Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
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Trial Identification
Brief Title: A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis
Study ID: NCT02473952
Conditions
Study Description
Brief Summary: The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.
Detailed Description: The primary objective is to evaluate the efficacy of IGIV-C in subjects with generalized myasthenia gravis (MG) on standard of care treatment at study entry in terms of improvement in MG symptoms as measured by the mean change in Quantitative Myasthenia Gravis (QMG) score from Baseline (Week 0) to Week 24 as compared to placebo. The safety objective of this study is to evaluate the safety and tolerability of IGIV-C loading dose of 2 g/kg followed by 7 maintenance dosages of 1 g/kg every 3 weeks through Week 21 in subjects with MG.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Phoenix Neurological Associates, Ltd., Phoenix, Arizona, United States
University of California-Irvine, Orange, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
University of Florida Health Science Center, Jacksonville, Florida, United States
University of South Florida, Tampa, Florida, United States
Georgia Regents University, Augusta, Georgia, United States
Indiana University, Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute, Inc., Kansas City, Kansas, United States
Rutgers New Jersey Medical School, Newark, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Houston Methodist Neurological Institute, Houston, Texas, United States
University of Vermont Medical Center, Burlington, Vermont, United States
University of Washington Medical Center, Seattle, Washington, United States
UZ Leuven, Leuven, , Belgium
London Health Sciences Centre - University Hospital, London, Ontario, Canada
University Health Network (UHN) - Toronto General Hospital, Toronto, Ontario, Canada
Fakultni nemocnice Brno, Dept of Neurologicka klinika, Brno, , Czechia
Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czechia
East Tallinn Central Hospital, Tallinn, , Estonia
CHU Nice - Hôpital de l'Archet 1, Ctre de Réf Maladies Neuromusculaires et SLA, Nice cedex 3, Alpes Maritimes, France
CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique, Strasbourg cedex, Bas Rhin, France
CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale, Toulouse cedex 9, Haute Garonne, France
Hopital Neurologique Pierre Wertheimer, Neuro-musculaire - Electromyographie, Bron cedex, Rhone, France
Universitaetsklinikum Regensburg, Parent, Regensburg, Bayern, Germany
Universitaetsmedizin Göttingen, Parent, Göttingen, Niedersachsen, Germany
Universitaetsklinikum Koeln, Neurologie und Psychiatrie, Koeln, Nordrhein Westfalen, Germany
Krankenhaus Martha-Maria Halle-Doelau, Klinik fuer Neurologie, Halle, Sachsen Anhalt, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden, Sachsen, Germany
Universitaetsklinikum Jena, Klinik fuer Neurologie, Jena, Thueringen, Germany
Universitaetsklinikum Hamburg-Eppendorf, Klinik und Poliklinik fuer Neurologie, Hamburg, , Germany
Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Neurologiai Osztaly, Budapest, , Hungary
Pest Megyei Flor Ferenc Korhaz, Neurologia es Stroke Osztaly, Kistarcsa, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged, , Hungary
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, , Lithuania
Uniwersyteckie Centrum Kliniczne, Dept of Neurology, Gdansk, , Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej, Krakow, , Poland
III Szpital Miejski w Lodzi im. Dr K. Jonschera, Lodz, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Dept of Neurology, Warszawa, , Poland
Contact Details
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