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 |
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.
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
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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University of Utah Research is a major component in the life of the U benefiting...
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University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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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
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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Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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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
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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