An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
NCT ID: NCT02003144
Last Updated: 2022-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
119 participants
INTERVENTIONAL
2015-01-12
2021-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eculizumab
Eculizumab intravenous infusion every two weeks.
eculizumab
Interventions
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eculizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient has given written informed consent
Exclusion Criteria
2. Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
The Research Center of Southern California
Oceanside, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami McKnight Brain Institute
Miami, Florida, United States
Neurological Services of Orlando
Orlando, Florida, United States
Allied Physicians Inc. of Fort Wayne
Fort Wayne, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Health Lexington
Nicholasville, Kentucky, United States
Johns Hopkins University Medical Center
Baltimore, Maryland, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Multiple Sclerosis Comprehensive Care Center NYU Langone Medical Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Ohio Health Reserach Institute
Columbus, Ohio, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Multiple Sclerosis Treatment Center of Dallas
Dallas, Texas, United States
The University of Texas Health Science
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Fundacion Rosarina de Neuro Rehabilitacion
Rosario, Santa Fe Province, Argentina
Hospital General de Agudos Juan Antonio Fernandez
Ciudad Autonoma, Buenos Aires, , Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma, Buenos Aires,, , Argentina
Brain and Mind Research Institute
Camperdown, New South Wales, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
The Ottawa Hospital
Ottawa, Ontario, Canada
Fundacion Cardiovascular de Colombia
Floridablanca, Santander Department, Colombia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
VFN v Praze
Prague, , Czechia
Krajska zdravotni, a.s. - Nemocnice
Teplice, , Czechia
Århus Universitetshospital
Aarhus, , Denmark
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Neurologische Klinik und Poliklinik
Munich, Bavaria, Germany
University Hospital Heinrich Heine University
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsmedizin Rostock
Rostock, , Germany
Prince of Wales Hospital
Shatin, , Hong Kong
Policlinico di Catania
Catania, , Italy
Azienda Ospedaliera Universitaria
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Rome, , Italy
Chiba University Hospital
Chiba, Chiba, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, HyogoKen, Japan
Kyoto Min-iren Chuo Hospital
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Yamaguchi University Hospital
Ube-shi, Yamaguchi, Japan
Kyushu University Hospital
Fukuoka, , Japan
National Center Hospital, NCNP
Tokyo, , Japan
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Republican Clinical Hospital for Rehabilitation of Healthcare Ministry of Republic of Tatarstan
Kazan', , Russia
SBEI "Krasnoyarsk SMU n.a. Prof. V.F. Voyno-Yasenetsky"
Krasnoyarsk, , Russia
Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia
Novosibirsk, , Russia
SEIHPE "Rostov SMU of MoH of RF"
Rostov-on-Don, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul University National Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Hospital de Cruces
Barakaldo, Bizkaia, Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Cheng Hsin General Hospital
Taipei, , Taiwan
Thammasat University Hospital
Pathum Thani, , Thailand
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Dokuz Eylul University Medicine Faculty
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, , Turkey (Türkiye)
The Walton Centre
Liverpool, , United Kingdom
Countries
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References
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Pittock SJ, Lennon VA, McKeon A, Mandrekar J, Weinshenker BG, Lucchinetti CF, O'Toole O, Wingerchuk DM. Eculizumab in AQP4-IgG-positive relapsing neuromyelitis optica spectrum disorders: an open-label pilot study. Lancet Neurol. 2013 Jun;12(6):554-62. doi: 10.1016/S1474-4422(13)70076-0. Epub 2013 Apr 26.
Pittock SJ, Fujihara K, Palace J, Berthele A, Kim HJ, Oreja-Guevara C, Nakashima I, Levy M, Shang S, Yountz M, Miller L, Armstrong R, Wingerchuk DM; PREVENT Study Group. Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension. Mult Scler. 2022 Mar;28(3):480-486. doi: 10.1177/13524585211038291. Epub 2021 Sep 9.
Kim HJ, Nakashima I, Viswanathan S, Wang KC, Shang S, Miller L, Yountz M, Wingerchuk DM, Pittock SJ, Levy M, Berthele A, Totolyan N, Palace J, Barnett MH, Fujihara K; PREVENT Study Group. Eculizumab in Asian patients with anti-aquaporin-IgG-positive neuromyelitis optica spectrum disorder: A subgroup analysis from the randomized phase 3 PREVENT trial and its open-label extension. Mult Scler Relat Disord. 2021 May;50:102849. doi: 10.1016/j.msard.2021.102849. Epub 2021 Feb 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-001151-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ECU-NMO-302
Identifier Type: -
Identifier Source: org_study_id
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