5512W-13 A randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety a

A randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of Eculizumab in patients with relapsing neuromyelitis optica (NMO)

Type of Study
Neuroscience - Neuromyelitis Optica (NMO)
Short Description
This study is to assess the efficacy and safety of eculizumab treatment as compared to placebo in relapsing NMO patients using a time to first relapse study design.  Eligible patients will be randomized 2:1 to one of two parallel treatment arms: 1) eculizumab infusion or 2) placebo infusion. Patients may continue to receive stable maintenance dose of protocol permitted supportive immunosuppressive therapies (ISTs) and must remain on that dose for the duration of the study or until the patient experiences a relapse
 
Status
Open
Principal Investigator
Pavle Repovic, MD
Eligibility Notes

Key Inclusion Criteria:

 
  1. Male or female patients ≥ 18 years old
  2. Diagnosis of NMO or NMO spectrum disorder
  3. All patients must be NMO-IgG seropositive
  4. Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months (with at least 1 relapse in the 12 months prior to the Screening)
  5. EDSS score ≤7
  6. Immunosuppressive therapy is allowed provided patients have been on a stable maintenance dose prior to the Screening and remain on a stable dose for the duration of the study

Key Exclusion Criteria:
 
 
  1. Use of rituximab within 3 months prior to screening
  2. Use of mitoxantrone within 3 months prior to screening
  3. Use of IVIg within 3 weeks prior to screening
Contact Name
Yuriko Courtney & Lauren Lennox
Phone
206-320-2647
Alternate Phone
206-320-4355
Email
Yuriko.courtney@swedish.org
Alternate Email
Lauren.lennox@swedish.org