A Double Blind Trial to Evaluate the Safety and Efficacy of Eculizumab in Relapsing NMO Patients (PREVENT Study)

Overview

About this study

The primary objective of the 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sean Pittock, M.D.

Closed for enrollment

More information

Publications

  • Complement activation after binding of an IgG autoantibody to aquaporin 4 (AQP4) is thought to be a major determinant of CNS inflammation and astrocytic injury in neuromyelitis optica. The aim of this study was to investigate the use of eculizumab--a therapeutic monoclonal IgG that neutralises the complement protein C5--in neuromyelitis optica spectrum disorders. Read More on PubMed

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions