Trial Condition(s):

Multiple Sclerosis, Relapsing-Remitting

BEYOND: Betaferon/Betaseron efficacy yielding outcomes of a new dose in Multiple Sclerosis (MS) Patients

Bayer Identifier:

91162

ClinicalTrials.gov Identifier:

NCT00099502

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to determine
- whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms
- whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

Inclusion Criteria
- Female and male patients
 - Aged 18-55 years
 - Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0
 - Treatment-naive to IFNB or Copaxone
Exclusion Criteria
- Neurological progression at disease onset or between relapses
 - Serious or acute heart diseases
 - History of severe depression or suicide attempt
 - Serious or acute liver, renal or bone marrow dysfunction
 - Monoclonal gammopathy
 - Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
 - Pregnancy or lactation

Trial Summary

Enrollment Goal
2244
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Sanatorio Britanico

Rosario, Argentina, S2000CVB

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Queen Elizabeth II Health Sciences Centre

Halifax, Canada, B3H 3A7

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Aarhus Universitetshospital

Aarhus C, Denmark, 8000

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Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

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Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33521

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Hopital Roger Salengro

Lille, France, 59037

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Neurology Departmant of Latvian

Riga, Latvia, LV-1015

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Moskva City MS Center

Moskva, Russia, 127018

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Danderyds sjukhus

Stockholm, Sweden, 182 88

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City Clinical Hospital #4

Kiev, Ukraine, 03110

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University of California Davis Medical Center

Sacramento, United States, 95817

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Fundacion de Neurorehabilitacion

Rosario, Argentina, S2000ZBL

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A. ö. Krankenhaus St. Pölten

St. Pölten, Austria, 3100

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National Centrum voor MS

MELSBROEK, Belgium, 1820

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Faculdade de Ciencias Medicas-Universidade Estadual Campinas

Campinas, Brazil, 13081- 970

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LNK Wagner Jauregg

Linz, Austria, 4020

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UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

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Universidade Federal de Sao Paulo - UNIFESP

Sao Paulo, Brazil, 04039

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Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

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Zala Megyei Korhaz

Zalaegerszeg, Hungary, 8900

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Beaumont Hospital

Dublin, Ireland, 9

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Sourasky Medical Center

Tel-Aviv, Israel, 64239

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Ospedale San Raffaele

Milano, Italy, 20132

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Multiple Sclerose Centrum Nijmegen

NIJMEGEN, Netherlands, 6533 PA

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Haukeland University Hospital, Bergen

Bergen, Norway, N-5021

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SP Szpital Kliniczny nr 5

Wroclaw, Poland, 50-417

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Klinicni center

Ljubljana, Slovenia, 1000

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St. George Private Medical Centre

Kogarah, Australia, 2217

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CHUM - Hopital Notre-Dame

Montreal, Canada, H2L 4M1

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Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41071

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Centre Hospitalier Universitaire

Nimes, France, 30029

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Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17489

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Oulun yliopisto

Oulu, Finland

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A IKA General Hospital

Athens, Greece, 15127

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Petz Aladar Megyei Korhaz

Györ, Hungary, 9024

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Akademiska Sjukhuset

Uppsala, Sweden, 75185

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Splosna Bolnisnica Marobor

Maribor, Slovenia, 2000

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Medizinische Universität Graz

Graz, Austria, 8036

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Gosford Hospital

Gosford, Australia, 2250

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AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

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Peterfy Sandor utcai Korhaz - Rendelointezet

Budapest, Hungary, 1076

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A.O.U. Careggi

Firenze, Italy, 50134

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Szpital im. N. Barlickiego

Lodz, Poland, 90-153

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Privatlakarna

Helsingborg, Sweden, 25278

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Institute of Neurology, Psychiatric and Narcology of AMSU

Kharkiv, Ukraine, 61068

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UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

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Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-900

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St Vincents University Hospital

Dublin, Ireland, DUBLIN 4

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Carmel Medical Center

Haifa, Israel, 34362

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Policlinico Consorziale

Bari, Italy, 70122

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Orbis Medisch Centrum

SITTARD, Netherlands, 6131 BK

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II Klinika Neurologii

Warszawa, Poland, 02957

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Institute of Neurology of Russian Academy of Medical Science

Moskva, Russia, 123367

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Donetsk state medical university

Donetsk, Ukraine, 83003

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University of Chicago Hospitals

Chicago, United States, 60637-1470

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Policlinica Bancaria

Buenos Aires, Argentina, C1416CRJ

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Hospital Israelita Albert Einstein

Sao Pulo, Brazil, 05651-901

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Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

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Krankenhaus Hennigsdorf

Hennigsdorf, Germany, 16761

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Hospital Regional Carlos Haya

Málaga, Spain, 29010

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Hopital Pontchaillou

Rennes, France, 35038

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Cork University Hospital

Cork, Ireland

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Hebrew University - Hadassah Medical School

Jerusalem, Israel, 91120

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Centre Hospitalier des Vallees de l'outaouais

Hull, Canada, J8Y 1W7

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Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

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Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, Germany, 06120

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G. Gennimatas General State Hospital of Athens

Athens, Greece, 11527

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Ospedale San Luigi Gonzaga

Orbassano, Italy, 10043

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St. Petersburg Medical University n.a. Pavlov

St. Petersburg, Russia, 197022

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Fundacion FACENE

Buenos Aires, Argentina, C1117ABE

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Montreal Neurological Hospital

Montreal, Canada, H3A 2B4

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Rabin Medical Center

Petach Tikva, Israel, 49100

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A.O. di Padova

Padova, Italy, 35128

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Sir Charles Gardiner Hospital

Nedlands, Australia, 6009

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Hospital da Restauracao

Recife, Brazil, 52010-040

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Health Science Centre

Winnipeg, Canada, R3A 1R9

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Uzsoki utkai Korhaz

Budapest, Hungary, 1145

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Bnai Zion Medical Center

Haifa, Israel, 31048

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1st Medical Academy Municipal Hospital N61

Moscow, Russia, 119048

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1st Pirogov Clinical Hospital

Moscow, Russia, 117049

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Neurology Associates

Tualatin, United States, 97062

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Hospital Británico

Buenos Aires, Argentina, C1280AEB

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St Vincents Hospital

Melbourne, Australia, 3065

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Centre hospitalier universitaire

nancy, France, 54035

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Borsod County Hospital

Miskolc, Hungary, 3526

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Misericordiae Hospital

Dublin, Ireland, 7

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Sheba Medical Center

Tel Hashomer, Israel, 52621

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Centralny Szpital Kliniczny AM

Warszawa, Poland, 02-097

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Regional Clinical Hospital

Lviv, Ukraine, 79000

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University of Alabama at Birmingham

Birmingham, United States, 35294

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Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

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Liverpool Hospital

Liverpool, Australia, 2170

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Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

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Hopital general

Dijon, France, 21033

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Pecsi TE Neurologiai Klinika

Pecs, Hungary, 7623

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Adelaide & Meath Hospital

Dublin, Ireland

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Jüdisches Krankenhaus

Berlin, Germany, 13347

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CHRU Cote de Nacre

CAEN, France, F-14033

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Barzili Medical Center

Ashkelon, Israel, 78306

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Siberian District Medical Center

Novosibirsk, Russia, 630007

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Hosp. Univ. Clementino Fraga Filho - Univ. do Rio de Janeiro

Rio de Janeiro, Brazil, 21949 900

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Bezirkskrankenhaus Bayreuth

Bayreuth, Germany, 95445

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C. H. U. Hopital Purpan

Toulouse, France, 31059

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Assaf Harofeh Medical Center

Zerifin, Israel, 70300

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MONIKI

Moskva, Russia, 129110

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Blake Neurology

Englewood, United States, 80110

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University of British Columbia Hospital

Vancouver, Canada, V6T 2B5

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Kamillus Klinik Asbach

Asbach, Germany, 53567

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Axiom Clinical Research

Tampa, United States, 33609

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Universitäts-Krankenhaus Eppendorf

Hamburg, Germany, 20251

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Northwest NeuroSpecialists, PLLC

Tucson, United States, 85741-3537

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Trilium Health Centre

Mississauga, Canada, L5B 1B8

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Hopital gabriel montpied

Clermont ferrand, France, 63003

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Amphia Ziekenhuis, locatie Langendijk

BREDA, Netherlands, 4819 EV

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Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Gdansk, Poland, 80-803

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Institute of Brain of Russian

Sankt-Peterburg, Russia, 197376

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University of Kentucky

Lexington, United States, 40536

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Hospital Militar de Cordoba

Cordoba, Argentina, X5000HGX

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Inselspital Bern

Bern, Switzerland, 3010

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Städtisches Klinikum "St. Georg" Leipzig

Leipzig, Germany, 04129

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Centre hospitalier universitaire

nice, France, 06000

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A.O. S.Andrea

Roma, Italy, 00189

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SP Szpital Kliniczny nr 2

Poznan, Poland, 60-355

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University of Nevada-Reno

Reno, United States, 89557-0035

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Royal Melbourne Hospital

Parkville, Australia, 3050

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Hospital das Clinicas da Universidade Federal do Paraná

Curitiba, Brazil, 80060-900

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Foothills Medical Centre

Calgary, Canada, T2N 2T9

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Katedra i Klinika Neurologii Sl.A.M

Katowice, Poland, 40752

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St. Mary's/Duluth Clinic Health System

Duluth, United States, 55805-1984

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Universitätsklinikum Heidelberg

Heidelberg, Germany, 69112

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East Bay Region Associates in Neurology

Berkeley, United States, 94705

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Vivantes Klinikum Spandau

Berlin, Germany, 13578

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SUNY at Stony Brook

Stony Brook, United States, 11794

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Universitätsklinikum Münster

Münster, Germany, 48149

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Klinikum der Universität Regensburg

Regensburg, Germany, 93053

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University of Rochester Medical Center

Rochester, United States, 14642

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Klinikum Offenbach

Offenbach, Germany, 63069

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Alfried Krupp Krankenhaus

Essen, Germany, 45177

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Neurological Associates of Albany

Albany, United States, 12208

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Advanced Neurosciences Institute

Nashville, United States, 37205

Locations

Dartmouth Hitchock Medical Center

Lebanon, United States, 03756-0001

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Wake Forest University Medical Center

Winston-Salem, United States, 27157-1009

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Virginia Mason Medical Center

Seattle, United States, 98101

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Thomas Jefferson University

Philadelphia, United States, 19107

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St. Michael's Hospital Health Centre

Toronto, Canada, M5C 2T2

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

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Klinikum der Philipps-Universität

Marburg, Germany, 35043

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Yaroslavl Medical Academy

Yaroslavl, Russia, 150039

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Washington University School of Medicine

St. Louis, United States, 63110

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London Health Sciences Centre

London, Canada, N6A 5A5

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Klinikum der Justus-Liebig-Universität

Gießen, Germany, 35392

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Hospital Pellegrin

Bordeaux, France, 33076

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City Hospital N 33

Nizhny Novogorod, Russia, 603076

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University of Medicine and Dentistry of New Jersey

New Brunswick, United States, 08901

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Hopital Charles LeMoyne

Greenfield Park, Canada, J4V 2H1

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Centre René Gauducheau

Nantes, France, 44805

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Medical Military Academy

Sankt-Peterburg, Russia, 194044

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Ottawa Headache Centre West

Nepean, Canada, K2G 6E2

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Hopital Neurologique

Lyon, France, 69003

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Asklepios Klinik St. Georg

Hamburg, Germany, 20099

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University of Kansas Medical Center

Kansas City, United States, 66160

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George Washington University

Washington, United States, 20037

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Integra Clinical Research, LLC

San Antonio, United States, 78229

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North Central Neurology Associates

Cullman, United States, 35058

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Louisiana State University Medical Center

Shreveport, United States, 71130

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University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15213-2592

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Riverhills Healthcare, Inc.

Cincinnati, United States, 45219

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Coastal Neurological Medical Group

La Jolla, United States, 92037

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Ohio State University Medical Center

Columbus, United States, 43210-1240

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Marshfield Clinic

Marshfield, United States, 54449

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Neurology Associates, PA

Wilmington, United States, 19806

Locations

High Point Neurological Associates

High Point, United States, 27262

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Medical University of South Carolina

Charleston, United States, 29425

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Neurology & Neurosurgery Associates of Tacoma, Inc.

Tacoma, United States, 98405

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Tampa General Hospital

Tampa, United States, 33606-3508

Locations

Henry Ford Health System

Detroit, United States, 48202

Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Locations

University of New Mexico

Albuquerque, United States, 87131

Locations

Henriettenstiftung

Hannover, Germany, 30171

Locations

University of California, San Francisco

San Francisco, United States, 94117

Locations

Bereich Humanmed. d. Georg-August-Universität Göttingen

Göttingen, Germany, 37075

Locations

Winthrop-University Hospital

Mineola, United States, 11501-3987

Locations

Fort Wayne Neurological Center

Fort Wayne, United States, 46805

Locations

Mercy Ruan Neurology Clinic

Des Moines, United States, 50314

Locations

Medical College of GA

Augusta, United States, 30912

Locations

Duke University Medical Center

Durham, United States, 27710

Locations

Nevada Neurological Consultants, Ltd.

Henderson, United States, 89052

Locations

Carolinas Medical Center

Charlotte, United States, 28203

Locations

St Lukes Medical Center

Milwaukee, United States, 53215

Locations

University Neurologists, PSC

Louisville, United States, 40202

Locations

Hospital of the University of Pennsylvania

Philadelphia, United States, 19104

Locations

Indiana University

Indianapolis, United States, 46202

Locations

Baylor College

Houston, United States, 77030

Locations

Neurology Foundation, Inc.

Providence, United States, 02905

Locations

Neurology Center of Fairfax, Ltd.

Fairfax, United States, 22031

Locations

University of Miami

Miami, United States, 33125

Locations

Shepherd Center

Atlanta, United States, 30309-1465

Locations

Barrow Neurology Clinic

Phoenix, United States, 85013

Locations

Dr. Tamara Miller, MD

Fort Collins, United States, 80528

Trial Design