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 | NCT05658484 (ClinicalTrials.gov) | April 13, 2023 | 12/12/2022 | A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China | A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China | Multiple Sclerosis | Drug: Dimethyl fumarate | Biogen | NULL | Not yet recruiting | 18 Years | 65 Years | All | 60 | Phase 4 | NULL |
| 2 | NCT04756687 (ClinicalTrials.gov) | March 10, 2021 | 12/2/2021 | Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera | A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 1507 | France | |
| 3 | NCT04221191 (ClinicalTrials.gov) | August 19, 2019 | 6/1/2020 | Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP | Study on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEP | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate;Other: PSP | Biogen | NULL | Recruiting | 18 Years | 55 Years | All | 350 | France | |
| 4 | EUCTR2018-000516-22-PT (EUCTR) | 08/07/2019 | 27/11/2018 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacyand Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 3 | United States;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Greece;Thailand;Turkey;Israel;Russian Federation;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 5 | NCT04022473 (ClinicalTrials.gov) | July 7, 2019 | 15/7/2019 | Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers | A Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female Volunteers | Multiple Sclerosis | Drug: Bafiertam;Drug: Tecfidera | Banner Life Sciences LLC | NULL | Completed | 18 Years | 65 Years | All | 210 | Phase 1 | United States |
| 6 | 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 | ||
| 7 | NCT03870763 (ClinicalTrials.gov) | March 19, 2019 | 7/3/2019 | Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate;Drug: Peginterferon Beta-1a;Drug: Placebo | Biogen | NULL | Terminated | 10 Years | 17 Years | All | 11 | Phase 3 | United States;Colombia;Estonia;Hungary;Jordan;Korea, Republic of;Malaysia;Mexico;Saudi Arabia;Taiwan;Thailand;Tunisia;Turkey |
| 8 | EUCTR2018-000516-22-HU (EUCTR) | 04/03/2019 | 02/01/2019 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 9 | EUCTR2017-001294-16-DE (EUCTR) | 18/02/2019 | 07/11/2018 | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | 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: N/A Product Code: ALKS 8700 Delayed Release (DR) INN or Proposed INN: Not available Other descriptive name: Diroximel fumarate Trade Name: Tecfidera® 120 mg Product Name: Tecfidera® 120 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240 mg Product Name: Tecfidera® 240 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Germany | ||
| 10 | EUCTR2018-000516-22-EE (EUCTR) | 14/01/2019 | 17/12/2018 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3- Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Estonia;Taiwan;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 11 | EUCTR2018-001292-21-FR (EUCTR) | 27/07/2018 | 05/06/2018 | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Secondary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AVONEX Product Name: BETAFERON Product Code: L03 AB 08 Product Name: EXTAVIA Product Name: REBIF Product Name: PLEDIGRY Product Name: COPAXONE Product Name: AUBAGIO Product Name: TECFIDERA Product Name: GILENYA Product Name: TYSABRI Product Name: IMUREL Product Name: NOVATREX Product Name: CELLCEPT Product Name: ENDOXAN | CHU de Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 12 | NCT03526224 (ClinicalTrials.gov) | June 14, 2018 | 3/5/2018 | Teriflunomide Tecfidera LMCE | Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study | Tecfidera;Teriflunomide | Drug: Dimethyl Fumarate;Drug: Teriflunomide | University at Buffalo | NULL | Completed | 18 Years | 65 Years | All | 120 | United States | |
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | EUCTR2017-002634-24-SE (EUCTR) | 29/09/2017 | 06/07/2017 | MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis. | MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS | Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Sweden | ||
| 16 | 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 | ||
| 17 | EUCTR2017-001294-16-PL (EUCTR) | 22/09/2017 | 29/06/2017 | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | 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: N/A Product Code: ALKS 8700 Delayed Release (DR) INN or Proposed INN: Not available Other descriptive name: Diroximel Fumarate (DRF) Trade Name: Tecfidera® 120 mg Product Name: Tecfidera® 120 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240 mg Product Name: Tecfidera® 240 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Poland;Germany | ||
| 18 | EUCTR2017-000559-26-IT (EUCTR) | 14/09/2017 | 30/09/2021 | A multicentric, international study in order to compare the effectiveness of fingolimod versus dimethyl-fumarate on patients with Multiple Sclerosis. | A multicentric randomized PRAGmatic trial to compare the effectiveness of fingolimod versus dimethyl-fumarate on patient overall disease experience in relapsing remitting Multiple Sclerosis: novel data to inform decision-makers – (PRAG-MS) - PRAG-MS | 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 MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE - BLISTER DIVISIBILE PER DOSE UNITARIA(PVC/PVDC/ALU) SCATOLA DA 7X1 CAPSULE INN or Proposed INN: FINGOLIMOD Trade Name: TECFIDERA - 240 MG - CAPSULA RIGIDA GASTRORESISTENTE - USO ORALE - BLISTER (PVC/PE/PVDC-PVC ALLUMINIO) - 56 CAPSULE INN or Proposed INN: DIMETIL-FUMARATO | FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1360 | Phase 4 | United States;Israel;Switzerland;Italy | ||
| 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 | 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 | ||
| 21 | EUCTR2016-003587-39-SE (EUCTR) | 22/05/2017 | 23/03/2017 | This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval. | COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) | Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3700 | Phase 4 | Sweden | ||
| 22 | EUCTR2016-001448-21-PL (EUCTR) | 09/05/2017 | 13/01/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Czech Republic;Slovakia;Spain;Poland;Ukraine;Turkey;Croatia;Russian Federation;Bulgaria;United Kingdom | ||
| 23 | EUCTR2016-001448-21-BG (EUCTR) | 11/04/2017 | 14/02/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria | ||
| 24 | 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 |
| 25 | NCT02975349 (ClinicalTrials.gov) | March 7, 2017 | 23/11/2016 | A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing-remitting Multiple Sclerosis | Drug: M2951;Drug: Placebo;Drug: Tecfidera | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Active, not recruiting | 18 Years | 65 Years | All | 267 | Phase 2 | Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States |
| 26 | EUCTR2016-001448-21-SK (EUCTR) | 16/02/2017 | 25/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Bulgaria | ||
| 27 | EUCTR2016-001448-21-CZ (EUCTR) | 06/02/2017 | 01/11/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 28 | NCT04570670 (ClinicalTrials.gov) | January 6, 2017 | 22/9/2020 | Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects | A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions | Relapsing Remitting Multiple Sclerosis | Drug: monomethyl fumarate 190 mg;Drug: dimethyl fumarate 240 mg | Banner Life Sciences LLC | NULL | Completed | 18 Years | 55 Years | All | 50 | Phase 1 | NULL |
| 29 | EUCTR2016-001448-21-ES (EUCTR) | 05/01/2017 | 26/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | NCT03101735 (ClinicalTrials.gov) | September 23, 2016 | 3/3/2017 | Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in Greece | A Real Life, Non-interventional, Multicentre Study to Assess Resource Utilization and Quality of Life of Patients With Relapsing Forms of Multiple Sclerosis Treated With Dimethyl Fumarate in Greece - the FIDELITY Study | RRMS | Drug: Dimethyl Fumarate (DMF) | Genesis Pharma CNS & Specialty | NULL | Completed | 18 Years | 65 Years | All | 455 | Greece | |
| 37 | EUCTR2016-000283-41-DK (EUCTR) | 12/09/2016 | 29/06/2016 | Treatment with dimethyl fumarate in patients with primary progressive multiple sclerosis | Dimethyl fumarate treatment of primary progressive multiple sclerosis - FUMAPMS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: dimethyl fumarate Product Code: dimethyl fumarate INN or Proposed INN: dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE | Finn Sellebjerg | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 2 | Denmark | ||
| 38 | 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 | ||
| 39 | 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 | ||
| 40 | NCT02675413 (ClinicalTrials.gov) | April 2016 | 11/1/2016 | Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS | Mechanisms of Action of Dimethyl Fumarate in Relapsing MS | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate | Washington University School of Medicine | Biogen | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | United States |
| 41 | NCT02739542 (ClinicalTrials.gov) | March 19, 2016 | 16/3/2016 | Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS) | Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE) | Multiple Sclerosis (MS) | Drug: Tecfidera;Drug: Placebo | University of Texas Southwestern Medical Center | Biogen | Completed | 18 Years | N/A | All | 87 | Phase 4 | United States |
| 42 | NCT02644083 (ClinicalTrials.gov) | February 2016 | 23/12/2015 | Tecfidera and MRI for Brain Energy in MS | Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate | Multiple Sclerosis | Drug: Dimethyl fumarate | Oregon Health and Science University | Biogen | Terminated | 18 Years | 55 Years | All | 4 | United States | |
| 43 | NCT02823951 (ClinicalTrials.gov) | February 2016 | 3/3/2016 | Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif® | Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT) | Relapsing-remitting Multiple Sclerosis | Drug: Rebif;Drug: Tecfidera | IMS HEALTH GmbH & Co. OHG | EMD Serono | Completed | 18 Years | 55 Years | All | 479 | United States;Canada | |
| 44 | EUCTR2015-004116-38-SE (EUCTR) | 18/12/2015 | 20/10/2015 | A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis. | RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. | Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Department of Clinical Sciences, Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Sweden | ||
| 45 | NCT02471560 (ClinicalTrials.gov) | November 6, 2015 | 11/6/2015 | Tecfidera and the Gut Microbiota | The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events. | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate;Drug: injectable MS DMT | Biogen | NULL | Completed | 18 Years | N/A | All | 36 | Phase 4 | Norway |
| 46 | NCT02686684 (ClinicalTrials.gov) | November 2015 | 11/2/2016 | Tecfidera Diffusion Tensor Imaging | An Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging | Drug: Dimethyl fumarate | University at Buffalo | NULL | Completed | 18 Years | N/A | Both | 115 | N/A | NULL |
| 47 | EUCTR2014-004562-22-DE (EUCTR) | 10/08/2015 | 27/05/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;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] | Trade Name: Tecfidera® Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Germany;Italy | ||
| 48 | EUCTR2014-000395-26-DE (EUCTR) | 07/08/2015 | 09/04/2014 | Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take Tecfidera | A 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.0;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] | Trade Name: Tecfidera INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 4 | Germany | ||
| 49 | NCT02683863 (ClinicalTrials.gov) | August 2015 | 14/1/2016 | Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers | An Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: BG00012 (DMF) (Tecfidera®.) | Multiple Sclerosis Center of Northeastern New York | Biogen | Completed | 25 Years | 65 Years | All | 20 | Phase 4 | United States |
| 50 | EUCTR2014-004562-22-CZ (EUCTR) | 28/07/2015 | 21/04/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose isEffective in Reducing the Incidence of Gastrointestinal Adverse Events inPatients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Germany;Italy | ||
| 51 | EUCTR2014-004562-22-HU (EUCTR) | 13/07/2015 | 30/04/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Belgium;Spain;Australia;Germany;Italy | ||
| 52 | NCT02519413 (ClinicalTrials.gov) | July 2015 | 16/7/2015 | Tecfidera Lymphocyte Chart Review | A Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis (REALIZE) | Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 483 | N/A | United States |
| 53 | EUCTR2015-000303-21-IT (EUCTR) | 24/06/2015 | 01/04/2015 | Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012 | A Phase IV, interventional, multicenteR, double-blind, randomized, placebo-controlled study tO explore the onset of efficacy on Magnetic resonance disease activity of BG00012 (dimethyl fumarate) in Patients with relapsing-remitTing Multiple Sclerosis (PROMPT) - PROMPT | Relapsing-remitting Multiple Sclerosis patients MedDRA version: 17.1;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: Tecfidera® Product Name: Tecfidera® Product Code: BG00012 INN or Proposed INN: Dimethyl fumarate | Biogen Idec Italia S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Italy | |||
| 54 | EUCTR2014-004562-22-IT (EUCTR) | 24/06/2015 | 06/05/2015 | Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose isEffective in Reducing the Incidence of Gastrointestinal Adverse Events inPatients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Germany;Italy | ||
| 55 | EUCTR2014-004562-22-BE (EUCTR) | 10/06/2015 | 09/04/2015 | Study to evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;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: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Germany;Italy | ||
| 56 | NCT02090348 (ClinicalTrials.gov) | June 2015 | 14/3/2014 | Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY) | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | NULL |
| 57 | EUCTR2015-001197-18-NO (EUCTR) | 20/05/2015 | 15/04/2015 | The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events. | The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events. | multiple sclerosis;Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21] | Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Norway | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | Norway | ||
| 58 | EUCTR2013-001025-53-ES (EUCTR) | 18/05/2015 | 03/03/2015 | A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate) | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule (TECNERGY) - TECNERGY | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;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: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Spain;Denmark;Norway;Netherlands;United Kingdom | |||
| 59 | EUCTR2014-003481-25-DE (EUCTR) | 13/05/2015 | 17/02/2015 | Investigation of the effect of Dimethyl fumarate on T cells in patients with relapsing remitting Multiple Sclerosis | A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on Immune-Modulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis - DIMAT-MS | relapsing remitting multiple sclerosis MedDRA version: 19.1;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: Tecfidera® 120mg magensaftresistente Hartkapseln INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240mg magensaftresistente Hartkapseln INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE | Universitätsklinikum Münster | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Germany | ||
| 60 | NCT02736279 (ClinicalTrials.gov) | May 2015 | 22/3/2016 | Impact of Tecfidera on Gut Microbiota | Measuring the Impact of Tecfidera on the Gut Microbiota: Does a Change in the Gut Flora Correlate With Gastrointestinal Disturbances Following Therapy Initiation? | Multiple Sclerosis | Drug: Dimethyl fumarate | Virginia Simnad | Biogen | Recruiting | 18 Years | N/A | Both | 25 | N/A | United States |
| 61 | NCT02323269 (ClinicalTrials.gov) | May 2015 | 18/12/2014 | Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve) | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve) | Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | N/A | Both | 24 | N/A | Canada |
| 62 | NCT02428231 (ClinicalTrials.gov) | April 2015 | 23/4/2015 | Tecfidera Slow-Titration Study | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | 65 Years | All | 62 | Phase 3 | United States;Belgium;Czech Republic;Italy;Australia;Canada;France;Germany;Hungary;Spain |
| 63 | NCT02410278 (ClinicalTrials.gov) | March 12, 2015 | 2/4/2015 | Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera | A Multicenter, Double- Blind, Placebo- Controlled Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera® (Dimethyl Fumarate) Delayed Release Capsules | Multiple Sclerosis | Drug: dimethyl fumarate;Drug: montelukast;Drug: Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 102 | Phase 4 | United States |
| 64 | EUCTR2013-001025-53-DK (EUCTR) | 05/03/2015 | 24/03/2014 | A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate) | A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsule - TECNERGY | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;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: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera (BG00012) Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 4 | Finland;Spain;Denmark;Norway;Netherlands;United Kingdom | ||
| 65 | NCT02343159 (ClinicalTrials.gov) | February 28, 2015 | 9/1/2015 | Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients. | A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients. | Multiple Sclerosis | Drug: dimethyl fumarate;Device: Medication Event Monitoring System (MEMS);Behavioral: Adherence counseling | Biogen | NULL | Terminated | 18 Years | 65 Years | All | 84 | Phase 4 | United States |
| 66 | NCT02097849 (ClinicalTrials.gov) | February 28, 2015 | 25/3/2014 | Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis. | An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis. | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate;Biological: tetanus diphtheria toxoids vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent);Drug: non-pegylated interferon | Biogen | NULL | Completed | 18 Years | 55 Years | All | 71 | Phase 2 | United States |
| 67 | NCT03092544 (ClinicalTrials.gov) | February 2015 | 23/6/2016 | Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients | Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients | Multiple Sclerosis | Drug: dimethyl fumarate | Multiple Sclerosis Center of Northeastern New York | Icahn School of Medicine at Mount Sinai;Biogen | Unknown status | 18 Years | 65 Years | All | 57 | Phase 4 | United States |
| 68 | NCT02218879 (ClinicalTrials.gov) | August 2014 | 12/8/2014 | Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS | Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Tecfidera | Yale University | NULL | Terminated | 18 Years | 60 Years | Both | 7 | N/A | United States |
| 69 | NCT02217982 (ClinicalTrials.gov) | July 2014 | 30/7/2014 | Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation | A Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide Administration | Relapsing Remitting Multiple Sclerosis | Drug: Simethicone;Drug: Loperamide;Other: Peanut Butter | Rocky Mountain MS Research Group, LLC | Biogen | Terminated | 18 Years | N/A | All | 5 | Phase 4 | United States |
| 70 | NCT02159573 (ClinicalTrials.gov) | July 2014 | 19/5/2014 | Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab) | A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate) | Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab;Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 530 | N/A | United States |
| 71 | EUCTR2013-001656-35-CZ (EUCTR) | 11/06/2014 | 26/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Belgium;Spain;Austria;Italy | ||
| 72 | EUCTR2013-001656-35-ES (EUCTR) | 06/06/2014 | 01/04/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera? (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;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: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Belgium;Spain;Austria;Italy | ||
| 73 | NCT02117050 (ClinicalTrials.gov) | June 2014 | 15/4/2014 | RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate | RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw) | Multiple Sclerosis | Drug: Rebif® | EMD Serono | NULL | Terminated | 18 Years | 65 Years | All | 1 | Phase 4 | United States |
| 74 | EUCTR2013-001656-35-BE (EUCTR) | 26/05/2014 | 24/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;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: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 75 | EUCTR2013-001656-35-SI (EUCTR) | 12/05/2014 | 09/05/2014 | A Study that evaluates effectiveness of Tecfidera™ (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Spain;Belgium;Austria;Italy | ||
| 76 | EUCTR2013-001486-17-DE (EUCTR) | 06/05/2014 | 05/03/2014 | TOLERATE - A Study that evaluates the Gastrointestinal Tolerability of DMF in Multiple Sclerosis Patients | A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects with Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE) | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;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: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 77 | EUCTR2013-001895-40-IE (EUCTR) | 02/05/2014 | 06/03/2014 | A study to evaluate the effect of aspirin on flushing in patients with RRMS treated with Tecfidera | A Phase 4, Randomized, Double-Blind Study with a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects with Relapsing-Remitting Multiple Sclerosis Treated with Tecfidera™ (dimethyl fumarate) delayed-release capsules (ASSURE) - ASSURE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;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: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Micropirin INN or Proposed INN: ACETYLSALICYLIC ACID Other descriptive name: ASA | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 4 | Ireland;United Kingdom | ||
| 78 | NCT02090413 (ClinicalTrials.gov) | May 2014 | 14/3/2014 | Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis | A Phase 4, Randomized, Double-Blind Study With a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects With Relapsing-Remitting Multiple Sclerosis Treated With Tecfidera® (Dimethyl Fumarate) Delayed-Release Capsules | Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Drug: acetylsalicylic acid;Drug: ASA-Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 241 | Phase 4 | Ireland;United Kingdom |
| 79 | EUCTR2013-001656-35-SK (EUCTR) | 28/04/2014 | 10/03/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;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: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 80 | EUCTR2013-001656-35-PT (EUCTR) | 14/04/2014 | 25/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 81 | EUCTR2013-001656-35-IT (EUCTR) | 14/04/2014 | 26/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1;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: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | France;Portugal;Hungary;Czech Republic;Slovakia;Slovenia;Canada;Spain;Belgium;Austria;Italy | ||
| 82 | EUCTR2013-001656-35-HU (EUCTR) | 11/04/2014 | 21/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Czech Republic;Hungary;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 83 | EUCTR2013-001656-35-AT (EUCTR) | 07/04/2014 | 18/02/2014 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 84 | EUCTR2013-001656-35-FR (EUCTR) | 07/04/2014 | 17/06/2015 | A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC) - PROTEC | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;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] | Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 4 | Portugal;France;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Spain;Belgium;Austria;Italy | ||
| 85 | EUCTR2012-004165-41-GB (EUCTR) | 04/11/2013 | 19/09/2013 | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS | Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: natalizumab Trade Name: Fingolimod Product Name: Gilenya INN or Proposed INN: Fingolimod Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG-12 120 INN or Proposed INN: dimethyl fumarate | Northwestern University | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | United States;United Kingdom | ||
| 86 | NCT03133403 (ClinicalTrials.gov) | November 2013 | 21/4/2016 | Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT) | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Recruiting | 18 Years | 55 Years | All | 5 | Phase 2/Phase 3 | United Kingdom |
| 87 | NCT01930708 (ClinicalTrials.gov) | October 31, 2013 | 15/8/2013 | A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes | A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 1114 | Phase 4 | Austria;Belgium;Canada;Czechia;France;Hungary;Italy;Portugal;Slovakia;Slovenia;Spain;Czech Republic |
| 88 | NCT01903291 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 333 | N/A | United States |
| 89 | NCT01873417 (ClinicalTrials.gov) | May 2013 | 9/5/2013 | Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States | A Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release Capsules | Relapsing Forms of Multiple Sclerosis | Drug: BG00012 (DMF) | Biogen | NULL | Completed | 18 Years | N/A | All | 237 | Phase 4 | United States |
| 90 | EUCTR2008-004753-14-DE (EUCTR) | 10/06/2009 | 08/05/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ENDORSE | 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: BG00012 Product Code: BG00012 INN or Proposed INN: Tecfidera Other descriptive name: Dimethyl Fumarate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand |