Spots Global Cancer Trial Database for Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
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Trial Identification
Brief Title: Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Official Title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Study ID: NCT04115293
Conditions
Study Description
Brief Summary: The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site 41: Diagnostic and Medical Clinic, Mobile, Alabama, United States
Site 116: Neuromuscular Clinic and Research Center, Phoenix, Arizona, United States
Site 4: University of Southern California, Los Angeles, California, United States
Site 31: University of California Irvine, Orange, California, United States
Site 220: Investigator Site, Pasadena, California, United States
Site 160: Forbes Norris MDA/ALS Research and Treatment Center, San Francisco, California, United States
Site 24: Yale University, New Haven, Connecticut, United States
Site 27: George Washington University, Washington, District of Columbia, United States
Site 182: Gelasio Baras Neurology, Miami, Florida, United States
Site 25: University of South Florida, Tampa, Florida, United States
Site 135: Augusta University Medical Center, Augusta, Georgia, United States
Site 176: Hawaii Pacific Neuroscience, Honolulu, Hawaii, United States
Site 188: North Shore Medical Group - Glenview, Glenview, Illinois, United States
Site 156: Indiana University Health Neuroscience Center, Indianapolis, Indiana, United States
Site 32: Kansas University Medical Center Research Institute, Kansas City, Kansas, United States
Site 221: Neurology Center of New England, Foxboro, Massachusetts, United States
Site 33: Detroit medical Center - University Health Center, Detroit, Michigan, United States
Site 49: Michigan State University, East Lansing, Michigan, United States
Site 127: University of Minnesota, Minneapolis, Minnesota, United States
Site 134: Neurology and Sleep Disorders Clinic, Columbia, Missouri, United States
Site 117: Las Vegas Clinic, Las Vegas, Nevada, United States
Site 123: Northwell Health Neuroscience Institute, Great Neck, New York, United States
Site 23: Hospital for Special Surgery, New York, New York, United States
Site 47: Mount Sinai Hospital, New York, New York, United States
Site 22: University of North Carolina, Chapel Hill, North Carolina, United States
Site 15: Duke University, Durham, North Carolina, United States
Site 122: Cleveland Clinic, Cleveland, Ohio, United States
Site 38: Ohio State University, Columbus, Ohio, United States
Site 40: Allegheny Neurological Associates, Pittsburgh, Pennsylvania, United States
Site 128: Medical University of South Carolina, Charleston, South Carolina, United States
Site 185: Neurology Clinic Cordova, Cordova, Tennessee, United States
Site 131: Austin Neuromuscular Center, Austin, Texas, United States
Site 19: University of Texas Southwestern, Dallas, Texas, United States
Site 39: University of Utah, Salt Lake City, Utah, United States
Site 164: University of Virginia Health System, Charlottesville, Virginia, United States
Site 154: University of Washington, Seattle, Washington, United States
Site 45: Center for Neurological Disorders, Milwaukee, Wisconsin, United States
Site 44: London Health Sciences Centre University Hospital, London, Ontario, Canada
Site 11: Montreal Neurological Institute and Hospital (McGill University), Montréal, Quebec, Canada
Site 191: Centre Hosptitalier Universitaire d'Angers, Angers Cedex 9, , France
Site 204: Centre Hospitalier Régional Universitaire de Lille, Lille, , France
Site 118: Hôpital Pasteur, Nice, , France
Site 105: Pitié-Salpêtrière University Hospital, Paris, , France
Site 137: Les Hôpitaux Universitaires de Strasbourg, Strasbourg, , France
Site 150: Universitätsmedizin Göttingen, Göttingen, , Germany
Site 129: Universitätsklinikum Tübingen, Tübingen, , Germany
Site 126: Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, , Italy
Site 132: Università Cattolica del Sacro Cuore - Campus di Milano, Roma, , Italy
Site 169: International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan
Site 151: Chiba University Hospital, Chiba, , Japan
Site 136: General Hanamaki Hospital, Iwata, , Japan
Site 179: Kagawa University Hospital - Collagen disease/Rheumatic int, Kita-gun, , Japan
Site 146: Nagasaki University Hospital, Nagasaki, , Japan
Site 152: Hokkaido Medical Center, Sapporo, , Japan
Site 144: Sendai Medical Center, Sendai, , Japan
Site 153: Toho University Ohashi Medical Center, Tokyo, , Japan
Site 163: Tokyo Medical University Hospital, Tokyo, , Japan
Site 141: Keio University Hospital, Tokyo, , Japan
Site 165: Osaka University Hospital, Tokyo, , Japan
Site 140: Haukeland University Hospital / Health Bergen, Bergen, , Norway
Site 143: Oslo Universitetssykehus, Oslo, , Norway
Site 205: Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz, Lublin, Lubelskie, Poland
Site 194: Twoja Przychodnia - Centrum Medyczne Nowa Sól, Nowa Sól, Lubuskie, Poland
Site 214: AmiCare Centrum Medyczne, Łódź, Lódzkie, Poland
Site 192: Krakowski Szpital Specjalistyczny im. Jana Pawła II, Kraków, Malopolskie, Poland
Site 201: Centrum Medyczne Pratia - Warszawa, Warszawa, Mazowieckie, Poland
Site 195: Wielospecjalistyczna Poradnia Lekarska Synapsis, Katowice, Slaskie, Poland
Site 213: Niepubliczny Zakład Opieki Zdrowotnej NOVO-MED, Katowice, Slaskie, Poland
Site 209: Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD, Poznań, Wielkopolskie, Poland
Site 193: Krakowska Akademia Neurologii - Centrum Neurologii Kliniczne, Kraków, , Poland
Site 211: Specjalistyczne Gabinety Sp. z o.o., Kraków, , Poland
Site 210: Clinhouse Centrum Medyczne, Lublin, , Poland
Site 133: Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
Site 168: Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Site 138: Hospital Universitario de Basurto, Bilbao, , Spain
Site 119: Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Site 130: Royal Hallamshire Hospital, Sheffield, , United Kingdom
Contact Details
Name: UCB Cares
Affiliation: 0018445992273 (UCB)
Role: STUDY_DIRECTOR
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