Status:
TERMINATED
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were an...
Eligibility Criteria
Inclusion
- Key
- Male or female participants ≥ 18 years old.
- Diagnosis of NMO or NMOSD.
- AQP4 antibody seropositive.
- Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening.
- Expanded Disability Status Scale score ≤ 7.
- If a participant entered the study receiving immunosuppressive therapy (IST) for relapse prevention, the participant must have been on a stable maintenance dose of IST(s), as defined by the treating physician, prior to Screening and must have remained on that dose for the duration of the study, unless the participant experienced a relapse.
- Female participants of childbearing potential were to have a negative pregnancy test (serum human chorionic gonadotropin). Participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.
- Key
Exclusion
- Use of rituximab within 3 months prior to Screening.
- Use of mitoxantrone within 3 months prior to Screening.
- Use of intravenous immunoglobulin within 3 weeks prior to Screening.
Key Trial Info
Start Date :
April 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2018
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01892345
Start Date
April 11 2014
End Date
July 17 2018
Last Update
June 26 2019
Active Locations (70)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
The Research Center of Southern California
Carlsbad, California, United States, 92011
3
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
4
University of Miami McKnight Brain Institute
Miami, Florida, United States, 33136