13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | EUCTR2019-001341-40-LV (EUCTR) | 02/09/2021 | 28/07/2021 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 2 | NCT04925778 (ClinicalTrials.gov) | June 30, 2021 | 8/6/2021 | Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate | An Open-label, Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® (Monomethyl Fumarate) From Dimethyl Fumarate (PERSIST) | Relapsing Remitting Multiple Sclerosis | Drug: monomethyl fumarate | Banner Life Sciences LLC | NULL | Withdrawn | 18 Years | N/A | All | 0 | NULL | |
| 3 | EUCTR2020-005752-38-DE (EUCTR) | 18/03/2021 | 19/01/2021 | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | secondary progressive multiple sclerosis (SPMS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mayzent 2 mg Filmtabletten Product Name: Mayzent 2 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Mayzent 0,25 mg Filmtabletten Product Name: Mayzent 0,25 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Spikevax INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE INN or Proposed INN: TERIFLUNOMIDE INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE INN or Proposed INN: RECOMBINANT INTERFERON BE | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Germany | ||
| 4 | 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 | |
| 5 | NCT04468165 (ClinicalTrials.gov) | February 23, 2021 | 8/7/2020 | Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region | Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region | Relapsing Remitting Multiple Sclerosis | Drug: Dimethyl Fumarate (DMF) | Hikma Pharmaceuticals LLC | NULL | Recruiting | 18 Years | N/A | All | 155 | Algeria;Egypt;Jordan | |
| 6 | EUCTR2019-001341-40-PL (EUCTR) | 20/01/2021 | 17/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 7 | EUCTR2019-001341-40-AT (EUCTR) | 10/09/2020 | 07/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 8 | EUCTR2019-001341-40-IT (EUCTR) | 09/09/2020 | 19/05/2021 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 9 | NCT04353492 (ClinicalTrials.gov) | July 14, 2020 | 16/4/2020 | An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab | A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy | Relapsing Multiple Sclerosis | Biological: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 60 Years | All | 550 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Estonia;Germany;Greece;Hungary;Italy;Latvia;Lebanon;Mexico;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Slovakia;Slovenia;Spain;Switzerland;Turkey;United Kingdom |
| 10 | EUCTR2019-001341-40-PT (EUCTR) | 15/06/2020 | 31/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 11 | EUCTR2019-001341-40-BG (EUCTR) | 12/06/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 12 | EUCTR2019-001341-40-CZ (EUCTR) | 07/05/2020 | 11/02/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom | ||
| 13 | EUCTR2019-001341-40-BE (EUCTR) | 29/04/2020 | 17/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 14 | EUCTR2019-001341-40-HU (EUCTR) | 29/04/2020 | 11/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 15 | EUCTR2019-001341-40-ES (EUCTR) | 24/04/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 16 | 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 | |
| 17 | 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 | ||
| 18 | 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 |
| 19 | 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 | ||
| 20 | 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 | Recruiting | 10 Years | 17 Years | All | 260 | Phase 3 | United States;Colombia;Estonia;Hungary;Jordan;Korea, Republic of;Malaysia;Mexico;Saudi Arabia;Taiwan;Thailand;Tunisia;Turkey |
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | |
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | NCT02901106 (ClinicalTrials.gov) | May 23, 2017 | 7/9/2016 | Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate | Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl fumarate | Fondation Ophtalmologique Adolphe de Rothschild | NULL | Terminated | 18 Years | N/A | All | 11 | Phase 4 | France |
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | NCT03345940 (ClinicalTrials.gov) | April 30, 2017 | 16/5/2017 | Fingolimod Versus Dimethyl-fumarate in 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 | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Dimethyl Fumarate | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Patient-Centered Outcomes Research Institute;Universita degli Studi di Genova | Terminated | 18 Years | N/A | All | 55 | Phase 4 | Italy |
| 36 | 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 | ||
| 37 | 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 |
| 38 | EUCTR2013-002318-11-FR (EUCTR) | 21/03/2017 | 17/06/2015 | A study on the safety and effectiveness of BG00012 in children from 10 to less than 18 years old with a type of Multiple Sclerosis that is called Relapsing-Remitting Multiple Sclerosis. | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis | 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] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Sweden;United Kingdom;Ukraine;Spain;Serbia | ||
| 39 | NCT03093324 (ClinicalTrials.gov) | March 15, 2017 | 16/3/2017 | A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2 | 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 | Drug: ALKS 8700;Drug: Dimethyl Fumarate | Biogen | Alkermes, Inc. | Completed | 18 Years | 65 Years | All | 506 | Phase 3 | United States;Germany;Poland |
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | 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 |
| 43 | 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 | ||
| 44 | NCT02969304 (ClinicalTrials.gov) | December 30, 2016 | 21/10/2016 | Study of Utilization Patterns of Dimethyl Fumarate in Germany | Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany | Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | N/A | N/A | All | 930 | N/A | Germany |
| 45 | 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 | ||
| 46 | 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 | ||
| 47 | NCT02959658 (ClinicalTrials.gov) | December 2016 | 8/11/2016 | Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis | Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: Dimethyl Fumarate;Drug: Placebo Oral Capsule | Rigshospitalet, Denmark | Biogen | Active, not recruiting | 18 Years | 65 Years | All | 54 | Phase 2 | Denmark |
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 | ||
| 51 | 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 | ||
| 52 | 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 | |
| 53 | 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 | ||
| 54 | 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 | ||
| 55 | 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 | ||
| 56 | EUCTR2015-003282-29-DE (EUCTR) | 17/06/2016 | 11/02/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With 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] | 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 | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany | ||
| 57 | EUCTR2015-003282-29-BG (EUCTR) | 14/05/2016 | 02/03/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) 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] | 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 | 18 | Phase 3 | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany | ||
| 58 | EUCTR2015-003282-29-CZ (EUCTR) | 05/05/2016 | 25/02/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | 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 | 18 | Phase 3 | Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany;United States;Czech Republic;Poland;Belgium | ||
| 59 | NCT02746744 (ClinicalTrials.gov) | May 2016 | 18/4/2016 | RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. | RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome. | Multiple Sclerosis, Relapsing-Remitting | Drug: Rituximab;Drug: Dimethyl fumarate;Drug: Sodium Chloride solution | Anders Svenningsson | NULL | Completed | 18 Years | 50 Years | All | 200 | Phase 3 | Sweden |
| 60 | NCT02428218 (ClinicalTrials.gov) | May 2016 | 23/4/2015 | Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate;Drug: Placebo | Biogen | NULL | Withdrawn | 10 Years | 17 Years | Both | 0 | Phase 3 | NULL |
| 61 | EUCTR2015-003282-29-BE (EUCTR) | 29/04/2016 | 19/02/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With 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] | 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 | 18 | Phase 3 | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany | ||
| 62 | EUCTR2015-003282-29-LV (EUCTR) | 20/04/2016 | 02/03/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) 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] | 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 | 18 | Phase 3 | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Kuwait;Germany;Latvia | ||
| 63 | EUCTR2013-002318-11-DE (EUCTR) | 15/04/2016 | 03/09/2015 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 64 | 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 |
| 65 | EUCTR2013-002318-11-ES (EUCTR) | 02/03/2016 | 08/05/2015 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis - CONNECT | 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] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Serbia;Portugal;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Croatia;Denmark;Sweden | ||
| 66 | NCT02555215 (ClinicalTrials.gov) | February 22, 2016 | 17/9/2015 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 10 Years | 17 Years | All | 20 | Phase 3 | United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic |
| 67 | EUCTR2015-001973-42-PL (EUCTR) | 22/02/2016 | 19/01/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Belgium;Poland;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 68 | EUCTR2015-001973-42-LT (EUCTR) | 11/02/2016 | 27/11/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 69 | EUCTR2015-001973-42-BG (EUCTR) | 11/02/2016 | 02/02/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 19.1;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: 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 | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 70 | 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 | |
| 71 | EUCTR2015-001973-42-HR (EUCTR) | 26/01/2016 | 28/04/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Slovakia;Canada;Poland;Belgium;Lithuania;Turkey;Croatia;Austria;Bulgaria;Kuwait;Sweden | ||
| 72 | 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 | ||
| 73 | EUCTR2015-001973-42-BE (EUCTR) | 17/12/2015 | 23/11/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting 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: 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 | 200 | Phase 3 | United States;Czech Republic;Canada;Poland;Belgium;Lithuania;Croatia;Turkey;Austria;Bulgaria;Kuwait | ||
| 74 | 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 |
| 75 | 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 |
| 76 | EUCTR2014-005624-98-IT (EUCTR) | 14/10/2015 | 23/02/2018 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety ofBG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of 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] | 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 | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | ||
| 77 | EUCTR2014-005003-24-DE (EUCTR) | 12/10/2015 | 25/02/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | 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] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 78 | NCT02410200 (ClinicalTrials.gov) | September 30, 2015 | 2/4/2015 | Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 10 Years | 17 Years | All | 22 | Phase 2 | United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic |
| 79 | EUCTR2014-005003-24-PL (EUCTR) | 25/09/2015 | 12/06/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | 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] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 80 | EUCTR2014-005003-24-CZ (EUCTR) | 21/09/2015 | 02/03/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | 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] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United States;Lebanon;Turkey;Lithuania;Israel;Italy;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 81 | EUCTR2014-005624-98-HU (EUCTR) | 09/09/2015 | 16/07/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of 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 | 172 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | |||
| 82 | EUCTR2014-005003-24-BG (EUCTR) | 21/08/2015 | 13/05/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | 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] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United States;Lebanon;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 83 | NCT02525874 (ClinicalTrials.gov) | August 11, 2015 | 10/7/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 65 Years | All | 218 | Phase 3 | United States;Belgium;Bulgaria;Kuwait;Lithuania;Poland;Turkey;Croatia |
| 84 | 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 | ||
| 85 | 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 | ||
| 86 | EUCTR2014-005003-24-BE (EUCTR) | 29/07/2015 | 30/06/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | 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] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 87 | 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 | ||
| 88 | 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 | ||
| 89 | EUCTR2014-003021-18-DE (EUCTR) | 09/07/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.1;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: 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 | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 90 | EUCTR2013-002318-11-PL (EUCTR) | 03/07/2015 | 09/06/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects Withrelapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Serbia;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 91 | 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 |
| 92 | NCT02472938 (ClinicalTrials.gov) | July 2015 | 11/5/2015 | Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis | 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 relapsingremitTing Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Other: Placebo | Biogen | GB Pharma Services & Consulting S.r.l. Unipersonale | Withdrawn | 18 Years | 50 Years | Both | 0 | Phase 4 | NULL |
| 93 | EUCTR2014-003021-18-DK (EUCTR) | 25/06/2015 | 09/04/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;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: 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 | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 94 | 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 | |||
| 95 | 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 | ||
| 96 | EUCTR2014-003021-18-CZ (EUCTR) | 22/06/2015 | 13/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;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: 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 | 1170 | Phase 3 | Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden;Slovakia;United States;Serbia | ||
| 97 | 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 | ||
| 98 | EUCTR2014-003021-18-IT (EUCTR) | 05/06/2015 | 18/02/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;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: 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 | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 99 | EUCTR2014-003021-18-BE (EUCTR) | 02/06/2015 | 24/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;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: 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 | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 100 | EUCTR2014-003021-18-FI (EUCTR) | 02/06/2015 | 28/05/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;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: 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 | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 101 | EUCTR2014-005003-24-LV (EUCTR) | 01/06/2015 | 19/02/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | 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] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Latvia;Germany;Kuwait | ||
| 102 | 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 |
| 103 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 4 | Norway | ||
| 104 | EUCTR2014-003021-18-SK (EUCTR) | 19/05/2015 | 10/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;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: 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 | 1170 | Sweden;Germany;Netherlands;Norway;Bulgaria;Denmark;Australia;Belgium;Poland;Argentina;Canada;Hungary;Czech Republic;France;Italy;Switzerland;United Kingdom;Russian Federation;Austria;Spain;Finland;Slovakia;Serbia;United States | |||
| 105 | 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 | |||
| 106 | EUCTR2014-003021-18-PL (EUCTR) | 17/05/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.1;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: 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 | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 107 | 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 | ||
| 108 | NCT02461069 (ClinicalTrials.gov) | May 6, 2015 | 27/5/2015 | 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) | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl fumarate | University Hospital Muenster | Biogen | Completed | 18 Years | 60 Years | All | 67 | Phase 4 | Germany |
| 109 | EUCTR2014-003021-18-AT (EUCTR) | 04/05/2015 | 30/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;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: 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 | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 110 | EUCTR2014-003021-18-NL (EUCTR) | 01/05/2015 | 12/03/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;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: 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 | 1170 | United States;Serbia;Slovakia;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 111 | 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 |
| 112 | NCT02430532 (ClinicalTrials.gov) | May 2015 | 27/4/2015 | BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive | Drug: dimethyl fumarate;Other: Placebo | Biogen | NULL | Terminated | 18 Years | 58 Years | All | 58 | Phase 3 | United States;Belgium;Czech Republic;Netherlands;Poland;Slovakia;Austria;Sweden |
| 113 | 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 |
| 114 | NCT02419638 (ClinicalTrials.gov) | May 2015 | 14/4/2015 | Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS | Multiple Sclerosis | Drug: Rebif (IFN ß-1a subcutaneous three times per week);Drug: Tecifdera (dimethyl fumarate) | Brigham and Women's Hospital | EMD Serono | Withdrawn | 18 Years | 65 Years | Both | 0 | N/A | United States | |
| 115 | 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 |
| 116 | EUCTR2014-003021-18-SE (EUCTR) | 25/03/2015 | 13/02/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;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: 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 | 1170 | Serbia;United States;Slovakia;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany;Sweden | |||
| 117 | 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 |
| 118 | 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 | ||
| 119 | 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 |
| 120 | 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 |
| 121 | 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 |
| 122 | NCT02283853 (ClinicalTrials.gov) | August 28, 2014 | 3/11/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Drug: Interferon ß-1a | Biogen | NULL | Active, not recruiting | 10 Years | 17 Years | All | 156 | Phase 3 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Kuwait;Poland;Serbia;Spain;Sweden;Turkey;United Kingdom;Argentina;Czech Republic;Romania |
| 123 | EUCTR2013-002318-11-DK (EUCTR) | 14/07/2014 | 25/04/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects Withrelapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 124 | EUCTR2013-002318-11-CZ (EUCTR) | 10/07/2014 | 02/05/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden | ||
| 125 | EUCTR2013-002318-11-GB (EUCTR) | 08/07/2014 | 16/03/2015 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Kuwait;Sweden | ||
| 126 | EUCTR2013-004533-32-PL (EUCTR) | 04/07/2014 | 05/05/2014 | A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | 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] | 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 | 202 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Taiwan;Poland;Japan;Korea, Republic of | ||
| 127 | 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 |
| 128 | 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 |
| 129 | EUCTR2013-002318-11-BE (EUCTR) | 17/06/2014 | 17/03/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With relapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, with Optional Open-Label Extension - CONNECT | 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: 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: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden | ||
| 130 | 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 | ||
| 131 | 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 | ||
| 132 | EUCTR2013-002318-11-SE (EUCTR) | 05/06/2014 | 14/03/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | 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: 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: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden | ||
| 133 | 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 |
| 134 | NCT02125604 (ClinicalTrials.gov) | June 2014 | 25/4/2014 | Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany | 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 | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 214 | Phase 4 | Germany |
| 135 | EUCTR2013-002318-11-HU (EUCTR) | 27/05/2014 | 08/04/2014 | Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS). | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders 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] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Sweden | ||
| 136 | 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 | ||
| 137 | EUCTR2013-002318-11-IT (EUCTR) | 13/05/2014 | 20/03/2014 | A study on the safety and effectiveness of BG00012 in children from 10 to less than 18 years old with a type of Multiple Sclerosis that is called Relapsing-Remitting Multiple Sclerosis. | Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis | 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] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: AVONEX Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | France;Serbia;Hungary;Czech Republic;Belgium;Poland;Ukraine;Denmark;United Kingdom;Italy;Sweden | |||
| 138 | 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 | ||
| 139 | 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 | ||||
| 140 | 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 | ||
| 141 | 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 |
| 142 | NCT02579681 (ClinicalTrials.gov) | April 30, 2014 | 16/10/2015 | Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012 | Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012 | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 221 | Phase 3 | Italy |
| 143 | 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 | ||
| 144 | EUCTR2013-004533-32-CZ (EUCTR) | 28/04/2014 | 08/01/2014 | A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | 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] | 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 | 202 | Phase 3 | Taiwan;Czech Republic;Poland;Japan;Korea, Republic of | ||
| 145 | 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 | ||
| 146 | 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 | ||
| 147 | 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 | ||
| 148 | 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 | ||
| 149 | 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 | ||
| 150 | NCT02047097 (ClinicalTrials.gov) | November 19, 2013 | 24/1/2014 | Dimethyl Fumarate (DMF) Observational Study | A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM) | Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Active, not recruiting | 18 Years | N/A | All | 5496 | United States;Argentina;Australia;Austria;Canada;Czechia;Denmark;France;Germany;Hungary;Ireland;Italy;Netherlands;New Zealand;Norway;Poland;Portugal;Puerto Rico;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic | |
| 151 | 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 | ||
| 152 | 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 |
| 153 | NCT01911767 (ClinicalTrials.gov) | October 30, 2013 | 25/7/2013 | Biogen Multiple Sclerosis Pregnancy Exposure Registry | Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry | Multiple Sclerosis;Exposure During Pregnancy | Drug: Dimethyl fumarate;Drug: Peginterferon beta-1a | Biogen | NULL | Recruiting | N/A | N/A | Female | 1125 | United States;Australia;Canada;France;Germany;Ireland;Italy;Poland;Spain;United Kingdom | |
| 154 | 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 |
| 155 | EUCTR2013-001422-25-IT (EUCTR) | 11/06/2013 | 17/04/2013 | Study to be conducted only in Italy to evaluate the effect of the treatment with BG00012 on cognitive function in patients with Relapsing Remitting Multiple Sclerosis | Single country study assessing cognition in Relapsing Remitting Multiple Sclerosis patients treated with BG00012 | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.1;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: dimethyl fumarate [DMF] Product Code: BG00012 INN or Proposed INN: dimetilfumarato Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Italia S.r.l. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Italy | ||
| 156 | 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 |
| 157 | NCT01838668 (ClinicalTrials.gov) | March 28, 2013 | 20/4/2013 | An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: Placebo;Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 225 | Phase 3 | Czechia;Japan;Korea, Republic of;Poland;Taiwan;Czech Republic |
| 158 | EUCTR2008-004753-14-BG (EUCTR) | 07/10/2010 | 11/06/2010 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | 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 | ||
| 159 | EUCTR2008-004753-14-NL (EUCTR) | 07/06/2010 | 04/03/2010 | 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: 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] | Product Name: BG00012 Product Code: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Belarus;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;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 160 | NCT01156311 (ClinicalTrials.gov) | June 2010 | 1/7/2010 | BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis | An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA) | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 108 | Phase 2 | United States |
| 161 | EUCTR2008-004753-14-GR (EUCTR) | 10/03/2010 | 21/10/2009 | 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 - N/A | 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 - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 162 | EUCTR2008-004753-14-AT (EUCTR) | 28/12/2009 | 10/11/2009 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 163 | EUCTR2008-004753-14-GB (EUCTR) | 16/10/2009 | 09/11/2010 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | 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 | ||
| 164 | EUCTR2008-004753-14-EE (EUCTR) | 29/09/2009 | 14/08/2009 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 165 | EUCTR2008-004753-14-FR (EUCTR) | 18/09/2009 | 06/08/2009 | 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 - N/A | 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 - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 166 | EUCTR2008-004753-14-IE (EUCTR) | 17/09/2009 | 02/06/2009 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | 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 | ||
| 167 | EUCTR2008-004753-14-ES (EUCTR) | 19/08/2009 | 01/07/2009 | 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 Estudio de extensión, multicéntrico y con dosis ciega para determinar la seguridad y la eficacia a largo plazo de dos dosis de BG00012 en monoterapia en pacientes con esclerosis múltiple recidivante-remitente - N/A | 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 Estudio de extensión, multicéntrico y con dosis ciega para determinar la seguridad y la eficacia a largo plazo de dos dosis de BG00012 en monoterapia en pacientes con esclerosis múltiple recidivante-remitente - N/A | Relapsing-Remitting Multiple Sclerosis Esclerosis Múltiple recidivante-remitente MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 168 | EUCTR2008-004753-14-LV (EUCTR) | 13/08/2009 | 03/06/2009 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Italy;Switzerland;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 | ||
| 169 | 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 | ||
| 170 | EUCTR2008-004753-14-CZ (EUCTR) | 16/03/2009 | 22/01/2009 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 171 | EUCTR2008-004753-14-SK (EUCTR) | 04/03/2009 | 03/02/2009 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | 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 | ||
| 172 | NCT00835770 (ClinicalTrials.gov) | February 3, 2009 | 2/2/2009 | BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) | 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 | Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate;Drug: Placebo | Biogen | NULL | Completed | 19 Years | 58 Years | All | 1736 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Greece;India;Ireland;Israel;Italy;Latvia;Mexico;Moldova, Republic of;Netherlands;New Zealand;North Macedonia;Poland;Puerto Rico;Romania;Serbia;Slovakia;South Africa;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Guatemala;Macedonia, The Former Yugoslav Republic of |
| 173 | EUCTR2008-004753-14-BE (EUCTR) | 22/01/2009 | 23/12/2008 | 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: 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: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 174 | EUCTR2006-003696-12-BG (EUCTR) | 06/01/2009 | 11/11/2008 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - DEFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 175 | EUCTR2006-003696-12-IT (EUCTR) | 18/11/2008 | 10/10/2008 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - ND | Relapsing-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Dimethyl Fumarate Product Code: BG00012 | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 176 | EUCTR2006-003696-12-DE (EUCTR) | 27/08/2008 | 13/02/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Greece;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 177 | EUCTR2006-003697-10-BG (EUCTR) | 14/08/2008 | 14/06/2008 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Estonia;Bulgaria;Ireland;Spain;Greece;Latvia | |||
| 178 | EUCTR2006-003696-12-NL (EUCTR) | 16/06/2008 | 19/03/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Product Code: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 179 | EUCTR2006-003697-10-GR (EUCTR) | 30/10/2007 | 31/05/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 180 | EUCTR2006-003696-12-GR (EUCTR) | 16/10/2007 | 14/05/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 181 | EUCTR2006-003697-10-DE (EUCTR) | 04/10/2007 | 06/04/2009 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Czech Republic;Germany;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 182 | EUCTR2006-003697-10-EE (EUCTR) | 18/09/2007 | 12/06/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 183 | EUCTR2006-003697-10-ES (EUCTR) | 29/08/2007 | 28/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A | Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: glatiramer acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Phase 3 | Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Latvia | ||
| 184 | EUCTR2006-003696-12-AT (EUCTR) | 28/08/2007 | 12/03/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 185 | EUCTR2006-003697-10-LV (EUCTR) | 22/08/2007 | 26/07/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 186 | EUCTR2006-003696-12-GB (EUCTR) | 06/08/2007 | 22/01/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Phase 3 | Czech Republic;Slovakia;Greece;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 187 | EUCTR2006-003697-10-BE (EUCTR) | 13/07/2007 | 23/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Phase 3 | Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;Latvia | ||
| 188 | EUCTR2006-003696-12-SE (EUCTR) | 06/07/2007 | 16/03/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 189 | EUCTR2006-003697-10-IE (EUCTR) | 04/07/2007 | 20/03/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Ireland;Greece;Latvia | |||
| 190 | EUCTR2006-003696-12-SK (EUCTR) | 18/04/2007 | 13/02/2007 | A Randomized, Multicenter, Double-Blind, Place-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. - N/A | A Randomized, Multicenter, Double-Blind, Place-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: Dimethyl Fumarate | Biogen Idec LtD. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Phase 3 | Czech Republic;Slovakia;Greece;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 191 | EUCTR2006-003697-10-CZ (EUCTR) | 13/04/2007 | 23/02/2007 | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE Trade Name: Copaxone Product Name: Copaxone Other descriptive name: Glatiramer Acetate | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1232 | Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia | |||
| 192 | EUCTR2006-003696-12-CZ (EUCTR) | 13/04/2007 | 23/02/2007 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Germany;United Kingdom;Czech Republic;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 193 | EUCTR2006-003696-12-BE (EUCTR) | 02/03/2007 | 05/12/2006 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1011 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden | ||||
| 194 | EUCTR2004-000663-99-HU (EUCTR) | 08/11/2004 | 08/09/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 195 | EUCTR2004-000663-99-CZ (EUCTR) | 12/10/2004 | 22/10/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Czech Republic;Sweden | |||
| 196 | EUCTR2004-000663-99-SE (EUCTR) | 10/09/2004 | 03/08/2004 | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. | MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years. | Product Name: second-generation fumaric acid Product Code: BG00012 INN or Proposed INN: dimethyl fumarate Other descriptive name: dimethyl fumarate | Biogen Idec Inc. | Biogen Idec Ltd | Not Recruiting | Female: yes Male: yes | 260 | Hungary;Sweden | |||
| 197 | EUCTR2014-005624-98-AT (EUCTR) | 17/09/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of 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 | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany | |||
| 198 | EUCTR2014-005624-98-EE (EUCTR) | 14/09/2015 | A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis. | A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of 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 | 172 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Spain;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Peru;South Africa;Netherlands;Kuwait;Bosnia and Herzegovina;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany |