A Double Blind Trial To Evaluate The Safety And Efficacy Of Eculizumab In Relapsing NMO Patients (PREVENT Study)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-001640
NCT ID: NCT01892345
Sponsor Protocol Number: ECU-NMO-301
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:
- Male or female patients ≥ 18 years old
- Diagnosis of NMO or NMO spectrum disorder
- All patients must be NMO-IgG seropositive
- 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)
- EDSS score ≤7
- 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:
- Use of rituximab within 3 months prior to screening
- Use of mitoxantrone within 3 months prior to screening
- 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
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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