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 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
68 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 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
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
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 3Russian Federation;United States;Portugal;Greece;Latvia;Sweden;Poland;Bulgaria;France;Lithuania;Serbia;Bosnia and Herzegovina;Croatia;Romania;Hungary;Ukraine;United Kingdom;Belarus;Spain;Canada;Czech Republic;Turkey;Finland;Italy;Mexico;Georgia;Israel;Germany
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
19EUCTR2012-000541-12-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
20EUCTR2012-000541-12-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
21EUCTR2012-000541-12-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
22EUCTR2012-000541-12-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
23EUCTR2012-000541-12-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
24EUCTR2012-000541-12-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
25EUCTR2012-000541-12-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
26EUCTR2012-000541-12-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
27EUCTR2012-000541-12-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
28EUCTR2012-000540-10-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
29EUCTR2012-000540-10-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
30EUCTR2012-000540-10-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
31EUCTR2012-000540-10-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
32EUCTR2012-000540-10-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
33EUCTR2012-000540-10-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
34EUCTR2012-000540-10-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
35EUCTR2012-000540-10-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
36EUCTR2012-000540-10-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
37EUCTR2012-000540-10-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
38EUCTR2012-000540-10-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
39EUCTR2012-000540-10-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
40EUCTR2012-000540-10-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
41EUCTR2009-011470-15-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
42EUCTR2009-011470-15-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
43EUCTR2009-011470-15-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
44EUCTR2009-011470-15-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
45EUCTR2009-011470-15-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
46EUCTR2009-011470-15-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
47EUCTR2009-011470-15-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
48EUCTR2008-006786-92-FR
(EUCTR)
27/05/201006/04/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden
49EUCTR2009-011470-15-ES
(EUCTR)
18/05/201022/03/2010Estudio de extensión del estudio AC-058B201, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, para evaluar la seguridad, tolerabilidad, y eficacia a largo plazo de 10, 20, y 40 mg/día de ACT-128800, un agonista oral de los receptores S1P1, en pacientes con esclerosis múltiple recurrente-remitente - Esclerosi Múltiple Recurrente-Remitente
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;Sweden
50EUCTR2009-011470-15-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
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;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
51EUCTR2009-011470-15-IT
(EUCTR)
29/04/201027/12/2011Multicenter, 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 ACT-128800, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis. - Relapsing-remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: ACT-128800
Product Code: ACT-128800
INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS
Product Name: ACT-128800
Product Code: ACT-128800
INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS
Product Name: ACT-128800
Product Code: ACT-128800
INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;Sweden
52EUCTR2009-011470-15-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
53EUCTR2009-011470-15-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
54EUCTR2008-006786-92-PL
(EUCTR)
08/12/200928/07/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
55EUCTR2008-006786-92-BG
(EUCTR)
20/11/200918/11/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400United Kingdom;Sweden;France;Hungary;Czech Republic;Finland;Poland;Spain;Austria;Bulgaria;Netherlands;Italy
56EUCTR2008-006786-92-AT
(EUCTR)
19/11/200916/09/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Poland;Austria;Sweden
57EUCTR2008-006786-92-NL
(EUCTR)
03/11/200918/06/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
58EUCTR2008-006786-92-BE
(EUCTR)
22/10/200924/09/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Sweden
59NCT01006265
(ClinicalTrials.gov)
October 1, 200930/10/2009Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple SclerosisMulticenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: ACT-128800 Dose 1;Drug: Placebo;Drug: ACT-128800 Dose 2;Drug: ACT-128800 Dose 3ActelionNULLCompleted18 Years55 YearsAll464Phase 2Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Austria;Belgium;United States;Czech Republic
60EUCTR2008-006786-92-IT
(EUCTR)
29/09/200910/08/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - NDMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - ND Multiple Sclerosis Relapsing Remitting
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
400Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
61EUCTR2008-006786-92-HU
(EUCTR)
18/09/200902/06/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Finland;Hungary;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
62EUCTR2008-006786-92-GB
(EUCTR)
17/07/200927/04/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Finland;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
63EUCTR2008-006786-92-SE
(EUCTR)
16/07/200908/05/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400France;Hungary;Czech Republic;Finland;Poland;Spain;Austria;Bulgaria;Netherlands;Italy;United Kingdom;Sweden
64EUCTR2008-006786-92-FI
(EUCTR)
06/07/200901/04/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple scelorsis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
65EUCTR2008-006786-92-ES
(EUCTR)
04/07/200906/05/2009Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitenteEstudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente Esclerosis Múltiple Recurrente-Remitente
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden
66EUCTR2008-006786-92-CZ
(EUCTR)
18/06/200926/03/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
460Phase 2Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden
67EUCTR2020-004431-24-PL
(EUCTR)
28/10/2022A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple SclerosisMulti-center, Randomized, Double-blind, Parallel-group, Double-dummy, Active-controlled, Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis - PIONEER 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: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN:
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
212Phase 3Hungary;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden;Turkey;Austria;United Kingdom;Serbia;Portugal;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Israel;Switzerland;Italy;France;Puerto Rico;Peru;Australia;Czechia;Finland
68EUCTR2020-004431-24-DE
(EUCTR)
22/09/2022A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple SclerosisMulti-center, Randomized, Double-blind, Parallel-group, Double-dummy, Active-controlled, Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis - PIONEER 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]
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
212Phase 3Serbia;Portugal;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Israel;Switzerland;Italy;France;Puerto Rico;Peru;Australia;Czechia;Finland;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden