A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

PHASE3TerminatedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

April 11, 2014

Primary Completion Date

July 17, 2018

Study Completion Date

July 17, 2018

Conditions
Neuromyelitis OpticaNeuromyelitis Optica Spectrum Disorder
Interventions
DRUG

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

DRUG

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

Trial Locations (70)

112

Cheng Hsin General Hospital, Taipei

1425

Hospital General de Agudos Juan Antonio Fernandez, Ciudad Autonoma, Buenos Aires

2050

University of Sydney, Brain and Mind Center, Camperdown

3065

St. Vincent's Hospital Melbourne, Fitzroy

8000

Århus Universitetshospital, Aarhus

10000

Clinical Hospital Centre Zagreb, Zagreb

10016

Multiple Sclerosis Comprehensive Care Center, NYU Langone Medical Center, New York

10300

Navamindradhiraj University, Vajira Hospital, Dusit

10408

National Cancer Center, Goyang-si

12120

Thammasat University Hospital, Pathum Thani

14011

Hospital Universitario Reina Sofia, Córdoba

15213

University of Pittsburgh, Pittsburgh

18147

Universitaetsmedizin Rostock, Klinik für Neurologie, Rostock

19104

Hospital of the University of Pennsylvania, Philadelphia

20007

Georgetown University Hospital, Washington D.C.

21201

University of Maryland Medical Center, Baltimore

21287

John Hopkins University School of Medicine, Baltimore

28040

Hospital Universitario Clinico San Carlos, Madrid

32806

Neurological Services of Orlando, Orlando

33136

University of Miami McKnight Brain Institute, Miami

34000

Sunprasitthiprasong Hospital, Ubon Ratchathani

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34381

Istanbul Bilim Universty Medical Fac., Istanbul

35340

Dokuz Eylul University Medicine Faculty, Izmir

40503

Baptist Health Lexington, Lexington

41380

Kocaeli University Medical Faculty, Kocaeli

43230

The Ohio State University, Wexner Medical Center, CarePoint at Gahanna, Gahanna

46804

Fort Wayne Neurological Center, Fort Wayne

48903

Hospital de Cruces, Barakaldo

50586

Hospital Kuala Lumpur, Kuala Lumpur

55139

Ondokuz Mayis Univ. Med. Fac., Samsun

55905

Mayo Clinic - Rochester, Rochester

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Medical Center, Kansas City

69120

Universitaetsklinikum Heidelberg, Abteilung Neuroonkologie, Heidelberg

75246

Multiple Sclerosis Treatment Center of Dallas, Dallas

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

81675

Klinikum rechts der Isar der TU Muenchen, Neurologische Klinik und Poliklinik, Munich

84132

University of Utah Health Care, Salt Lake City

85259

Mayo Clinic Arizona, Scottsdale

92011

The Research Center of Southern California, Carlsbad

95123

Universitaria Policlinico di Catania, Catania

98122

Swedish Neuroscience Institute, Seattle

197022

First Pavlov State Medical University of St.Petersburg, Saint Petersburg

344022

"SBEIHPE Rostov SMU of MoH of RF", Rostov-on-Don

420021

Republican Clinical Hospital for Rehabilitation of Healthcare Ministry of Republic of Tatarstan, Kazan'

630037

FSBHI 'Siberian Clinical Center of FMBA', Krasnoyarsk

630067

Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia, Novosibirsk

C1221

Hospital J. M. Ramos Mejia, Ciudad Autonoma, Buenos Aires

B1629ODT

Hospital Universitario Austral, Pilar

S2000BZL

Fundacion Rosarina de Neuro Rehabilitacion, Rosario

128 21

Vseobecna fakultni nemocnice Neurologicka klinika, Prague

Unknown

Prince of Wales Hospital, Shatin

00151

Azienda Ospedaliera San Camillo Forlanini, Rome

00178

Neurological Centre of Latium Dipartimento di Neuroscienze, Rome

260-8677

Chiba University Hospital, Chiba

663-8501

Hyogo College of Medicine Hospital, Nishinomiya-shi

604-8453

Kyoto Min-iren Chuo Hospital, Kyoto

980-8574

Tohoku University Hospital, Sendai

113-8519

Tokyo Medical and Dental University, Bunkyo-ku

755-8505

Yamaguchi University Hospital, Ube-shi

812-8582

Kyushu University Hospital, Fukuoka

187-8551

National Center Hospital, NCNP, Tokyo

02841

Korea University Anam Hospital, Seoul

03080

Seoul University National Hospital, Seoul

03722

Severance Hospital, Yonsei University, Seoul

06351

Samsung Medical Center, Seoul

06100

Hacettepe University Medical Faculty, Ankara

L9 7LJ

The Walton Centre, Liverpool

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors
All Listed Sponsors
lead

Alexion Pharmaceuticals, Inc.

INDUSTRY