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

PHASE3CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

February 29, 2016

Study Completion Date

June 30, 2016

Conditions
Refractory Generalized Myasthenia Gravis
Interventions
BIOLOGICAL

Eculizumab

Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26

DRUG

Placebo

Placebo

Trial Locations (114)

1181

Hospital Italiano, Ciudad Autonoma

1204

Jahn Ferenc Del-Pesti Korhaz, Budapest

2100

Rigshospitalet, København Ø

2650

UZ Antwerpen, Edegem

3000

UZ Leuven, Leuven

3065

St Vincent's Hospital Melbourne, Fitzroy

6000

Royal Perth Hospital, Perth

6725

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

8000

Århus Universitetshospital, Aarhus C

9000

AZ Sint-Lucas - Campus Sint-Lucas, Ghent

10021

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

10029

Mount Sinai School of Medicine, New York

11521

Navy Hospital of Athens, Athens

14203

Buffalo General Hospital, Buffalo

17176

Karolinska Universitetssjukhuset - Solna, Stockholm

19104

University of Pennsylvania, Philadelphia

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

20520

Neuro NEO Oy, Turku

21201

University of Maryland Medical Center, Baltimore

27599

University of North Carolina at Chapel Hill, Chapel Hill

27705

Duke University Health System, Durham

28046

Hospital Universitario La Paz, Madrid

28207

Carolinas Healthcare System, Charlotte

30114

Medical Associates of North Georgia, Canton

30625

Medizinische Hochschule Hannover, Hanover

30912

Georgia Regents University, Augusta

32209

University of Florida Health Science Center, Jacksonville

33000

Groupe Hospitalier Pellegrin - Hôpital Pellegrin, Bordeaux

33136

University of Miami School of Medicine, Miami

33612

University of South Florida, Tampa

35128

Ospedale San Camillo IRCCS, Padua

35233

University of Alabama, Birmingham

35340

Dokuz Eylul University Medicine Faculty, Izmir

37232

Vanderbilt Medical Center, Nashville

38018

Wesley Neurology Clinic, Cordova

38122

Ospedale Santa Chiara, Trento

41345

Sahlgrenska Sjukhuset, Gothenburg

41380

Kocaeli University Medical Faculty, Kocaeli

43210

Ohio State University Medical Center, Columbus

46202

Indiana University, Indianapolis

48201

Wayne State University School of Medicine, Detroit

52242

University of Iowa College of Medicine, Iowa City

55139

Ondokuz Mayıs University of Medicine, Samsun

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

57010

"General Hospital of Thessaloniki G. Papanikolaou", Thessaloniki

59037

Hopital Roger Salengro - CHU Lille, Lille

61080

Karadeniz Tecnical Uni. Med. Fac., Istanbul

62702

Southern Illinois University School of Medicine, Springfield

66160

University of Kansas Medical Center, Kansas City

69677

Hopital Neurologique Pierre Wertheimer, Bron

75390

UT Southwestern, Dallas

77030

Methodist Neurological Institute, Houston

78229

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

80131

"Azienda Ospedaliera Universitaria Federico II", Napoli

80336

LMU-Campus Innenstadt, Munich

89145

Las Vegas Clinic, Las Vegas

90033

University of Southern California, Los Angeles

92868

University of California-Irvine, Orange

93720

University of California San Francisco-Fresno, Fresno

94115

California Pacific Medical Center, San Francisco

94305

Stanford University School of Medicine, Stanford

95123

Policlinico di Catania, Catania

95765

University of California Davis Health System, Sacramento

97239

Oregon Health & Science University, Portland

98195

University of Washington, Seattle

156707

Seoul Metropolitan Government Seoul National University, Seoul

06510

Yale New Haven Hospital, New Haven

21287-0876

Johns Hopkins University School Of Medicine, Baltimore

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

01805

Lahey Clinic Inc., Burlington

02905

Rhode Island Hospital, Providence

05405

University of Vermont Medical Center, Burlington

C1428AQK

Instituto de Investigaciones Neurologicas Raul Carrea, FLENI, Ciudad Autonoma

90110-270

Hospital Mãe de Deus, Porto Alegre

Postal Code: 09060-650

Faculdade de Medicina do ABC, Santo André

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

21941-913

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

04037-002

UNIFESP - Universidade Federal de São Paulo, São Paulo

T6G 2B7

University of Alberta Hospital, Edmonton

M5G 2C4

Toronto General Hospital, Toronto

H3A 2B4

Montreal Neurological Institute, Montreal

120 00

Vseobecna fakultni nemocnice v Praze, Prague

625 00

Fakultni nemocnice Brno, Brno

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

00290

Helsingin yliopistollinen keskussairaala, Helsinki

06202

CHU de Nice Hôpital Pasteur 2, Nice

00161

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

00168

Policlinico Universitario Agostino Gemelli, Roma

00189

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

260-8677

Chiba University Hospital, Chiba

812-8582

Kyushu University Hospital, Fukuoka

060-8543

Sapporo Medical University Hospital, Sapporo

025-0075

Hanamaki General Hospitals, Hanamaki-shi

983-8520

NHO Sendai Medical Center, Sendai

859-3615

NHO Nagasaki Kawatana Medical Center, Kawatana

852-8501

Nagasaki University Hospital, Nagasaki

589-8511

Kinki University Hospital, Osakasayama-shi

565-0871

Osaka University Hospital, Suita-shi

153-8515

Toho University Ohashi Medical Center, Meguro-ku

755-8505

Yamaguchi University Hospital, Ube-shi

1105 AZ

Academisch Medisch Centrum, Amsterdam

2333 ZA

Leiden Universitair Medisch Centrum, Leiden

6229 HX

Maastricht University Medical Center, Maastricht

120-752

Severance Hospital, Yonsei University Health System, Seoul

135-710

Samsung Medical Center, Seoul

136-705

Korea University Anam Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08907

Hospital Universitari de Bellvitge, Barcelona

06100

Hacettepe University Medical Faculty, Ankara

L9 7LJ

The Walton Centre, Liverpool

B15 2WB

Queen Elizabeth Hospital, Birmingham

SE5 9NU

King's College Hospital, London

Sponsors
All Listed Sponsors
lead

Alexion Pharmaceuticals, Inc.

INDUSTRY