13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

  
54 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-000541-12-HR
(EUCTR)
23/04/201917/05/2019Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Portugal;Greece;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Australia;Denmark;Bulgaria;Germany
2EUCTR2016-004719-10-GR
(EUCTR)
15/10/201824/07/2018Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT Relapsing multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Serbia;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden
3EUCTR2016-004719-10-FI
(EUCTR)
25/07/201812/06/2018A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT Relapsing multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Romania;Bulgaria;Georgia;Germany;Sweden;Croatia;Poland;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Finland;Czechia;Bosnia and Herzegovina;Latvia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Portugal;Belarus;Serbia;United States
4EUCTR2016-004719-10-PT
(EUCTR)
02/07/201812/02/2018A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden
5EUCTR2012-000541-12-BE
(EUCTR)
07/05/201809/02/2018Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany
6EUCTR2016-004719-10-GB
(EUCTR)
26/04/201822/05/2018A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
7EUCTR2016-004719-10-HR
(EUCTR)
27/03/201812/04/2018A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
8EUCTR2016-004719-10-LV
(EUCTR)
30/01/201810/11/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
9EUCTR2016-004719-10-BG
(EUCTR)
24/01/201801/11/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Portugal;Belarus;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden
10EUCTR2016-004719-10-CZ
(EUCTR)
22/01/201829/09/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
11EUCTR2016-004719-10-HU
(EUCTR)
11/01/201820/11/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
12EUCTR2016-004719-10-LT
(EUCTR)
29/12/201704/12/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden
13EUCTR2016-004719-10-PL
(EUCTR)
02/12/201724/08/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden
14EUCTR2016-004719-10-SE
(EUCTR)
04/10/201728/07/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden
15EUCTR2012-000541-12-FI
(EUCTR)
03/10/201717/08/2017Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
16EUCTR2016-004719-10-ES
(EUCTR)
02/10/201704/07/2017A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
17EUCTR2012-000541-12-BG
(EUCTR)
28/09/201704/07/2017Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
18EUCTR2012-000541-12-PL
(EUCTR)
05/09/201727/07/2017Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
19NCT03232073
(ClinicalTrials.gov)
July 5, 201720/7/2017Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple SclerosisMulticenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: PonesimodActelionNULLActive, not recruiting18 Years65 YearsAll877Phase 3United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom
20EUCTR2012-000541-12-FR
(EUCTR)
13/06/201717/07/2017Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
21NCT02907177
(ClinicalTrials.gov)
March 30, 201725/8/2016Clinical 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®)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®)Multiple SclerosisDrug: Ponesimod;Other: PlaceboActelionNULLTerminated18 Years55 YearsAll136Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;Russian Federation;Spain;Switzerland;United Kingdom;Croatia;Czech Republic;Finland;Norway
22EUCTR2012-000541-12-GR
(EUCTR)
21/12/201624/08/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
23EUCTR2012-000541-12-PT
(EUCTR)
05/12/201619/07/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
24EUCTR2012-000541-12-ES
(EUCTR)
21/11/201611/08/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
25EUCTR2012-000541-12-DE
(EUCTR)
15/11/201606/07/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
26EUCTR2012-000541-12-DK
(EUCTR)
07/11/201620/07/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
27EUCTR2012-000541-12-AT
(EUCTR)
02/11/201622/07/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
28EUCTR2012-000541-12-HU
(EUCTR)
08/09/201621/07/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
29EUCTR2012-000541-12-CZ
(EUCTR)
29/08/201622/07/2016Clinical 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®)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®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
30EUCTR2012-000540-10-PT
(EUCTR)
23/10/201521/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Hungary;United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
31EUCTR2012-000540-10-LT
(EUCTR)
21/10/201517/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-1
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
32EUCTR2012-000540-10-HU
(EUCTR)
15/10/201519/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
33EUCTR2012-000540-10-SE
(EUCTR)
07/10/201514/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
34EUCTR2012-000540-10-GR
(EUCTR)
02/10/201505/11/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-1
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
35EUCTR2012-000540-10-LV
(EUCTR)
25/09/201514/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-1
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
36EUCTR2012-000540-10-FI
(EUCTR)
23/09/201519/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-1
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
37EUCTR2012-000540-10-HR
(EUCTR)
23/09/201501/10/2015Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
38EUCTR2012-000540-10-DE
(EUCTR)
23/09/201503/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
39EUCTR2012-000540-10-ES
(EUCTR)
21/09/201511/09/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Serbia;Portugal;Belarus;United States;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
40EUCTR2012-000540-10-CZ
(EUCTR)
15/09/201517/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-1
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
41EUCTR2012-000540-10-PL
(EUCTR)
25/08/201512/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
42EUCTR2012-000540-10-FR
(EUCTR)
31/07/201503/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Trade Name: Aubagio®
Product Name: Aubagio®
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-1
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
43NCT02425644
(ClinicalTrials.gov)
June 4, 201521/4/2015Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple SclerosisMulticenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: ponesimod;Drug: teriflunomideActelionNULLCompleted18 Years55 YearsAll1133Phase 3United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic
44EUCTR2009-011470-15-NL
(EUCTR)
03/12/201003/06/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden
45EUCTR2009-011470-15-PL
(EUCTR)
14/09/201025/05/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden
46EUCTR2009-011470-15-DE
(EUCTR)
20/08/201008/04/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: ponesimod
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: ponesimod
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN:
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
353Phase 2Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden
47EUCTR2009-011470-15-BG
(EUCTR)
12/08/201030/04/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2United States;Serbia;Czechia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
48EUCTR2009-011470-15-AT
(EUCTR)
03/08/201028/06/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: ponesimod
Product Name: ponesimod
Product Code: ACT-128800
INN or Proposed INN: ponesimod
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN:
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden
49EUCTR2009-011470-15-HU
(EUCTR)
08/07/201001/06/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
50EUCTR2009-011470-15-GB
(EUCTR)
22/06/201029/03/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Sweden;United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands
51NCT01093326
(ClinicalTrials.gov)
May 12, 201024/3/2010Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple SclerosisMulticenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mgActelionNULLActive, not recruiting18 Years55 YearsAll353Phase 2Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Austria;Bulgaria;Canada;Czechia;Finland;France;United States;Czech Republic;Italy
52EUCTR2009-011470-15-CZ
(EUCTR)
30/04/201029/03/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Canada;Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden
53EUCTR2009-011470-15-SE
(EUCTR)
12/04/201004/03/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Sweden;Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany
54EUCTR2009-011470-15-FI
(EUCTR)
30/03/201009/02/2010An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis.Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ponesimod
Product Code: ACT-128800
Product Name: ponesimod
Product Code: ACT-128800
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
353Phase 2Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden