy of Eculizumab in patients with relapsing NMO
Brief Description Of Study
The primary purpose of this study is to assess how effective eculizumab treatment is compared with placebo in relapsing NMO patients based on the time to first relapse and relapse risk reduction. Eligible patients will be randomized 2:1 to one of two treatment arms: 1) eculizumab infusion or 2) placebo infusion. In this "time-to-event" trial, the trial duration for an individual patient will vary depending on when a patient enters the trial and on the patient’s outcome. The course of the trial for an individual patient will consist of: Screening Period, Study Period, and Safety Follow-up Period. Patients may be provided with the opportunity to participate in an extension trial to receive eculizumab.
Additional Information About The Study
Eculizumab/ Placebo will be administered as follows: The Induction Phase: Placebo or Eculizumab infusion weekly for 5 weeks Maintenance Phase: Placebo or Eculizumab infusion every 2 weeks from the time of the last dose of the induction phase.