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NCT05269004Active, not recruitingPhase 3

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1300 (estimated)
First submitted
11 Feb 2022
Start date
3 May 2022
Primary completion date
31 Dec 2027
Lead sponsor
Hoffmann-La Roche
NCT number
NCT05269004
EU CT number
2023-505974-14-00
EudraCT number
2021-005746-15

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1300
  • From 3 May 2022 to the primary completion date, 31 Dec 2027
  • 228 sites in 37 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in any clinical trial (other than the Parent study)

Other

  • Unable or unwilling to comply with the requirements of the protocol

Who the study is looking for

  • Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (228)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Español
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Ciudad Autonoma Bs AsArgentinaUnknown status
Fundacion Rosarina de Neurorehabilitacion
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RosarioArgentinaUnknown status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Konvent Der Barmherzigen Brueder
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LinzAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
St Vincent's Hospital Melbourne
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FitzroyAustraliaUnknown status
Royal North Shore Hospital
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St LeonardsAustraliaUnknown status
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumActive, not recruiting
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
Algemeen Ziekenhuis Alma
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EekloBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Multiprofile Hospital For Active Treatment Avis Medika OOD
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PlevenBulgariaActive, not recruiting
MHAT National Heart Hospital EAD
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SofiaBulgariaActive, not recruiting
Tokuda Hospital
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SofiaBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
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SofiaBulgariaActive, not recruiting
Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
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SofiyaBulgariaActive, not recruiting
Military Medical Academy
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SofiyaBulgariaActive, not recruiting
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
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GoiniaBrazilUnknown status
Clinica Neurologica e Neurocirurgica de Joinville
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JoinvilleBrazilUnknown status
IMV Pesquisa Neurologica Sociedade Simples Ltda
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Porto AlegreBrazilUnknown status
Hospital So Lucas da PUCRS
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Porto AlegreBrazilUnknown status
HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro
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Rio de JaneiroBrazilUnknown status
Hospital Universitario Gaffree e Guinle
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Rio de JaneiroBrazilUnknown status
Grodno University Hospital
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GrodnoBelarusUnknown status
State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology
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MinskBelarusUnknown status
Vitebsk Regional Clinical Hospital
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VitebskBelarusUnknown status
Foothills Medical Centre Calgary
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CalgaryCanadaUnknown status
University of Alberta
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EdmontonCanadaUnknown status
Clinique Neuro-Outaouais
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GatineauCanadaUnknown status
Recherche Sepmus Inc.
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Greenfield ParkCanadaUnknown status
Montreal Neurological Institute and Hospital
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MontrealCanadaUnknown status
The Ottawa Hospital - General Campus
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OttawaCanadaUnknown status
UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials
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VancouverCanadaUnknown status
Universitaetsspital Basel
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BaselSwitzerlandUnknown status
Ospedale Regionale di Lugano
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LuganoSwitzerlandUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaActive, not recruiting
Nemocnice Jihlava prispevkova organizace
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Jihlava 1CzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Nemocnice Pardubickeho kraje a.s.
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PardubiceCzechiaActive, not recruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaActive, not recruiting
Neurospol s.r.o.
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Slezska OstravaCzechiaActive, not recruiting
Krajska zdravotni a.s.
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TepliceCzechiaActive, not recruiting
Klinikum Bayreuth GmbH
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BayreuthGermanyActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Juedisches Krankenhaus Berlin Stiftung Des Buergerlichen Rechts
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BerlinGermanyActive, not recruiting
Neurologie in Bonn
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BonnGermanyActive, not recruiting
Pharmakologisches Studienzentrum Chemnitz GmbH
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ChemnitzGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyActive, not recruiting
Zentrum fuer ambulante Neurologie
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EssenGermanyActive, not recruiting
Universitaet Leipzig
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LeipzigGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
University of Regensburg
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RegensburgGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
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UlmGermanyActive, not recruiting
Studienzentrum Nord-West
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WesterstedeGermanyActive, not recruiting
Laane-Tallinna Keskhaigla AS
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Pohja-Tallinna LinnaosaEstoniaActive, not recruiting
Tartu University Hospital
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Tartu LinnEstoniaActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Basurto
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BilbaoSpainActive, not recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Santa Caterina Ias
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SaltSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Suomen Terveystalo Oy
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TampereFinlandActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Hospital Pierre Wertheimer
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BronFranceActive, not recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceActive, not recruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
CHRU de Nancy
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NancyFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Centre Hospitalier Intercommunal De Poissy Saint Germain
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PoissyFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Royal Devon and Exeter Hospital (Wonford)
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ExeterUnited KingdomUnknown status
Walton Centre For Neurology and Neurosurgery
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LiverpoolUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Royal Victoria Infirmary
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NewcastleUnited KingdomUnknown status
Nottingham University Hospitals Queen's Medical Centre
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NottinghamUnited KingdomUnknown status
Morriston Hospital
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SwanseaUnited KingdomUnknown status
KBC Zagreb
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Grad ZagrebCroatiaActive, not recruiting
Opca Bolnica Varazdin
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VarazdinCroatiaActive, not recruiting
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
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BudapestHungaryActive, not recruiting
S-Medicon Egeszsegugyi Szolgaltato Kft.
Coordinator of this site? Confirm its status
BudapestHungaryActive, not recruiting
University of Pecs
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PécsHungaryActive, not recruiting
Hadassah University Hospital - Ein Kerem
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Rabin Medical Center-Beilinson Campus
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Petah TikvaIsraelUnknown status
Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Della Valle Olona
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Busto ArsizioItalyActive, not recruiting
Fondazione Istituto G. Giglio Di Cafalu
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Cefalu'ItalyActive, not recruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
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MontichiariItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
Azienda Sanitaria Locale Della Provincia Di Biella
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PonderanoItalyActive, not recruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyActive, not recruiting
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
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KaunasLithuaniaActive, not recruiting
Vilniaus universiteto ligonine Santaros klinikos VšĮ
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VilniusLithuaniaActive, not recruiting
Pauls Stradins Clinical University Hospital
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RigaLatviaActive, not recruiting
Latvijas Juras medicinas centrs AS
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RigaLatviaActive, not recruiting
Hospital Angeles Chihuahua
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Chihuahua CityMexicoUnknown status
Neurociencias Estudios Clinicos S.C.
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CuliacánMexicoUnknown status
Hospital Mexico Americano
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GuadalajaraMexicoUnknown status
Grupo Medico Camino
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MéxicoMexicoUnknown status
Mexico Centre for Clinical Research
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Mexico CityMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Centro de Estudios Clínicos y Especialidades Médicas S.C.
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MonterreyMexicoUnknown status
Clinical Research Institute
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TlalnepantlaMexicoUnknown status
Zuyderland Medisch Centrum Stichting
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GeleenNetherlandsActive, not recruiting
Haukeland Universitetssykehus
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BergenNorwayUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Vitamed Galaj i Cichomski sp.j.
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BydgoszczPolandActive, not recruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandActive, not recruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandActive, not recruiting
MA-LEK Clinical Sp. z o.o.
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KatowicePolandActive, not recruiting
Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala
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KatowicePolandActive, not recruiting
NEURO-MEDIC Sp. z o. o.
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KatowicePolandActive, not recruiting
Neuro-Care Sp. z o.o. sp.k.
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KatowicePolandActive, not recruiting
Centrum Neurologii Krzysztof Selmaj
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ŁódźPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandActive, not recruiting
Wojewódzki Szpital Specjalistyczny w Olsztynie
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OlsztynPolandActive, not recruiting
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
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PlewiskaPolandActive, not recruiting
NeuroProtect Sp. z o.o.
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WarsawPolandActive, not recruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalActive, not recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalActive, not recruiting
Clubul Sanatatii S.R.L.
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CampulungRomaniaActive, not recruiting
Clinical Center Kragujevac
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KragujevacSerbiaUnknown status
Clinical Center Nis
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NišSerbiaUnknown status
Siberian Medical Center
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BarnaulRussiaUnknown status
SAHI "Interregional Clinical and Diagnostic Center"
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KazanRussiaUnknown status
SAIH "Kemerovo Regional Clinical Hospital"
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KemerovoRussiaUnknown status
Kirov RSBIH "Kirov City Clinical Hospital # 1"
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KirovRussiaUnknown status
SBIH City Polyclinic 2 of the Department of Health of the City of Moscow
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MoscowRussiaUnknown status
FSBI 'Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Techno
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MoscowRussiaUnknown status
FSBIH Siberian Clinical Center of FMBA of Novosibirsk
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NovosibirskRussiaUnknown status
SBEI HPE " Perm State Medical University n.a. Academician E.A. Vagner" of the MoH of the RF
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PermRussiaUnknown status
SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk
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PyatigorskRussiaUnknown status
Pavlov First Saint Petersburg State Medical University
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Saint PetersburgRussiaUnknown status
SPb SBIH "City Multy-field Hospital # 2"
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Saint PetersburgRussiaUnknown status
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
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Saint PetersburgRussiaUnknown status
SBEI HPE "Samara State Medical University" of the MoH of the RF
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SamaraRussiaUnknown status
SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"
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SaranskRussiaUnknown status
Saratov State Medical University
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SaratovRussiaUnknown status
RSBIH "Smolensk Regional Clinical Hospital"
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SmolenskRussiaUnknown status
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik
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TyumenRussiaUnknown status
Sverdlovsk Regional Clinical Hospital #1
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YekaterinburgRussiaUnknown status
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenActive, not recruiting
Region Stockholm – SLSO
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StockholmSwedenActive, not recruiting
Karolinska University Hospital
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StockholmSwedenActive, not recruiting
MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.
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Banská BystricaSlovakiaActive, not recruiting
University Hospital Bratislava
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BratislavaSlovakiaActive, not recruiting
Fakultna nemocnica s poliklinikou Zilina
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ŽilinaSlovakiaActive, not recruiting
Hopital Razi
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MannoubaTunisiaUnknown status
Hopital Universitaire Fattouma Bourguiba
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MonastirTunisiaUnknown status
CMPI Chernihiv Regional Hospital
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ChernihivUkraineUnknown status
Separated structural unit ?University hospital? of Dnipro State Medical University
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DniproUkraineUnknown status
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
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Ivano-FrankivskUkraineUnknown status
Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine
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KharkivUkraineUnknown status
Medical Center of Limited Liability Company Medbud-Clinic
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KyivUkraineUnknown status
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
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LvivUkraineUnknown status
CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
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LvivUkraineUnknown status
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
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OdesaUkraineUnknown status
Medical Center of Limited Liability Company Medical Center Saliutem
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VinnytsiaUkraineUnknown status
Abington Neurological Associates
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AbingtonUnited StatesUnknown status
University of New Mexico
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AlbuquerqueUnited StatesUnknown status
Atlanta Neuroscience Institute
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AtlantaUnited StatesUnknown status
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
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AuroraUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of Vermont Medical Center
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BurlingtonUnited StatesUnknown status
The Neurological Institute PA
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CharlotteUnited StatesUnknown status
Atrium Health
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CharlotteUnited StatesUnknown status
Onsite Clinical Solutions, LLC
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CharlotteUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University Neurology Inc.
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CincinnatiUnited StatesUnknown status
Neurology Clinic, PC
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CordovaUnited StatesUnknown status
Wayne State University
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DetroitUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Michigan Institute for Neurological Disorders
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Farmington HillsUnited StatesUnknown status
Advanced Neurosciences Research, Llc
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Fort CollinsUnited StatesUnknown status
Minneapolis Clinic of Neurology
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Golden ValleyUnited StatesUnknown status
Uni of Texas Health Science Center At Houston
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HoustonUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Indiana Univ School of Med
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IndianapolisUnited StatesUnknown status
Kansas University Medical Center
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Kansas CityUnited StatesUnknown status
Sibyl Wray MD Neurology PC
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KnoxvilleUnited StatesUnknown status
MS Center of California
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Laguna HillsUnited StatesUnknown status
Bhupesh Dihenia M.D. P.A.
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LubbockUnited StatesUnknown status
Neurology Associates PA
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MaitlandUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Rutgers New Jersey Medical School Department of Neurology
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NewarkUnited StatesUnknown status
Consultants in Neurology, Ltd
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NorthbrookUnited StatesUnknown status
Oklahoma Medical Research Foundation
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Oklahoma CityUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Neurological Services of Orlando
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OrlandoUnited StatesUnknown status
Stanford Hospital and Clinics
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Palo AltoUnited StatesUnknown status
Arizona Neuroscience Research, LLC
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PhoenixUnited StatesUnknown status
Barrow Neurological Institute
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PhoenixUnited StatesUnknown status
Providence Neurological Specialties
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PortlandUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
Raleigh Neurology Associates
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RaleighUnited StatesUnknown status
Neurology Center of San Antonio
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San AntonioUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Swedish Neuroscience Research
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SeattleUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
SUNY at Stony Brook
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Stony BrookUnited StatesUnknown status
MultiCare Health System Institute for Research and Innovation
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TacomaUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
Holy Name Hospital
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TeaneckUnited StatesUnknown status
Vero Beach Neurology and Research Institute
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Vero BeachUnited StatesUnknown status
Columbus Neuroscience
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WestervilleUnited StatesUnknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Ondokuz Mayis Univ. Med. Fac.
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SamsunTurkey (Türkiye)Unknown status
Karadeniz Tecnical Uni Med Fac
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TrabzonTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.