Clinical trial NCT00930553: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Official title: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2009-06-30
Enrollment: 1314
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\] also known as CARE-MS I, or CAMMS324 \[NCT00548405\] also known as CARE-MS II). The purposes of this study were:

1. To examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies.
2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
3. To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

Detailed description: Alemtuzumab treatment was on a fixed schedule of two treatment courses a year apart for participants who received Rebif® in one of the prior Genzyme-sponsored studies of alemtuzumab or on an as needed schedule (e.g. due to documented evidence of resumed Multiple Sclerosis \[MS\] activity) for participants who had already completed a fixed schedule of treatment with alemtuzumab in one of the prior Genzyme-sponsored studies. There was no comparison treatment in this study. All participants were required to return to their study site every 3 months for neurologic and other assessments. In addition, safety-related laboratory tests and surveys were performed at least monthly. Participation in the extension study was at least 48 months from enrollment. Study duration could be extended to allow participants to remain in the study until a follow-up study was available in their country or through month 60 (month 72 in USA), whichever occurred first.

Eligibility criteria: Inclusion Criteria:

* 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received disease modifying treatments (other than glatiramer acetate or interferon beta); or
* 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received alternative disease modifying treatments (other than glatiramer acetate or another interferon beta); or
* 3.Participated in CAMMS223.
* NOTE: Criteria 1 and 2 above meant that participants who enrolled in CAMMS323 or CAMMS324 but did not complete the 2-year study period or went on to receive non-study drug DMTs after randomization were not eligible for inclusion in the Extension Study. Participants who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria 1 or 2 to be eligible for inclusion in the Extension Study.

Exclusion Criteria:

* Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or was participating in any other investigational study, unless approved by Genzyme. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab retreatment.
* Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of the following criteria. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab treatment. a) Did not wish to receive alemtuzumab; b) Ongoing participation in any other investigational study, unless approved by Genzyme; c) Had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies); d) Known bleeding disorder or therapeutic anticoagulation; e) Diagnosis of idiopathic thrombocytopenia purpura or other autoimmune hematologic abnormality; f) History of malignancy, except basal cell skin carcinoma; g) Intolerance of pulsed corticosteroids, especially a history of steroid psychosis h) Significant Autoimmune disorder (other than MS); i) Major psychiatric disorder or epileptic seizures not adequately controlled by treatment; j) Active infection or high risk for infection k) Unwilling to use a reliable and acceptable contraceptive method during and for at least 6 months following each alemtuzumab treatment cycle (fertile participants only).

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively)
measure: Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
measure: Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment
timeFrame: Year 1 prior to retreatment, Year 1, 2, 3 after retreatment
measure: Number of Participants With Sustained Accumulation of Disability (SAD)
timeFrame: Baseline (Year 0) up to Year 6
measure: Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
Secondary outcomes:
measure: Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6
timeFrame: Baseline (Year 0) up to Year 6
measure: Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study
timeFrame: Extension study (CAMMS03409) baseline up to Extension Year 2
measure: Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6
timeFrame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
measure: Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
measure: Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment
timeFrame: Retreatment baseline, Year 1, 2 and 3 after retreatment baseline
measure: Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity
timeFrame: Year 3, 4, 5 and 6
measure: Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
measure: Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment
timeFrame: Retreatment Baseline, Year 1, 2 and 3 after retreatment
measure: Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6
timeFrame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
measure: Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity
timeFrame: Year 3, 4, 5 and 6
measure: Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6
timeFrame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
measure: Percentage of Relapse Free Participants
timeFrame: Year 3, 4, 5 and 6
measure: Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6
timeFrame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension group", "alemtuzumab Treatment CAMMS324 Extension" group, respectively),Year 3, 4, 5 and 6
measure: Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
measure: Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6
timeFrame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
measure: Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
measure: Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6
timeFrame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
measure: Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
measure: Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6
timeFrame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
measure: Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison
timeFrame: Baseline (Year 0 of initial studies) up to Year 4
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, P.C.
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona (Scottsdale)
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, PLLC
state: Arizona
city: Berkeley
country: United States
facility: East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation
state: California
city: La Habra
country: United States
facility: Neurology Center North Orange County
state: California
city: Los Angeles
country: United States
facility: University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics, Inc.
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Science Center - Aurora
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurology of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale MS Research Center
state: Connecticut
city: Washington, D.C.
country: United States
facility: The George Washington University Medical Faculty Associates
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida Neuroscience Institute
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, P.A.
state: Florida
city: Pompano Beach
country: United States
facility: Neurological Associates
state: Florida
city: Sarasota
country: United States
facility: Negroski, Stein, Sutherland and Hanes Neurology
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University Department of Neurology
state: Georgia
city: Atlanta
country: United States
facility: Shepherd Center Multiple Sclerosis Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology, LTD
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Multiple Sclerosis Center
state: Indiana
city: Des Moines
country: United States
facility: Iowa Health Physicians
state: Iowa
city: Des Moines
country: United States
facility: Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Department of Neurology
state: Kansas
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Lexington
country: United States
facility: Associates in Neurology, P.S.C.
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Neuroscience Research
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland, Maryland Center for MS
state: Maryland
city: Boston
country: United States
facility: The MS Center at St. Elizabeth's
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
city: Clinton
country: United States
facility: Michigan Neurology Association
state: Michigan
city: Detroit
country: United States
facility: Wayne State University, The School of Medicine, Department of Neurology
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic
state: Michigan
city: Traverse City
country: United States
facility: Northern Michigan Neurology
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Brain & Stroke Institute
state: Missouri
city: Reno
country: United States
facility: Renown Institute for Neurosciences
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Teaneck
country: United States
facility: MS Center at Holy Name Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico, Dept. of Neurology
state: New Mexico
city: Latham
country: United States
facility: Empire Neurology P.C.
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital Multiple Sclerosis Treatment Center
state: New York
city: New York
country: United States
facility: MS Care Center at NYUMC and HJD
state: New York
city: New York
country: United States
facility: The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
state: New York
city: Patchogue
country: United States
facility: South Shore Neurologic Associates, P.C.
state: New York
city: Rochester
country: United States
facility: Rochester Multiple Sclerosis Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University, Department of Neurology
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Science Department of Neurology
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Uniontown
country: United States
facility: Oak Clinic for Multiple Sclerosis
state: Ohio
city: Oklahoma City
country: United States
facility: OMRF Multiple Sclerosis Center of Excellence
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital Neurosciences and Pain Research
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital MS Center - The Neurology Foundation, Inc
state: Rhode Island
city: Cordova
country: United States
facility: Neurology Clinic PC
state: Tennessee
city: Franklin
country: United States
facility: Advanced Neurosciences Institute
state: Tennessee
city: Knoxville
country: United States
facility: Hope Neurology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine, Maxine Mesinger MS Clinic
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Vienna
country: United States
facility: MS Center of Greater Washington
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical MS Center
state: Washington
city: Buenos Aires
country: Argentina
facility: DIABAID
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Southern Neurology
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Auchenflower QLD
country: Australia
facility: The Wesley Research Institute
city: Woodville, SA
country: Australia
facility: The Queen Elizabeth Hospital
city: Vienna
country: Austria
facility: AKH Wien-Universitätskliniken für Neurologie
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-luc
city: Esneux
country: Belgium
facility: CHU Ourthe Amblève
city: Leuven
country: Belgium
facility: University Hospital Leuven, Campus Gasthuisberg
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
city: Recife, PE
country: Brazil
facility: Hospital da Restauração, Neurology department
city: São Paulo, SP
country: Brazil
facility: Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department
city: São Paulo,SP
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department
city: Calgary
country: Canada
facility: University of Calgary, Department of Neurology
state: Alberta
city: Kingston
country: Canada
facility: Kingston General Hospital MS Clinic
state: Ontario
city: Gatineau
country: Canada
facility: Clinique Neuro-Outaouais
state: Quebec
city: Greenfield Park
country: Canada
facility: Recherche Sepmus, Inc.
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: London, ON
country: Canada
facility: London Health Sciences Centre - University Hospital
city: Ottawa, Ontario
country: Canada
facility: The Ottawa Hospital - MS Research
city: Vancouver, BC
country: Canada
facility: University of British Columbia
city: Osijek
country: Croatia
facility: Clinical Hospital Osijek
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Varazdin
country: Croatia
facility: General Hospital Varazdin, Department for Neurology
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre "Sestre Milosrdnice"
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
city: Brno
country: Czechia
facility: St. Anne's University Hospital Brno
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Králové
city: Prague
country: Czechia
facility: General Hospital, 128 21 Praha 2
city: Teplice
country: Czechia
facility: Hospital Teplice, Neurology Department, MS centrum
city: Copenhagen
country: Denmark
facility: Rigshospitalet Department of Neurology
city: Århus C
country: Denmark
facility: Aarhus Sygehus
city: Dijon Cedex
country: France
facility: Hôpital Général
city: Paris Cedex 13
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central
city: Rennes Cedex 9
country: France
facility: CHU Pontchaillou
city: Strasbourg Cedex
country: France
facility: Hôpital Civil
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse, Hôpital Purpan
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
state: DE
city: Berlin-Mitte
country: Germany
facility: Jüdisches Krankenhaus Berlin
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus Dresden
city: Frankfurt am Main
country: Germany
facility: Klinikum der JW Goethe Universität
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hennigsdorf
country: Germany
facility: Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Rostock
country: Germany
facility: Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Klinik für Neurologie im RKU
city: Wermsdorf
country: Germany
facility: Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin
city: Ein Karem, Jerusalem
country: Israel
facility: Hadassah Medical Center Ein Karem
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Tel Aviv Medical Center
city: Cagliari
country: Italy
facility: Università di Cagliari
city: Gallarate (Varese)
country: Italy
facility: Ospedale S. Antonio Abate di Gallarate
city: Orbassano (TO)
country: Italy
facility: Ospedale S. Luigi Gonzaga
city: Roma
country: Italy
facility: Universita Degli Studi di Roma "La Sapienza"
city: Chihuahua, CHH
country: Mexico
facility: Unidad de Investigación en Salud
city: Mexico City, DFE
country: Mexico
facility: Medica Sur
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medisch Concern
city: Krakow
country: Poland
facility: Centrum Neurologii Klinicznej Sp. Zo.o.
city: Lodz
country: Poland
facility: Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii
city: Kazan
country: Russian Federation
facility: Research Medical Complex "Your Health" Ltd
city: Moscow
country: Russian Federation
facility: Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department
city: Moscow
country: Russian Federation
facility: Neurology Research Center under the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: Russian State Medical University, Department of Neurology and Neurosurgery
city: Nizhny Novgorod
country: Russian Federation
facility: Municipal Treatment and Prevention Institution, City Hospital #33
city: Novosibirsk
country: Russian Federation
facility: Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency
city: Pyatigorsk
country: Russian Federation
facility: Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital n.a. Kalinin
city: St. Petersburg
country: Russian Federation
facility: Institute of Human Brain RAS, Laboratory of Neuroimmunology
city: St. Petersburg
country: Russian Federation
facility: St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg General Hospital #2, Neurology Department #2
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital
city: Ufa
country: Russian Federation
facility: State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
city: Belgrade
country: Serbia
facility: Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade
city: Belgrade
country: Serbia
facility: Military Medical Academy, Institute of Neurology
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac, Clinic of Neurology
city: Nis
country: Serbia
facility: Clinical Centre Nis, Clinic of Neurology
city: Novi Sad
country: Serbia
facility: Clinical Centre Vojvodina
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d' Hebron
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Málaga
country: Spain
facility: Hospital Carlos Haya, Neurology Service
city: Seville
country: Spain
facility: Hospital Virgen Macarena
city: Göteborg
country: Sweden
facility: SU/Östra sjukhuset
city: Umeå
country: Sweden
facility: Norrlands Universitets sjukhus
city: Kharkov
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS
city: Kiev-21
country: Ukraine
facility: Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.
city: Kiev
country: Ukraine
facility: Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
city: Lviv
country: Ukraine
facility: Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Dept of Neurology
city: London
country: United Kingdom
facility: Royal London Hospital
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Genzyme Coorporation
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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