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®)

PHASE3TerminatedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

March 30, 2017

Primary Completion Date

March 26, 2020

Study Completion Date

March 26, 2020

Conditions
Multiple Sclerosis
Interventions
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).

OTHER

Placebo

One tablet of matching placebo administered orally once daily in the morning

Trial Locations (119)

1010

MS Ambulanz Maida, Vienna

1090

Medizinische Universität Wien, Universitätsklinik für Neurologie, Vienna

Hospital universitair Brussels_neurology department, Brussels

1113

"Multiprofile Hospital for Active Treatment of Neurology and Psychiatry - Sveti Naum EAD - Neurology Clinic for Movement Disorders", Sofia

1145

Uzsoki utcai Kórház, Neurológiai Osztály, Budapest

1431

"University Multiprofile Hospital for Active Treatment - Alexandrovska EAD, Neurology Clinic", Sofia

"University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Neurology Clinic", Sofia

2143

Pest Megyei Flór Ferenc Kórház, Neurológia és Stroke ambulancia, Kistarcsa

2500

Valeomed EGÉSZSÉGÜGYI KÖZPONT, Esztergom

2600

Glostrup Hospital, Neurologisk afdelning, Glostrup Municipality

3084

Austin Health - Neuro-Immunology Clinical Research, Education and Support Service, Heidelberg

3900

Hospital - Revalidatie & MS Centrum Overpelt_Neurology Department, Overpelt

4031

Univeritätsspital Basel Neurologie, Neurologische Klinik und Poliklinik, Basel

6903

Ospedale Regionale di Lugano - Civico e Italiano, Neurologia, Lugano, Lugano

9000

Hospital - Universitair Gent __Neurology Department, Ghent

Aalborg Universitetshospital, Skleroseklinikken Neurologisk afdelning, Aalborg

10016

NYU Langone Medical Center - MS Comprehensive Care Center, New York

10043

Azienda Ospedaliero Universitaria San Luigi Gonzaga - Centro Sclerosi Multipla CRESM, Orbassano

11521

Naval Hospital of Athens - Neurology Dpt, Athens

11525

401 Military Hospital of Athens - Neurology Dept, Athens

11528

Aeginition Hospital - Neurology Department, Athens

14050

Unidad de Investigacion en Salud de Chihuahua SC, Médica Sur, Unidad de Neurociencias, Tlalpan

15125

Medical Center of Athens - Neurology Dpt, Marousi

15703

Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Neurology Department 2, Santiago de Compostela

16132

AOU San Martino di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DINOGMI), Genova

17190

Hospital Santa Caterina - Neurology Department, Salt

17475

Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Neurologie, Greifswald

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital - Dpt Neurology MS Center, Philadelphia

20133

Istituto Neurologico Carlo Besta, UOC Neurologia 4, Neuroimmunologia e Malattie Neuromuscolari, Centro Sclerosi Multipla, Milan

21079

CHU de Dijon - Hôpital François Miterrand, Service de Neurologie, Dijon

26655

Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West (Study Center), Westerstede

28007

Hosp Gregorio Marañón, Neurology, Madrid

28040

Hospital Clinico San Carlos, Neurology, Madrid

30029

Hôpital Universitaire Carémeau, Service de Neurologie, Nîmes

30120

Hosp Virgen de la Arrixaca, Neurology, El Palmar

30625

Medizinische Hochschule Hannover, Neurologie, Hanover

31203

Unidad de Investigación de Salud en Chihuahua, Chihuahua City

32174

Neurology Assoc of Ormond Beach - CNS Trials, Ormond Beach

32751

Neurology Associates - MS Center of Greater Orlando, Maitland

32960

The MS Center of Vero Beach, Vero Beach

33713

Suncoast Neuroscience Associates, Inc, St. Petersburg

34205

Bradenton Research Center, Bradenton

34295

Hopital Gui de Chauliac - CHU Montpellier, Montpellier

35033

Hosp Pontchaillou, Dept Cardiology, Rennes

35233

UAB Dpt of Neurology, Birmingham

35385

Universitätsklinikum Giessen Klinik und Poliklinik für Neurologie, Giessen

37064

Advanced Neuroscience Institute, Franklin

41009

Hospital Universitario Virgen Macarena - Neurofisiology Department, Seville

41013

Centro de Neurologia Avanzada, Neurology, Seville

43214

OhioHealth Research Institute, Columbus

44500

Desarrollo Ético en Investigación Clínica S.C ., Guadalajara

45212

Riverhills Healthcare, Inc., Cincinnati

46825

Fort Wayne Neurological Center - North Office, Fort Wayne

48149

Universitätsklinikum Münster, Klinik für Allgemeine Neurologie, Münster

48202

Henry Ford Health System - Neurology, Detroit

50139

Università degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi - CTO - SOD Neurologia 2, Florence

53100

Azienda Ospedaliera Universitaria Senese - Dipartimento di Scienze Neurologiche e neurosensoriali - UOSA Neurologia Sperimentale, Siena

54035

Hôpital Central - CHU Nancy, Département Neurologie, Nancy

57010

General Hospital of Thessaloniki, Thessaloniki

57076

Medizinzentrum Siegerland Weidenau, Siegen

59037

CHRU de Lille - Hôpital Roger Salengro, Service de Neurologie, Lille

61348

Zentrum für klinische Forschung Dr. med. Irma Schöll, Bad Homburg

63003

Hosp Gabriel Montpied, Dept Neurology, Clermont-Ferrand

64060

Axis Heilsa S. de R.L. de C.V. (Althian), Nuevo León

66160

University of Kansas Med Center, Kansas City

66214

MidAmerica Neuroscience Research Foundation/Rowe Neurology, Lenexa

73102

Neurology and Neuromuscular Center, Oklahoma City

76000

Hosp Charles Nicolle Dept Neurology, Rouen

78258

Neurology Center of San Antonio, San Antonio

78303

CHI POISSY-Saint Germay en Laye_Service de Neurologie et Réeducation, Poissy

80045

University of Colorado Hospital, Aurora

80131

"Azienda Ospedaliera Universitaria (AOU) Federico II - Centro Regionale Per la Sclerosi Multipla c/o Clinica Neurologica II - Dipartimento di Scienze", Napoli

80138

AOU Università degli Studi della Campania L. Vanvitelli - I° Policlinico - DAI di Medicina Interna e Specialistica CS, Centro Sclerosi Multipla, Napoli

80209

Mountain View Clinical Research, Inc, Denver

86077

IRCCS NEUROMED - Istituto Neurologico Mediterraneo - Unità Operativa di Neurologia I, Pozzilli

87131

Univ of New Mexico - Health Sciences Center, Albuquerque

89073

NeuroPoint GmbH, Gesellschaft für vorbeugende Gesundheitspflege, Ulm

90015

Fondazione Istituto San Raffaele , Unità Operativa di Neurologia, Cefalù

90502

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance

91100

Centre Hospitalier Sud Francilien - Service de Neurologie, Corbeil-Essonnes

91105

SC3 Research - Pasadena, Pasadena

91321

Care Access Research - Santa Clarita, Santa Clarita

93000

Hôpital Avicenne, Service de Neurologie, Bobigny

93710

Neuro-Pain Medical Center, Fresno

99089

Helios Klinikum Erfurt, Erfurt

111539

Moscow State Budgetary Healthcare Institution Filatov City Clinical Hospital No.15 of Moscow Health Department, Moscow

117186

Neuro-Clinic, LLC, Moscow

119049

Moscow State Budgetary Healthcare Institution Pirogov City Clinical Hospital No. 1 of Moscow Health Department, Moscow

127015

Moscow State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow Health Department, Moscow

350051

Center of Professional Therapy, LLC, Krasnodar

454021

State Budgetary Healthcare Institution Regional Clinical Hospital No 3, Chelyabinsk

06810

Associated Neurologists, Danbury

T6G 1Z1

University of Alberta, Edmonton

656 91

Fakultní nemocnice u sv. Anny Brno, RS Centrum, Brno

500 05

Fakultní nemocnice Hradec Králové, Neurologická klinika, Hradec Králové

586 33

Nemocnice Jihlava, Neurologické oddělení, Jihlava

532 03

Pardubicka krajska nemocnice, MS Centrum, Pardubice

415 29

Krajská zdravotní a.s. - Nemonice Teplice o.z., RS Centrum, Teplice

01307

Neurologische Klinik und Poliklinik - Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften, Dresden

04107

AFL Arzneimittelforschung Leipzig GmbH, Leipzig

00189

Azienda Ospedaliera S. Andrea di Roma - Unità Operativa Complessa di Neurologia, Roma

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Neurologii i Oddziat Udarowy, Bialystok

85-795

B&B Robert Bonek, Pawel Bochniak S.C, Bydgoszcz

80-803

COPERNICUS - Podmiot Leczniczy Sp. z o.o., Gdansk

40-571

Centrum Terapii SM, Katowice

40-752

Neuro-Medic Janusz Zbrojkiewicz Poradnia Weilospecjalistyczna, Katowice

05-510

Centrum Kompleksowej Rehabilitacji, Konstancin-Jeziorna

95-054

Centrum Opieki Zdrowotnej Orkan - Med., Ksawerów

02-957

Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Warsaw

51-685

WroMedica, J. Bielicka A. Strzałkowska SC, Wroclaw

1169-050

Centro Hospitalar de Lisboa Central, Lisbon

1649-035

Hospital de Santa Maria - Neurology Department, Lisbon

4200-319

Centro Hospitalar de São João, E.P.E. - Hospital de São João - Neurology Department, Porto

08041

Hospital Santa Creu I Sant Pau - Neurology Dpt, Barcelona

WC1N 3BG

Queen Square MS Centre / NMR research Unit UCL Institute of Neurology, London

OX3 9DU

Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford

S10 2JF

Royal Hallamshire Hospital, Sheffield

ST4 6QG

University Hospitals of North Midlands NHS Trust, Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY

NCT02907177 - 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®) | Biotech Hunter | Biotech Hunter