A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

Study Identifier:
ECU-NMO-301
ClinicalTrials.gov Identifier:
NCT01892345
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Available Documents

ProtocolStatistical Analysis Plan

Study Details

Medical Condition
  • Neuromyelitis Optica
  • Neuromyelitis Optica Spectrum Disorder
Study Drug
  • Drug: Eculizumab
  • Drug: Placebo
Date
Apr 2014 - Jul 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Neuromyelitis Optica
  • Neuromyelitis Optica Spectrum Disorder
Study Drug
  • Drug: Eculizumab
  • Drug: Placebo
Date
Apr 2014 - Jul 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information

Protocol 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 anti-aquaporin-4 (AQP4) antibody-positive.

Trial Locations

Location
Status
Location
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Status
N/A
Location
The Research Center of Southern California
Carlsbad, California, United States, 92011
Status
N/A
Location
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Status
N/A
Location
University of Miami McKnight Brain Institute
Miami, Florida, United States, 33136
Status
N/A
Location
Neurological Services of Orlando
Orlando, Florida, United States, 32806
Status
N/A
Location
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46804
Status
N/A
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