A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
NCT ID: NCT01892345
Last Updated: 2019-06-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
143 participants
INTERVENTIONAL
2014-04-11
2018-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Eculizumab
Biological/Vaccine: Eculizumab; Induction Period: Participants received eculizumab (900 milligrams \[mg\]) via intravenous (IV) infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards.
Eculizumab
Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks
Placebo
Placebo contains the same buffer components without the active ingredient. Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards.
Placebo
Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks
Interventions
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Eculizumab
Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks
Placebo
Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of NMO or NMOSD.
3. AQP4 antibody seropositive.
4. 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.
5. Expanded Disability Status Scale score ≤ 7.
6. 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.
7. 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.
Exclusion Criteria
2. Use of mitoxantrone within 3 months prior to Screening.
3. Use of intravenous immunoglobulin within 3 weeks prior to Screening.
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
Carlsbad, 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
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
John Hopkins University School of Medicine
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
The Ohio State University, Wexner Medical Center, CarePoint at Gahanna
Gahanna, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Multiple Sclerosis Treatment Center of Dallas
Dallas, Texas, United States
University of Utah Health Care
Salt Lake City, Utah, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Hospital General de Agudos Juan Antonio Fernandez
Ciudad Autonoma, Buenos Aires, Buenos Aires, Argentina
Hospital J. M. Ramos Mejia
Ciudad Autonoma, Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Fundacion Rosarina de Neuro Rehabilitacion
Rosario, Santa Fe Province, Argentina
University of Sydney, Brain and Mind Center
Camperdown, New South Wales, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Vseobecna fakultni nemocnice Neurologicka klinika
Prague, , Czechia
Århus Universitetshospital
Aarhus, , Denmark
Universitaetsklinikum Heidelberg, Abteilung Neuroonkologie
Heidelberg, Baden-Wurttemberg, Germany
Klinikum rechts der Isar der TU Muenchen, Neurologische Klinik und Poliklinik
Munich, Bavaria, Germany
Universitaetsmedizin Rostock, Klinik für Neurologie
Rostock, , Germany
Prince of Wales Hospital
Shatin, , Hong Kong
Universitaria Policlinico di Catania
Catania, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
Neurological Centre of Latium Dipartimento di Neuroscienze
Rome, , Italy
Chiba University Hospital
Chiba, Chiba, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyōgo, Japan
Kyoto Min-iren Chuo Hospital
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan
Yamaguchi University Hospital
Ube-shi, Yamaguchi, Japan
Kyushu University Hospital
Fukuoka, , Japan
National Center Hospital, NCNP
Tokyo, , Japan
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Republican Clinical Hospital for Rehabilitation of Healthcare Ministry of Republic of Tatarstan
Kazan', , Russia
FSBHI 'Siberian Clinical Center of FMBA'
Krasnoyarsk, , Russia
Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia
Novosibirsk, , Russia
SBEIHPE "Rostov SMU of MoH of RF"
Rostov-on-Don, , Russia
First Pavlov State Medical University of St.Petersburg
Saint Petersburg, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul University National Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Samsung Medical Center
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
Navamindradhiraj University, Vajira Hospital
Dusit, , Thailand
Thammasat University Hospital
Pathum Thani, , Thailand
Sunprasitthiprasong Hospital
Ubon Ratchathani, , Thailand
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Istanbul Bilim Universty Medical Fac.
Istanbul, , 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
John Radcliffe Hospital
Oxford, , 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, Berthele A, Fujihara K, Kim HJ, Levy M, Palace J, Nakashima I, Terzi M, Totolyan N, Viswanathan S, Wang KC, Pace A, Fujita KP, Armstrong R, Wingerchuk DM. Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N Engl J Med. 2019 Aug 15;381(7):614-625. doi: 10.1056/NEJMoa1900866. Epub 2019 May 3.
Singh P, Gao X, Kleijn HJ, Bellanti F, Pelto R. Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Neuromyelitis Optica Spectrum Disorder. Front Neurol. 2021 Nov 3;12:696387. doi: 10.3389/fneur.2021.696387. eCollection 2021.
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.
Palace J, Wingerchuk DM, Fujihara K, Berthele A, Oreja-Guevara C, Kim HJ, Nakashima I, Levy M, Terzi M, Totolyan N, Viswanathan S, Wang KC, Pace A, Yountz M, Miller L, Armstrong R, Pittock S; PREVENT Study Group. Benefits of eculizumab in AQP4+ neuromyelitis optica spectrum disorder: Subgroup analyses of the randomized controlled phase 3 PREVENT trial. Mult Scler Relat Disord. 2021 Jan;47:102641. doi: 10.1016/j.msard.2020.102641. Epub 2020 Nov 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Alexion Clinical Trials Website
Other Identifiers
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ECU-NMO-301
Identifier Type: -
Identifier Source: org_study_id
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