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Spots Global Cancer Trial Database for Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

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Trial Identification

Brief Title: Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Study ID: NCT01997229

Interventions

Eculizumab
Placebo

Study Description

Brief Summary: The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama, Birmingham, Alabama, United States

University of California San Francisco-Fresno, Fresno, California, United States

University of Southern California, Los Angeles, California, United States

University of California-Irvine, Orange, California, United States

University of California Davis Health System, Sacramento, California, United States

California Pacific Medical Center, San Francisco, California, United States

Stanford University School of Medicine, Stanford, California, United States

Yale New Haven Hospital, New Haven, Connecticut, United States

University of Florida Health Science Center, Jacksonville, Florida, United States

University of Miami School of Medicine, Miami, Florida, United States

University of South Florida, Tampa, Florida, United States

Georgia Regents University, Augusta, Georgia, United States

Medical Associates of North Georgia, Canton, Georgia, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Indiana University, Indianapolis, Indiana, United States

University of Iowa College of Medicine, Iowa City, Iowa, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

University of Maryland Medical Center, Baltimore, Maryland, United States

Johns Hopkins University School Of Medicine, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Brigham and Women's Hospital, Boston, Massachusetts, United States

Lahey Clinic Inc., Burlington, Massachusetts, United States

Wayne State University School of Medicine, Detroit, Michigan, United States

Las Vegas Clinic, Las Vegas, Nevada, United States

Buffalo General Hospital, Buffalo, New York, United States

Hospital For Special Surgery/New York Presbyterian Hospital Cornell Campus, New York, New York, United States

Mount Sinai School of Medicine, New York, New York, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Carolinas Healthcare System, Charlotte, North Carolina, United States

Duke University Health System, Durham, North Carolina, United States

Ohio State University Medical Center, Columbus, Ohio, United States

Oregon Health & Science University, Portland, Oregon, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Wesley Neurology Clinic, Cordova, Tennessee, United States

Vanderbilt Medical Center, Nashville, Tennessee, United States

UT Southwestern, Dallas, Texas, United States

Methodist Neurological Institute, Houston, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

University of Vermont Medical Center, Burlington, Vermont, United States

University of Washington, Seattle, Washington, United States

Hospital Italiano, Ciudad Autonoma, Buenos Aires, Argentina

Instituto de Investigaciones Neurologicas Raul Carrea, FLENI, Ciudad Autonoma, Buenos Aires, Argentina

St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia

Royal Perth Hospital, Perth, Western Australia, Australia

UZ Antwerpen, Edegem, , Belgium

AZ Sint-Lucas - Campus Sint-Lucas, Gent, , Belgium

UZ Leuven, Leuven, , Belgium

Hospital Mãe de Deus, Porto Alegre, Rio Grande Do Sul, Brazil

Faculdade de Medicina do ABC, Santo André, Sao Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto, Sao Paulo, Brazil

HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro, Rio De Janeiro, , Brazil

UNIFESP - Universidade Federal de São Paulo, São Paulo, , Brazil

University of Alberta Hospital, Edmonton, Alberta, Canada

Toronto General Hospital, Toronto, Ontario, Canada

Montreal Neurological Institute, Montreal, Quebec, Canada

Vseobecna fakultni nemocnice v Praze, Praha, Prague, Czechia

Fakultni nemocnice Brno, Brno, , Czechia

Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czechia

Århus Universitetshospital, Aarhus C, , Denmark

Rigshospitalet, København Ø, , Denmark

Helsingin yliopistollinen keskussairaala, Helsinki, , Finland

Neuro NEO Oy, Turku, , Finland

CHU de Nice Hôpital Pasteur 2, Nice Cedex 3, Alpes Maritimes, France

Groupe Hospitalier Pellegrin - Hôpital Pellegrin, Bordeaux Cedex, Gironde, France

Hopital Roger Salengro - CHU Lille, Lille Cedex, Nord, France

Hopital Neurologique Pierre Wertheimer, Bron cedex, Rhone, France

LMU-Campus Innenstadt, Muenchen, Bayern, Germany

Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany

Navy Hospital of Athens, Athens, , Greece

General Hospital of Thessaloniki "G. Papanikolaou", Thessaloniki, , Greece

Jahn Ferenc Del-Pesti Korhaz, Budapest, , Hungary

Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp., Szeged, , Hungary

Policlinico di Catania, Catania, , Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, , Italy

Azienda Ospedaliera Universitaria "Federico II", Napoli, , Italy

Ospedale San Camillo IRCCS, Padova, , Italy

Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy

Umberto I Pol. di Roma-Università di Roma La Sapienza, Roma, , Italy

Policlinico Universitario Agostino Gemelli, Roma, , Italy

Azienda Ospedaliera Sant'Andrea - Università di Roma La Sapienza, Roma, , Italy

Ospedale Santa Chiara, Trento, , Italy

Chiba University Hospital, Chiba-shi, Chiba-Ken, Japan

Kyushu University Hospital, Fukuoka-shi, Fukuoka-Ken, Japan

Sapporo Medical University Hospital, Sapporo-shi, Hokkaido, Japan

Hanamaki General Hospitals, Hanamaki-shi, Iwate-Ken, Japan

NHO Sendai Medical Center, Sendai-shi, Miyagi-Ken, Japan

NHO Nagasaki Kawatana Medical Center, Kawatana, Nagasaki-Ken, Japan

Nagasaki University Hospital, Nagasaki-shi, Nagasaki-Ken, Japan

Kinki University Hospital, Osakasayama-shi, Osaka-Fu, Japan

Osaka University Hospital, Suita-shi, Osaka-Fu, Japan

Toho University Ohashi Medical Center, Meguro-ku, Tokyo-To, Japan

Yamaguchi University Hospital, Ube-shi, Yamaguchi-Ken, Japan

Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Korea University Anam Hospital, Seoul, , Korea, Republic of

Seoul Metropolitan Government Seoul National University, Seoul, , Korea, Republic of

Academisch Medisch Centrum, Amsterdam, , Netherlands

Leiden Universitair Medisch Centrum, Leiden, , Netherlands

Maastricht University Medical Center, Maastricht, , Netherlands

Hospital Universitari Vall d'Hebron, Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Hospital Universitari de Bellvitge, Barcelona, , Spain

Hospital Universitario La Paz, Madrid, , Spain

Sahlgrenska Sjukhuset, Göteborg, , Sweden

Karolinska Universitetssjukhuset - Solna, Stockholm, , Sweden

Hacettepe University Medical Faculty, Ankara, , Turkey

Karadeniz Tecnical Uni. Med. Fac., Istanbul, , Turkey

Dokuz Eylul University Medicine Faculty, Izmir, , Turkey

Kocaeli University Medical Faculty, Kocaeli, , Turkey

Ondokuz Mayıs University of Medicine, Samsun, , Turkey

The Walton Centre, Liverpool, Merseyside, United Kingdom

Queen Elizabeth Hospital, Birmingham, West Midlands, United Kingdom

King's College Hospital, London, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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