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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)

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ponesimod
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB Dpt of Neurology
  • Neuro-Pain Medical Center
  • SC3 Research - Pasadena
  • Care Access Research - Santa Clarita
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • University of Colorado Hospital
  • Mountain View Clinical Research, Inc
  • Associated Neurologists
  • Bradenton Research Center
  • Neurology Associates - MS Center of Greater Orlando
  • Neurology Assoc of Ormond Beach - CNS Trials
  • Suncoast Neuroscience Associates, Inc
  • The MS Center of Vero Beach
  • Fort Wayne Neurological Center - North Office
  • University of Kansas Med Center
  • MidAmerica Neuroscience Research Foundation/Rowe Neurology
  • Henry Ford Health System - Neurology
  • Univ of New Mexico - Health Sciences Center
  • NYU Langone Medical Center - MS Comprehensive Care Center
  • Riverhills Healthcare, Inc.
  • OhioHealth Research Institute
  • Neurology and Neuromuscular Center
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University Hospital - Dpt Neurology MS Center
  • Advanced Neuroscience Institute
  • Neurology Center of San Antonio
  • Austin Health - Neuro-Immunology Clinical Research, Education and Support Service
  • MS Ambulanz Maida
  • Medizinische Universität Wien, Universitätsklinik für Neurologie
  • Hospital universitair Brussels_neurology department
  • Hospital - Universitair Gent __Neurology Department
  • Hospital - Revalidatie & MS Centrum Overpelt_Neurology Department
  • "Multiprofile Hospital for Active Treatment of Neurology and Psychiatry - Sveti Naum" EAD - Neurology Clinic for Movement Disorders
  • "University Multiprofile Hospital for Active Treatment - Alexandrovska" EAD, Neurology Clinic
  • University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Neurology Clinic
  • University of Alberta
  • Fakultní nemocnice u sv. Anny Brno, RS Centrum
  • Fakultní nemocnice Hradec Králové, Neurologická klinika
  • Nemocnice Jihlava, Neurologické oddělení
  • Pardubicka krajska nemocnice, MS Centrum
  • Krajská zdravotní a.s. - Nemonice Teplice o.z., RS Centrum
  • Aalborg Universitetshospital, Skleroseklinikken Neurologisk afdelning
  • Glostrup Hospital, Neurologisk afdelning
  • Hôpital Avicenne, Service de Neurologie
  • Hosp Gabriel Montpied, Dept Neurology
  • Centre Hospitalier Sud Francilien - Service de Neurologie
  • CHU de Dijon - Hôpital François Miterrand, Service de Neurologie
  • CHRU de Lille - Hôpital Roger Salengro, Service de Neurologie
  • Hopital Gui de Chauliac - CHU Montpellier
  • Hôpital Central - CHU Nancy, Département Neurologie
  • Hôpital Universitaire Carémeau, Service de Neurologie
  • CHI POISSY-Saint Germay en Laye_Service de Neurologie et Réeducation
  • Hosp Pontchaillou, Dept Cardiology
  • Hosp Charles Nicolle Dept Neurology
  • Zentrum für klinische Forschung Dr. med. Irma Schöll
  • Neurologische Klinik und Poliklinik - Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften
  • Helios Klinikum Erfurt
  • Universitätsklinikum Giessen Klinik und Poliklinik für Neurologie
  • Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Neurologie
  • Medizinische Hochschule Hannover, Neurologie
  • AFL Arzneimittelforschung Leipzig GmbH
  • Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
  • Medizinzentrum Siegerland Weidenau
  • NeuroPoint GmbH, Gesellschaft für vorbeugende Gesundheitspflege
  • Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West (Study Center)
  • Naval Hospital of Athens - Neurology Dpt
  • 401 Military Hospital of Athens - Neurology Dept
  • Aeginition Hospital - Neurology Department
  • Medical Center of Athens - Neurology Dpt
  • General Hospital of Thessaloniki
  • Uzsoki utcai Kórház, Neurológiai Osztály
  • Valeomed EGÉSZSÉGÜGYI KÖZPONT
  • Pest Megyei Flór Ferenc Kórház, Neurológia és Stroke ambulancia
  • Fondazione Istituto San Raffaele , Unità Operativa di Neurologia
  • Università degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi - CTO - SOD Neurologia 2
  • AOU San Martino di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DINOGMI)
  • Istituto Neurologico Carlo Besta, UOC Neurologia 4, Neuroimmunologia e Malattie Neuromuscolari, Centro Sclerosi Multipla
  • Azienda Ospedaliera Universitaria (AOU) "Federico II" - Centro Regionale Per la Sclerosi Multipla c/o Clinica Neurologica II - Dipartimento di Scienze
  • AOU Università degli Studi della Campania L. Vanvitelli - I° Policlinico - DAI di Medicina Interna e Specialistica CS, Centro Sclerosi Multipla
  • Azienda Ospedaliero Universitaria San Luigi Gonzaga - Centro Sclerosi Multipla CRESM
  • IRCCS NEUROMED - Istituto Neurologico Mediterraneo - Unità Operativa di Neurologia I
  • Azienda Ospedaliera S. Andrea di Roma - Unità Operativa Complessa di Neurologia
  • Azienda Ospedaliera Universitaria Senese - Dipartimento di Scienze Neurologiche e neurosensoriali - UOSA Neurologia Sperimentale
  • Unidad de Investigacion en Salud de Chihuahua SC, Médica Sur, Unidad de Neurociencias
  • Desarrollo Ético en Investigación Clínica S.C .
  • Axis Heilsa S. de R.L. de C.V. (Althian)
  • Unidad de Investigación de Salud en Chihuahua
  • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Neurologii i Oddziat Udarowy
  • B&B Robert Bonek, Pawel Bochniak S.C
  • COPERNICUS - Podmiot Leczniczy Sp. z o.o.
  • Centrum Terapii SM
  • Neuro-Medic Janusz Zbrojkiewicz Poradnia Weilospecjalistyczna
  • Centrum Kompleksowej Rehabilitacji
  • Centrum Opieki Zdrowotnej Orkan - Med.
  • Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna
  • WroMedica, J. Bielicka A. Strzałkowska SC
  • Centro Hospitalar de Lisboa Central
  • Hospital de Santa Maria - Neurology Department
  • Centro Hospitalar de São João, E.P.E. - Hospital de São João - Neurology Department
  • State Budgetary Healthcare Institution Regional Clinical Hospital No 3
  • Center of Professional Therapy, LLC
  • Moscow State Budgetary Healthcare Institution Filatov City Clinical Hospital No.15 of Moscow Health Department
  • Neuro-Clinic, LLC
  • Moscow State Budgetary Healthcare Institution Pirogov City Clinical Hospital No. 1 of Moscow Health Department
  • Moscow State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow Health Department
  • Hospital Santa Creu I Sant Pau - Neurology Dpt
  • Hosp Virgen de la Arrixaca, Neurology
  • Hosp Gregorio Marañón, Neurology
  • Hospital Clinico San Carlos, Neurology
  • Hospital Santa Caterina - Neurology Department
  • Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Neurology Department 2
  • Hospital Universitario Virgen Macarena - Neurofisiology Department
  • Centro de Neurologia Avanzada, Neurology
  • Univeritätsspital Basel Neurologie, Neurologische Klinik und Poliklinik
  • Ospedale Regionale di Lugano - Civico e Italiano, Neurologia, Lugano
  • Queen Square MS Centre / NMR research Unit UCL Institute of Neurology
  • Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital
  • Royal Hallamshire Hospital
  • University Hospitals of North Midlands NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ponesimod

Placebo

Arm Description

Ponesimod

Placebo

Outcomes

Primary Outcome Measures

Annualized Confirmed Relapse Rate (ARR)
Relapse: occurrence of acute episode of one or more new or worsened symptoms of Multiple sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicates overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).

Secondary Outcome Measures

Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96
Percentage of participants with 12-week CDA as assessed by Kaplan Meier estimate at week 96 was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS).
Percentage of Participants Experiencing a Confirmed Relapse as Assessed by Kaplan Meier Estimate at Week 96
Percentage of participants experiencing a confirmed relapse as assessed by Kaplan Meier estimate at week 96 was reported. The time to first confirmed relapse (in days) is defined as [Date of first confirmed relapse minus Date of randomization plus 1] in days. Relapse: Occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not related with fever/infection and lasting 24 hours after 30 days stable period.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Full Information

First Posted
August 25, 2016
Last Updated
April 27, 2021
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT02907177
Brief Title
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®)
Acronym
POINT
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®)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
sponsor decision due to low recruitment
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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®).
Detailed Description
The study will assess the efficacy, safety, and tolerability of add-on therapy with ponesimod 20 mg vs placebo in adult participants with active relapsing multiple sclerosis (RMS) who are treated with dimethyl fumarate (DMF). Approximately 600 participants who have been receiving DMF for at least 6 months will be randomized in a 1:1 ratio to ponesimod 20 mg or placebo. The study consists of the following study periods: Pre-randomization period; Treatment period; Post-treatment observation period. The study includes one ponesimod treatment arm at the maintenance dose of 20 mg o.d. corresponding to the optimal dose when used as monotherapy based on the Phase 2 dose-finding trial and its ongoing extension. The study includes a placebo comparator arm, but all patients will remain on DMF background therapy throughout the study. Moreover, participants who experience a confirmed relapse or an event of 24-week confirmed disability accumulation (DMF) while on study drug will have the option to switch to an alternative treatment. The treatment period has a variable duration from a minimum of 60 weeks (for the last subject randomized) to a maximum of 156 weeks for the first subjects randomized in the trial and includes a gradual up-titration of ponesimod from a 2 mg starting dose to a 20 mg maintenance dose over a period of 14 days. The total duration of the study will be approximately up to 167 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ponesimod
Arm Type
Experimental
Arm Description
Ponesimod
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ponesimod
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
One tablet of matching placebo administered orally once daily in the morning
Primary Outcome Measure Information:
Title
Annualized Confirmed Relapse Rate (ARR)
Description
Relapse: occurrence of acute episode of one or more new or worsened symptoms of Multiple sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicates overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).
Time Frame
Through study completion, an average of 68 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96
Description
Percentage of participants with 12-week CDA as assessed by Kaplan Meier estimate at week 96 was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS).
Time Frame
Week 96
Title
Percentage of Participants Experiencing a Confirmed Relapse as Assessed by Kaplan Meier Estimate at Week 96
Description
Percentage of participants experiencing a confirmed relapse as assessed by Kaplan Meier estimate at week 96 was reported. The time to first confirmed relapse (in days) is defined as [Date of first confirmed relapse minus Date of randomization plus 1] in days. Relapse: Occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not related with fever/infection and lasting 24 hours after 30 days stable period.
Time Frame
Week 96
Title
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Up to 147 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Scherz, MD, PhD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
UAB Dpt of Neurology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
SC3 Research - Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Care Access Research - Santa Clarita
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91321
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mountain View Clinical Research, Inc
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Associated Neurologists
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Neurology Associates - MS Center of Greater Orlando
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Neurology Assoc of Ormond Beach - CNS Trials
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
The MS Center of Vero Beach
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Fort Wayne Neurological Center - North Office
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
University of Kansas Med Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MidAmerica Neuroscience Research Foundation/Rowe Neurology
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Henry Ford Health System - Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Univ of New Mexico - Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
NYU Langone Medical Center - MS Comprehensive Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Riverhills Healthcare, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Neurology and Neuromuscular Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital - Dpt Neurology MS Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Advanced Neuroscience Institute
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Neurology Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Austin Health - Neuro-Immunology Clinical Research, Education and Support Service
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
MS Ambulanz Maida
City
Wien
ZIP/Postal Code
1010
Country
Austria
Facility Name
Medizinische Universität Wien, Universitätsklinik für Neurologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital universitair Brussels_neurology department
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Hospital - Universitair Gent __Neurology Department
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hospital - Revalidatie & MS Centrum Overpelt_Neurology Department
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
"Multiprofile Hospital for Active Treatment of Neurology and Psychiatry - Sveti Naum" EAD - Neurology Clinic for Movement Disorders
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
"University Multiprofile Hospital for Active Treatment - Alexandrovska" EAD, Neurology Clinic
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Neurology Clinic
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University of Alberta
City
Edmonton
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Fakultní nemocnice u sv. Anny Brno, RS Centrum
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Fakultní nemocnice Hradec Králové, Neurologická klinika
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Nemocnice Jihlava, Neurologické oddělení
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Pardubicka krajska nemocnice, MS Centrum
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Krajská zdravotní a.s. - Nemonice Teplice o.z., RS Centrum
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Aalborg Universitetshospital, Skleroseklinikken Neurologisk afdelning
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Glostrup Hospital, Neurologisk afdelning
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Hôpital Avicenne, Service de Neurologie
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hosp Gabriel Montpied, Dept Neurology
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier Sud Francilien - Service de Neurologie
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
CHU de Dijon - Hôpital François Miterrand, Service de Neurologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHRU de Lille - Hôpital Roger Salengro, Service de Neurologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Gui de Chauliac - CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Central - CHU Nancy, Département Neurologie
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hôpital Universitaire Carémeau, Service de Neurologie
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
CHI POISSY-Saint Germay en Laye_Service de Neurologie et Réeducation
City
Poissy
ZIP/Postal Code
78303
Country
France
Facility Name
Hosp Pontchaillou, Dept Cardiology
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hosp Charles Nicolle Dept Neurology
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Zentrum für klinische Forschung Dr. med. Irma Schöll
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Neurologische Klinik und Poliklinik - Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitätsklinikum Giessen Klinik und Poliklinik für Neurologie
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Neurologie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Neurologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
AFL Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Medizinzentrum Siegerland Weidenau
City
Siegen
ZIP/Postal Code
57076
Country
Germany
Facility Name
NeuroPoint GmbH, Gesellschaft für vorbeugende Gesundheitspflege
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West (Study Center)
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Naval Hospital of Athens - Neurology Dpt
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
401 Military Hospital of Athens - Neurology Dept
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
Aeginition Hospital - Neurology Department
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Medical Center of Athens - Neurology Dpt
City
Marousi
ZIP/Postal Code
15125
Country
Greece
Facility Name
General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Uzsoki utcai Kórház, Neurológiai Osztály
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Valeomed EGÉSZSÉGÜGYI KÖZPONT
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Pest Megyei Flór Ferenc Kórház, Neurológia és Stroke ambulancia
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Fondazione Istituto San Raffaele , Unità Operativa di Neurologia
City
Cefalù
ZIP/Postal Code
90015
Country
Italy
Facility Name
Università degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi - CTO - SOD Neurologia 2
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
AOU San Martino di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DINOGMI)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Neurologico Carlo Besta, UOC Neurologia 4, Neuroimmunologia e Malattie Neuromuscolari, Centro Sclerosi Multipla
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria (AOU) "Federico II" - Centro Regionale Per la Sclerosi Multipla c/o Clinica Neurologica II - Dipartimento di Scienze
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU Università degli Studi della Campania L. Vanvitelli - I° Policlinico - DAI di Medicina Interna e Specialistica CS, Centro Sclerosi Multipla
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Luigi Gonzaga - Centro Sclerosi Multipla CRESM
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
IRCCS NEUROMED - Istituto Neurologico Mediterraneo - Unità Operativa di Neurologia I
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
Azienda Ospedaliera S. Andrea di Roma - Unità Operativa Complessa di Neurologia
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese - Dipartimento di Scienze Neurologiche e neurosensoriali - UOSA Neurologia Sperimentale
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Unidad de Investigacion en Salud de Chihuahua SC, Médica Sur, Unidad de Neurociencias
City
Tlalpan
State/Province
DF
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Desarrollo Ético en Investigación Clínica S.C .
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44500
Country
Mexico
Facility Name
Axis Heilsa S. de R.L. de C.V. (Althian)
City
Nuevo Leon
State/Province
Monterrey
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Unidad de Investigación de Salud en Chihuahua
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Neurologii i Oddziat Udarowy
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
B&B Robert Bonek, Pawel Bochniak S.C
City
Bydgoszcz
ZIP/Postal Code
85-795
Country
Poland
Facility Name
COPERNICUS - Podmiot Leczniczy Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Centrum Terapii SM
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Neuro-Medic Janusz Zbrojkiewicz Poradnia Weilospecjalistyczna
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Centrum Kompleksowej Rehabilitacji
City
Konstancin-Jeziorna
ZIP/Postal Code
05-510
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan - Med.
City
Ksawerów
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
WroMedica, J. Bielicka A. Strzałkowska SC
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Centro Hospitalar de Lisboa Central
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Hospital de Santa Maria - Neurology Department
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar de São João, E.P.E. - Hospital de São João - Neurology Department
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
State Budgetary Healthcare Institution Regional Clinical Hospital No 3
City
Chelyabinsk
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
Center of Professional Therapy, LLC
City
Krasnodar
ZIP/Postal Code
350051
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution Filatov City Clinical Hospital No.15 of Moscow Health Department
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Neuro-Clinic, LLC
City
Moscow
ZIP/Postal Code
117186
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution Pirogov City Clinical Hospital No. 1 of Moscow Health Department
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow Health Department
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Hospital Santa Creu I Sant Pau - Neurology Dpt
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hosp Virgen de la Arrixaca, Neurology
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hosp Gregorio Marañón, Neurology
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico San Carlos, Neurology
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Santa Caterina - Neurology Department
City
Salt
ZIP/Postal Code
17190
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Neurology Department 2
City
Santiago de Compostela
ZIP/Postal Code
15703
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena - Neurofisiology Department
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Centro de Neurologia Avanzada, Neurology
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Univeritätsspital Basel Neurologie, Neurologische Klinik und Poliklinik
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Ospedale Regionale di Lugano - Civico e Italiano, Neurologia, Lugano
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
Queen Square MS Centre / NMR research Unit UCL Institute of Neurology
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
University Hospitals of North Midlands NHS Trust
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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®)

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