Multiple Sclerosis Clinical Trial

An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

Summary

The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.

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Full Description

This study is an open label extension study to confirm the long term safety and efficacy of eculizumab in subjects with relapsing NMO who have completed the initial double-blind, randomized, placebo-controlled trial ECU-NMO-301.

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Eligibility Criteria

Key Inclusion Criteria:

Patient completed the ECU-NMO-301 trial
Patient has given written informed consent

Key Exclusion Criteria:

Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

119

Study ID:

NCT02003144

Recruitment Status:

Completed

Sponsor:

Alexion

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There are 56 Locations for this study

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Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States
The Research Center of Southern California
Oceanside California, 92056, United States
Georgetown University Hospital
Washington District of Columbia, 20007, United States
University of Miami McKnight Brain Institute
Miami Florida, 33136, United States
Neurological Services of Orlando
Orlando Florida, 32806, United States
Allied Physicians Inc. of Fort Wayne
Fort Wayne Indiana, 46805, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Baptist Health Lexington
Nicholasville Kentucky, 40503, United States
Johns Hopkins University Medical Center
Baltimore Maryland, 21287, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Multiple Sclerosis Comprehensive Care Center NYU Langone Medical Center
New York New York, 10016, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
Ohio Health Reserach Institute
Columbus Ohio, 43214, United States
University of Pennsylvania School of Medicine
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh Pennsylvania, 15232, United States
Multiple Sclerosis Treatment Center of Dallas
Dallas Texas, 75246, United States
The University of Texas Health Science
San Antonio Texas, 78229, United States
University of Utah
Salt Lake City Utah, 84108, United States
Hospital Universitario Austral
Pilar Buenos Aires, B1629, Argentina
Fundacion Rosarina de Neuro Rehabilitacion
Rosario Santa Fe, S2000, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma, Buenos Aires, , C1221, Argentina
Hospital General de Agudos Juan Antonio Fernandez
Ciudad Autonoma, Buenos Aires , C1425, Argentina
Brain and Mind Research Institute
Camperdown New South Wales, , Australia
St. Vincent's Hospital
Fitzroy Victoria, 3065, Australia
The Ottawa Hospital
Ottawa Ontario, K1H 8, Canada
Fundacion Cardiovascular de Colombia
Floridablanca Santander, , Colombia
Clinical Hospital Centre Zagreb
Zagreb , 10000, Croatia
VFN v Praze
Praha , , Czechia
Krajska zdravotni, a.s. - Nemocnice
Teplice , 415 0, Czechia
Ã…rhus Universitetshospital
Arhus , 8000, Denmark
University Hospital Heidelberg
Heidelberg Baden Wuerttemberg, 69120, Germany
Neurologische Klinik und Poliklinik
Munich Bayern, 81675, Germany
University Hospital Heinrich Heine University
Dusseldorf Nordrhein Westfalen, 40225, Germany
Universitaetsmedizin Rostock
Rostock , 18147, Germany
Prince of Wales Hospital
Shatin , , Hong Kong
Policlinico di Catania
Catania , 95123, Italy
Azienda Ospedaliera Universitaria
Napoli , 80131, Italy
Azienda Ospedaliera di Padova
Padova , 35128, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Rome , 00178, Italy
Chiba University Hospital
Chiba-shi Chiba-Ken, 260-8, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi HyogoKen, , Japan
Kyoto Min-iren Chuo Hospital
Kyoto-shi Kyoto-Fu, 604-8, Japan
Tohoku University Hospital
Sendai-shi Miyagi-Ken, 980-8, Japan
Yamaguchi University Hospital
Ube-shi Yamaguchi-Ken, 755-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
National Center Hospital, NCNP
Tokio , , Japan
National Cancer Center
Goyang-si Gyeonggi-do, 410-7, Korea, Republic of
Seoul University National Hospital
Seoul , 11074, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Korea University Anam Hospital
Seoul , 136-7, Korea, Republic of
Severance Hospital, Yonsei University
Seoul , 136-7, Korea, Republic of
Hospital Umum Sarawak
Kuching Sarawak, 93586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur , 50586, Malaysia
Republican Clinical Hospital for Rehabilitation of Healthcare Ministry of Republic of Tatarstan
Kazan , 42002, Russian Federation
SBEI "Krasnoyarsk SMU n.a. Prof. V.F. Voyno-Yasenetsky"
Krasnoyarsk , 66003, Russian Federation
Federal State Budget Institution of Healthcare - Siberian District Medical Center of FMBA of Russia
Novosibirsk , 63006, Russian Federation
SEIHPE "Rostov SMU of MoH of RF"
Rostov-on Don , , Russian Federation
Hospital de Cruces
Barakaldo Bizkaia, 48903, Spain
Hospital Universitario Reina Sofia
Cordoba , 14404, Spain
Hospital Universitario Clinico San Carlos
Madrid , 28040, Spain
Cheng Hsin General Hospital
Taipei , , Taiwan
Thammasat University Hospital
Pathum Thani , , Thailand
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Trakya University Medical Faculty
Edirne , , Turkey
Dokuz Eylul University Medicine Faculty
Izmir , 35340, Turkey
Kocaeli University Medical Faculty
Kocaeli , , Turkey
Ondokuz Mayis Univ. Med. Fac.
Samsun , , Turkey
The Walton Centre
Liverpool , L97LJ, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

119

Study ID:

NCT02003144

Recruitment Status:

Completed

Sponsor:


Alexion

How clear is this clinincal trial information?

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