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Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) (POINT)

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ClinicalTrials.gov Identifier: NCT02907177
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ponesimod Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ponesimod
Ponesimod
Drug: Ponesimod
One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).

Placebo Comparator: Placebo
Placebo
Other: Placebo
One tablet of matching placebo administered orally once daily in the morning




Primary Outcome Measures :
  1. Annualized relapse rate (ARR) [ Time Frame: From randomization up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Number of confirmed relapses per subject-year


Secondary Outcome Measures :
  1. Time to 12-week confirmed disability accumulation (CDA) [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Time to 12-week confirmed disability accumulation (CDA)

  2. Time to first confirmed relapse [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Time to first confirmed relapse

  3. Mean number of combined unique active lesions (CUALs) per post-baseline scan [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Mean number of combined unique active lesions (CUALs) per post-baseline scan

  4. Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ-RMS

  5. Longitudinal percent change from baseline over time in brain volume [ Time Frame: From baseline up to EOS; for a max. total time of approx. 167 weeks, i.e. 3.3 years ]
    Longitudinal percent change from baseline over time in brain volume


Other Outcome Measures:
  1. Treatment-emergent adverse events (AEs) and serious AEs [ Time Frame: From time of first study drug intake up to 30 days after study treatment discontinuation ]
    Treatment-emergent adverse events (AEs) and serious AEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to initiation of any study-mandated procedure.
  • Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
  • Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
  • Ongoing treatment with DMF for at least 6 months prior to screening
  • Active disease after at least 3 months of DMF treatment
  • Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

Exclusion Criteria:

  • Lactating or pregnant women and women intending to become pregnant during the study.
  • Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
  • Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907177


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Locations
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United States, Alabama
UAB Dpt of Neurology Recruiting
Birmingham, Alabama, United States, 35233
Contact: Principal Investigator    205-934-2402    kbashir@uabmc.edu   
United States, California
Neuro-Pain Medical Center Recruiting
Fresno, California, United States, 93710
Contact: Principal Investigator    559-437-9700    bhatia@neuropain.com   
SC3 Research - Pasadena Recruiting
Pasadena, California, United States, 91105
Contact: Principal Investigator    626-250-2070    shubinPI@neurosearch-usa.com   
Care Access Research - Santa Clarita Recruiting
Santa Clarita, California, United States, 91321
Contact: Principal Investigator    415-408-2360    drdhillon@careaccessresearch.com   
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Principal Investigator    310-222-3897    bmehta@labiomed.org   
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Principal Investigator    303-724-2187    timothy.vollmer@ucdenver.edu   
Mountain View Clinical Research, Inc Recruiting
Denver, Colorado, United States, 80209
Contact: Principal Investigator    720-583-1754    b.machanic@mtnviewclinicalresearch.com   
United States, Connecticut
Associated Neurologists Recruiting
Danbury, Connecticut, United States, 06810
Contact: Principal Investigator    203-748-2551    dgreco@assocneuro.com   
United States, Florida
Florida Academic Research, LLC Withdrawn
Boca Raton, Florida, United States, 33487
Bradenton Research Center Recruiting
Bradenton, Florida, United States, 34205
Contact: Principal Investigator    941-708-0005    om_md@bradentonresearch.com   
Neurology Associates - MS Center of Greater Orlando Recruiting
Maitland, Florida, United States, 32751
Contact: Principal Investigator    407-647-5996 ext 204    neurologyassoc@hotmail.com   
Neurology Assoc of Ormond Beach - CNS Trials Recruiting
Ormond Beach, Florida, United States, 32174
Contact: Principal Investigator    386-676-6340    neurojscott@yahoo.com   
Suncoast Neuroscience Associates, Inc Recruiting
Saint Petersburg, Florida, United States, 33713
Contact: Principal Investigator    727-202-2623    abvmd@aol.com   
Tallahassee Neurological Clinic Withdrawn
Tallahassee, Florida, United States, 32308
The MS Center of Vero Beach Recruiting
Vero Beach, Florida, United States, 32960
Contact: Principal Investigator    772-299-4304    stjasjafer@aol.com   
United States, Indiana
Fort Wayne Neurological Center - North Office Recruiting
Fort Wayne, Indiana, United States, 46825
Contact: Principal Investigator    260-460-3100    agupta@fwnc.com   
United States, Kansas
University of Kansas Med Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Principal Investigator    913-588-6980    slynch@kumc.edu   
MidAmerica Neuroscience Research Foundation/Rowe Neurology Recruiting
Lenexa, Kansas, United States, 66214
Contact: Principal Investigator    913-827-4202    vroweresearch@neurokc.com   
United States, Michigan
Henry Ford Health System - Neurology Recruiting
Detroit, Michigan, United States, 48202
Contact: Principal Investigator    313-916-7202    mcerghe1@hfhs.org   
United States, New Mexico
Univ of New Mexico - Health Sciences Center Not yet recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Principal Investigator    505-272-0760    msspecialtyclinic@salud.unm.edu   
United States, New York
NYU Langone Medical Center - MS Comprehensive Care Center Recruiting
New York, New York, United States, 10016
Contact: Principal Investigator    646-501-7500    ilya.kister@nyumc.org   
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for Multiple Sclerosis Withdrawn
New York, New York, United States, 10029-6501
United States, Ohio
Riverhills Healthcare, Inc. Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Principal Investigator    513-241-2370    czadikoff@riverhillsneuro.com   
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Principal Investigator    614-566-1250    aaron.boster@ohiohealth.com   
United States, Oklahoma
Neurology and Neuromuscular Center Recruiting
Oklahoma City, Oklahoma, United States, 73102
Contact: Principal Investigator    405-534-5349    tariq@hightowerclinical.com   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Principal Investigator    212-662-3647    Eric.Williamson@uphs.upenn.edu   
Thomas Jefferson University Hospital - Dpt Neurology MS Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Principal Investigator    215-955-6871    Thomas.Leist@jefferson.edu   
United States, Tennessee
Advanced Neuroscience Institute Recruiting
Franklin, Tennessee, United States, 37064
Contact: Principal Investigator    615-791-5470    frontdesk@neurosci.us   
United States, Texas
Neurology Center of San Antonio Recruiting
San Antonio, Texas, United States, 78258
Contact: Principal Investigator    210-490-0016    annofb@hotmail.com   
Australia, Victoria
Austin Health - Neuro-Immunology Clinical Research, Education and Support Service Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Principal Investigator    +61 3 9496 5000    richard.macdonell@austin.org.au   
Austria
MS Ambulanz Maida Recruiting
Wien, Austria, 1010
Contact: Principal Investigator    +43(1) 5043187-16    eva@maida.at   
Medizinische Universität Wien, Universitätsklinik für Neurologie Recruiting
Wien, Austria, 1090
Contact: Principal Investigator    +43 140 400-31170    paulus.rommer@meduniwien.ac.at   
Belgium
Hospital universitair Brussels_neurology department Recruiting
Brussels, Belgium, 1090
Contact: Principal Investigator    0032024776012    miguel.dhaeseleer@uzbrussel.be   
Hospital - Universitair Gent __Neurology Department Recruiting
Gent, Belgium, 9000
Contact: Principal Investigator    +32 9 332 45 29    guy.laureys@uzgent.be   
Hospital - Revalidatie & MS Centrum Overpelt_Neurology Department Recruiting
Overpelt, Belgium, 3900
Contact: Principal Investigator    +32 11 809 100    bart.vanwijmeersch@uhasselt.be   
Bulgaria
"Multiprofile Hospital for Active Treatment of Neurology and Psychiatry - Sveti Naum" EAD - Neurology Clinic for Movement Disorders Recruiting
Sofia, Bulgaria, 1113
Contact: Principal Investigator    +359 2 8703 298    ubalnp@yahoo.com   
Multiprofile Hospital for Active Treatment "National Cardiology Hospital" EAD, Neurology Clinic Withdrawn
Sofia, Bulgaria, 1309
"University Multiprofile Hospital for Active Treatment - Alexandrovska" EAD, Neurology Clinic Recruiting
Sofia, Bulgaria, 1431
Contact: Principal Investigator    +359 898422757    shotekov@abv.bg   
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Neurology Clinic Recruiting
Sofia, Bulgaria, 1431
Contact: Principal Investigator    +359 2 9230 670    itournev@emhpf.org   
Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia, Neurology Clinic Withdrawn
Sofia, Bulgaria, 1606
Canada
University of Alberta Recruiting
Edmonton, Canada, T6G 1Z1
Contact: Principal Investigator    780-248-1775    Gregg.Blevins@ualberta.ca   
Czechia
Fakultní nemocnice u sv. Anny Brno, RS Centrum Recruiting
Brno, Czechia, 656 91
Contact: Principal Investigator    00420 543 182 615    michal.dufek@fnusa.cz   
Fakultní nemocnice Hradec Králové, Neurologická klinika Recruiting
Hradec Králové, Czechia, 500 05
Contact: Principal Investigator    +420 495 835 251    valismar@seznam.cz   
Nemocnice Jihlava, Neurologické oddělení Recruiting
Jihlava, Czechia, 586 33
Contact: Principal Investigator    00420 567 157 251    skodao@nemji.cz   
Pardubicka krajska nemocnice, MS Centrum Recruiting
Pardubice, Czechia, 532 03
Contact: Principal Investigator    00 420 466014733    mares_miroslav@yahoo.es   
Krajská zdravotní a.s. - Nemonice Teplice o.z., RS Centrum Recruiting
Teplice, Czechia, 415 29
Contact: Principal Investigator    00420 417 519 625    marta.vachova@kzcr.eu   
Denmark
Aalborg Universitetshospital, Skleroseklinikken Neurologisk afdelning Recruiting
Aalborg, Denmark, 9000
Contact: Principal Investigator    + 45 97 66 22 33    ccp@rn.dk   
Glostrup Hospital, Neurologisk afdelning Recruiting
Glostrup, Denmark, 2600
Contact: Principal Investigator    (+45) 38 63 30 41    jette.lautrup.battistini@regionh.dk   
Finland
Terveystalo Tampere Withdrawn
Tampere, Finland, 33100
Mehiläinen NEO Withdrawn
Turku, Finland, 20520
France
Hôpital Avicenne, Service de Neurologie Recruiting
Bobigny, France, 93000
Contact: Principal Investigator    + 33 1 48 95 54 01    irene.coman@gmail.com   
Hosp Gabriel Montpied, Dept Neurology Recruiting
Clermont Ferrand, France, 63003
Contact: Principal Investigator    +33 4 73 75 22 01    pclavelou@chu-clermontferrand.fr   
Centre Hospitalier Sud Francilien - Service de Neurologie Recruiting
Corbeil-Essonnes, France, 91100
Contact: Principal Investigator    + 33 (0)1 61 69 75 82    ivania.patry@chsf.fr   
CHU de Dijon - Hôpital François Miterrand, Service de Neurologie Recruiting
Dijon, France, 21079
Contact: Principal Investigator    +33 3 80 29 52 70    thibault.moreau@chu-dijon.fr   
CHRU de Lille - Hôpital Roger Salengro, Service de Neurologie Recruiting
Lille, France, 59037
Contact: Principal Investigator    +33 3 20 44 60 53    patrick.vermersch@univ-lille2.fr   
Hopital Gui de Chauliac - CHU Montpellier Recruiting
Montpellier, France, 34295
Contact: Principal Investigator    + 33 4 67 33 09 56    p-labauge@chu-montpellier.fr   
Hôpital Central - CHU Nancy, Département Neurologie Recruiting
Nancy, France, 54035
Contact: Principal Investigator    +33 3 83 85 97 69    G.MATHEY@chru-nancy.fr   
Hôpital Universitaire Carémeau, Service de Neurologie Recruiting
Nimes, France, 30029
Contact: Principal Investigator    + 33 4 66 68 32 61    giovanni.castelnovo@chu-nimes.fr   
CHI POISSY-Saint Germay en Laye_Service de Neurologie et Réeducation Recruiting
Poissy, France, 78303
Contact: Principal Investigator    +33 1 39 27 41 81    oheinzlef@chi-poissy-st-germain.fr   
Hosp Pontchaillou, Dept Cardiology Recruiting
Rennes, France, 35033
Contact: Principal Investigator    + 33 2 99 28 41 22    gilles.edan@chu-rennes.fr   
Hosp Charles Nicolle Dept Neurology Recruiting
Rouen, France, 76000
Contact: Principal Investigator    + 33 2 32 88 82 94    bertrand.bourre@chu-rouen.fr   
Germany
Zentrum für klinische Forschung Dr. med. Irma Schöll Recruiting
Bad Homburg, Germany, 61348
Contact: Principal Investigator    +49 (0)6172- 2675833    privat@dr-schoell.de   
Neurologische Klinik und Poliklinik - Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften Recruiting
Dresden, Germany, 01307
Contact: Principal Investigator    +49 (0)351 458 3565    Tjalf.Ziemssen@uniklinikum-dresden.de   
Helios Klinikum Erfurt Recruiting
Erfurt, Germany, 99089
Contact: Principal Investigator    +49 731 15 97 97 94    andreas.steinbrecher@helios-kliniken.de   
Universitätsklinikum Giessen Klinik und Poliklinik für Neurologie Recruiting
Giessen, Germany, 35385
Contact: Principal Investigator    + 49 (0)641/985-44306    Martin.Berghoff@neuro.med.uni-giessen.de   
Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Neurologie Recruiting
Greifswald, Germany, 17475
Contact: Principal Investigator    +49 3834 86-6839    matthias.grothe@uni-greifswald.de   
Medizinische Hochschule Hannover, Neurologie Recruiting
Hannover, Germany, 30625
Contact: Principal Investigator    +49 511 532 - 6676    stangel.martin@mh-hannover.de   
AFL Arzneimittelforschung Leipzig GmbH Recruiting
Leipzig, Germany, 04107
Contact: Principal Investigator    +49 (0)341-910 4884    strauss@af-leipzig.de   
Universitätsklinikum Münster, Klinik für Allgemeine Neurologie Recruiting
Münster, Germany, 48149
Contact: Principal Investigator    +49 251 / 83-46811    Luisa.Klotz@ukmuenster.de   
Medizinzentrum Siegerland Weidenau Recruiting
Siegen, Germany, 57076
Contact: Principal Investigator    +49 (0)271 / 313 937 10    schlegel@zns-siegen.de   
NeuroPoint GmbH, Gesellschaft für vorbeugende Gesundheitspflege Recruiting
Ulm, Germany, 89073
Contact: Principal Investigator    +49 361 781 21 32    rau@neurologie-ulm.de   
Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West (Study Center) Recruiting
Westerstede, Germany, 26655
Contact: Principal Investigator    +49 (0)4488-72999    joachim.springub@ewetel.net   
Greece
Naval Hospital of Athens - Neurology Dpt Recruiting
Athens, Greece, 11521
Contact: Principal Investigator    +306944307299    ntoskastr@gmail.com   
401 Military Hospital of Athens - Neurology Dept Recruiting
Athens, Greece, 11525
Contact: Principal Investigator    +302107494431    drfakas@yahoo.gr   
Aeginition Hospital - Neurology Department Recruiting
Athens, Greece, 11528
Contact: Principal Investigator    +302107289293    dimosmitsikostas@me.com   
Medical Center of Athens - Neurology Dpt Recruiting
Marousi, Greece, 15125
Contact: Principal Investigator    +306944583995    k.karageorgiou@iatriko.gr   
General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 57010
Contact: Principal Investigator    +302313307333    ubic1@otenet.gr   
Hungary
Uzsoki utcai Kórház, Neurológiai Osztály Recruiting
Budapest, Hungary, 1145
Contact: Principal Investigator    +36 1 467 3714    jakabg@uzsoki.hu   
Valeomed EGÉSZSÉGÜGYI KÖZPONT Recruiting
Esztergom, Hungary, 2500
Contact: Principal Investigator    +36 33 542336    satori.maria@gmail.com   
Pest Megyei Flór Ferenc Kórház, Neurológia és Stroke ambulancia Recruiting
Kistarcsa, Hungary, 2143
Contact: Principal Investigator    +3628507600/353    birozitamaria@gmail.com   
Vas Megyei Markusovszky Kórház Neurológiai osztály Withdrawn
Szombathely, Hungary, 9700
Veszprem Megyei Csolnoki Ferenc Korhaz -Neurológiai Osztály Withdrawn
Veszprem, Hungary, 8200
Italy
Fondazione Istituto San Raffaele , Unità Operativa di Neurologia Recruiting
Cefalù, Italy, 90015
Contact: Principal Investigator    +39 0921 920470    luigi.grimaldi@hsrgiglio.it   
Università degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi - CTO - SOD Neurologia 2 Recruiting
Firenze, Italy, 50139
Contact: Principal Investigator    +39 055 4277956    luca.massacesi@unifi.it   
AOU San Martino di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DINOGMI) Not yet recruiting
Genova, Italy, 16132
Contact: Principal Investigator    0039 010 3538476    m.inglese@unige.it   
Istituto Neurologico Carlo Besta, UOC Neurologia 4, Neuroimmunologia e Malattie Neuromuscolari, Centro Sclerosi Multipla Not yet recruiting
Milano, Italy, 20133
Contact: Principal Investigator    +39 022 394 2282    renato.mantegazza@istituto-besta.it   
Azienda Ospedaliera Universitaria (AOU) "Federico II" - Centro Regionale Per la Sclerosi Multipla c/o Clinica Neurologica II - Dipartimento di Scienze Recruiting
Napoli, Italy, 80131
Contact: Principal Investigator    +39 081 746 3741    vincenzo.bresciamorra2@unina.it   
AOU Università degli Studi della Campania L. Vanvitelli - I° Policlinico - DAI di Medicina Interna e Specialistica CS, Centro Sclerosi Multipla Recruiting
Napoli, Italy, 80138
Contact: Principal Investigator    +39 081 5665299    antonio.gallo@unina2.it   
Azienda Ospedaliero Universitaria San Luigi Gonzaga - Centro Sclerosi Multipla CRESM Recruiting
Orbassano, Italy, 10043
Contact: Principal Investigator    0039 011 9026397    simona.malucchi@gmail.com   
IRCCS NEUROMED - Istituto Neurologico Mediterraneo - Unità Operativa di Neurologia I Recruiting
Pozzilli, Italy, 86077
Contact: Principal Investigator    +39 0865 929267    centonze@uniroma2.it   
Azienda Ospedaliera S. Andrea di Roma - Unità Operativa Complessa di Neurologia Recruiting
Roma, Italy, 00189
Contact: Principal Investigator    +39 06 33775662/5374    carlo.pozzilli@uniroma1.it   
Azienda Ospedaliera Universitaria Senese - Dipartimento di Scienze Neurologiche e neurosensoriali - UOSA Neurologia Sperimentale Recruiting
Siena, Italy, 53100
Contact: Principal Investigator    +39 0577 233260    destefano@unisi.it   
Mexico
Unidad de Investigacion en Salud de Chihuahua SC, Médica Sur, Unidad de Neurociencias Recruiting
Tlalpan, DF, Mexico, 14050
Contact: Principal Investigator    +52 55 85331598    jflores.rivera@gmail.com   
Desarrollo Ético en Investigación Clínica S.C . Not yet recruiting
Guadalajara, Jalisco, Mexico, 44500
Contact: Principal Investigator    +52 3339681905    drasandy1806@hotmail.com   
Axis Heilsa S. de R.L. de C.V. (Althian) Recruiting
Nuevo Leon, Monterrey, Mexico, 64060
Contact: Principal Investigator    +52 (81) 477 02 482 ext 122    mezazavala@hotmail.com   
Unidad de Investigación de Salud en Chihuahua Recruiting
Chihuahua, Mexico, 31203
Contact: Principal Investigator    +52 (614) 437 2837    drmartinezmanzanera@gmail.com   
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Neurologii i Oddziat Udarowy Not yet recruiting
Bialystok, Poland, 15-276
Contact: Principal Investigator    +48 85 831 8326    alakul@umb.edu.pl   
B&B Robert Bonek, Pawel Bochniak S.C Recruiting
Bydgoszcz, Poland, 85-795
Contact: Principal Investigator    +48 52 330 22 94    robertbonek.bb@gmail.com   
COPERNICUS - Podmiot Leczniczy Sp. z o.o. Recruiting
Gdansk, Poland, 80-803
Contact: Principal Investigator    +48 58 300 58 43    w.fryze@wp.pl   
Centrum Terapii SM Recruiting
Katowice, Poland, 40-571
Contact: Principal Investigator    +48 32 749 41 87    m.m@ctsm.pl   
Neuro-Medic Janusz Zbrojkiewicz Poradnia Weilospecjalistyczna Recruiting
Katowice, Poland, 40-752
Contact: Principal Investigator    +48 32 252 14 20    jzbrojkiewicz@op.pl   
Centrum Kompleksowej Rehabilitacji Recruiting
Konstancin-Jeziorna, Poland, 05-510
Contact: Principal Investigator    +48227030280    lidia.ledzion@gmail.com   
Centrum Opieki Zdrowotnej Orkan - Med. Recruiting
Ksawerów, Poland, 95-054
Contact: Principal Investigator    +48 42 213 64 12    jolanta.pentela.nowicka@gmail.com   
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna Recruiting
Warszawa, Poland, 02-957
Contact: Principal Investigator    +48 22 842 76 83    czlonkow@ipin.edu.pl   
WroMedica, J. Bielicka A. Strzałkowska SC Recruiting
Wroclaw, Poland, 51-685
Contact: Principal Investigator    +48 71 340 00 21    wiak.andrzej@wp.pl   
Portugal
Hospital Fernando Da Fonseca - Neurology Dpt Withdrawn
Amadora, Portugal, 2720 276
Centro Hospitalar de Lisboa Central Recruiting
Lisboa, Portugal, 1169-050
Contact: Principal Investigator    +351 21 313 6300    carlos.capela.trabalho@gmail.com   
Hospital de Santa Maria - Neurology Department Recruiting
Lisboa, Portugal, 1649-035
Contact: Principal Investigator    +351 21 780 5000    jcorreiasa@gmail.com   
Centro Hospitalar de São João, E.P.E. - Hospital de São João - Neurology Department Recruiting
Porto, Portugal, 4200-319
Contact: Principal Investigator    +351 225512100    mjsa@med.up.pt   
Russian Federation
State Budgetary Healthcare Institution Regional Clinical Hospital No 3 Recruiting
Chelyabinsk, Russian Federation, 454021
Contact: Principal Investigator    +7 (351) 792 9469    nervugmado@yandex.ru   
Center of Professional Therapy, LLC Recruiting
Krasnodar, Russian Federation, 350051
Contact: Principal Investigator    +78612051781    laraneuro@mail.ru   
Moscow State Budgetary Healthcare Institution Filatov City Clinical Hospital No.15 of Moscow Health Department Recruiting
Moscow, Russian Federation, 111539
Contact: Principal Investigator    +7 495 375-08-47    nerv2005@mail.ru   
Neuro-Clinic, LLC Recruiting
Moscow, Russian Federation, 117186
Contact: Principal Investigator    +7 499 940 19 50    boykoan13@gmail.com   
Moscow State Budgetary Healthcare Institution Pirogov City Clinical Hospital No. 1 of Moscow Health Department Recruiting
Moscow, Russian Federation, 119049
Contact: Principal Investigator    +7 (916) 121 2737    ivashchukin@gmail.com   
Moscow State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow Health Department Recruiting
Moscow, Russian Federation, 127015
Contact: Principal Investigator    +7 495 613-04-08    mdavydovskaya@gmail.com   
Spain
Hospital Santa Creu I Sant Pau - Neurology Dpt Recruiting
Barcelona, Spain, 08041
Contact: Principal Investigator    +34 93 553 71 15    lquerol@santpau.cat   
Hosp Virgen de la Arrixaca, Neurology Recruiting
El Palmar, Spain, 30120
Contact: Principal Investigator    +34 968369389    pmecal@gmail.com   
Hosp Gregorio Marañón, Neurology Recruiting
Madrid, Spain, 28007
Contact: Principal Investigator    +34 91 426 96 10    marisamgines@hotmail.com   
Hospital Clinico San Carlos, Neurology Recruiting
Madrid, Spain, 28040
Contact: Principal Investigator    +34 91 3303001 ext 7060    orejacbn@gmail.com   
Hospital Santa Caterina - Neurology Department Recruiting
Salt, Spain, 17190
Contact: Principal Investigator    +34 972 186929    llramio.girona.ics@gencat.cat   
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Neurology Department 2 Recruiting
Santiago de Compostela, Spain, 15703
Contact: Principal Investigator    +34981950000    ariascenlle@gmail.com   
Hospital Universitario Virgen Macarena - Neurofisiology Department Recruiting
Sevilla, Spain, 41009
Contact: Principal Investigator    +34 955 00 90 25    saraeichau@hotmail.com   
Centro de Neurologia Avanzada, Neurology Recruiting
Sevilla, Spain, 41013
Contact: Principal Investigator    +34954 03 20 00    javierabriljaramillo@hotmail.com   
Switzerland
Univeritätsspital Basel Neurologie, Neurologische Klinik und Poliklinik Recruiting
Basel, Switzerland, 4031
Contact: Principal Investigator    +41 61 265 71 84    jens.kuhle@usb.ch   
Ospedale Regionale di Lugano - Civico e Italiano, Neurologia, Lugano Recruiting
Lugano, Switzerland, 6903
Contact: Principal Investigator    +41 91 811 69 21    chiara.zecca@eoc.ch   
United Kingdom
North Bristol NHS Trust, Southmead Hospital, Bristol Brain Centre Withdrawn
Bristol, United Kingdom, BS10 5NB
King's College Hospital, Clinical trials office Withdrawn
London, United Kingdom, SE5 9RS
Queen Square MS Centre / NMR research Unit UCL Institute of Neurology Recruiting
London, United Kingdom, WC1N 3BG
Contact: Principal Investigator    020 3448 4778    jeremy.chataway@nhs.net   
Royal Victoria Infirmary Newcastle Withdrawn
Newcastle, United Kingdom, NE1 4LP
Queen's Medical Centre Nottingham Withdrawn
Nottingham, United Kingdom, NG7 2UH
Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Principal Investigator    01865 231907    matthew.craner@ndcn.ox.ac.uk   
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Principal Investigator    0114 226 5638    David.Paling@sth.nhs.uk   
University Hospitals of North Midlands NHS Trust Recruiting
Stoke-on-Trent, United Kingdom, ST4 6QG
Contact: Principal Investigator    0178 267 9458    roby.abraham@uhns.nhs.uk   
Sponsors and Collaborators
Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02907177     History of Changes
Other Study ID Numbers: AC-058B302
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs