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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-000541-12-HR (EUCTR) | 23/04/2019 | 17/05/2019 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 2 | NCT05762003 (ClinicalTrials.gov) | January 1, 2019 | 9/2/2023 | Czech Pharmaco-epidemiological Study on Disease Modifying Drugs | Czech Pharmaco-epidemiological Real World Data Study Focused on Effectiveness of Different Disease Modifying Drugs | Multiple Sclerosis | Drug: interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab | IMPULS Endowment Fund | NULL | Completed | N/A | N/A | All | 17478 | Czechia | |
| 3 | EUCTR2016-004719-10-GR (EUCTR) | 15/10/2018 | 24/07/2018 | 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 4 | EUCTR2016-004719-10-FI (EUCTR) | 25/07/2018 | 12/06/2018 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 5 | EUCTR2016-004719-10-PT (EUCTR) | 02/07/2018 | 12/02/2018 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 6 | EUCTR2012-000541-12-BE (EUCTR) | 07/05/2018 | 09/02/2018 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany | ||
| 7 | EUCTR2016-004719-10-GB (EUCTR) | 26/04/2018 | 22/05/2018 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 8 | EUCTR2016-004719-10-HR (EUCTR) | 27/03/2018 | 12/04/2018 | A 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. | NULL | Authorised-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): no | Serbia;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 | ||
| 9 | EUCTR2016-004719-10-LV (EUCTR) | 30/01/2018 | 10/11/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Russian 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 | ||
| 10 | EUCTR2016-004719-10-BG (EUCTR) | 24/01/2018 | 01/11/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 11 | EUCTR2016-004719-10-CZ (EUCTR) | 22/01/2018 | 29/09/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 12 | EUCTR2016-004719-10-HU (EUCTR) | 11/01/2018 | 20/11/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;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 | ||
| 13 | EUCTR2016-004719-10-LT (EUCTR) | 29/12/2017 | 04/12/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 14 | EUCTR2016-004719-10-PL (EUCTR) | 02/12/2017 | 24/08/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 15 | EUCTR2016-004719-10-SE (EUCTR) | 04/10/2017 | 28/07/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United 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 | ||
| 16 | EUCTR2012-000541-12-FI (EUCTR) | 03/10/2017 | 17/08/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 17 | EUCTR2016-004719-10-ES (EUCTR) | 02/10/2017 | 04/07/2017 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;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 | ||
| 18 | EUCTR2012-000541-12-BG (EUCTR) | 28/09/2017 | 04/07/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 19 | EUCTR2012-000541-12-PL (EUCTR) | 05/09/2017 | 27/07/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 20 | NCT03232073 (ClinicalTrials.gov) | July 5, 2017 | 20/7/2017 | Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis | Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod | Actelion | NULL | Active, not recruiting | 18 Years | 65 Years | All | 877 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom |
| 21 | EUCTR2012-000541-12-FR (EUCTR) | 13/06/2017 | 17/07/2017 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 22 | NCT02907177 (ClinicalTrials.gov) | March 30, 2017 | 25/8/2016 | Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) | Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) | Multiple Sclerosis | Drug: Ponesimod;Other: Placebo | Actelion | NULL | Terminated | 18 Years | 55 Years | All | 136 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;Russian Federation;Spain;Switzerland;United Kingdom;Croatia;Czech Republic;Finland;Norway |
| 23 | EUCTR2012-000541-12-GR (EUCTR) | 21/12/2016 | 24/08/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 24 | EUCTR2012-000541-12-PT (EUCTR) | 05/12/2016 | 19/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 25 | EUCTR2012-000541-12-ES (EUCTR) | 21/11/2016 | 11/08/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 26 | EUCTR2012-000541-12-DE (EUCTR) | 15/11/2016 | 06/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 27 | EUCTR2012-000541-12-DK (EUCTR) | 07/11/2016 | 20/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | ||
| 28 | EUCTR2012-000541-12-AT (EUCTR) | 02/11/2016 | 22/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 29 | EUCTR2012-000541-12-HU (EUCTR) | 08/09/2016 | 21/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 30 | EUCTR2012-000541-12-CZ (EUCTR) | 29/08/2016 | 22/07/2016 | Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | ||
| 31 | EUCTR2012-000540-10-PT (EUCTR) | 23/10/2015 | 21/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Hungary;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 | ||
| 32 | EUCTR2012-000540-10-LT (EUCTR) | 21/10/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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-1 | Actelion Pharmaceuticals Ltd | NULL | Not 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): no | Serbia;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 | ||
| 33 | EUCTR2012-000540-10-HU (EUCTR) | 15/10/2015 | 19/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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 Product Name: Ponesimod Product Code: ACT | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;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 | ||
| 34 | EUCTR2012-000540-10-SE (EUCTR) | 07/10/2015 | 14/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;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 | ||
| 35 | EUCTR2012-000540-10-GR (EUCTR) | 02/10/2015 | 05/11/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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: 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 Ltd | NULL | Not 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): no | Serbia;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 | ||
| 36 | EUCTR2012-000540-10-LV (EUCTR) | 25/09/2015 | 14/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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-1 | Actelion Pharmaceuticals Ltd | NULL | Authorised-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): no | Serbia;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 | ||
| 37 | EUCTR2012-000540-10-DE (EUCTR) | 23/09/2015 | 03/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;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 | ||
| 38 | EUCTR2012-000540-10-HR (EUCTR) | 23/09/2015 | 01/10/2015 | 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 | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United 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 | ||
| 39 | EUCTR2012-000540-10-FI (EUCTR) | 23/09/2015 | 19/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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-1 | Actelion Pharmaceuticals Ltd | NULL | Not 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): no | Serbia;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 | ||
| 40 | EUCTR2012-000540-10-ES (EUCTR) | 21/09/2015 | 11/09/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Greece;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 | ||
| 41 | EUCTR2012-000540-10-CZ (EUCTR) | 15/09/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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-1 | Actelion Pharmaceuticals Ltd | NULL | Not 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): no | Serbia;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 | ||
| 42 | EUCTR2012-000540-10-PL (EUCTR) | 25/08/2015 | 12/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;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 | ||
| 43 | EUCTR2012-000540-10-FR (EUCTR) | 31/07/2015 | 03/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | 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-1 | Actelion Pharmaceuticals Ltd | NULL | Not 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): no | Serbia;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 | ||
| 44 | NCT02425644 (ClinicalTrials.gov) | June 4, 2015 | 21/4/2015 | Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis | 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 | Multiple Sclerosis | Drug: ponesimod;Drug: teriflunomide | Actelion | NULL | Completed | 18 Years | 55 Years | All | 1133 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic |
| 45 | EUCTR2009-011470-15-NL (EUCTR) | 03/12/2010 | 03/06/2010 | An 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 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | 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;Sweden | ||
| 46 | EUCTR2009-011470-15-PL (EUCTR) | 14/09/2010 | 25/05/2010 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | 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;Sweden | ||
| 47 | EUCTR2009-011470-15-DE (EUCTR) | 20/08/2010 | 08/04/2010 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 353 | Phase 2 | 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;Sweden | ||
| 48 | EUCTR2009-011470-15-BG (EUCTR) | 12/08/2010 | 30/04/2010 | An 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 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United 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 | ||
| 49 | EUCTR2009-011470-15-AT (EUCTR) | 03/08/2010 | 28/06/2010 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | 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;Sweden | ||
| 50 | EUCTR2009-011470-15-HU (EUCTR) | 08/07/2010 | 01/06/2010 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;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 | ||
| 51 | EUCTR2009-011470-15-GB (EUCTR) | 22/06/2010 | 29/03/2010 | An 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 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Sweden;United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands | ||
| 52 | NCT01093326 (ClinicalTrials.gov) | May 12, 2010 | 24/3/2010 | Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod 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 Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mg | Actelion | NULL | Active, not recruiting | 18 Years | 55 Years | All | 353 | Phase 2 | United States;Austria;Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Czech Republic;Italy |
| 53 | EUCTR2009-011470-15-CZ (EUCTR) | 30/04/2010 | 29/03/2010 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;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 | ||
| 54 | EUCTR2009-011470-15-SE (EUCTR) | 12/04/2010 | 04/03/2010 | An 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Sweden;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 | ||
| 55 | EUCTR2009-011470-15-FI (EUCTR) | 30/03/2010 | 09/02/2010 | An 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 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | 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;Sweden | ||
| 56 | EUCTR2020-004431-24-PL (EUCTR) | 28/10/2022 | A 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 Sclerosis | Multi-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 NV | NULL | NA | Female: yes Male: yes | 212 | Phase 3 | Hungary;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 | |||
| 57 | EUCTR2020-004431-24-DE (EUCTR) | 22/09/2022 | A 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 Sclerosis | Multi-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 NV | NULL | NA | Female: yes Male: yes | 212 | Phase 3 | Serbia;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 |