A Double Blind Trial To Evaluate The Safety And Efficacy Of Eculizumab In Relapsing NMO Patients (PREVENT Study)



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:January 2014
End Date:July 2018

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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)

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.


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
We found this trial at
25
sites
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Augusta, Georgia 30912
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Baltimore, Maryland 21287
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Columbus, Ohio 43214
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3600 Gaston Avenue
Dallas, Texas 75246
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Fort Wayne, Indiana 46805
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Miami, FL
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New York, New York 10029
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Newark, Delaware 19713
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1740 Nicholasville Road
Nicholasville, Kentucky 40503
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Oceanside, CA
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Orlando, Florida 32806
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Philadelphia, Pennsylvania 19104
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Pilar, Buenos Aires
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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7703 Floyd Curl Drive
San Antonio, Texas 78229
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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