DDrare: Database of Drug Development for Rare Diseases

Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (-)-trans-delta-9-Tetrahydrocannabinol; (IM) AVONEX®; (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide; 0,5 mg Fingolimod; 0.25 mg RPC1063; 0.25mg RPC1063; 0.5 mg RPC1063; 0.5mg RPC1063; 1 - Andrographis paniculata p/st extract; 1 mg RPC1063; 1% Steroid Cream; 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone; 1.0mg RPC1063; 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP); 10000IU vitamin D; 11C-ACETATE; 11C-PBR28; 11C-PIB; 13-PCV Booster; 13-valent pneumococcal conjugate vaccine (13-PCV); 1393641-34-3; 15 mg fampridine-SR (4-aminopyridine, 4-AP); 18F-DPA-714 and 18F-FDG; 18F-FDG; 18F-PM-PBB3; 19 nor vitamin d; 2 - Excipients; 2-(2-(2-Amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate ester; 2-CdA; 2-CdA, 2-chloro-2'-deoxy-beta-D-adenosine; 2-CdA, 2-chloro-2'-deoxy-ß-D-adenosine; 2-CdA, 2-chloro-2?-deoxy-beta-D-adenosine; 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine; 2-CdA, 2-chloro-2’-deoxy-beta-D-adenosine; 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine; 2-chloro-2'-deoxy-beta-D-adenosine (2-CdA); 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA); 2-chloro-2'-deoxyadenosine (2-CdA); 2-chloro-2'-deoxyadenosine, 2CdA; 2-chloro-2?-deoxy-beta-D-adenosine; 2-chloro-2?-deoxy-ß-D-adenosine; 2-chloro-2’-deoxy-beta-D-adenosine; 2-chloro-2’-deoxy-beta-D-adenosine (2-CdA); 2-chloro-2’-deoxy-ß-D-adenosine; 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA); 2-chloro-2’-deoxyadenosine (2-CdA); 20 mg GA; 20 mg MitoQ; 20 mg fampridine-SR (4-aminopyridine, 4-AP); 200106 or EMD 28162; 20mg/0.5ml GA; 20mg/0.5ml glatiramer acetate; 23-PPV; 23-valent pneumococcal polysaccharide vaccine; 23-valent pneumococcal polysaccharide vaccine (23-PPV); 25OH-Vitamin D; 2B3-201; 3 mg Melatonin; 3,4-diaminopyridine; 4-AP; 4-Aminopyridine; 4-aminopyridine; 4.5 mg Naltrexone; 40 mg GA; 40 mg Glatiramer Acetate; 40 mg Glatiramer acetato; 40 mg glatiramer acetate; 40mg of MitoQ; 5 mg Melatonin; 5000IU vitamin D; 52069.00.01; 9060X; 95% Pure ECGC capsules 200mg; A4I Antagonist; AB1010; ABR-215062; ABR-215062 sodium salt; ABT-555; ABT-874/Human monoclonal antibody against IL-12; ABX-1431; ABX-1431 HCl; ACETYLSALICYLIC ACID; ACT; ACT-1; ACT-128800; ACT-128800 Dose 1; ACT-128800 Dose 2; ACT-128800 Dose 3; ACTH; ACTHAR; ACTHAR Gel (ACTH); ACTHar; ACTOS (Pioglitazone); ADS-5102; ADS-5102, 137 mg; ADS-5102, 274 mg; AERT, (R)-Baclofen; AGEE cream; AHSC; AIMSPRO; AIN; AIN457; ALEMTUZUMAB; ALKS 8700; ALKS 8700 Delayed Release (DR); ALKS 8700 Delayed Release (DR) Capsule; ALTRI FARMACI DEL SISTEMA NERVOSO; ALXN1210; AMILORIDE HYDROCHLORIDE, 2 H2O; AMPYRA; AN100226; AN100226, BG00002; ANK-700; ANTITHYMOCYTE GAMMA IMMUNOGLOBULIN; ANTITHYMOCYTE IMMUNOGLOBULIN; AP; ARICEPT; ARN-6039; ASA; ASB-683699; ATA188; ATG; ATL1102; ATX-MS-1467; AUBAGIO; AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE; AUTOLOGOUS T-LYMPHOCYTES; AV605; AVONEX; AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable; AVONEX 30 µg/0,5 ml solution for injection; AVONEX IM 4SIR 30MCG/0,5ML 4AG; AVONEX*IM 4SIR 30MCG/0,5ML+4AG; AVONEX®; AVP-923; AZATIOPRINA HEX. 50CPR 50MG BL; Abatacept; Abobotulinumtoxin A; Acetaminophen; Acetaminophen Tab 650mg; Acetate; Acetazolamide; Acetylcysteine; Acetylsalicylic acid; Acetylsalicylic acid at 1st visit,; Aciclovir; Aclasta; Aclasta 5 mg Infusionslösung; Aclasta 5mg solution for infusion; Acthar; Acthar Gel; Active Comparator receiving Extavia®; Active Control; Acyclovir; Adderall XR; Adderall XR 10 mg; Adderall XR 5mg; Adenosine; Adrenocorticotropic Hormone; Adrenocorticotropic hormone; Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®); Alanine; Albumin (Human) 25%, United States Pharmacopeia (USP); Albuterol; Alcohol; Alemtuzumab; Alemtuzumab (GZ402673); Alemtuzumab 12 mg; Alemtuzumab 24 mg; Alemtuzumab GZ402673; Alemtuzumab Injection; Alemtuzumab Injection [Lemtrada]; Alemtuzumab immunotherapy; Alfuzosin; Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells; Allogeneic fecal microbiota; Alpha Lipoic Acid; Alpha lipoic acid; Alpha-lipoic acid; Alpha1-antitrypsin; Amantadine; American Ginseng; American ginseng extract HT-1001; Amiloride; Amiloride Hydrochloride; Amilostad; Amilostad HCT; Amilostad HCT tablets; Ampyra; Amyvid; Amyvid radiopharmaceutical; Anakinra; AndroGel 1 % Topical Gel; Androgel 10 grams of gel containing 100 mg of testosterone; Andrographolides; Anesthetic Topical Adhesive Synera; Anti LP40 antibody, subclass IgG4 LA294; Anti-CD25 Humanized Monoclonal Antibody; Anti-CD52 monoclonal antibody; Anti-IL-12; Anti-Thymocyte Globulin; Anti-thymocyte globulin; Anticholinergic medication; Anticuerpo monoclonal anti-LINGO-1 humano; Antihistamine; Antimycotic; Antithymocyte; Antithymocyte immunoglobulin; Antithymocyte immunoglobulin (rabbit); Anxiety/depression and work and activities; Apitox - pure honeybee toxin; Arbaclofen; Arbaclofen ER Tablets; Arbaclofen Extended Release Tablets; Arbaclofen Placarbil; Arbaclofen placarbil; Arbaclofen placarbil 15 mg BID; Arbaclofen placarbil 30 mg BID; Arbaclofen placarbil 45 mg BID; Aricept 10 mg; Aricept 10 mg filmdragerade tabletter; Aricept 5 mg; Aricept 5 mg filmdragerade tabletter; Arm 1 - GEH120714 (18F) Injection; Armodafinil; Arzerra; Arzerra®; Aspirin; Aspirin 650mg Oral Capsule; Atacicept; Atacicept 150 mg; Atacicept 25 mg; Atacicept 75 mg; Atomoxetine; Atorvastatin; Aubagio; Aubagio®; Autologous Bone Marrow-Derived Mononuclear Stem Cells; Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope; Autologous Hematopoietic Stem Cell; Autologous Mesenchymal Cell Product; Autologous Mesenchymal Stem Cells; Autologous Stem Cells; Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3); Autologous adipose derived mesenchymal cells; Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved; Autologous hematopoietic stem cells; Autologous mesenchymal stem cell transplantation; Autologous mesenchymal stem cells; Avonex; Avonex (Interferon beta 1a); Avonex (interferon beta-1a), Biogen Idec Ltd; Avonex 30 microgram/0.5 ml Solution for Injection; Avonex 30 microgramos/0.5 ml Solución para inyección; Avonex and Topamax; Avonex/Betaseron/Copaxone/Rebif; Avonex/Zocor; Avonex®; Avonex® monotherapy (6.0 MIU administered i.m. each week); Azathioprine; Azathioprine (AZA); Azatioprina; Azithromycin; BACLOFEN; BAF312; BAF312 0,25 mg tablet; BAF312 1 mg tablet; BAF312 4 mg tablet; BAF312 hemifumarate; BAF312A; BAT4406F; BAY 79-4998; BAY86-5046; BAY86-5046_Interferon-beta-1b; BBR 2778; BCD-033 (interferon beta 1a); BCD-054 180 mcg; BCD-054 240 mcg; BCD-063; BCD-132; BCD-132, 125 mg; BCD-132, 500 mg; BCG20-0134; BEAM Regimen; BETACAROTENE; BETAFERON; BETAFERON 250 mcg; BETAFERON 500 mcg; BETAFERON SC 15F 0,25MG 15SIR; BETAFERON*15CONFEZ 0,25MG/ML+; BETAFERON® (interferon beta-1b); BG-12 120; BG00002; BG00002 (natalizumab); BG00002-E (natalizumab high titer); BG00012; BG00012 (DMF); BG00012 (DMF) (Tecfidera®.); BG0002 (natalizumab); BG9418 (interferon beta 1-a); BG9418 (interferon beta-1a); BGC20-0134; BGG492; BHT-3009; BHT-3009 0.5 mg; BHT-3009 1.5 mg; BHT-3009-01; BIIB017; BIIB017 (Peginterferon beta-1a); BIIB017 (peginterferon beta-1a); BIIB019; BIIB019 (Daclizumab High Yield Process); BIIB019 (Daclizumab); BIIB033; BIIB033 (ANTI-LINGO); BIIB033 (ANTI-LINGO) - EV Substance Code SUB118957; BIIB033 (opicinumab); BIIB041; BIIB041 (Fampridine-SR); BIIB041 (PR Fampridine); BIIB041 (fampridine); BIIB061; BIIB133; BIOTIN; BIRT 2584 XX; BIRT 2584XX; BMMNC; BMS 188667 (Abatacept); BORAGE OIL; BORAGE OIL 20% GLA; BOSWELAN; BOTOX; BOTOX®; BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX; BOTULINUM TOXIN TYPE A; BX-1; Bacille Calmette-Guerin vaccine; Bacille of Calmette-Guerin; Baclofen; Baclofen 20 mg; Baclofen ER Capsules (GRS) 10 mg; Baclofen ER Capsules (GRS) 20 mg; Baclofen ER Capsules (GRS) 30mg; Baclofen ER Capsules (GRS) 40mg; Baclofen ER Capsules (GRS) 50 mg; Baclofen IR; Baclofen Tablets USP; Baclofen Tablets USP 10 mg; Bafiertam; Balance; Baminercept; Baseline Treatment; Bazedoxifene; Bazedoxifene Acetate; Beetainterferoni -1a; Behavioral: 6 months weight resistance and balance program; Behavioral: Adherence counseling; Behavioral: Assessment of disability; Behavioral: Assessment of impact of MS on cognition; Behavioral: Balance Training; Behavioral: Collaborative Care (CC); Behavioral: Medical Marijuana; Behavioral: Motivational Interviewing; Behavioral: Physical Activity Together for PwMS and their CGs (PAT-MS); Behavioral: Step Tracking; Behavioral: Telephone-based Cognitive Behavioral Therapy; Behavioral: Water Tracking; Behavioral: learning; Behavioral: meditation; Behavioral: self massage; Best Available Therapy (BAT); Beta-1b interferoni; Beta-Alanine; Beta-Carotene; Beta-Interferon; Beta-alanine; Beta-alanine supplementation; Beta-carotene; Beta-interferon; Betacarotene; Betaferon; Betaferon 250 microgram/mL, powder and solvent for solution for injection.; Betaferon 250 microgram/ml; Betaferon 250 microgram/ml, powder and solvent for solution for injection; Betaferon 250 microgramos; Betaferon 250mcg; Betaferon 250µg; Betaferon 500 µg; Betaferon 500mcg; Betaferon 500µg; Betaferon, BAY 86-5046; Betaferon/Betaseron; Betaferon®; Betaseron; Betaseron (Interferon beta-1b, BAY86-5046); Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG; Bevacizumab; Bexarotene; Biotin; Biotina; Bisacodyl; Blood sample; Blood samples; Blood sampling; Bone marrow autologous mesenchymal stem cells transplantation; Borage oil; Bortezomib; Bosentan; Boswellia Serrata; Boswellia Serrata Extract; Boswellia serrata extract PS0201Bo capsules; Boswellic acids (BOSWELAN); Botox; Botulinum Toxin Type A; Botulinum Toxin Type A 200U; Botulinum Toxin Type A 300U; Botulinum toxin; Botulinum toxin A; Botulinum toxin type A; Botulinum toxin type A infiltrations; Brimonidine; Brimonidine tartrate; C1-esterase inhibitor (Cinryze); C105; CALCIO FOLINATO DC.IT; CANNABIDIOL; CBD; CC; CCI-779; CDP323; CELLCEPT; CETIRIZINE HYDROCHLORIDE; CGP 77116; CHOLECALCIFEROL; CHR-1103 / GBR500; CIANOCOBALAMINA FU DC.IT; CISAPRIDE; CITOCHINE ED IMMUNOMODULATORI; CLADRIBINA; CLADRIBINE; CLOSTRIDIUM BOTULINUM TOXIN TYPE A; CNM-Au8; CNTO 1275; CO; CO-14; COLECALCIFEROL; COLECALCIFEROL CONCENTRATE (OILY FORM); COP; COP-1; COP-1/Copolymer-1; COPAXONE; COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE; COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO; COPAXONE 20 mg/ml solución inyectable en jeringa precargada; COPAXONE*SC 28SIR 20MG/ML; CS-0777 tablets; CT103A cells; CYCLOPHOSPHAMIDE; CYCLOPHOSPHAMIDE MONOHYDRATE; Caffeine; Calcio; Calcium; Calcium and Vitamin D combination; Calcium carbonate; Calcium levofolinate; Cannabidiol; Cannabidiol / Dronabinol capsule 5 mg+2,5 mg; Cannabidiol Botanical Drug Substance (CBD BDS); Cannabidiol capsule 5 mg; Cannabis; Cannabis Based Medicine Extract (Sativex); Cannabis, Medical; Cannador; Caprylic Triglyceride; Caprylic triglyceride; Capsules with 160 mg Teavigo (at least 94% EGCG); Carbamazepine; Carbidopa; Carbonate; Carmustine; Carmustine, etoposide, cytarabine, and melphalan (BEAM); Carnitine; Carnosine; Carnosine, capsulle, 2 g/day, 8 weeks; Cellular therapy with EBV specific autologous CTL infusion; Ceralifimod; Ceralifmod; Cesamet™ (nabilone); Ceterizine; Cetirizina; Cetirizina Mylan Generics; Cetirizine; Charcoal; Chloride; Cholecalciferol; Cholecalciferol (Vitamin D3); Cholecalciferol, Vitamin D3; Cholestyramine; Cianocobalamina; Ciclofosfamide; Cinryze; Circadin; Circadin ( INN= Melatonin); Cisapride; Citalopram; Cladribina; Cladribina oral; Cladribine; Cladribine 3.5 mg/kg; Cladribine 5.25 mg/kg; Cladribine Oral Tablet; Cladribine Tablet; Cladribine Tablets; Cladribine tablets; Clemastine; Clemastine fumarate; Clostridium botulinum; Cnp-MS-0601; Coconut; Coconut oil; Coconut oil and epigallocatechin gallate; Coenzyme Q; Colecalciferol; Combination Product: ofatumumab with AI; Combination Product: ofatumumab with PRF; Copaxone; Copaxone 20 mg; Copaxone 20 mg/ml; Copaxone 20 mg/ml Solution for Injection, pre-filled syringe; Copaxone 20 mg/ml solución para inyección en jeringa precargada; Copaxone 20 mg/ml, Solution for Injection, pre-filled syringes; Copaxone 20mg/ml Solution for Injection, pre-filled syringe; Copaxone 40 mg/ml; Copaxone 40 mg/ml solution for injection, pre-filled syringe; Copaxone subcutaneous injection syringe; Copaxone-Teva; Copaxone®; Copolymer 1; Copolymer-1; Corticosteroid; Corticosteroids & tanCART19/20; Corticotropin; Cranberry; Creatine; Curcumin; Cyclophosfamide; Cyclophosphamide; Cyclophosphamide (drug); Cyclophosphamide and ATG; Cyclophosphamide and fludarabine; Cyclophosphamide monohydrate; Cyclophosphamide/Glatiramer acetate; Cymbalta; Cysteine; Cytarabine; Cytolytic CD4+ T cells; Cápsulas de Laquinimod 0.6 mg; Células madre mesenquimales; D Mannose; D-BIOTIN; D-BIOTINA; D-Biotin; D-aspartate; DAC; DAC HYP; DAC-HYP; DACLIZUMAB; DACLIZUMAB HYP; DAPIROLIZUMAB PEGOL; DC-TAB; DELTA-9-TETRAHYDROCANNABINOL; DEMESTRIL SEPTEM; DEXTROMETHORPHAN HYDROBROMIDE; DEXTROMETORFANO HIDROBROMURO; DEXTROMETORFANO HiDROBROMURO; DIBASE; DIMETHYL FUMARATE; DMT; DMT continuation; DPA; DPA-714 PET/MRI; DRONABINOL; DULOXETINE; DYDROGESTERONE; DYSPORT*SC IM 2FL 500U; DYSPORT®; Daclizumab; Daclizumab (Anti-CD25 Humanized Monoclonal Antibody); Daclizumab HYP; Daclizumab HYP (DAC HYP; Daclizumab HYP (DAC HYP); Daclizumab High Yield Process; Daclizumab wih Greek suffix; Daclizumab with Greek suufix; Dalfampridine; Dalfampridine ER; Dalfampridine-ER 10mg; Dalfampridine-ER 5mg; Dantrolene; Dapirolizumab Pegol; Dapirolizumab pegol; Darifenacin; Darifenacin (BAY79-4998); Dekristol; Dekristol 20000 IE; Dekristol® 400-Tabletten; Dekristol®-Tablette 1 (400 IE); Delta-9-tetrahydrocannabinol; Device: 2 mA Transcranial Direct Current Stimulation; Device: 4 mA Transcranial Direct Current Stimulation; Device: Avonex prefilled syringe via manual IM injection; Device: BETACONNECT; Device: BETACONNECT auto-injector.; Device: BETACONNECT device; Device: BIIB017 (peginterferon beta-1a) Autoinjector; Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS); Device: Balance platform therapy; Device: Betaconnect Autoinjector; Device: Betaconnect auto-injector; Device: CIC using LoFric Primo; Device: Capacity of muscular oxygen extraction; Device: Dynamic Vessel Analyzer (DVA); Device: Extracorporeal Photopheresis; Device: Four-point cane (FPC); Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Lokomat training; Device: Magnetic Resonance Imaging; Device: Medication Event Monitoring System (MEMS); Device: Metabolic fatigue; Device: NIRS after bosentan administration; Device: NIRS baseline; Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV; Device: Nintendo Wii Fit Balance Board; Device: Optical coherence tomography (OCT); Device: Optical coherence tomography angiography (OCTA); Device: Paired associative stimulation (PAS); Device: Repetitive transcranial magnetic stimulation (rTMS); Device: Sham Transcranial Direct Current Stimulation (tDCS); Device: Single-point cane (SPC); Device: Single-pulse transcranial magnetic stimulation (spTMS); Device: Single-use autoinjector; Device: Sleep assessment; Device: TCD after bosentan administration; Device: TCD baseline; Device: Transcranial Magnetic Stimulation (TMS); Device: Trekking pole (TP).; Device: Video game therapy; Device: Wristband physical activity monitor; Device: interferon beta-1a; Device: myBETAapp; Device: single-use autoinjector with a prefilled liquid Avonex syringe; Dexamethason; Dexamethasone; Dexamethasone soduim phosphate; Dexchlorpheniramine; Dexrazoxane; Dexrazoxane (DRZ) plus Mitoxantrone (MX); Dextromethorphan; Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg; Dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg; Dextromethorphan/Quinidine; Dextrometorfano; Dextrometorfano/Quinidina; Diagnostic Test: Entire-body PET-CT scans; Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: PET with [11C]Flumazenil; Diagnostic Test: Stroop test; Diagnostic Test: Testing of autonomous nervous system function; Diazoxide; Diclofenac; Diclofenac sodium topical gel; Dietary Supplement: vitamin A; Dimethyl Fumarate; Dimethyl Fumarate (DMF); Dimethyl fumarate; Dimethyl fumarate 240 mg; Dimethyl fumarate [DMF]; Dimetilfumarato; Diphenydramine; Diphtheria toxoid; Diroximel Fumarate (DRF); Diroximel fumarate; Dirucotide; Dirucotide acetate; Discontinuation of disease modifying therapy; Disease Modifying therapy; Domperidone; Donepezil; Donepezil HCI (drug); Dosing Interruption of Natalizumab; Dotarem; Dotarem 0,5mmol/ml,; Doxycycline; Dronabinol; Dronabinol 25 mg/ml, oral drops; Dronabinol capsule 2,5 mg; Duloxetine; Duloxetine Hydrochloride (HCI); Dydrogesterone; Dysport; Dysport®; EBIXA; ECP002A; ECULIZUMAB; EFALIZUMAB; EGCG; EGb 761® (Tanakan®); EK-12; ELND002; EMD 28162; EMSELEX 15 mg Retardtabletten; EMSELEX 7,5 mg Retardtabletten; ENA713; ENDOXAN; ENDOXAN BAXTER; EPARMEFOLIN 30 CPR 0,1/0,5MG; EPO; ESTRADIOL HEMIHYDRATE; ETHINYLESTRADIOL; ETIMS; ETIMS (EDC-fixed autologous PBMCs coupled with 7 immunodominant myelin peptides in MS patients); EU/1/08/454/001-002, EU/1/08/454/005-007; EU/1/95/003/005-010; EU/1/97/033/002; EU/1/98/063/001-003; EU/1/98/063/004-006; EVOBRUTINIB; EXTAVIA; EXTAVIA*SC 15FL 250MCG/ML+15SI; Early Highly Effective Therapies Group; Eculizumab; Efalizumab; Elezanumab; Emselex; Encapsulated Baclofen 20 mg; Encapsulated Simvastatin tablets; Endoxan; Endoxan - ciclofosfamide; Enriched Hematopoetic Stem Cell Infusion; Enspryng; Epigallocatechin; Epigallocatechin gallate; Epigallocatechin-gallate (Sunphenon); Epo; Epoetin alfa; Epoetin beta; Equal; Erypo/Erypo FS; Erythropoietin; Escalation Therapies Group; Escitalopram; Escitalopram oxalate antidepressant; Esomeprazole; Essential - hydroxytyrosol; Essential fatty acids; Estradiol; Estriol; Estroprogestins; Eszopiclone; Ethinylestradiol; Etifoxine; Etoposide; Evobrutinib; Evobrutinib 10mg; Evobrutinib 25mg; Exelon; Exelon transdermales Pflaster; Experimental Glatiramer Acetate; Exposure to one or more disease-modifying drug(s)(DMDs) used to treat MS; Extavia; Extavia (interferon beta-1b), Novartis Pharma AG; Extavia 250 microgram/ml; Extavia 250 micrograms/ml; Extavia®; Extended release fampridine; Extended-release oxycodone; Extended-release quetiapine fumarate; F-18 FEDAA1106 (BAY85-8101); FAMPRIDINA; FAMPRIDINE; FAMPYRA; FAMPYRA - 10 MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - FLACONE (HDPE) 56 COMPRESSE (4 FLACONI DA 14); FENEBRUTINIB; FINGOLIMOD; FINGOLIMOD HYDROCHLORIDE; FISH OIL, RICH IN OMEGA-3-ACIDS; FISH OIL,RICH IN OMEGA 3 ACIDS; FLUDARA; FLUOXETINE; FLUOXETINE HYDROCHLORIDE; FLURBIPROFEN; FMP30 Donor Stool; FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE; FPC; FTY720; FTY720D; Famciclovir; Fampridina; Fampridine; Fampridine SR; Fampridine-SR; Fampridine-SR b.i.d. (Twice Daily); Fampyra; Fampyra 10 mg prolonged-release tablets; Fampyra 10mg prolonged release tablets; Fatigue; Febuxostat; Fecal Microbial Transplants; Fecal microbial transplant (FMT); Fecal microbiota; Femoston 1/10; Femoston 2/10; Fenebrutinib; Feraheme; Ferumoxytol; Filgrastim; Fingolimob (FTY); Fingolimod; Fingolimod (FTY720); Fingolimod 0.5 mg; Fingolimod 1.25 mg; Fingolimod Hydrochloride; Fingolimod hydrochloride; Fingolimodi; Fingolmod; Firategrast; Firategrast (USAN approved name); Firategrast 150 mg; Firategrast 300 mg; Firategrast gastro-retentive solution; Firategrast immediate release tablet; Firategrast modified release tablet; Fish Oil; Fish oil; Fish oil concentrate; Fludara; Fludarabine; Flumazenil; Fluoxetin; Fluoxetin Hexal; Fluoxetine; Fluoxetine hydrochloride; Flupirtin; Flupirtine; Flupirtinmaleat; Flurbiprofen; Folate; FolateScan (Technetium Tc 99mEC20); Formistin; Formistin 10 mg; Formulation A; Formulation B; Formulation C; Formulation D; Freshly-Pressed Extra Virgin Olive Oil; Full Spectrum vitamin; Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody; Fumaric Acid; G-CSF; G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process); GA; GA 20 mg/mL; GA 40 mg/mL; GA Depot; GA Depot 40 mg; GA Depot 40mg once monthly; GA Depot 80 mg; GABAPENTIN; GADOBUTROL; GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado; GBP; GDC-0853 RO7010939; GILENYA; GLA; GLATIRAMER ACETATE; GLATIRAMER ACETATO; GLATIRAMERO ACETATO; GNbAC1; GNbAC1 Monoclonal Antibody; GSK1223249; GSK1841157; GSK2018682; GSK2018682 CD2 Capsule; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state; GSK239512; GSK2395612; GTR; GTR.ace; GW-1000-02; GYLENIA; GYLENIA 0,5 mg; GZ402668; GZ402673; Gabapentin; Gabapentine; Gabapentine 300mg; Gadobenate; Gadobenate Dimeglumine; Gadobutrol; Gadolinium; Gadolinium-based contrast; Gadopentetate; Gadoteric acid; Gadoteridol; Gadovist; Gadovist 1.0 mmol/ml Injektionslösung; Gamma-Tocopherol; Gamma-tocopherol; Genotropin; Gilenya; Gilenya / Imusera; Gilenya 0,5 mg Hartkapseln; Gilenya®; Gileyna; Ginkgo; Ginkgo biloba; Ginseng; Glatiramer; Glatiramer Acetate; Glatiramer Acetate (Copaxone®); Glatiramer Acetate (DB); Glatiramer Acetate (GA); Glatiramer Acetate (GA) 40 mg; Glatiramer Acetate (GTR); Glatiramer Acetate (OL); Glatiramer Acetate 20 mg/0.5 mL; Glatiramer Acetate [GA]; Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b; Glatiramer Acetate, N-Acetylcysteine; Glatiramer acetate; Glatiramer acetate (GA); Glatiramer acetate 150mg enteric coated tablets; Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets; Glatiramer acetate 20 mg; Glatiramer acetate 20 mg, with mitoxantrone; Glatiramer acetate 20 mg/0.5 mL; Glatiramer acetate 40 mg; Glatiramer acetate injection with oral cetirizine hydrochloride; Glatiramer acetate with minocycline; Glatiramer acetate, (Copaxone®); Glatiramer acetato; Glicerol-1,3-didecanoato-2-octadeca-(6Z,9Z,12Z)-trienoato; Glucose; Glutamate and aspartate; Glycerol; Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate; Gold; Gold nanocrystals; Granulocyte-colony stimulating factor (G-CSF) and prednisone; Growth hormone; Guanabenz; H.P. Acthar Gel (repository corticotropin injection); H5G1.1-mAb; HBM9161 Injection; HMR 1726D; HMR1726; HMR1726D; HP184; HUMAN LEUCOCYTE INTERFERON-ALPHA; HYDROCHLOROTHIAZIDE; Helminth ova; Hematopoetic stem cell infusion; Hematopoietic stem cell transplantation; Hidrocloruro de fingolimod; High Dose Aspirin (1300 mg/day); High/Low Sodium Diet; Histamine; Histidine; Hookworm larvae; HuL001; HuMax-CD20; Human Neural Stem Cells; Human Umbilical Cord Mesenchymal Stem Cells; Human anti-IL-12 IgG1 Mab; Human anti-IL-12 Mab; Human anti-LINGO-1 monoclonal antibody; Human autologous mesenchymal stem cells; Human fetal-derived Neural Stem Cells (hNSCs); Human interferon beta; Human interferon beta 1a (Rebif); Human interferon beta-1a and glatiramer acetate; Human monoclonal antibody (CNTO 1275) to interleukin-12p40; Human normal immunoglobulin; Human recombinant growth hormone; Human umbilical cord mesenchymal stem cells; Hydrochlorothiazide; Hydrogen; Hydrogen peroxide; Hydroxychloroquine; Hydroxytyrosol; Hydroxyurea; Hyperimmune caprine serum against HIV lysate; IFA Incomplete Freund's Adjuvant; IFN beta 1a 44 mcg TIW; IFN beta-1a; IFN ß-1a; IFN-beta-1a (Rebif®); IFN-beta-1a, (Avonex®); IFN-ß-1a (Rebif®); IFN-ß-1a, (Avonex®); IL2; IMATINIB MESILATE; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENTS; IMU-838; IMU-838 (30 mg/day); IMU-838 (45 mg/day); IMUREL; INF beta-1a; INN COLECALCIFEROL; INT131; INTERFERON BETA-1A; INTERFERON BETA-1A (Avonex®); INTERFERON BETA-1B; INTERFERON BETA-1a; INTERFERON BETA-1b; INTERFERON BETA1A; IPX056; IPX056 10 mg; IPX056 20 mg; IPX056 30 mg; IPX056 35 mg; IPX056 40 mg; IPX056-10 mg; IPX056-20 mg; IPX056-25 mg; IPX056-30 mg; IPX056-35 mg; IPX056-40 mg; IR902; ISENTRESS; IV methylprednisolone; IV methylprednisolone (steroids); IVIg; Ibudilast; Ibuprofen; Ibuprofen Sandoz 400 mg Filmtabletten; Idebenone; Imatinib; Imatinib Mesylate; Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified; Immune globulin; Immunoglobulin; Impact; Imurel; IncabotulinumtoxinA; Incobotulinum toxin A; Inebilizumab; Influenza Vaccine; Influenza vaccine; Inhaled Cannabis; Injectable MS DMT; Injection of autologous stem cells; Injection of cell free media; Inosine; Insulin; Interferon Beta; Interferon Beta 1; Interferon Beta 1a; Interferon Beta 1a pegilado; Interferon Beta Therapy; Interferon Beta-1a; Interferon beta; Interferon beta - 1a (IFN); Interferon beta -1b; Interferon beta 1-A; Interferon beta 1-a; Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046); Interferon beta 1B; Interferon beta 1a; Interferon beta 1a 30 ug IM once weekly; Interferon beta 1a, oral doxycycline; Interferon beta 1b; Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta treatment to add-on atorvastatin treatment; Interferon beta type 1a; Interferon beta-1 a; Interferon beta-1a; Interferon beta-1a (Avonex); Interferon beta-1a (Avonex®); Interferon beta-1a (Rebif); Interferon beta-1a (Rebif®) alone; Interferon beta-1a (current approved manufacturing process invloving FBS); Interferon beta-1a (new process, manufactured without FBS); Interferon beta-1a 30 µg; Interferon beta-1a FBS-free/HSA free, RNF; Interferon beta-1a FBS-free/HSA-free; Interferon beta-1a FBS-free/HSA-free, RNF; Interferon beta-1a HSA+ biosimilar; Interferon beta-1a HSA-free biosimilar; Interferon beta-1a original; Interferon beta-1a, 30 µg/0.5 ml; Interferon beta-1b; Interferon beta-1b (Betaferon, BAY 86-5046); Interferon beta-1b (Betaferon, BAY86-5046); Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Interferon beta-1b (Betaferon®, BAY 86-5046); Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, Betaferon, BAY86-5046); Interferon beta-1b (PF530, Betaferon); Interferon beta-1b and Tacrolimus; Interferon beta-1b group; Interferon beta-1b, (Betaseron BAY86-5046); Interferon beta-1b, FRP about 6 weeks after randomization; Interferon beta-1b, FRP within 15 days after randomization; Interferon beta-1b/Atorvastatin group; Interferon ß-1a; Interferon ß-1a (Avonex®); Interferon ß-1a 30 µg; Interferon ß-1b; Interferon-1beta (Betaseron, BAY86-5046); Interferon-Beta; Interferon-beta; Interferon-beta (IFN-beta); Interferon-beta 1a; Interferon-beta 1a FBS-free/HSA free, RNF; Interferon-beta 1a FBS-free/HSA-free, RNF; Interferon-beta 1b; Interferon-beta 1b (Betaseron); Interferon-beta [IFN-beta]; Interferon-beta and human leukocyte Interferon-a; Interferon-beta-1; Interferon-beta-1a; Interferon-beta-1a (Avonex) plus methylprednisolone; Interferon-beta-1a FBS-free/HSA free, RNF; Interferon-beta-1a FBS-free/HSA-free; Interferon-beta-1b; Interferon-beta-1b (BETASERON, BAY 86-5046); Interferon-beta1; Interferon-ß; Interferon-ß [IFN-ß]; Interferon-ß-1; Interferon-ß-1a; Interferon-ß-1b; Interferone; Interferón Beta-1a pegilado; Interferón beta 1a; Interferón beta 1a pegilado; Intradetrusor injection of Botulinum Toxin-A; Intratect; Intrathecal MSC-NP injection; Intrathecal administration of autologous MSC-NP; Intrathecal methotrexate; Intravenous (IV) infusions; Intravenous Immunoglobulin; Intravenous Methylprednisolone; Intravenous injection of mesenchymal stem cells; Intravenous steroid; Iron oxide; Isentress; Isoxsuprine; Isoxsuprine Hydrochloride; Ixazomib; Ixazomib (NINLARO®) capsules; JM; JM-4; KEPPRA; KLH; Kemstro; Kepivance; Keppra; Keppra 250mg; Keppra 500mg; Keppra ®; Ketamine; Ketoconazole; Keyhole limpet hemocyanin; Keyhole limpet hemocyanin (KLH); Keyhole limpet hemocyanin (KLH) neo-antigen; L acetyl carnitine; L-000124467; L-Carnitine; L-Histidine; L-carnitine; L01BB04; L03 AB; L03 AB 08; L03 AB07; L03AB13; L04AA04; L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE; L04AA31; LA; LAQUINIMOD; LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung; LEVOFOLENE 4 MG 30 CPR; LEVONORGESTREL; LFB-R603; LFB-R603, TGTX1101; LUTENYL; LY2127399; LY248686; Lactose; Lactose monohydrate; Lamotrigine; Lamotrigine extended release tablets; Laquinimod; Laquinimod 0.3; Laquinimod 0.6; Laquinimod 1.2; Laquinimod Capsulas 0.6 mg; Laquinimod Capsules 0.3 mg; Laquinimod Capsules 0.6 mg; Laquinimod Sodium (USAN); Laquinimod Tablets 0.3 mg; Laquinimod capsules 0.6 mg; Lemtrada; Lenograstim; Levetiracetam; Levitra; Levocarnil; Levofolene; Levonorgestrel; Lidocaine; Lidocaine patch 5%; Linoleic Acid/Oleic Acid; Linoleic acid; Liofen XL; Liothyronine; Liothyronine sodium; Lipoic Acid; Lipoic acid; Lipoic acid (LA) with fish oil and LA without fish oil; Lipoic acid and omega-3 fatty acids; Lisdexamfetamine; Lisdexamfetamine sulfate; Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; Lithium Carbonate; Lithium carbonate; Live Hookworm Larvae; Live Necator americanus larvae; Locally approved intravenous contrast medium for contrast enhanced MRI; Loperamide; Loratadine; Low Dose Aspirin (162 mg/day); Low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day; Low dose cannabis; Low immunogenic interferon-beta-1a; Lubiprostone; Lumbar puncture; Lysine; M2951; MABCAMPATH; MABCAMPATH 10 mg/ml concentrado para solución para perfusión; MABTHERA; MANTADAN*20CPR 100MG; MAVENCLAD; MAVENCLAD 10 mg tablets; MBP peptide; MBP8298; MBP8298 Synthetic Peptide; MD1003; MD1003 100mg capsule; MEDI-551; MEDI-551 100 MG-IV; MEDI-551 30 MG-IV; MEDI-551 300 MG-SC; MEDI-551 60 MG-SC; MEDI-551 600 MG-IV; MEMANTINE; MESNA; METHYLPHENIDATE HYDROCHLORIDE; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM HEMISUCCINATE; METHYLPREDNISOLONE SODIUM SUCCINATE; MIS416; MK0812; MLN1202; MMF; MOG peptide; MONITOR; MOR103; MSC2015; MSC2304479A; MSC2304480A; MSC2304481A; MSC2304482A; MSC2358825A; MSC2364447C; MSC2430913A or ONO-4641 (to be used as synonyms); MSC2491529A; MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046); MSTC-001 (MS-STAT); MT-1303; MT-1303 [0.1]; MT-1303 [0.2]; MT-1303 [0.4]; MT-1303-FormA; MT-1303-FormB; MT-1303-High; MT-1303-Low; MT-1303-Middle; MabCampath; MabCampath ®; MabCampath-1h; MabCampath®; MabThera; MabThera (Rituximab); Mabcampath; Mabthera; Mabthera or biosimilar rituximab product; Mabthera®; Magnesium; Maltodextrin; Maltodextrin fiber supplement; Mangafodipir; Mangafodipir (Teslascan); Mannose; Marijuana; Masitinb mesylate; Masitinib; Masitinib mesylate; Mastinib; Mavenclad; Mavenclad tabletter 10 mg; Mavenclad®; Mayzent; Medical Marijuana; Medrol; Megadose oral methylprednisolone; Melatonin; Melphalan; Memantine; Meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent); Menitorix; Mesenchymal Stem Cells; Mesenchymal stem cells; Mesenchymal stem cells (MSCs); Mesenchymal stem/stromal cells; Mesna; Metex; Metformin; Methelphenidate; Methotrexat; Methotrexate; Methyl B12; Methyl Prednisolonate; Methyl folate; Methyloprednisolone; Methylphenidate; Methylphenidate modified release; Methylphenidate modified release 20 mg; Methylphenidate modified release 30 mg; Methylphenidate modified release 40 mg; Methylprednisolon; Methylprednisolon-21-hydrogensuccinat, Natriumsalz; Methylprednisolone; Methylprednisolone (drug); Methylprednisolone 1250 mg/24h x3 days; Methylprednisolone IV; Methylprednisolone PO; Methylprednisolone hemisuccinate; Metilprednisolone sodio succinato; Mg; Microgynon; Microgynon®; Micropirin; Midazolam; Mild dose cannabis; Mineral boost (magnesium); Minocycline; Minocycline 100 mg Film-coated Tablets; Minocycline 100mg; Minocycline Hydrochloride; Mirabegron; MitoQ; Mitoquinone; Mitoxantrone; Modafinil; Monoclonal antibody M-T412; Monomethyl fumarate; Monomethyl fumarate 190 mg; Montelukast; Multiferon; Multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides); Mutagrip; Mycophenolate; Mycophenolate Mofetil (CellCept); Mycophenolate Mofetil (cellcept); Mycophenolate mofetil; Mycophenolate mofetil (Cellcept); Mycophenolate mofetil (MMF); Méthylprednisolone; Méthylprednisolone Mylan; N acetylcysteine; N-acetyl Cysteine; N-acetyl cysteine; N-acetylcysteine; N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine; N.A.; N.a.; N02BG10; N03AX12; N06DX01; NATALIZUMAB; NBI-5788; NBT-NM108 (60 g/day); ND; NEUPOGEN; NEUROASPIS PLP10®; NEURONTIN; NOVANTRONE*INF 2MG/ML 5ML; NOVATREX; NPB-01; NT-KO-003; NU100; NVF233; Nabilone; Nabiximols; Nabiximols - Sativex; Naltrexone; Namisol; Nanocort; Nanocurcumin; Naproxen; Natalizumab; Natalizumab (BG00002); Natalizumab (NTZ); Natalizumab (Tysabri); Natalizumab IV; Natalizumab Injection [Tysabri]; Natalizumab SC; Natalizumab for IV Infusion; Natalizumab for Subcutaneous Injection; Natalizumab treatment; Nd; Nebido; Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection; Necator americanus; NeoRecormon; Neorecormon; Neramexane; Neramexane mesylate; Nerispirdine; Nerispirdine (HP184); Nerispirdine hydrochloride; Neupogen; NeuroVax; NeuroVax 300ug/mL Dose for IM Injection; Neurontin 300 mg hard capsule; New Formulation of rebif - human interferon beta-1a; Niacinamide; Ninlaro; Nitrofurantoin; Nivolumab; Nomegestrol; Nomegestrol acetate; Non-pegylated interferon; Norethindrone; Normal Saline for Injection; Novantrone; Novartis Pharmaceuticals Corporation; Null; NurOwn (MSC-NTF cells); OCH-NCNP1; OCR; OCRELIZUMAB; OCREVUS; OFATUMUMAB; OMB157; OMB157G; ONO-4641; ONO-4641/ MSC2430913A; ONO-4641/MSC2430913A; ORY2001; OS440; OVASTAT; Oclelizumab; Ocrelizumab; Ocrelizumab 300 mg; Ocrelizumab 300mg; Ocrelizumab 300mg /10ml; Ocrelizumab 300mg/10 ml; Ocrelizumab 300mg/10ml; Ocrelizumab 600 mg; Ocrelizumab Dose 1; Ocrelizumab Dose 2 and Dose 3; Ocrelizumab at home; Ocrevus; Ocrrelizumab 300 mg; Octagam; Octagam 5%; Octagam 50 mg/ml; Ofatumumab; Ofatumumab 100; Ofatumumab 300; Ofatumumab 30mg; Ofatumumab 3mg; Ofatumumab 60mg; Ofatumumab 700; Ofatumumab subcutaneous injection; Oleic Acid; Oleovit D3 14.400 IU/ml oral drops, solution; Olesoxime (TRO19622); Olive; Olive oil; Omega 3; Omega 3 fatty acids; Omega-3; Omega-3 fatty acids; Omeprazole; OnabotulinumtoxinA; Opicinumab; Oral Methylprednisolone 625 mg/24h x3 days; Oral THC; Oral corticosteroids; Oral lipoic acid (LA); Other H1 antagonist; Other analgesics and antipyretics; Other disease-modifying therapy; Other nervous system drugs; Other: Balance; Other: Balance Trainer Balance Exercises; Other: Balance exercises; Other: Balance training; Other: Berg Balance Scale; Other: Caffeine; Other: Cardiopulmonary evaluation; Other: Cawthorne Cooksey exercises; Other: Classic, progressive endurance training; Other: CoDuSe balance training and step square exercises; Other: Core stability; Other: DMT withdrawal; Other: Determination of calcium intake by a dietician interview; Other: Dual Task Performance; Other: Dynamic Balance Training; Other: Evaluation of degree chronic fatigue.; Other: Exercise intervention; Other: Fear of falling; Other: Four Square Step Test; Other: Functional Reach Test; Other: Functional mobility; Other: Group balance training; Other: Histamine; Other: Hydrogen peroxide; Other: Imaging; Other: Incontinence Severity; Other: Intrathecal saline injection; Other: Laboratory Biomarker Analysis; Other: Liberation therapy; Other: Modified paleolithic diet; Other: NBT-NM108 (0 g/day); Other: Natalizumab; Other: Natalizumab discontinuation; Other: Neuromuscular evaluation; Other: Nintendo Wii Fit Balance exercises; Other: No MSDMDs therapy (control); Other: No Treatment Arm; Other: No device; Other: Non Impact Aerobics; Other: Observation of Ocrelizumab as Treatment in RRMS Patients; Other: Observational Control; Other: One-leg Stance Test; Other: Other: Disease modifying therapies (DMT); Other: PEAK; Other: PNF; Other: PSP; Other: Passive : lecture series; Other: Peanut Butter; Other: Periodized exercise training; Other: Position Sense; Other: Progressive exercise; Other: QALCIMUM questionnaire; Other: Questionnaires; Other: Rhythmic Auditory Stimulation (RAS); Other: Spinning grp; Other: Static Balance Test; Other: Strength training; Other: Supervised physical therapy; Other: Timed Up an Go Test; Other: Training groupe; Other: Trunk impairment; Other: Trunk position sense; Other: USPIO MRI - Gadolinium MRI; Other: Vestibular habituation exercises; Other: Vestibular rehabilitation: balance and eye movement exercises; Other: Virtual reality group; Other: Vitamin K; Other: Vitamin K Cream; Other: Withdrawal of dalfampridine-ER 10mg; Other: anxiety; Other: balance; Other: conventional balance training; Other: dual task performance; Other: fatigue; Other: fingolimod; Other: mitoxantrone - immunomodulator; Other: myBETAapp; Other: natalizumab; Other: normal saline; Other: pain; Other: plasticity-based computerized cognitive remediation program; Other: position sense; Other: propensity score; Other: specifically design 6 month resistance training program; Other: standard of care; Ovastat 1000; Ovastat 5000; Oxcarbazepine; Oxine; Oxybutynin; Oxybutynin Hydrochloride; Oxycodone; Oxygen; Ozanimod; Ozanimod 0.5 mg; Ozanimod 1 mg; Ozanimod HCI; Ozanimod HCl; Ozanimod hydrochloride; PAS; PAT; PB006; PCV; PEG; PEG-liposomal Prednisolone Sodium Phosphate; PEG-liposomal prednisolone sodium phosphate; PEGINTERFERON BETA-1A; PEGylated Intereron Beta-1a; PEGylated Interferon Beta-1a; PET with 11C-Flumazenil; PF-06342674 0.25 mg/kg; PF-06342674 1.5 mg/kg; PF-06342674 6.0 mg/kg; PHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR; PI-2301; PL 04515/0127; PL 12762/0049; PLEDIGRY; PLEGRIDY - 125 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - PENNA PRERIEMPITA - 0,5 ML - 6 PENNE PRERIEMPITE; PLP; PLP peptide; PNU-215062 sodium salt; PO; PONESIMOD; PRD806998; PREDNISOLONE SODIUM PHOSPHATE; PRN2246; PRUCALOPRIDE; PTL201; PV; Palifermin; Pantoprazole; Paracetamol; Paracetamolo 500 mg; Paroxetine; Part A: 100 mg/mL GSK2618960; Part B: Dose of GSK2618960 decided from Part A; Part C: Dose of GSK2618960 decided from Part A and B; Peanut; Peginterferon Beta-1a; Peginterferon beta-1a; Pending; Personalized extended interval dosing of natalizumab; Phenytoin; Phosphate; Pioglitazone; Pixantrone; Placebo; Platelet transfusion; Platform; Plegridy; Plegridy (peginterferon beta-1a), Biogen Idec Ltd; Plegridy 125 micrograms; Plegridy 63 micrograms; Pleneva TM BGC20-0134; Plovamer acetate; Plovamer acetate 0.5 milligram (mg); Plovamer acetate 10 mg; Plovamer acetate 20 mg; Plovamer acetate 3 mg; Pneumovax II; Polyphenon E; Ponesimod; Ponesimod 10 mg; Ponesimod 20 mg; Ponesimod 40 mg; Pravastatin; Prebiotics (Prebiotin Prebiotic Fiber Stick Pac); Prednisolone; Prednisolone Sodium Phosphate; Prednisone; Pregabalin; Prepulsid; Probiotics (Visbiome®); Procedure: Alcohol Wipes vs. No Alcohol Wipes; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Autologous Stem Cell Transplantation; Procedure: Autologous bone marrow transplantation; Procedure: Autologous hematopoietic stem cell transplant; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Exergame; Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool; Procedure: Hematopoietic Stem Cell Therapy; Procedure: Hematopoietic Stem Cell Transplantation; Procedure: Hematopoietic stem cell transplantation (HSCT); Procedure: Home based balance training; Procedure: Immunoadsorption; Procedure: Lumbar Puncture; Procedure: MRI; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Plasma exchange; Procedure: Radiation therapy; Procedure: Syngeneic Bone Marrow Transplantation; Procedure: Warm compress prior to injection of glatiramer acetate; Procedure: irradiation; Procedure: peripheral blood stem cell transplantation; Prohance (Gadoteridol); Prolonged-release Fampridine; Prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal); Provigil; Provigil (modafinil); Prucalopride; Quadrivalent influenza vaccine; Quality of life; Quetiapine; Quinidina; Quinidina sulfato; Quinidine; Quinidine Sulfate; R lipoic acid; RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN; RAS; RATG; RAVULIZUMAB; RC18 160 mg; RC18 160mg; RC18 240mg; REBIF; REBIF 44 microgramos solución inyectable; REBIF 44 microgramos solución inyectable en jeringa precargada; REBIF SC 12SIR 12000000UI44MCG; REBIF SC 12SIR 6000000UI 22MCG; REBIF*SC 12SIR 12000000UI44MCG; REBIF*SC 12SIR 6000000UI 22MCG; RECOMBINANT INTERFERON BETA-1B; REVAXIS; RG2077 (CTLA4-IgG4m); RHB-104; RHIgM22; RHuPH20; RITUXIMAB; RNF; RNS60; RNS60 125 ml; RNS60 250 ml; RO0506997; RO4964913; RO4964913 F07; RO4964913/F03; RO4964913/F07; RO4964913/F07-01; RO4964913/F07-01 (commercial); RO4964913/F07-01 (development); RO5333787; RO7010939; RPC-1063; RPC1063; RTL1000 (recombinant T cell receptor ligand); Rabbit; Rabbit anti-human thymocyte immunoglobulin; Radiation: Gadopentetate Dimeglumine; Ralenova; Raltegravir; Ramatroban; Ranitidine; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravulizumab; Rebif; Rebif (IFN beta-1a subcutaneous three times per week); Rebif (IFN ß-1a subcutaneous three times per week); Rebif (Interferon beta-1a); Rebif (interferon beta 1a); Rebif (interferon beta-1a), Merck Serono Europe Ltd; Rebif 22; Rebif 22 micrograms; Rebif 22 y 44 mcg; Rebif 22®; Rebif 44; Rebif 44 micrograms; Rebif 44 micrograms solution for injection; Rebif 44 micrograms solution for injection in pre-filled syringe; Rebif 44 µg; Rebif 44®; Rebif 8,8 µg, Rebif 22µg; Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack; Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack.; Rebif New Formulation + ibuprofen PRN; Rebif New Formulation + prophylactic Ibuprofen; Rebif New Formulation 44mcg multidose cartridge; Rebif New Formulation Non Titrated; Rebif New Formulation Titrated; Rebif®; Rebif® (clone 484-39); Rebif® New Formulation; Rebif® New Formulation (IFN-beta-1a, RNF); Rebif® New Formulation (RNF) using RebiSmartTM; Rebif® new formulation (RNF); Recombinant Human Erythropoietin; Recombinant Interferon Beta-1b; Recombinant human IFN beta; Recombinant human alpha B-crystallin; Recombinant human interferon beta; Recombinant humanized anti-alpha 4 integrin antibody; Recombinant interferon beta-1b; Repository Corticotropin Injection; Repository corticotropin injection; Revaxis; RhEPO; RhIFN beta-1b; RhIGF-1 (CEP-151); RhuMab 2H7; RhumAb to IL-17A igG1-k-class; RhumAb to Il-17A (IgG1-k-class); Riboflavin; Rifampin; Rilutek; Riluzole; Ritalin; Ritalin LA 20mg capsules; Ritalin LA 30mg capsules; Ritalin LA 40mg capsules; Rituximab; Rituximab IT; Rituximab IV; Rituximab Infusion; Rituximab konsentrat til infusjonsvaeske oppløsning 10 mg/ml; Rivastigmin; Rivastigmine; Rivastigmine transdermal patch; Ro 496-4913/F03; Ro 496-4913/F07; Rolipram; S-Warfarin; S-warfarin; SA237; SAR339658; SAR442168; SATIVEX; SB-683699; SB683699; SC Peginterferon beta-1a; SC interferon beta-1a; SC interferon beta-1b; SCLEROLYM; SCM; SCM-010; SECUKINUMAB; SH U 555 C; SIMVASTATIN; SMderpept; SOLIRIS; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; SOLU-MODERIN 1 g; SPARC0921; SR-fampridine; SUB0750MIG; SUB175614; SUB22282; Saline; Sativex; Sativex Oromucosal Spray; Sativex Oromucosal Spray (non-marketed); Sativex®; Satralizumab; Satralizumab (120 mg/PFS with NSD); Satralizumab (120 mg/vial); Satralizumab (120mg/vial); Satralizumab (RO5333787/Enspryng /SA237); Satralizumab (RO5333787/Enspryng/SA237); Satralizumab (RO5333787/SA237); Satralizumab (r-INN); Satrazlizumab (RO5333787/ Enspryng /SA237); Seasonal Quadrivalent influenza vaccine; Seasonal influenza vaccine; Second-generation fumaric acid; Secukinumab; See Intervention Description); Selenium; Sendoxan; Sendoxane; Serum Free Avonex; Serum containing Avonex; Silodyx; Simethicone; SimvaHEXAL® 40 mg Filmtabletten; Simvastatin; Simvastatin 40 mg film-coated tablets; Simvastatin Alternova; Simvastatin in relapsing remitting multiple sclerosis; Simvastatina; Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG; Simvastatine; Simvastatine Sandoz 40 mg filmomhulde tabletten; Simvastatine Sandoz 40mg deelbare filmomhulde tabletten; Sinvastatina Sandoz 40 mg comprimidos revestidos por película; Siponimod; Siponimod 0.25 mg tablet; Siponimod 0.5 mg tablet; Siponimod 1 mg tablet; Siponimod 2 mg tablet; Sirolimus; Sivatin; Sivatin 40 mg film-coated tablets; Sivelestat; Smoked Cannabis; Sodium Chloride solution; Sodium chlorid; Sodium chloride; Solifenacin; Solifenacin Succinate; Soliris; Solu-Medrol; Solu-medrol; SoluMedrol; Solumedrol IM 125mg/2ml; Somatorelin; Spiropent; Ss-interferon; Standard MS DMT; Standard MS DMTs; Standard gadolinium contrast; Standard interval dosing; Standard of Care; Standard treatment with a conventional drug; Standardized cannabis extract; Statin; Stem Cell Transplantation; Study Drug; Sublingual tizanidine 12 mg; Sulfate; Sunphenon; Sunphenon EGCG; Sunphenon EGCg; Sunphenon EGCg TM; Suspension media; Sustained-release oral dalfampridine; Suvorexant; T cell vaccination; T-Cell Vaccination; TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE; TACI-Fc5; TECFIDERA; TERIFLUNOMIDE; TERIFLUNOMIDE HMR1726; TETRAHYDROCANNABINOL Botanical Drug Substance (THC BDS); TG; TG-1101; THC; THIOPLEX; THYMOGLOBULINE; TMP001; TORVAST*10CPR 10MG; TREOSULFAN; TRO19622; TSO; TT Vaccine; TV-5010; TV-5600; TYSABRI; TYSABRI 300 mg concentrado para solución para perfusión; TYSABRI 300 mg concentrate for solution for infusion; TYSABRI 300 mg solution à diluer pour perfusion; TYSABRI and AVONEX; TYSABRI*IV 1FL 300MG 15ML; TYSABRI®; Tachipirina; Tacrolimus; Tanakan; Tarenflurbil; Targretin; Taurine; Tauroursodeoxycholic Acid; Tauroursodeoxycholic acid; Tcelna; Tecfidera; Tecfidera (BG00012); Tecfidera (BG12); Tecfidera®; Tecfidera® 120 mg; Tecfidera® 120mg magensaftresistente Hartkapseln; Tecfidera® 240 mg; Tecfidera® 240mg magensaftresistente Hartkapseln; Tecifdera (dimethyl fumarate); Temelimab; Temelimab 18 mg/kg; Temelimab 36 mg/kg; Temelimab 54 mg/kg; Temsirolimus; Temsirolimus Tablets; Teriflunomide; Teriflunomide (HMR1726); Teriflunomide 14 MG; Teriflunomide 14 MG Oral Tablet [Aubagio]; Teriflunomide HMR1726; Teriflunomide capsule; Testosterone; Testosterone undecanoate; Tetanus diphtheria toxoid vaccine (Td); Tetanus diphtheria toxoids vaccine; Tetanus toxoid; Tetanus toxoid (TT) containing vaccine (Td, Tdap); Tetanus toxoid vaccine; Tetracycline; Tetracycline - Statin - Antimycotic; Tetrahydrocannabinol; Tetrahydrocannabinol Botanical Drug Substance (THC BDS); Thiamine; Thioplex; Thiotepa; Thymoglobuline; Thymoglobuline®; Tissue Selective Estrogen Complex; Tizanidine; Tizanidine (sublingual or oral); Tizanidine hydrochloride capsule; Tocilizumab; Tocilizumab Injection; Tocopherol; Tolerogenic Dendritic cells loaded with myelin peptides; Tolerogenic dendritic cells (tolDC); Tolperisone; Tolperisone HC1; Tolperisone HCl; Tolpersan; Tolposan; Topical Preparation H arm; Torvast; Tovaxin; Tovaxin Autologous T Cell Vaccine; Tovaxin Autologous T cell vaccine; Tracleer; Trancopal; Trancopal Dolo; Treosulfan; Trichuris suis Ova; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (eggs), embryonated, viable; Trileptal; Triomar™ (omega-3 fatty acids); Trivalent seasonal influenza vaccine; Trulicity; Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere; Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere.; Tylenol Pill; Tysabri; Tysabri ® (Natalizumab); Tysabri®; Tysabri® (natalizumab); UBLITUXIMAB; UK: Sativex Oromucosal Spray; UNDIFFERENTIATED AUTOLOGOUS MESENCHYMAL STEM CELLS; URBASON 40 mg comprimidos; URBASON FORTE; UVEDOSE 100 000 UI; UVEDOSE 100 000 UI, solution buvable en ampoule; Ublituximab; Ubltuximab; Ucb L059; Ultomiris; Ultra small particles of iron oxide (USPIO); Ultrasmall particles of iron oxide; Umbilical cord derived Mesenchymal Stem Cells; Umbilical cord mesenchymal stem cells; Untreated to atorvastatin treatment; Urbason; Urbason 40 mg; Urbason Forte; Urbason solubile forte 1000mg; Urbason® solubile forte 1000 mg; Urine samples; V08CA02; V08CA09; VARDENAFILO HIDROCLORURO; VAY736; VB13S1; VB5S2; VB6S5; VENLAFAXINE HYDROCHLORIDE; VIDOFLUDIMUS CALCIUM; VIGANTOL OIL; VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA; VSN16R; VSN16R 100mg; VX15/2503; Vaginal estriol; Vardenafil; Vardenafil (hidrocloride); Vardenafilo; Vatelizumab; Vehicle Gel; Venlafaxin Hexal; Venlafaxine; Verum arm receiving Gilenya®; Verum arm receiving Vitamin D oil; Vessel; Vidofludimus; Vidofludimus calcium; VigantOL oil plus interferon beta-1a (Rebif); Vigantol; Vigantol Oel; Vigantol Oil; Vigantol® Oil; Vigantol® Öl 20.000 I.E./ml; Vitamin A; Vitamin D; Vitamin D3; Vitamin E; Vitamin E/Selenium; Vitamin K; WAY-130799; Warfarin; Water; XBD173; XCEL-MC-ALPHA; XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector; Xeomin; Xyosted; ZK 157046; ZOL446H; ZOLEDRONIC ACID MONOHYDRATE; Zenapax; Zinbryta; Zoledronic Acid; Zoledronic acid; [11C]flumazenil; [123I]CLINDE; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F] PBR06; [18F]-FEPPA; [18F]DPA-714; [18F]Florbetapir and PET imaging; [C-11]Methylreboxetine; [C-11]PBR28; [C11]PK-1195 PET scan; [F-18]PBR06; [F-18]SDM-8; [Formistin 10 mg]; [MD1003]; [Metilprednisolone]; [OMB157]; [Tachipirina CPR 500mg]; [Zr-89]Oxine-labeled leukocytes PET/MR

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	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
2	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;Taiwan;Thailand;Turkey
3	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]		Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	340	Phase 3	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
4	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]		Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	340	Phase 3	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
5	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	Serbia;Spain;Ukraine;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Sweden
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
6	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]		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
7	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
8	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
9	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
10	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
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
11	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
12	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	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
13	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
14	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
15	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
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
16	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
17	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]		Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait
18	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
19	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
20	NCT02471560 (ClinicalTrials.gov)	November 30, 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	37	Phase 4	Norway
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
21	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
22	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
23	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
24	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
25	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
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
26	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
27	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
28	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
29	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
30	NCT02683863 (ClinicalTrials.gov)	August 2015	14/1/2016	Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers	An Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple Sclerosis	Multiple Sclerosis	Drug: BG00012 (DMF) (Tecfidera®.)	Multiple Sclerosis Center of Northeastern New York	Biogen	Completed	25 Years	65 Years	All	20	Phase 4	United States
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
31	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
32	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 3b	France;United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Germany;Italy
33	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 3b	France;United States;Czech Republic;Hungary;Canada;Belgium;Spain;Australia;Germany;Italy
34	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
35	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: 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;Germany;Kuwait;Sweden
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
36	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
37	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
38	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
39	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
40	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	Authorised-recruitment may be ongoing or finished			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
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
41	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
42	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
43	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
44	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
45	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
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
46	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		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
47	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
48	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
49	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
50	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
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
51	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
52	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
53	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
54	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
55	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
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
56	EUCTR2013-002318-11-DK (EUCTR)	14/07/2014	25/04/2014	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: 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]		Biogen Idec Research Limited	NULL	Not Recruiting			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
57	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
58	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
59	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]		Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	202	Phase 3	Czech Republic;Taiwan;Poland;Japan;Korea, Republic of
60	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
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
61	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: 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]		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
62	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
63	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
64	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: 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
65	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
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
66	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
67	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
68	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
69	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
70	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
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
71	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
72	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
73	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
74	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
75	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1080	Phase 4	France;Portugal;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Belgium;Spain;Austria;Italy
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
76	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
77	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
78	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
79	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 3	Italy
80	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
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
81	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
82	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
83	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700		Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Italy;Switzerland;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;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand
84	EUCTR2008-004753-14-IT (EUCTR)	07/06/2010	10/09/2010		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 - ND	Relapsing-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399	Product Code: BG00012	BIOGEN IDEC LTD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700		Germany;Netherlands;France;Bulgaria;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Greece
85	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
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
86	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	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700		Germany;Netherlands;France;Bulgaria;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Greece
87	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]		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
88	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
89	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	Authorised-recruitment may be ongoing or finished			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
90	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		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
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
91	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
92	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		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
93	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]		Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1700	Phase 3	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
94	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
95	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]		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
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
96	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
97	NCT00837785 (ClinicalTrials.gov)	February 28, 2009	4/2/2009	A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS	A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis	Drug: BG00012	Biogen	NULL	Completed	18 Years	55 Years	All	48	Phase 1	Germany;United Kingdom
98	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
99	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]		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
100	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
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
101	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
102	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
103	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
104	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
105	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
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
106	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
107	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
108	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
109	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1232		Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia
110	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
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
111	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
112	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
113	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
114	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
115	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
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
116	NCT00451451 (ClinicalTrials.gov)	June 2007	21/3/2007	Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis	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	Relapsing-Remitting Multiple Sclerosis	Drug: BG00012;Drug: Placebo;Drug: Glatiramer Acetate	Biogen	NULL	Completed	18 Years	55 Years	All	1417	Phase 3	United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Costa Rica;Croatia;Czech Republic;Estonia;France;Germany;Greece;India;Ireland;Israel;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;New Zealand;Poland;Puerto Rico;Romania;Serbia;Slovakia;Spain;Ukraine;Australia;Italy;Kazakhstan;Lithuania;Russian Federation
117	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
118	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
119	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
120	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
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
121	NCT00420212 (ClinicalTrials.gov)	January 2007	8/1/2007	Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis	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	Relapsing-Remitting Multiple Sclerosis	Drug: BG00012;Drug: Placebo	Biogen	NULL	Completed	18 Years	55 Years	All	1234	Phase 3	United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czech Republic;France;Germany;Greece;Guatemala;India;Israel;Italy;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Serbia;Slovakia;South Africa;Switzerland;Ukraine;United Kingdom;Virgin Islands (U.S.);Belarus;Bulgaria;Kazakhstan;Russian Federation;Sweden;Turkey
122	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
123	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
124	NCT00168701 (ClinicalTrials.gov)	October 2004	9/9/2005	Efficacy and Safety of BG00012 in MS	Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis	Multiple Sclerosis	Drug: BG00012	Biogen Idec	NULL	Completed	18 Years	55 Years	Both	260	Phase 2	Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Sweden;Switzerland;Turkey;United Kingdom
125	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
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
126	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
127	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

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

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

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;Taiwan;Thailand;Turkey

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]

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

Phase 3

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

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]

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

Phase 3

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

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

Serbia;Spain;Ukraine;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Sweden

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

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]

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany

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

Phase 3

United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany

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

Phase 3

Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany;United States;Czech Republic;Poland;Belgium

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

Phase 3

NULL

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

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

Phase 3

United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany

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

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

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

Phase 3

United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Kuwait;Germany;Latvia

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).

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]

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

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).

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]

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

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

Phase 3

United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic

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

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

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

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

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]

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait

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

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

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

NCT02471560
(ClinicalTrials.gov)

November 30, 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

Phase 4

Norway

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

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

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

Phase 2

Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia

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

Phase 2

United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic

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

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

Phase 2

Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia

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

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

Phase 2

United States;Lebanon;Turkey;Lithuania;Israel;Italy;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia

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

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.

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

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

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

Phase 2

United States;Lebanon;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia

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

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

NCT02683863
(ClinicalTrials.gov)

August 2015

14/1/2016

Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers

An Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple Sclerosis

Multiple Sclerosis

Drug: BG00012 (DMF) (Tecfidera®.)

Multiple Sclerosis Center of Northeastern New York

Biogen

Completed

25 Years

65 Years

All

Phase 4

United States

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

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

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

Phase 2

Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia

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

Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3b

France;United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Germany;Italy

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

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 3b

France;United States;Czech Republic;Hungary;Canada;Belgium;Spain;Australia;Germany;Italy

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

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).

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]

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;Germany;Kuwait;Sweden

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

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

Phase 4

NULL

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

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

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

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

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1170

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

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

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

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

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

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

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

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

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

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

Phase 2

Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Latvia;Germany;Kuwait

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

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

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

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

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

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

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

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

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

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

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

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

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

Phase 3

United States;Belgium;Czech Republic;Netherlands;Poland;Slovakia;Austria;Sweden

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

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

EUCTR2013-001025-53-DK
(EUCTR)

05/03/2015

24/03/2014

A Study that evaluates Fatigue in Multiple Sclerosis Patients taking Tecfidera® (Dimethyl Fumarate)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

320

Phase 4

Finland;Spain;Denmark;Norway;Netherlands;United Kingdom

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

Phase 2

United States

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

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

EUCTR2013-002318-11-DK
(EUCTR)

14/07/2014

25/04/2014

Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS).

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]

Biogen Idec Research Limited

NULL

Not Recruiting

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

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).

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]

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

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).

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

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]

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

202

Phase 3

Czech Republic;Taiwan;Poland;Japan;Korea, Republic of

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

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

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).

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]

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

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

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

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]

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

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).

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]

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

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).

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]

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

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

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

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

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.

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

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

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]

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

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)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

Germany

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

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 4

Ireland;United Kingdom

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

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

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

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

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

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

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

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

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

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]

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1080

Phase 4

France;Portugal;Hungary;Czech Republic;Slovenia;Slovakia;Canada;Belgium;Spain;Austria;Italy

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

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

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

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

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

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

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

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 3

Italy

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

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

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

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

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Italy;Switzerland;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;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand

EUCTR2008-004753-14-IT
(EUCTR)

07/06/2010

10/09/2010

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 - ND

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399

Product Code: BG00012

BIOGEN IDEC LTD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Germany;Netherlands;France;Bulgaria;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Greece

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

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

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

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Germany;Netherlands;France;Bulgaria;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Greece

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]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1738

Phase 3

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

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

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

Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: Dimethyl Fumarate
Other descriptive name: DIMETHYL FUMARATE

Biogen Idec Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

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

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

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

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

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

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

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

Relapsing-Remitting Multiple Sclerosis Esclerosis Múltiple recidivante-remitente
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

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

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]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1700

Phase 3

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

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

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]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1738

Phase 3

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

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

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

NCT00837785
(ClinicalTrials.gov)

February 28, 2009

4/2/2009

A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS

A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis

Drug: BG00012

Biogen

NULL

Completed

18 Years

55 Years

All

Phase 1

Germany;United Kingdom

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

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]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1738

Phase 3

100

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

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

101

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

102

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

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

103

EUCTR2006-003697-10-BG
(EUCTR)

14/08/2008

14/06/2008

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

104

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

105

EUCTR2006-003697-10-GR
(EUCTR)

30/10/2007

31/05/2007

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

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

106

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

107

EUCTR2006-003697-10-DE
(EUCTR)

04/10/2007

06/04/2009

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

108

EUCTR2006-003697-10-EE
(EUCTR)

18/09/2007

12/06/2007

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

109

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

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1232

Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia

110

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

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

111

EUCTR2006-003697-10-LV
(EUCTR)

22/08/2007

26/07/2007

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

112

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

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

113

EUCTR2006-003697-10-BE
(EUCTR)

13/07/2007

23/02/2007

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

114

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

115

EUCTR2006-003697-10-IE
(EUCTR)

04/07/2007

20/03/2007

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

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

116

NCT00451451
(ClinicalTrials.gov)

June 2007

21/3/2007

Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis

Drug: BG00012;Drug: Placebo;Drug: Glatiramer Acetate

Biogen

NULL

Completed

18 Years

55 Years

All

1417

Phase 3

United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Costa Rica;Croatia;Czech Republic;Estonia;France;Germany;Greece;India;Ireland;Israel;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;New Zealand;Poland;Puerto Rico;Romania;Serbia;Slovakia;Spain;Ukraine;Australia;Italy;Kazakhstan;Lithuania;Russian Federation

117

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

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

118

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

119

EUCTR2006-003697-10-CZ
(EUCTR)

13/04/2007

23/02/2007

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

120

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

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

121

NCT00420212
(ClinicalTrials.gov)

January 2007

8/1/2007

Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis

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

Relapsing-Remitting Multiple Sclerosis

Drug: BG00012;Drug: Placebo

Biogen

NULL

Completed

18 Years

55 Years

All

1234

Phase 3

United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czech Republic;France;Germany;Greece;Guatemala;India;Israel;Italy;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Serbia;Slovakia;South Africa;Switzerland;Ukraine;United Kingdom;Virgin Islands (U.S.);Belarus;Bulgaria;Kazakhstan;Russian Federation;Sweden;Turkey

122

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.

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

123

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.

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

124

NCT00168701
(ClinicalTrials.gov)

October 2004

9/9/2005

Efficacy and Safety of BG00012 in MS

Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: BG00012

Biogen Idec

NULL

Completed

18 Years

55 Years

Both

260

Phase 2

Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Sweden;Switzerland;Turkey;United Kingdom

125

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.

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

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

126

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.

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

127

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.

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