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	NCT04660539 (ClinicalTrials.gov)	January 11, 2021	24/11/2020	A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)	A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis Optica Spectrum Disorder	Drug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroids	Hoffmann-La Roche	NULL	Not yet recruiting	18 Years	N/A	All	127	Phase 3	United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom
2	NCT03807973 (ClinicalTrials.gov)	December 30, 2020	14/1/2019	Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.	Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.	Fibromyalgia;Chronic Fatigue Syndrome;Multiple Sclerosis;Healthy	Drug: [Zr-89]Oxine-labeled leukocytes PET/MR	University of Alabama at Birmingham	NULL	Not yet recruiting	18 Years	65 Years	All	120	Phase 1	NULL
3	NCT04586023 (ClinicalTrials.gov)	December 26, 2020	8/10/2020	Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)	A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis	Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo	Hoffmann-La Roche	NULL	Recruiting	18 Years	55 Years	All	734	Phase 3	United States
4	NCT04586010 (ClinicalTrials.gov)	December 18, 2020	8/10/2020	A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)	A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis	Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo	Hoffmann-La Roche	NULL	Recruiting	18 Years	55 Years	All	734	Phase 3	United States
5	NCT04667117 (ClinicalTrials.gov)	December 17, 2020	8/12/2020	A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab	An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously	Relapsing Multiple Sclerosis	Biological: Quadrivalent influenza vaccine;Drug: Ofatumumab	Novartis Pharmaceuticals	NULL	Not yet recruiting	18 Years	55 Years	All	66	Phase 4	NULL
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	EUCTR2019-003919-53-GB (EUCTR)	17/12/2020	26/11/2020	FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis	A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary Progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 RO7010939 Trade Name: Ocrevus Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	946	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
7	NCT04544436 (ClinicalTrials.gov)	December 15, 2020	4/9/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)	A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone	Hoffmann-La Roche	NULL	Recruiting	18 Years	55 Years	All	786	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
8	NCT04548999 (ClinicalTrials.gov)	December 3, 2020	9/9/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)	A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone	Hoffmann-La Roche	NULL	Recruiting	18 Years	55 Years	All	699	Phase 3	United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
9	NCT04578639 (ClinicalTrials.gov)	November 2, 2020	22/9/2020	Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease	Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing	Relapsing Remitting Multiple Sclerosis	Drug: Rituximab;Drug: Ocrelizumab	Haukeland University Hospital	University Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North Norway	Recruiting	18 Years	60 Years	All	211	Phase 3	Norway
10	NCT04150549 (ClinicalTrials.gov)	November 2020	11/10/2019	FMT for MS Patients	Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial	Multiple Sclerosis	Biological: Fecal Microbial Transplants	Lawson Health Research Institute	NULL	Not yet recruiting	18 Years	55 Years	All	34	Phase 2	NULL
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	EUCTR2020-000893-69-PL (EUCTR)	28/10/2020	09/07/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS	Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	786	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
12	NCT04544449 (ClinicalTrials.gov)	October 26, 2020	4/9/2020	A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis	A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.	Multiple Sclerosis, Primary Progressive	Drug: fenebrutinib;Drug: ocrelizumab;Drug: placebo	Hoffmann-La Roche	NULL	Recruiting	18 Years	65 Years	All	946	Phase 3	United States;Canada;France;Argentina;Australia;Austria;Belgium;Brazil;Czechia;Denmark;Germany;Greece;Hungary;Israel;Italy;Mexico;New Zealand;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
13	EUCTR2020-000893-69-BE (EUCTR)	23/10/2020	23/10/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS	Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	786	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
14	NCT04626921 (ClinicalTrials.gov)	October 22, 2020	30/10/2020	A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis	VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis	Drug: CNM-Au8	Clene Nanomedicine	George Clinical	Enrolling by invitation	18 Years	55 Years	All	150	Phase 2;Phase 3	Australia
15	EUCTR2019-001829-26-DE (EUCTR)	19/10/2020	08/01/2020	A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)	A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder	Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Soliris Product Name: Soliris Product Code: Soliris INN or Proposed INN: ECULIZUMAB Other descriptive name: h5G1.1-mAb	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	15	Phase 2;Phase 3	United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
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	EUCTR2020-000893-69-PT (EUCTR)	12/10/2020	09/07/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS	Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	786	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
17	EUCTR2020-000894-26-PT (EUCTR)	12/10/2020	13/07/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	699	Phase 3	Portugal;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
18	EUCTR2020-000893-69-HU (EUCTR)	09/10/2020	06/08/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS	Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	786	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
19	EUCTR2020-000894-26-FR (EUCTR)	08/10/2020	11/08/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	699	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
20	EUCTR2020-000893-69-GB (EUCTR)	25/09/2020	29/07/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS - BN42082 Study to evaluate high dose Ocrelizumab in RMS	Relapsing Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrevus Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	786	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;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
21	EUCTR2020-000894-26-GB (EUCTR)	25/09/2020	30/07/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a HigherDose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - BN42083 Study to evaluate high dose Ocrelizumab in PPMS	Relapsing Multiple Sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrevus Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	786	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
22	EUCTR2020-000894-26-HU (EUCTR)	22/09/2020	06/08/2020	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary Progressive Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	699	Phase 3	United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
23	NCT04561557 (ClinicalTrials.gov)	September 22, 2020	10/9/2020	Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System	An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System	Autoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum Disorder	Biological: CT103A cells;Drug: Cyclophosphamide and fludarabine	Tongji Hospital	NULL	Recruiting	18 Years	65 Years	All	12	Early Phase 1	China
24	NCT04528121 (ClinicalTrials.gov)	September 15, 2020	22/8/2020	Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis	Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Other: CoDuSe balance training and step square exercises;Other: conventional balance training	Lama Saad El-Din Mahmoud	NULL	Recruiting	20 Years	40 Years	All	52	N/A	Egypt
25	EUCTR2019-001341-40-AT (EUCTR)	10/09/2020	07/07/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;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
26	EUCTR2019-003625-16-HR (EUCTR)	26/08/2020	12/11/2020	An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis	An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ublituximab Product Code: TG -1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603, TGTX1101	TG Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Belarus;Poland;Ukraine;Romania;Croatia;Russian Federation;Georgia
27	NCT04510220 (ClinicalTrials.gov)	August 2020	31/7/2020	9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis	Open-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis	Relapsing Multiple Sclerosis	Drug: Ofatumumab;Drug: [F-18]PBR06	Brigham and Women's Hospital	Novartis	Not yet recruiting	18 Years	60 Years	All	10	Phase 3	United States
28	NCT04377555 (ClinicalTrials.gov)	July 30, 2020	1/5/2020	Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) Before and During Treatment With Ocrelizumab	An Open-Label, Multicenter Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab	Multiple Sclerosis, Relapsing	Drug: Ocrelizumab	Genentech, Inc.	NULL	Recruiting	18 Years	65 Years	All	150	Phase 4	United States;Puerto Rico
29	NCT04353492 (ClinicalTrials.gov)	July 14, 2020	16/4/2020	An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab	A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy	Relapsing Multiple Sclerosis	Biological: Ofatumumab	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	60 Years	All	550	Phase 3	United States;Australia;Belgium;Bulgaria;Czechia;Germany;Greece;Hungary;Portugal;Russian Federation;Slovakia;Spain;Turkey
30	EUCTR2019-001341-40-PT (EUCTR)	15/06/2020	31/03/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Austria;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;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
31	EUCTR2019-001341-40-BG (EUCTR)	12/06/2020	07/05/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
32	EUCTR2019-003352-37-NL (EUCTR)	11/06/2020	24/02/2020	Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.	A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD	Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 3	United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
33	EUCTR2019-001341-40-GR (EUCTR)	20/05/2020	10/03/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
34	EUCTR2019-003352-37-DE (EUCTR)	11/05/2020	06/01/2020	Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.	A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD	Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 3	United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of
35	EUCTR2019-001341-40-CZ (EUCTR)	07/05/2020	11/02/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom
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	EUCTR2019-001341-40-HU (EUCTR)	29/04/2020	11/03/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
37	EUCTR2019-001341-40-BE (EUCTR)	29/04/2020	17/03/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
38	EUCTR2019-001341-40-ES (EUCTR)	24/04/2020	07/05/2020	An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab	A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Farmacéutica S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
39	EUCTR2017-001313-93-DE (EUCTR)	27/03/2020	12/02/2020	A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis	AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS	Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria
40	EUCTR2019-003352-37-AT (EUCTR)	27/03/2020	13/02/2020	Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.	A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD	Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 3	United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of
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	EUCTR2018-001511-73-DE (EUCTR)	17/03/2020	17/06/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
42	EUCTR2018-001511-73-IE (EUCTR)	16/03/2020	08/05/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
43	EUCTR2018-003008-38-DE (EUCTR)	10/03/2020	06/05/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension	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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta -1a Other descriptive name: Interferon Beta -1a 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 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 Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a 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	United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
44	EUCTR2016-002667-34-PL (EUCTR)	06/03/2020	14/11/2019	A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis	AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS	Relapsing-remitting multiple sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	United States;Poland;Italy
45	EUCTR2018-001511-73-PT (EUCTR)	02/03/2020	30/04/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;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
46	EUCTR2019-003352-37-ES (EUCTR)	25/02/2020	14/01/2020	Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.	A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD	Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 3	United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
47	NCT04291456 (ClinicalTrials.gov)	January 31, 2020	18/11/2019	Minocycline in MS: Confirmation of Benefit	Open-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment Benefit	Multiple Sclerosis;Clinically Isolated Syndrome	Drug: Minocycline 100mg	University of Calgary	Hotchkiss Brain Institute, University of Calgary	Recruiting	18 Years	60 Years	All	148	Phase 3	Canada
48	NCT04140305 (ClinicalTrials.gov)	January 16, 2020	24/10/2019	Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)	A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)	Multiple Sclerosis	Drug: RPC-1063	Celgene	NULL	Recruiting	18 Years	65 Years	All	250	Phase 3	United States;Canada;Puerto Rico
49	EUCTR2019-003352-37-DK (EUCTR)	15/01/2020	19/12/2019	Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.	A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD	Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 3	United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
50	NCT04155424 (ClinicalTrials.gov)	January 14, 2020	5/11/2019	A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder	A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder	Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder	Drug: Eculizumab	Alexion Pharmaceuticals	NULL	Recruiting	2 Years	17 Years	All	15	Phase 2;Phase 3	United States;Japan;Korea, Republic of;Spain;Canada;Germany;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
51	NCT04075266 (ClinicalTrials.gov)	January 9, 2020	14/8/2019	A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis	An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab	Hoffmann-La Roche	NULL	Recruiting	10 Years	18 Years	All	12	Phase 2	United States;Italy;Poland
52	EUCTR2018-001511-73-GB (EUCTR)	23/12/2019	09/04/2019	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HAND	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HAND		Trade Name: Ocrevus Product Name: Ocrevus Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: no	1000	Phase 3	Portugal;Hungary;Poland;Spain;Ireland;Croatia;Bulgaria;Germany;United Kingdom
53	NCT03993171 (ClinicalTrials.gov)	December 19, 2019	31/5/2019	31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.	A Phase 2, Open-Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Multiple Sclerosis.	Relapsing Remitting Multiple Sclerosis	Drug: gold nanocrystals	Clene Nanomedicine	University of Texas Southwestern Medical Center	Recruiting	18 Years	55 Years	All	30	Phase 2	United States
54	EUCTR2018-001511-73-HU (EUCTR)	18/12/2019	08/11/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
55	EUCTR2019-001829-26-ES (EUCTR)	18/12/2019	06/11/2019	A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)	A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder	Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	15	Phase 2;Phase 3	United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
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	EUCTR2018-001511-73-HR (EUCTR)	16/12/2019	17/01/2020	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
57	NCT04201262 (ClinicalTrials.gov)	December 13, 2019	11/12/2019	An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD	A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder	Biological: Ravulizumab	Alexion Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	55	Phase 3	United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain
58	EUCTR2018-003008-38-HR (EUCTR)	10/12/2019	17/01/2020	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension	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: 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	142	Phase 3	Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
59	NCT04130997 (ClinicalTrials.gov)	November 18, 2019	16/10/2019	An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis	TG1101-RMS303 is an Open-label, Single-arm Extension Study Designed to Evaluate Long-term Safety and Efficacy of Ublituximab in Subjects With Relapsing Multiple Sclerosis. Subjects Who Complete the 96-week, Double-blind Treatment Period o TG1101-RMS301 or TG1101-RMS302 Are Eligible for Participation in This Open Label Extension (OLE) Study.	Relapsing Multiple Sclerosis (RMS)	Biological: Ublituximab	TG Therapeutics, Inc.	NULL	Enrolling by invitation	18 Years	N/A	All	1000	Phase 3	United States;Belarus;Croatia;Georgia;Poland;Russian Federation;Serbia;Ukraine
60	NCT04171310 (ClinicalTrials.gov)	November 13, 2019	19/11/2019	Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects	An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male Subjects	Multiple Sclerosis	Drug: SAR442168	Sanofi	NULL	Completed	30 Years	65 Years	Male	6	Phase 1	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
61	NCT03958877 (ClinicalTrials.gov)	October 18, 2019	20/5/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension	Multiple Sclerosis, Relapsing-Remitting	Drug: BIIB017 (peginterferon beta-1a);Drug: Interferon beta type 1a	Biogen	NULL	Recruiting	10 Years	18 Years	All	142	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Croatia;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Kuwait;Portugal;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Tunisia;Turkey
62	NCT04121403 (ClinicalTrials.gov)	October 16, 2019	23/9/2019	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) A Prospective Randomized Open-label Blinded Endpoint (PROBE) Multicenter Non-inferiority Study	Relapsing Multiple Sclerosis;Multiple Sclerosis	Biological: Rituximab;Drug: Cladribine	Oslo University Hospital	University of Oslo;Göteborg University;Sykehuset Ostfold;Sykehuset Telemark;Vestre Viken Hospital Trust;Sorlandet Hospital HF;Helse Stavanger HF;Sykehuset Innlandet HF;Sykehuset i Vestfold HF;Helse Forde;University Hospital of North Norway;St. Olavs Hospital	Recruiting	18 Years	65 Years	All	264	Phase 3	Norway
63	JPRN-JapicCTI-205119	15/10/2019	20/01/2020	A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients	A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients	neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD)	Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Chugai Pharmaceutical Co., Ltd.	F. Hoffmann-La Roche Ltd	complete	12	74	BOTH	30	NA	Japan
64	EUCTR2018-001511-73-BG (EUCTR)	02/10/2019	19/06/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
65	EUCTR2018-001511-73-PL (EUCTR)	30/09/2019	06/08/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;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
66	EUCTR2018-003008-38-PT (EUCTR)	02/09/2019	02/04/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension	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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta -1a Other descriptive name: Interferon Beta -1a 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 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 Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a 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	United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Kuwait;Germany
67	EUCTR2018-001511-73-ES (EUCTR)	21/08/2019	04/07/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis	A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Primary progressive multiple sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
68	NCT04035005 (ClinicalTrials.gov)	August 12, 2019	17/7/2019	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis	A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis	Multiple Sclerosis, Primary Progressive	Drug: Ocrelizumab;Drug: Placebo	Hoffmann-La Roche	NULL	Recruiting	18 Years	65 Years	All	1000	Phase 3	United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Egypt;France;Georgia;Germany;Hungary;Ireland;Italy;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;Netherlands
69	NCT03972306 (ClinicalTrials.gov)	August 12, 2019	29/5/2019	A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis	A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis	Multiple Sclerosis (MS)	Drug: Ocrelizumab;Drug: rHuPH20	Hoffmann-La Roche	NULL	Recruiting	18 Years	65 Years	All	135	Phase 1	United States
70	EUCTR2019-001505-24-NO (EUCTR)	25/07/2019	28/05/2019	A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis	Norwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS	Relapsing Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	264	Phase 3	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
71	EUCTR2018-003008-38-BE (EUCTR)	17/07/2019	19/04/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension	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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta -1a Other descriptive name: Interferon Beta -1a 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 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 Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a 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	United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
72	EUCTR2018-003008-38-BG (EUCTR)	10/07/2019	05/04/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension	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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX ® Product Name: interferon beta -1a , 30 µg/0.5 ml Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta -1a Other descriptive name: Interferon Beta -1a 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 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 Trade Name: AVONEX ® Product Name: interferon beta -1a , 30 µg/0.5 ml Product Code: IFN ß-1a 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	United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
73	EUCTR2018-003008-38-GR (EUCTR)	27/06/2019	03/05/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension	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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta -1a Other descriptive name: Interferon Beta -1a 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 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 Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a 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	United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
74	EUCTR2018-003008-38-SK (EUCTR)	24/06/2019	26/04/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension	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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta -1a Other descriptive name: Interferon Beta -1a 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 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 Trade Name: AVONEX ® Product Name: interferon beta -1a Product Code: IFN ß-1a 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;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
75	EUCTR2017-004703-51-GB (EUCTR)	18/06/2019	15/10/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;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
76	EUCTR2017-004703-51-BE (EUCTR)	17/06/2019	15/01/2019	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
77	EUCTR2018-003008-38-HU (EUCTR)	30/05/2019	08/04/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension	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	142	Phase 3	Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Germany;Tunisia
78	EUCTR2017-004703-51-HR (EUCTR)	06/05/2019	03/06/2019	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
79	EUCTR2017-004703-51-GR (EUCTR)	24/04/2019	27/03/2019	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
80	EUCTR2018-003008-38-ES (EUCTR)	02/04/2019	17/05/2019	A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis	An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension	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	142	Phase 3	Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;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
81	EUCTR2017-004703-51-NL (EUCTR)	29/03/2019	16/10/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
82	EUCTR2017-004703-51-LV (EUCTR)	28/03/2019	24/01/2019	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
83	EUCTR2018-002145-11-GB (EUCTR)	21/03/2019	11/10/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329	Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 3	United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
84	EUCTR2017-004703-51-PT (EUCTR)	18/03/2019	24/10/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
85	EUCTR2018-002145-11-NL (EUCTR)	14/03/2019	05/11/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration	Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 3	United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;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
86	NCT03799718 (ClinicalTrials.gov)	March 13, 2019	7/1/2019	Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS	A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS	Multiple Sclerosis, Chronic Progressive	Biological: NurOwn (MSC-NTF cells)	Brainstorm-Cell Therapeutics	NULL	Active, not recruiting	18 Years	65 Years	All	20	Phase 2	United States
87	EUCTR2018-002145-11-FR (EUCTR)	08/03/2019	31/10/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - NOVA	Relapsing-remitting multiple sclerosis (RRMS) 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	480	Phase 3	United States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
88	EUCTR2017-004703-51-LT (EUCTR)	19/02/2019	03/12/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
89	EUCTR2018-002145-11-DE (EUCTR)	15/02/2019	17/10/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration	Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 3	United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;New Zealand;Italy
90	NCT03623243 (ClinicalTrials.gov)	February 14, 2019	7/8/2018	Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.	Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study	Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis	Drug: Siponimod	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	65 Years	All	400	Phase 3	United States;Puerto Rico
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	NCT03825601 (ClinicalTrials.gov)	February 1, 2019	21/1/2019	PET With [18F]Flumazenil as an Index of Neurodegeneration in MS	PET With [18F]Flumazenil as an Index of Neurodegeneration in MS: Sensitivity at an Early Disease Stage and Pathophysiological Meaning	Multiple Sclerosis;Relapsing-Remitting Multiple Sclerosis	Diagnostic Test: PET with [11C]Flumazenil	Institut National de la Santé Et de la Recherche Médicale, France	NULL	Not yet recruiting	18 Years	55 Years	All	45	N/A	NULL
92	NCT03784547 (ClinicalTrials.gov)	February 1, 2019	13/12/2018	Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM	Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America	Multiple Sclerosis	Drug: Ocrelizumab	Hospital Italiano de Buenos Aires	NULL	Recruiting	N/A	N/A	All	100		Argentina
93	NCT03696485 (ClinicalTrials.gov)	February 1, 2019	30/9/2018	Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS	A Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)	Secondary Progressive Multiple Sclerosis (SPMS)	Biological: SCM -010	Stem Cell Medicine Ltd.	NULL	Not yet recruiting	18 Years	60 Years	All	12	Phase 1;Phase 2	Israel
94	EUCTR2017-004703-51-ES (EUCTR)	31/01/2019	25/10/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Farmacéutica, S.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
95	EUCTR2017-004702-17-PL (EUCTR)	25/01/2019	17/10/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;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
96	EUCTR2017-004703-51-DK (EUCTR)	18/01/2019	11/12/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
97	EUCTR2017-004703-51-FR (EUCTR)	18/01/2019	22/10/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
98	EUCTR2017-004886-29-IE (EUCTR)	11/01/2019	09/05/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
99	EUCTR2017-004703-51-DE (EUCTR)	10/01/2019	27/09/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
100	EUCTR2018-002145-11-ES (EUCTR)	02/01/2019	05/11/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment	Relapsing-remitting multiple sclerosis (RRMS) 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	480	Phase 3	France;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;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
101	EUCTR2017-004703-51-FI (EUCTR)	02/01/2019	11/12/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
102	NCT03650114 (ClinicalTrials.gov)	December 28, 2018	17/8/2018	Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS	An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis	Biological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigen	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	2010	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom
103	NCT03689972 (ClinicalTrials.gov)	December 26, 2018	27/9/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration	Multiple Sclerosis, Relapsing-Remitting	Drug: Natalizumab	Biogen	NULL	Active, not recruiting	18 Years	60 Years	All	500	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom
104	EUCTR2017-004703-51-SE (EUCTR)	17/12/2018	15/11/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
105	EUCTR2017-004702-17-ES (EUCTR)	12/12/2018	17/09/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Novartis Farmacéutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;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
106	EUCTR2017-004702-17-BG (EUCTR)	03/12/2018	23/10/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
107	NCT03944447 (ClinicalTrials.gov)	December 1, 2018	3/5/2019	Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19	Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19	Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus	Drug: Cannabis , Medical	OMNI Medical Services, LLC	OMNI Medical Services Inc	Recruiting	7 Years	N/A	All	200000	Phase 2	United States
108	EUCTR2017-004703-51-HU (EUCTR)	29/11/2018	11/10/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
109	EUCTR2017-004703-51-AT (EUCTR)	28/11/2018	17/10/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
110	EUCTR2017-004703-51-SK (EUCTR)	21/11/2018	28/09/2018	Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis	An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2233	Phase 3	Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;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	NCT03691077 (ClinicalTrials.gov)	November 11, 2018	28/9/2018	Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714	A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714	Multiple Sclerosis;Relapse;Primary Progressive Multiple Sclerosis	Drug: Ocrelizumab	Assistance Publique - Hôpitaux de Paris	Roche Pharma AG;Institut du Cerveau et de la Moelle épinière	Recruiting	18 Years	60 Years	All	51	Phase 3	France
112	EUCTR2017-004702-17-IT (EUCTR)	07/11/2018	04/11/2020	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND	Multiple sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders 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]	Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Product Name: Formistin 10 mg Product Code: [Formistin 10 mg] Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [Tachipirina CPR 500mg] Other descriptive name: paracetamolo 500 mg Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Solumedrol IM 125mg/2ml Product Code: [Metilprednisolone] Other descriptive name: Metilprednisolone sodio succinato Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: Ofatumumab Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: OFATUMUMAB	NOVARTIS PHARMA AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia
113	NCT03593590 (ClinicalTrials.gov)	November 2, 2018	11/7/2018	Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis	A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY	Multiple Sclerosis	Drug: Ocrelizumab	Hoffmann-La Roche	NULL	Recruiting	18 Years	N/A	All	1250		Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Portugal;Qatar;Romania;Russian Federation;Saudi Arabia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel
114	EUCTR2017-004702-17-LV (EUCTR)	02/11/2018	03/09/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy
115	EUCTR2017-004702-17-LT (EUCTR)	31/10/2018	17/09/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;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
116	EUCTR2017-004702-17-CZ (EUCTR)	23/10/2018	16/08/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
117	EUCTR2017-004702-17-EE (EUCTR)	17/09/2018	28/08/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
118	NCT03606460 (ClinicalTrials.gov)	September 14, 2018	23/7/2018	A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)	A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3	Genentech, Inc.	NULL	Completed	18 Years	55 Years	All	141	Phase 3	United States
119	NCT03560739 (ClinicalTrials.gov)	September 11, 2018	15/5/2018	A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients	A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients	Multiple Sclerosis	Combination Product: ofatumumab with PRF;Combination Product: ofatumumab with AI	Novartis Pharmaceuticals	NULL	Completed	18 Years	55 Years	All	284	Phase 2	United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain
120	EUCTR2017-004886-29-NL (EUCTR)	05/09/2018	27/06/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;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	EUCTR2017-004702-17-AT (EUCTR)	01/09/2018	10/08/2018	A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.	A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients	Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 2	United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
122	EUCTR2014-000253-36-NL (EUCTR)	30/08/2018	16/04/2018	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab	MedImmune LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	252	Phase 2;Phase 3	Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;India;Peru;Australia;South Africa;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;New Zealand;Japan
123	EUCTR2017-004886-29-CZ (EUCTR)	08/08/2018	10/05/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
124	NCT03589105 (ClinicalTrials.gov)	August 6, 2018	5/7/2018	A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting	An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mg	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	N/A	All	423	Phase 4	France
125	EUCTR2017-004886-29-SE (EUCTR)	23/07/2018	05/06/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1224	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;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	NCT03567057 (ClinicalTrials.gov)	July 18, 2018	22/5/2018	A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment	A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment	Multiple Sclerosis;Walking Impairment	Drug: ADS-5102	Adamas Pharmaceuticals, Inc.	NULL	Active, not recruiting	18 Years	70 Years	All	540	Phase 3	United States;Canada
127	NCT03599245 (ClinicalTrials.gov)	July 12, 2018	25/6/2018	This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)	A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials	Multiple Sclerosis	Drug: Ocrelizumab	Hoffmann-La Roche	NULL	Recruiting	18 Years	65 Years	All	1500	Phase 4	Czechia;Denmark;Estonia;Finland;France;Ireland;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom
128	EUCTR2017-001313-93-CZ (EUCTR)	09/07/2018	26/03/2018	A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis	AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS	Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Panama;United Arab Emirates;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina
129	EUCTR2017-004886-29-FR (EUCTR)	05/07/2018	17/05/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
130	EUCTR2017-004886-29-GB (EUCTR)	03/07/2018	02/07/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1224	Phase 3	France;Czech Republic;Estonia;Finland;Spain;Ireland;Denmark;Netherlands;United Kingdom;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
131	EUCTR2017-004886-29-DK (EUCTR)	21/06/2018	18/05/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1224	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
132	EUCTR2017-001313-93-HU (EUCTR)	21/06/2018	25/04/2018	A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis	AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS	Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
133	EUCTR2017-004886-29-FI (EUCTR)	19/06/2018	15/06/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
134	EUCTR2017-001313-93-PL (EUCTR)	08/06/2018	15/03/2018	A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis	AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS	Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
135	EUCTR2017-004886-29-EE (EUCTR)	31/05/2018	18/04/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;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
136	NCT03552211 (ClinicalTrials.gov)	May 30, 2018	25/4/2018	Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis	Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis	Progressive Multiple Sclerosis	Drug: biotin;Other: propensity score	University Hospital, Clermont-Ferrand	OFSEP (Observatoire Français de la Sclérose en Plaques);SFSEP (Société Francophone de la Sclérose en Plaques);MedDay Pharmaceuticals SA	Unknown status	18 Years	80 Years	All	3000		France
137	NCT03523858 (ClinicalTrials.gov)	May 28, 2018	16/4/2018	A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis	An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis	Progressive Multiple Sclerosis (PMS)	Drug: Ocrelizumab	Hoffmann-La Roche	NULL	Recruiting	18 Years	65 Years	All	900	Phase 3	United States;Bosnia and Herzegovina;Brazil;Canada;Colombia;Costa Rica;Czechia;Denmark;Egypt;France;Germany;Guatemala;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;Netherlands;Panama;Poland;Russian Federation;Saudi Arabia;Spain;United Arab Emirates;Algeria
138	EUCTR2017-004886-29-ES (EUCTR)	22/05/2018	09/04/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial	A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL	Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
139	EUCTR2017-001313-93-ES (EUCTR)	11/05/2018	02/03/2018	A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis	AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS	Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
140	EUCTR2017-001313-93-IE (EUCTR)	03/05/2018	06/02/2018	A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis	AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS	Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 (development) INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 (commercial) INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
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
141	NCT03585569 (ClinicalTrials.gov)	May 1, 2018	16/3/2018	Treating MS Patients With Lower Extremity Spasticity Using Dysport	A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport	Multiple Sclerosis;Spasticity, Muscle	Biological: Abobotulinumtoxin A	Neurology Center of New England P.C.	Ipsen	Unknown status	N/A	N/A	All	30	Phase 3	United States
142	EUCTR2017-004101-40-HR (EUCTR)	27/04/2018	16/05/2019	Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity	An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).	Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen	Osmotica Pharmaceutical US LLC	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
143	EUCTR2017-001313-93-DK (EUCTR)	04/04/2018	23/02/2018	A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis	AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS	Progressive multiple sclerosis (PMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	United Arab Emirates;Panama;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina
144	NCT03319732 (ClinicalTrials.gov)	April 3, 2018	13/10/2017	A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS	An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)	Multiple Sclerosis;Spasticity, Muscle	Drug: Arbaclofen	Osmotica Pharmaceutical US LLC	NULL	Active, not recruiting	18 Years	65 Years	All	323	Phase 3	United States
145	EUCTR2017-004101-40-BG (EUCTR)	23/03/2018	09/01/2018	Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity	An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).	Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen	Osmotica Pharmaceutical US LLC	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
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
146	EUCTR2017-004101-40-PL (EUCTR)	21/03/2018	12/02/2018	Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity	An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).	Spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Arbaclofen Extended Release Tablets Product Code: OS440 INN or Proposed INN: Arbaclofen Other descriptive name: AERT, (R)-Baclofen	Osmotica Pharmaceutical US LLC	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
147	JPRN-JapicCTI-173711	15/3/2018	14/09/2017	Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab	A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab	Relapsing Multiple Sclerosis	Intervention name : Ofatumumab INN of the intervention : - Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks	Novartis Pharma K.K.	NULL	complete	18	55	BOTH	30	Phase 2	Japan, Russia
148	NCT03249714 (ClinicalTrials.gov)	March 15, 2018	11/8/2017	Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab	A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab	Relapsing Multiple Sclerosis	Drug: Ofatumumab subcutaneous injection;Drug: Placebo subcutaneous injection matching ofatumumab	Novartis Pharmaceuticals	NULL	Completed	18 Years	55 Years	All	64	Phase 2	Japan;Russian Federation
149	NCT03551275 (ClinicalTrials.gov)	February 22, 2018	13/2/2018	Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis	A Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple Sclerosis	Multiple Sclerosis	Biological: BCD-132	Biocad	NULL	Unknown status	18 Years	60 Years	All	48	Phase 1	Russian Federation
150	EUCTR2017-001224-22-DE (EUCTR)	23/01/2018	28/07/2017	Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;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
151	EUCTR2017-001224-22-NL (EUCTR)	11/01/2018	12/09/2017	Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS	Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO)	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden
152	EUCTR2017-001224-22-GB (EUCTR)	28/12/2017	12/07/2017	Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Spain;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
153	EUCTR2017-001224-22-CZ (EUCTR)	19/12/2017	14/08/2017	Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
154	NCT03362294 (ClinicalTrials.gov)	December 11, 2017	15/11/2017	Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects With PPMS	A Prospective, Multicenter, Single Arm, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)	Primary Progressive Multiple Sclerosis	Drug: GA Depot 40mg once monthly	Mapi Pharma Ltd.	NULL	Recruiting	18 Years	65 Years	All	24	Phase 2	Israel
155	EUCTR2016-002937-31-HR (EUCTR)	29/11/2017	13/04/2018	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;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
156	EUCTR2016-003100-30-DE (EUCTR)	29/11/2017	07/03/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
157	NCT03222973 (ClinicalTrials.gov)	November 14, 2017	17/7/2017	Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies	Multiple Sclerosis	Drug: BIIB033 (opicinumab);Drug: Placebo	Biogen	NULL	Active, not recruiting	18 Years	58 Years	All	263	Phase 2	United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom
158	NCT03350633 (ClinicalTrials.gov)	November 1, 2017	10/11/2017	Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders	Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial	Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica	Drug: Tocilizumab Injection;Drug: Azathioprine	Tianjin Medical University General Hospital	NULL	Completed	18 Years	N/A	All	118	Phase 2;Phase 3	China
159	EUCTR2016-003100-30-GR (EUCTR)	27/10/2017	21/04/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	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]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden
160	NCT03368664 (ClinicalTrials.gov)	October 24, 2017	2/11/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis	Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist	Genzyme, a Sanofi Company	NULL	Active, not recruiting	10 Years	17 Years	All	50	Phase 3	Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland
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
161	NCT03283826 (ClinicalTrials.gov)	October 19, 2017	13/9/2017	Phase 1 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis	A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis	Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis	Biological: ATA188;Drug: Placebo	Atara Biotherapeutics	NULL	Recruiting	18 Years	55 Years	All	97	Phase 1	United States;Australia
162	EUCTR2015-005431-41-PL (EUCTR)	16/10/2017	07/04/2016	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 3	United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
163	EUCTR2016-003100-30-NO (EUCTR)	12/10/2017	12/04/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	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]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden
164	EUCTR2016-003100-30-NL (EUCTR)	28/09/2017	11/05/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden
165	NCT03257358 (ClinicalTrials.gov)	September 19, 2017	18/8/2017	A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod	A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]	Relapsing Multiple Sclerosis	Drug: Fingolimod	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	382	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
166	EUCTR2016-002937-31-NO (EUCTR)	12/09/2017	18/04/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
167	EUCTR2016-002937-31-DE (EUCTR)	11/09/2017	02/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
168	EUCTR2016-002937-31-GB (EUCTR)	06/09/2017	05/09/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
169	EUCTR2016-003100-30-PT (EUCTR)	28/08/2017	04/05/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	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]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
170	NCT03183869 (ClinicalTrials.gov)	August 24, 2017	9/5/2017	Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients	Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients	Autoimmune Diseases;Relapsing Multiple Sclerosis	Drug: Fecal microbiota	Lawson Health Research Institute	NULL	Terminated	18 Years	N/A	All	14	Phase 2	Canada
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
171	EUCTR2016-002937-31-NL (EUCTR)	21/08/2017	15/06/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1228	Phase 3	Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Netherlands;Kuwait;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;Sweden
172	EUCTR2016-003100-30-AT (EUCTR)	03/08/2017	10/08/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	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]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
173	EUCTR2016-002937-31-BG (EUCTR)	02/08/2017	30/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
174	EUCTR2016-002937-31-ES (EUCTR)	31/07/2017	29/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	Roche Farma S.A. (Soc.unipersonal)que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
175	EUCTR2016-002937-31-FR (EUCTR)	26/07/2017	30/10/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;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
176	EUCTR2016-002937-31-PT (EUCTR)	24/07/2017	04/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
177	EUCTR2016-003100-30-BE (EUCTR)	14/07/2017	22/05/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	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]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
178	EUCTR2016-002937-31-BE (EUCTR)	10/07/2017	05/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
179	EUCTR2016-002937-31-HU (EUCTR)	29/06/2017	08/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Slovakia;Slovenia;Finland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Poland;Belgium;Brazil;Romania;Croatia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden
180	EUCTR2016-002820-10-DE (EUCTR)	26/06/2017	08/11/2016	Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab	A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN)	Remitting-Relapsing 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]	Trade Name: Zinbryta Product Name: Daclizumab Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Canada;Germany;Italy;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
181	EUCTR2016-002937-31-PL (EUCTR)	26/06/2017	10/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
182	EUCTR2016-002937-31-AT (EUCTR)	19/06/2017	20/04/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
183	EUCTR2016-002937-31-SE (EUCTR)	19/06/2017	20/04/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
184	EUCTR2016-002937-31-SK (EUCTR)	16/06/2017	11/05/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
185	EUCTR2016-002937-31-SI (EUCTR)	16/06/2017	13/06/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1228	Phase 3	Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;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
186	EUCTR2016-002937-31-DK (EUCTR)	08/06/2017	28/04/2017	A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis	An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1225	Phase 3	United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
187	NCT03239860 (ClinicalTrials.gov)	June 6, 2017	12/7/2017	Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis	A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: GNbAC1 Monoclonal Antibody	GeNeuro SA	Les Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales Servier	Terminated	18 Years	55 Years	All	220	Phase 2	Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
188	EUCTR2016-003100-30-GB (EUCTR)	05/06/2017	27/03/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	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]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
189	NCT03381170 (ClinicalTrials.gov)	June 1, 2017	18/12/2017	An Extension of the TG1101-RMS201 Trial	An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis	Biological: Ublituximab	TG Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	55 Years	All	48	Phase 2	United States
190	EUCTR2015-002500-91-SE (EUCTR)	01/06/2017	27/06/2016	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2495	Phase 3	Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia
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
191	EUCTR2016-003587-39-SE (EUCTR)	22/05/2017	23/03/2017	This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.	COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS)	Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA -1B Other descriptive name: INTERFERON BETA -1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA -1B Other descriptive name: INTERFERON BETA -1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3700	Phase 4	Sweden
192	EUCTR2011-005249-12-SI (EUCTR)	15/05/2017	13/03/2017	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS	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]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 3	Portugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;France;Macedonia, the former Yugoslav Republic of;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland;Bulgaria
193	EUCTR2016-001448-21-PL (EUCTR)	09/05/2017	13/01/2017	A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.	Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 2	United States;Serbia;Czech Republic;Slovakia;Spain;Poland;Ukraine;Turkey;Croatia;Russian Federation;Bulgaria;United Kingdom
194	EUCTR2011-005249-12-PT (EUCTR)	24/04/2017	01/02/2017	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS	Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Israel;Russian Federation;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland
195	NCT02881567 (ClinicalTrials.gov)	April 18, 2017	24/8/2016	Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab	A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)	Relapsing-Remitting Multiple Sclerosis (RRMS)	Drug: Daclizumab	Biogen	AbbVie	Terminated	18 Years	55 Years	All	41	Phase 3	United States;Canada;Germany;Italy;Puerto Rico;France;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
196	EUCTR2016-001448-21-BG (EUCTR)	11/04/2017	14/02/2017	A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.	Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 2	Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria
197	EUCTR2016-003100-30-IT (EUCTR)	11/04/2017	14/05/2019	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) - na	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]		GENZYME CORPORATION	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
198	NCT03085810 (ClinicalTrials.gov)	April 4, 2017	16/3/2017	Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)	An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: Ocrelizumab	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	55 Years	All	1225	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Denmark;France;Germany;Hungary;Italy;Kuwait;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Slovakia;Slovenia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Finland
199	EUCTR2016-003100-30-ES (EUCTR)	04/04/2017	22/02/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	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]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
200	EUCTR2014-000253-36-GR (EUCTR)	31/03/2017	30/01/2017	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 19.1;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		MedImmune LLC	NULL	Not Recruiting			Female: yes Male: yes	212	Phase 2;Phase 3	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;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
201	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
202	EUCTR2011-005249-12-NL (EUCTR)	15/03/2017	08/11/2016	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS	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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	Portugal;Serbia;United States;Estonia;Morocco;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina
203	EUCTR2016-002820-10-GB (EUCTR)	13/03/2017	08/11/2016	Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab	A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - 205MS305_Biogen	Remitting-Relapsing 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]	Trade Name: Zinbryta Product Name: Zinbryta Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;United States;Canada;Denmark;Germany;Italy;United Kingdom
204	NCT02975349 (ClinicalTrials.gov)	March 7, 2017	23/11/2016	A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.	Relapsing-remitting Multiple Sclerosis	Drug: M2951;Drug: Placebo;Drug: Tecfidera	EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany	Active, not recruiting	18 Years	65 Years	All	267	Phase 2	Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States
205	EUCTR2016-001448-21-SK (EUCTR)	16/02/2017	25/10/2016	A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.	Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 2	Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom
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
206	NCT02949908 (ClinicalTrials.gov)	February 9, 2017	17/10/2016	MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)	A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line Treatment	Multiple Sclerosis	Drug: Rebif	Merck KGaA, Darmstadt, Germany	Merck B.V., Netherlands	Terminated	18 Years	65 Years	All	2	Phase 4	Germany
207	EUCTR2016-001448-21-CZ (EUCTR)	06/02/2017	01/11/2016	A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.	Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: M2951 Product Code: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 2	Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom
208	NCT03062579 (ClinicalTrials.gov)	February 1, 2017	13/2/2017	A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD	Single-center, Open Label Trial of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders (NMOSD)	Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica;Devic's Disease	Drug: Tocilizumab	Fu-Dong Shi	NULL	Completed	18 Years	N/A	All	10	Phase 1;Phase 2	China
209	NCT03177083 (ClinicalTrials.gov)	January 30, 2017	26/1/2017	Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy	Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)	Relapsing Remitting Multiple Sclerosis	Drug: peginterferon beta-1a;Drug: interferon beta -1a;Drug: interferon beta -1b	Biogen	NULL	Completed	18 Years	65 Years	All	80	Phase 4	Portugal
210	EUCTR2014-000253-36-HU (EUCTR)	24/01/2017	23/11/2016	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab	MedImmune LLC	NULL	Not Recruiting			Female: yes Male: yes	252	Phase 2;Phase 3	United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;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
211	NCT04570670 (ClinicalTrials.gov)	January 6, 2017	22/9/2020	Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects	A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions	Relapsing Remitting Multiple Sclerosis	Drug: monomethyl fumarate 190 mg;Drug: dimethyl fumarate 240 mg	Banner Life Sciences LLC	NULL	Completed	18 Years	55 Years	All	50	Phase 1	NULL
212	EUCTR2016-001448-21-ES (EUCTR)	05/01/2017	26/10/2016	A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.	Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 2	Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom
213	EUCTR2015-005431-41-HR (EUCTR)	30/11/2016	15/12/2016	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 3	United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
214	EUCTR2015-004616-37-DE (EUCTR)	24/11/2016	05/08/2016	A Study to Explore the Mechanism of Action of Ocrelizumab and B-cell Biology in Patients with Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis.	An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis or primary progressive multiple sclerosis.	- Relapsing multiple sclerosis (RMS)/Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	GENENTECH Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	99	Phase 3	United States;Germany;Switzerland;Sweden
215	EUCTR2016-000434-21-PT (EUCTR)	14/11/2016	14/09/2016	PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)	PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)	Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy 125 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A Trade Name: Rebif 22 micrograms INN or Proposed INN: Interferon beta -1a Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta -1a Other descriptive name: INTERFERON BETA -1A Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Extavia 250 micrograms/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Plegridy 63 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A	Biogen Portugal	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	75	Phase 4	Portugal
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
216	NCT02913157 (ClinicalTrials.gov)	November 2016	20/9/2016	Hydroxychloroquine in Primary Progressive Multiple Sclerosis	Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS)	Multiple Sclerosis, Primary Progressive	Drug: Hydroxychloroquine	University of Calgary	NULL	Active, not recruiting	18 Years	65 Years	All	35	Phase 2	Canada
217	EUCTR2015-005597-38-CZ (EUCTR)	07/10/2016	17/06/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
218	NCT02807285 (ClinicalTrials.gov)	October 2016	16/6/2016	Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis	An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab	Genentech, Inc.	NULL	No longer available	18 Years	55 Years	All		N/A	United States
219	JPRN-UMIN000024312	2016/09/20	25/05/2017	Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds.		Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis	Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks	Tsukuba International Clinical Pharmacology Clinic	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	12	Not selected	Japan
220	EUCTR2015-005597-38-FI (EUCTR)	12/09/2016	21/06/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;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
221	NCT02861014 (ClinicalTrials.gov)	September 9, 2016	5/8/2016	A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)	An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment	Multiple Sclerosis, Relapsing-Remitting	Biological: Ocrelizumab	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	55 Years	All	681	Phase 3	Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong
222	EUCTR2015-005160-41-DE (EUCTR)	27/07/2016	04/03/2016	an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis	A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Bulgaria;Russian Federation;Germany
223	EUCTR2015-005597-38-BE (EUCTR)	14/07/2016	16/06/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
224	EUCTR2015-005597-38-NL (EUCTR)	11/07/2016	01/06/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
225	EUCTR2015-005597-38-DE (EUCTR)	29/06/2016	07/04/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;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
226	EUCTR2015-005160-41-BG (EUCTR)	27/06/2016	04/05/2016	an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis	A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1	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]		Alkermes, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;United States;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany
227	NCT02797015 (ClinicalTrials.gov)	June 23, 2016	26/5/2016	Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS	A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis	Multiple Sclerosis	Drug: RPC1063	Celgene	NULL	Completed	18 Years	55 Years	All	22	Phase 1	United States
228	EUCTR2015-002500-91-HR (EUCTR)	13/06/2016	06/07/2016	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
229	EUCTR2016-000464-42-DE (EUCTR)	13/06/2016	11/04/2016	The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab	A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse	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]		Genzyme GmbH	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Germany
230	EUCTR2015-005160-41-PL (EUCTR)	07/06/2016	13/04/2016	an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis	A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1	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]		Alkermes, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;United States;Canada;Belgium;Spain;Poland;Ukraine;Russian Federation;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
231	EUCTR2015-002500-91-PT (EUCTR)	06/06/2016	13/04/2016	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
232	EUCTR2015-005160-41-ES (EUCTR)	06/06/2016	20/04/2016	an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis	A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis	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]		Alkermes, Inc.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Serbia;United States;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany
233	EUCTR2015-005597-38-DK (EUCTR)	02/06/2016	06/04/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
234	EUCTR2015-002500-91-LT (EUCTR)	31/05/2016	17/03/2016	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2495	Phase 3	United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
235	EUCTR2015-005597-38-SE (EUCTR)	25/05/2016	15/03/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;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
236	EUCTR2015-005597-38-EE (EUCTR)	25/05/2016	06/04/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
237	EUCTR2015-005597-38-FR (EUCTR)	23/05/2016	15/02/2018	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
238	EUCTR2015-005597-38-GB (EUCTR)	19/05/2016	09/03/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
239	EUCTR2015-005597-38-IE (EUCTR)	13/05/2016	10/03/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
240	NCT02720107 (ClinicalTrials.gov)	May 12, 2016	21/3/2016	Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)	Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720)	Relapsing-remitting Multiple Sclerosis	Drug: fingolimod	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	133	Phase 4	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
241	NCT02688985 (ClinicalTrials.gov)	April 29, 2016	18/2/2016	Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)	An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis	Relapsing Multiple Sclerorsis;Multiple Sclerosis, Primary Progressive	Drug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: Antihistamine	Genentech, Inc.	NULL	Active, not recruiting	18 Years	55 Years	All	127	Phase 3	United States;Canada;Germany;Sweden
242	EUCTR2015-005160-41-BE (EUCTR)	27/04/2016	07/03/2016	an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis	A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700	Alkermes, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Serbia;United States;Canada;Poland;Spain;Belgium;Ukraine;Russian Federation;Bulgaria;Germany
243	EUCTR2015-005597-38-ES (EUCTR)	26/04/2016	18/03/2016	A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis	An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING	Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Ocrelizumab Product Code: RO4964913/F07 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB	Roche Farma S.A. que representa en España a F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
244	EUCTR2015-002500-91-LV (EUCTR)	20/04/2016	19/02/2016	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
245	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
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
246	EUCTR2015-002500-91-EE (EUCTR)	04/04/2016	07/03/2016	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2495	Phase 3	Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
247	NCT02782858 (ClinicalTrials.gov)	April 2016	23/5/2016	Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS	An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: GNbAC1;Drug: Placebo	GeNeuro SA	Les Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical Trials	Completed	18 Years	55 Years	All	270	Phase 2	Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
248	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
249	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
250	EUCTR2015-000922-12-DE (EUCTR)	12/02/2016	02/10/2015	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE	Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;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
251	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
252	NCT02637856 (ClinicalTrials.gov)	February 11, 2016	18/12/2015	A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)	An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment	Multiple Sclerosis, Relapsing-Remitting	Drug: Ocrelizumab	Genentech, Inc.	NULL	Completed	18 Years	55 Years	All	608	Phase 3	United States;Canada
253	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
254	EUCTR2015-000922-12-FR (EUCTR)	28/01/2016	26/02/2016	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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]		Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
255	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
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
256	EUCTR2015-002500-91-SK (EUCTR)	22/01/2016	28/10/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain
257	EUCTR2015-002500-91-PL (EUCTR)	20/01/2016	01/12/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
258	EUCTR2015-002500-91-BG (EUCTR)	13/01/2016	20/10/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru
259	EUCTR2015-000922-12-ES (EUCTR)	12/01/2016	13/01/2016	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE	Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	820	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
260	EUCTR2015-000922-12-PL (EUCTR)	05/01/2016	03/12/2015	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE	Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;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
261	EUCTR2015-000922-12-BE (EUCTR)	04/01/2016	01/10/2015	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE	Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
262	NCT02276963 (ClinicalTrials.gov)	January 2016	21/10/2014	Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses	Phase I, Single-Center, Open Label Trial of Ublituximab + Glucocorticoids for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder	Drug: Ublituximab	Johns Hopkins University	NULL	Completed	18 Years	100 Years	All	6	Phase 1	United States
263	NCT02644044 (ClinicalTrials.gov)	January 2016	23/3/2015	Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study	Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study	To Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MS	Drug: Intrathecal methotrexate	Tel-Aviv Sourasky Medical Center	NULL	Not yet recruiting	18 Years	75 Years	Both	30	Phase 0	NULL
264	EUCTR2015-000922-12-IE (EUCTR)	22/12/2015	09/10/2015	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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]		Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
265	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
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
266	EUCTR2015-000922-12-FI (EUCTR)	15/12/2015	07/12/2015	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE	Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
267	EUCTR2015-000922-12-HR (EUCTR)	11/12/2015	04/02/2016	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE	Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
268	NCT02634307 (ClinicalTrials.gov)	December 10, 2015	16/12/2015	A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1	A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis	Drug: ALKS 8700	Biogen	Alkermes, Inc.	Active, not recruiting	18 Years	65 Years	All	1057	Phase 3	United States;Belgium;Bulgaria;Canada;Germany;Poland;Russian Federation;Serbia;Spain;Ukraine
269	EUCTR2013-001151-12-HR (EUCTR)	08/12/2015	01/02/2016	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	Relapsing Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	132	Phase 3	United States;Saudi Arabia;Taiwan;Hong Kong;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Romania;Croatia;Germany;Japan;Sweden
270	NCT02583594 (ClinicalTrials.gov)	December 6, 2015	16/10/2015	A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis	A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis	Progressive Multiple Sclerosis	Drug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: Dexchlorpheniramine	Genzyme, a Sanofi Company	NULL	Active, not recruiting	18 Years	N/A	All	24	Phase 1	Spain
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
271	NCT02893111 (ClinicalTrials.gov)	December 2015	27/8/2016	Efficacy and Safety of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder	Single-center, Open Label Trial of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder	Neuromyelitis Optica Spectrum Disorder	Drug: Bortezomib	Tianjin Medical University General Hospital	NULL	Completed	18 Years	N/A	Female	5	Phase 2	China
272	EUCTR2015-002500-91-ES (EUCTR)	24/11/2015	05/10/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod	Receptos, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2350		Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden
273	EUCTR2015-000922-12-AT (EUCTR)	19/11/2015	01/10/2015	A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE	Teva Pharmaceutical Industries, Ltd	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
274	EUCTR2012-003735-32-GR (EUCTR)	19/11/2015	06/08/2015	Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.	A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment	Relapsing-remitting multiple sclerosis (RR MS) 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: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib mesylate	AB Science	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany
275	EUCTR2015-002500-91-GR (EUCTR)	18/11/2015	04/11/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI	Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;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
276	EUCTR2015-002500-91-BE (EUCTR)	10/11/2015	02/09/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
277	EUCTR2015-002500-91-GB (EUCTR)	10/11/2015	18/09/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	2496	Phase 3	United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
278	EUCTR2011-005249-12-LT (EUCTR)	06/11/2015	02/10/2015	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS	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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria
279	EUCTR2015-000922-12-IT (EUCTR)	05/11/2015	28/02/2018	A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml daily	A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE	Relapsing-Remitting Multiple Sclerosis (RRMS) 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: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO	TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 4	United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
280	NCT02686684 (ClinicalTrials.gov)	November 2015	11/2/2016	Tecfidera Diffusion Tensor Imaging	An Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple Sclerosis	Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging	Drug: Dimethyl fumarate	University at Buffalo	NULL	Completed	18 Years	N/A	Both	115	N/A	NULL
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
281	NCT02545868 (ClinicalTrials.gov)	October 27, 2015	8/9/2015	A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis	A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Biological: 23-PPV;Biological: 13-PCV Booster;Biological: Influenza Vaccine;Biological: KLH;Drug: OCR;Biological: TT Vaccine	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	55 Years	All	102	Phase 3	United States;Canada
282	NCT02576717 (ClinicalTrials.gov)	October 16, 2015	28/9/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients	Multiple Sclerosis	Drug: RPC1063	Celgene	NULL	Active, not recruiting	18 Years	55 Years	All	2495	Phase 3	United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Germany;Greece;Hungary;Italy;Latvia;Lithuania;Moldova, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Ukraine;United Kingdom
283	EUCTR2015-002500-91-HU (EUCTR)	12/10/2015	26/08/2015	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis	A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Celgene International II Sàrl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2496	Phase 3	Belgium;Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
284	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
285	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
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
286	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
287	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
288	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
289	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
290	NCT02499900 (ClinicalTrials.gov)	August 10, 2015	1/7/2015	Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®	CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily	Multiple Sclerosis	Drug: Copaxone ®	Teva Pharmaceutical Industries, Ltd.	NULL	Completed	18 Years	N/A	All	861	Phase 4	United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey
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
291	EUCTR2014-000395-26-DE (EUCTR)	07/08/2015	09/04/2014	Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take Tecfidera	A 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISION	Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tecfidera INN or Proposed INN: Dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE	Biogen GmbH	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 4	Germany
292	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
293	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
294	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
295	NCT02506751 (ClinicalTrials.gov)	July 2015	12/7/2015	Open-label Study of Liothyronine in MS	A Phase 1b, Open-label Study to Evaluate the Safety and Tolerability of the Putative Remyelinating Agent, Liothyronine, in Individuals With MS	Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive	Drug: liothyronine	Johns Hopkins University	NULL	Completed	18 Years	58 Years	All	20	Phase 1	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
296	NCT02665221 (ClinicalTrials.gov)	July 2015	22/1/2016	Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY	Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.	Multiple Sclerosis	Other: No Treatment Arm;Drug: Topical Preparation H arm	New York University School of Medicine	NULL	Terminated	18 Years	70 Years	All	32	Phase 4	United States
297	EUCTR2011-005249-12-PL (EUCTR)	11/06/2015	07/07/2014	A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis	A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis with Relapsing Forms of Multiple Sclerosis Followed byan Open-Label Extension - TERIKIDS	Multiple Sclerosis MedDRA version: 18.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	165		United States;Estonia;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Poland;Belgium;Australia;China
298	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
299	NCT02090348 (ClinicalTrials.gov)	June 2015	14/3/2014	Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate	A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)	Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis	Drug: dimethyl fumarate	Biogen	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 4	NULL
300	EUCTR2014-001579-30-NL (EUCTR)	21/05/2015	26/11/2014	A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO	Primary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN)	Teva Pharmaceutical Industries Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Canada;Poland;Spain;Ukraine;Russian Federation;Germany;Netherlands;Italy;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
301	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
302	EUCTR2013-003752-21-ES (EUCTR)	07/05/2015	11/03/2015	A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody	Chugai Pharmaceutical Co. Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom
303	EUCTR2013-003752-21-HU (EUCTR)	04/05/2015	25/02/2015	A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 18.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody	Chugai Pharmaceutical Co. Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	France;United States;Taiwan;Hungary;Poland;Spain;Germany;Japan;Italy;United Kingdom
304	NCT02323269 (ClinicalTrials.gov)	May 2015	18/12/2014	Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)	A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)	Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple Sclerosis	Drug: dimethyl fumarate	Biogen	NULL	Terminated	18 Years	N/A	Both	24	N/A	Canada
305	EUCTR2014-005548-17-FR (EUCTR)	28/04/2015	03/06/2015	TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY	TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY	PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR MedDRA version: 18.0;Level: PT;Classification code 10029864;Term: Nystagmus;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: NEURONTIN Product Name: Gabapentine Product Code: N03AX12 Other descriptive name: GABAPENTIN Trade Name: EBIXA Product Name: MEMANTINE Product Code: N06DX01 INN or Proposed INN: MEMANTINE	HOSPICES CIVILS DE LYON	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	France
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
306	EUCTR2013-001151-12-CZ (EUCTR)	22/04/2015	19/09/2014	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;United Arab Emirates;Saudi Arabia;Thailand;Spain;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden;Taiwan;Hong Kong;Martinique
307	JPRN-UMIN000017217	2015/04/21	21/04/2015	An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica	An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2	Neuromyelitis optica	Rituximab intravenous infusion	Clinical Research Center, Utano National Hospital, National Hospital Organization	Zenyaku Kogyo Co., Ltd.	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Phase 2;Phase 3	Japan
308	EUCTR2012-003735-32-SK (EUCTR)	01/04/2015	09/04/2015	Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.	A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment	Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		AB Science	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany
309	EUCTR2013-001151-12-DK (EUCTR)	25/03/2015	11/02/2015	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;Hong Kong;Taiwan;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Singapore;Croatia;Romania;Germany;Japan;Sweden
310	EUCTR2014-001579-30-DE (EUCTR)	20/03/2015	11/11/2014	A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO	Primary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;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
311	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
312	NCT02343159 (ClinicalTrials.gov)	February 28, 2015	9/1/2015	Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.	A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients.	Multiple Sclerosis	Drug: dimethyl fumarate;Device: Medication Event Monitoring System (MEMS);Behavioral: Adherence counseling	Biogen	NULL	Terminated	18 Years	65 Years	All	84	Phase 4	United States
313	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
314	EUCTR2014-000253-36-DE (EUCTR)	27/02/2015	30/09/2014	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab	MedImmune LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	231	Phase 2;Phase 3	Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand
315	EUCTR2013-004622-29-DE (EUCTR)	23/02/2015	11/11/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;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
316	EUCTR2014-000253-36-ES (EUCTR)	16/02/2015	22/12/2014	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: NA	MedImmune LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	212		United States;Taiwan;Estonia;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Japan;New Zealand
317	EUCTR2014-000253-36-BG (EUCTR)	04/02/2015	05/11/2014	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		MedImmune LLC	NULL	Not Recruiting			Female: yes Male: yes	231	Phase 2;Phase 3	Serbia;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand
318	NCT02418351 (ClinicalTrials.gov)	February 2015	8/4/2015	A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS	An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS	Multiple Sclerosis, Relapsing-Remitting	Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy	Genesis Limited	NULL	Terminated	18 Years	60 Years	Both	69	Phase 1;Phase 2	India;Trinidad and Tobago
319	NCT02418325 (ClinicalTrials.gov)	February 2015	8/4/2015	A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS	An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)	Multiple Sclerosis, Relapsing-Remitting	Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy	Genesis Limited	NULL	Terminated	18 Years	60 Years	Both	69	Phase 1;Phase 2	Trinidad and Tobago
320	NCT02587715 (ClinicalTrials.gov)	February 2015	26/10/2015	A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS	An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)	Multiple Sclerosis, Relapsing-Remitting	Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy	Novo Cellular Medicine Institute LLP	NULL	Recruiting	18 Years	60 Years	Both	69	Phase 1;Phase 2	Trinidad and Tobago
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
321	NCT02490046 (ClinicalTrials.gov)	February 2015	28/4/2015	D-mannose for the Prevention of UTIs in Multiple Sclerosis	Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis	Multiple Sclerosis;Recurrent Urinary Tract Infections	Dietary Supplement: D Mannose	University College, London	UCLH	Recruiting	18 Years	65 Years	Both	20	Phase 1	United Kingdom
322	NCT02587806 (ClinicalTrials.gov)	February 2015	26/10/2015	A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS	An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS	Multiple Sclerosis, Relapsing-Remitting	Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy	Novo Cellular Medicine Institute LLP	NULL	Recruiting	18 Years	60 Years	Both	69	Phase 1;Phase 2	India;Trinidad and Tobago
323	NCT02308137 (ClinicalTrials.gov)	February 2015	2/12/2014	Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)	Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Domperidone 10mg QID for Reducing Progression of Disability in Patients With Secondary Progressive Multiple Sclerosis (SPMS)	Multiple Sclerosis, Secondary Progressive	Drug: Domperidone	University of Calgary	Alberta Innovates Health Solutions	Completed	18 Years	60 Years	All	64	Phase 2	Canada
324	EUCTR2013-004622-29-DK (EUCTR)	29/01/2015	04/12/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden
325	EUCTR2013-005586-39-DE (EUCTR)	29/01/2015	02/09/2014	Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other Therapies	A Phase 4 Multicenter, Open-Label, Single Arm Study toEvaluate Switching from BRACET/Gilenya® to Natalizumabin Subjects with Relapsing Forms of Multiple Sclerosis (MS)	Multiple Sclerosis (MS) MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United States;Germany;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
326	NCT02284568 (ClinicalTrials.gov)	January 12, 2015	31/10/2014	A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo	A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS)	Primary Progressive Multiple Sclerosis	Drug: Placebo;Drug: Laquinimod	Teva Branded Pharmaceutical Products R&D, Inc.	NULL	Completed	25 Years	55 Years	All	374	Phase 2	United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
327	NCT02200770 (ClinicalTrials.gov)	January 6, 2015	16/7/2014	A Double-masked, Placebo-controlled Study With Open Label Period to Evaluate MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	Drug: Inebilizumab;Other: Placebo	MedImmune LLC	NULL	Active, not recruiting	18 Years	N/A	All	231	Phase 2;Phase 3	United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine
328	NCT02003144 (ClinicalTrials.gov)	January 2015	18/11/2013	An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients	A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)	Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder	Biological: eculizumab	Alexion Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	119	Phase 3	United States;Argentina;Australia;Canada;Colombia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;France;Singapore
329	EUCTR2013-004622-29-SE (EUCTR)	30/12/2014	29/09/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
330	EUCTR2014-000253-36-PL (EUCTR)	30/12/2014	14/11/2014	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		MedImmune LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	231	Phase 2;Phase 3	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;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
331	EUCTR2014-001579-30-ES (EUCTR)	22/12/2014	23/10/2014	A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO	Primary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN)	Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom
332	EUCTR2014-000253-36-CZ (EUCTR)	08/12/2014	14/08/2014	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab	MedImmune LLC	NULL	Not Recruiting			Female: yes Male: yes	231	Phase 2;Phase 3	United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand
333	EUCTR2014-001579-30-IT (EUCTR)	04/12/2014	19/09/2014	A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO	Primary Progressive Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN)	Teva Pharmaceutical Industries Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy;United States;Canada;Spain
334	EUCTR2013-004622-29-ES (EUCTR)	03/12/2014	03/10/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
335	NCT02142192 (ClinicalTrials.gov)	December 2014	16/5/2014	Natalizumab Subcutaneous Immunogenicity and Safety Study	A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis	Drug: natalizumab	Biogen	NULL	Terminated	18 Years	65 Years	Both	2	Phase 2	Belgium;Denmark;Germany;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
336	NCT02342704 (ClinicalTrials.gov)	November 30, 2014	15/1/2015	Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Relapsing-Remitting Multiple Sclerosis	Drug: natalizumab;Drug: fingolimod	Biogen	NULL	Terminated	18 Years	60 Years	All	111	Phase 4	United States;Australia;Czechia;France;Germany;Italy;Spain;Sweden;United Kingdom;Czech Republic;Denmark
337	EUCTR2014-001579-30-GB (EUCTR)	27/11/2014	08/09/2014	A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as compared to placebo	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO	Primary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Teva Pharmaceutical Industries Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom
338	EUCTR2014-000917-30-DE (EUCTR)	25/11/2014	03/07/2014	Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis	A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis	Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	113	Phase 2	Belgium;Denmark;Germany;Italy
339	EUCTR2013-004622-29-GB (EUCTR)	20/11/2014	28/08/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
340	EUCTR2013-002378-26-SE (EUCTR)	13/11/2014	15/08/2013	Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes	Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext	The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera ® Product Name: Mabthera	Västerbottens Läns Landsting	NULL	Not Recruiting			Female: yes Male: yes	74	Phase 2	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
341	EUCTR2013-004622-29-IT (EUCTR)	10/11/2014	05/08/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540		France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden
342	NCT02253264 (ClinicalTrials.gov)	November 2014	29/9/2014	A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients	A Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal Enhancement	Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis	Drug: Rituximab	Johns Hopkins University	NULL	Completed	18 Years	N/A	All	8	Phase 1	United States
343	NCT02310048 (ClinicalTrials.gov)	November 2014	14/11/2014	Comparative Oral Bioavailability Study of MT-1303	A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male Subjects	Relapsing-remitting Multiple Sclerosis	Drug: MT-1303-FormA;Drug: MT-1303-FormB	Mitsubishi Tanabe Pharma Corporation	NULL	Completed	18 Years	55 Years	Male	34	Phase 1	United Kingdom
344	EUCTR2013-004622-29-CZ (EUCTR)	31/10/2014	13/08/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
345	EUCTR2014-003669-97-BE (EUCTR)	27/10/2014	02/09/2014	A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.	A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.	Relapsing Forms of Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB	Biogen Idec	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 4	Belgium
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
346	EUCTR2014-000253-36-EE (EUCTR)	24/10/2014	13/10/2014	A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders	A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD	Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab	MedImmune LLC	NULL	Not Recruiting			Female: yes Male: yes	231	Phase 2;Phase 3	United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand
347	EUCTR2014-000917-30-BE (EUCTR)	21/10/2014	24/07/2014	Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis	A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis	Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	113		Belgium;Denmark;Italy
348	NCT02212886 (ClinicalTrials.gov)	October 2014	5/8/2014	Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS	A Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)	Multiple Sclerosis	Drug: GA Depot 80 mg;Drug: GA Depot 40 mg	Mapi Pharma Ltd.	NULL	Active, not recruiting	18 Years	70 Years	All	25	Phase 1;Phase 2	Israel
349	NCT02296346 (ClinicalTrials.gov)	October 2014	18/11/2014	Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis	A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS)	Secondary Progressive Multiple Sclerosis	Drug: SoluMedrol;Device: Extracorporeal Photopheresis	University of Utah	Mallinckrodt	Terminated	18 Years	75 Years	All	13	N/A	United States
350	NCT02234869 (ClinicalTrials.gov)	October 2014	5/9/2014	Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy	Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017)	Relapsing Multiple Sclerosis	Drug: Interferon Beta;Drug: BIIB017 (Peginterferon beta-1a)	Biogen Idec	NULL	Withdrawn	18 Years	65 Years	Both	0	Phase 4	NULL
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
351	NCT02269930 (ClinicalTrials.gov)	October 2014	17/10/2014	Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers	An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers	Multiple Sclerosis	Drug: peginterferon beta-1a;Drug: Rebif	Biogen Idec	NULL	Completed	18 Years	45 Years	Both	30	Phase 1	United States
352	NCT02241785 (ClinicalTrials.gov)	September 30, 2014	12/9/2014	Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies	A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS)	Relapsing Multiple Sclerosis	Drug: natalizumab	Biogen	NULL	Terminated	18 Years	60 Years	All	47	Phase 4	United States;Germany
353	EUCTR2011-005249-12-GB (EUCTR)	29/09/2014	14/07/2014	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS	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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria
354	NCT02232061 (ClinicalTrials.gov)	September 29, 2014	2/9/2014	Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod	Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod	Multiple Sclerosis	Drug: Fingolimod	Novartis Pharmaceuticals	NULL	Completed	N/A	N/A	All	6	Phase 4	Belgium;Germany;Italy
355	EUCTR2014-000917-30-DK (EUCTR)	02/09/2014	10/07/2014	Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis	A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis	Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	113		Belgium;Denmark;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
356	NCT02293967 (ClinicalTrials.gov)	September 2014	14/11/2014	Mass Balance Study of MT-1303	An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.	Relapsing-remitting Multiple Sclerosis	Drug: MT-1303	Mitsubishi Tanabe Pharma Corporation	NULL	Completed	30 Years	65 Years	Male	8	Phase 1	United Kingdom
357	EUCTR2013-003752-21-PL (EUCTR)	31/08/2014	04/07/2014	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Satralizumab (120mg/vial) Product Code: Satralizumab (RO5333787/Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom
358	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
359	EUCTR2011-005249-12-EE (EUCTR)	13/08/2014	27/02/2014	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS	Multiple Sclerosis MedDRA version: 17.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165		United States;Estonia;Greece;Canada;Spain;Belgium;Lebanon;Turkey;Australia;Russian Federation;Israel;China
360	NCT02073279 (ClinicalTrials.gov)	August 5, 2014	25/2/2014	Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)	Drug: Satralizumab;Drug: Placebo	Hoffmann-La Roche	Chugai Pharmaceutical	Active, not recruiting	18 Years	74 Years	All	95	Phase 3	United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Puerto Rico;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Singapore
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
361	EUCTR2014-000917-30-IT (EUCTR)	25/07/2014	07/07/2014	Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis	A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis	Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	113		Belgium;Denmark;Italy
362	EUCTR2013-001151-12-AT (EUCTR)	23/07/2014	14/02/2014	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
363	EUCTR2012-000835-18-PL (EUCTR)	22/07/2014	06/06/2014	A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS	Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis	Primary progressive multiple sclerosis. MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: Fingolimod hydrochloride	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	700		United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
364	NCT02201108 (ClinicalTrials.gov)	July 16, 2014	17/7/2014	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension	Multiple Sclerosis	Drug: Teriflunomide;Drug: Placebo	Genzyme, a Sanofi Company	NULL	Active, not recruiting	10 Years	17 Years	All	166	Phase 3	United States;Belgium;Bulgaria;Canada;China;Estonia;France;Greece;Israel;Lebanon;Lithuania;Morocco;Netherlands;North Macedonia;Portugal;Russian Federation;Serbia;Slovenia;Spain;Tunisia;Turkey;Ukraine;United Kingdom;Australia;Macedonia, The Former Yugoslav Republic of;Poland
365	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
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
366	EUCTR2011-005249-12-BE (EUCTR)	11/07/2014	17/03/2014	Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis	A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS	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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;France;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria
367	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
368	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
369	EUCTR2012-000835-18-DK (EUCTR)	23/06/2014	09/05/2014	A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS	Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis	Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: FTY720	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
370	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
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
371	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
372	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
373	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
374	NCT02117050 (ClinicalTrials.gov)	June 2014	15/4/2014	RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate	RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw)	Multiple Sclerosis	Drug: Rebif ®	EMD Serono	NULL	Terminated	18 Years	65 Years	All	1	Phase 4	United States
375	NCT02125604 (ClinicalTrials.gov)	June 2014	25/4/2014	Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany	A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)	Relapsing-Remitting Multiple Sclerosis	Drug: dimethyl fumarate	Biogen	NULL	Completed	18 Years	N/A	All	214	Phase 4	Germany
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
376	NCT01941004 (ClinicalTrials.gov)	June 2014	9/9/2013	Safety and Efficacy of Fingolimod in MS Patients in China	A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis	Multiple Sclerosis (Relapsing Remitting)	Drug: fingolimod;Drug: Placebo (6mos) + open label fingolimod (6 mos)	Novartis Pharmaceuticals	NULL	Withdrawn	18 Years	50 Years	All	0	Phase 3	NULL
377	NCT02064816 (ClinicalTrials.gov)	May 31, 2014	13/2/2014	A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis	Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: Rebif ®	Merck KGaA, Darmstadt, Germany	NULL	Completed	18 Years	60 Years	All	200	Phase 4	Germany
378	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
379	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
380	EUCTR2013-003752-21-DE (EUCTR)	22/05/2014	20/12/2013	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;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
381	EUCTR2013-003752-21-GB (EUCTR)	19/05/2014	15/10/2013	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom
382	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
383	EUCTR2013-001151-12-FR (EUCTR)	13/05/2014	25/09/2015	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	Relapsing Neuromyelitis Optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	93	Phase 3	United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
384	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
385	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
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
386	NCT02046629 (ClinicalTrials.gov)	May 2014	23/1/2014	A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers	An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects	Multiple Sclerosis	Drug: Teriflunomide HMR1726;Drug: cholestyramine	Sanofi	NULL	Completed	18 Years	45 Years	Both	12	Phase 1	China
387	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
388	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
389	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
390	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
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
391	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
392	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
393	NCT04256252 (ClinicalTrials.gov)	April 2014	2/2/2020	Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)	Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial	Neuromyelitis Optica Spectrum Disorder	Drug: Rituximab	Tang-Du Hospital	NULL	Completed	16 Years	75 Years	All	108	Phase 4	NULL
394	NCT02865018 (ClinicalTrials.gov)	April 2014	9/8/2016	Neuromyelitis Optica (NMO) & Cetirizine	An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica	Neuromyelitis Optica	Drug: cetirizine	Icahn School of Medicine at Mount Sinai	Guthy Jackson Foundation	Completed	18 Years	85 Years	Both	16	Phase 1;Phase 2	United States
395	EUCTR2013-003752-21-IT (EUCTR)	28/03/2014	06/02/2014	A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder	A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 16.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: SA237 INN or Proposed INN: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody	Chugai Pharmaceutical Co. Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	France;Hungary;Taiwan;Spain;Poland;Germany;United Kingdom;Japan;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
396	NCT02087813 (ClinicalTrials.gov)	March 2014	11/3/2014	Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses	A Single Center Open Label Pilot Study of Alpha1-Antitrypsin: A Novel Treatment to Mitigate Neuromyelitis Optica Attacks	Neuromyelitis Optica	Drug: Alpha1-antitrypsin;Drug: methylprednisolone	Stanford University	NULL	Withdrawn	18 Years	75 Years	All	0	Phase 1	United States
397	NCT01973491 (ClinicalTrials.gov)	February 28, 2014	23/10/2013	ATX-MS-1467 in Multiple Sclerosis	An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and Its Effect on Immune Tolerance in Subjects With Relapsing Multiple Sclerosis	Multiple Sclerosis	Drug: ATX-MS-1467	Merck KGaA	NULL	Completed	18 Years	65 Years	All	37	Phase 2	Germany
398	NCT02028884 (ClinicalTrials.gov)	February 20, 2014	6/1/2014	Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)	Drug: Satralizumab;Drug: Placebo;Drug: Baseline Treatment	Hoffmann-La Roche	Chugai Pharmaceutical	Active, not recruiting	12 Years	74 Years	All	83	Phase 3	United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom
399	JPRN-JapicCTI-132397	20/2/2014	26/12/2013	Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD	A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)	Neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)	Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : subcutaneous administration of SA237 Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Chugai Pharmaceutical Co., Ltd.	F. Hoffmann-La Roche Ltd	complete	12	74	BOTH	85	Phase 3	Japan, Asia except Japan, North America, Europe
400	EUCTR2013-001151-12-GB (EUCTR)	18/02/2014	25/07/2013	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	132	Phase 3	United States;Taiwan;Hong Kong;Spain;Russian Federation;Colombia;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;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
401	NCT02166346 (ClinicalTrials.gov)	February 2014	16/6/2014	Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)	Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch)	Transverse Myelitis;Neuromyelitis Optica;Idiopathic Transverse Myelitis;Myelitis NOS	Drug: Dalfampridine;Drug: Placebo	Johns Hopkins University	Acorda Therapeutics	Completed	18 Years	70 Years	All	24	Phase 2	United States
402	EUCTR2013-002082-19-NL (EUCTR)	09/01/2014	17/10/2013	A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO	Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Teva Pharmaceutical Industries, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
403	EUCTR2013-002082-19-ES (EUCTR)	02/01/2014	31/10/2013	A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon beta-1a (Avonex, authorised drug) administered once weekly.	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon beta-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO	Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Teva Pharmaceutical Industries, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
404	NCT01975298 (ClinicalTrials.gov)	January 2014	28/10/2013	A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).	Relapsing Remitting Multiple Sclerosis	Drug: Laquinimod;Drug: Avonex ®	Teva Pharmaceutical Industries	NULL	Withdrawn	18 Years	55 Years	Both	0	Phase 3	Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
405	EUCTR2013-002916-28-LV (EUCTR)	12/12/2013	16/10/2013	An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis	An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis	Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Russian Federation;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
406	EUCTR2013-001151-12-DE (EUCTR)	12/12/2013	02/07/2013	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden
407	EUCTR2013-002082-19-FI (EUCTR)	04/12/2013	15/10/2013	A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO	Relapsing remitting multiple sclerosis 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: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Teva Pharmaceutical Industries, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
408	EUCTR2013-002082-19-DK (EUCTR)	03/12/2013	03/12/2013	A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO	Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Teva Pharmaceutical Industries, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
409	EUCTR2013-002082-19-BE (EUCTR)	25/11/2013	13/09/2013	A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO	Relapsing remitting multiple sclerosis MedDRA version: 16.0;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: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Teva Pharmaceutical Industries, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
410	EUCTR2013-002082-19-SE (EUCTR)	21/11/2013	13/09/2013	A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO	Relapsing remitting multiple sclerosis MedDRA version: 16.0;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: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Teva Pharmaceutical Industries, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;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
411	EUCTR2013-002082-19-GB (EUCTR)	13/11/2013	06/11/2013	A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.	A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO	Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Teva Pharmaceutical Industries, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden
412	NCT01939002 (ClinicalTrials.gov)	November 2013	23/8/2013	Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017)	An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017	Relapsing Multiple Sclerosis	Drug: BIIB017;Drug: naproxen	Biogen	NULL	Completed	18 Years	65 Years	All	251	Phase 3	United States
413	NCT02048358 (ClinicalTrials.gov)	November 2013	17/1/2014	Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients	Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201	Healthy Volunteers;Multiple Sclerosis	Drug: 2B3-201;Drug: Placebo;Drug: Methylprednisolone hemisuccinate	BBB-Therapeutics B.V.	NULL	Terminated	18 Years	65 Years	Both	47	Phase 1	Netherlands
414	NCT01930708 (ClinicalTrials.gov)	October 31, 2013	15/8/2013	A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes	A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting	Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis	Drug: dimethyl fumarate	Biogen	NULL	Completed	18 Years	N/A	All	1114	Phase 4	Austria;Belgium;Canada;Czechia;France;Hungary;Italy;Portugal;Slovakia;Slovenia;Spain;Czech Republic
415	EUCTR2012-003176-39-DK (EUCTR)	30/10/2013	25/10/2013	Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301	A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND	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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP)	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 3	Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden;Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada
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
416	EUCTR2013-001151-12-ES (EUCTR)	17/10/2013	08/08/2013	EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)	Relapsing Neuromyelitis Optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden
417	NCT01863888 (ClinicalTrials.gov)	October 2013	23/5/2013	Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis	Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Drug: teriflunomide HMR1726;Drug: cholestyramine;Drug: charcoal	Sanofi	NULL	Completed	18 Years	55 Years	Both	70	Phase 3	Belgium;Germany;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

NCT04660539
(ClinicalTrials.gov)

January 11, 2021

24/11/2020

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica Spectrum Disorder

Drug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroids

Hoffmann-La Roche

NULL

Not yet recruiting

18 Years

N/A

All

127

Phase 3

United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom

NCT03807973
(ClinicalTrials.gov)

December 30, 2020

14/1/2019

Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

Fibromyalgia;Chronic Fatigue Syndrome;Multiple Sclerosis;Healthy

Drug: [Zr-89]Oxine-labeled leukocytes PET/MR

University of Alabama at Birmingham

NULL

Not yet recruiting

18 Years

65 Years

All

120

Phase 1

NULL

NCT04586023
(ClinicalTrials.gov)

December 26, 2020

8/10/2020

Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)

A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo

Hoffmann-La Roche

NULL

Recruiting

18 Years

55 Years

All

734

Phase 3

United States

NCT04586010
(ClinicalTrials.gov)

December 18, 2020

8/10/2020

A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)

Relapsing Multiple Sclerosis

Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo

Hoffmann-La Roche

NULL

Recruiting

18 Years

55 Years

All

734

Phase 3

United States

NCT04667117
(ClinicalTrials.gov)

December 17, 2020

8/12/2020

A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

Relapsing Multiple Sclerosis

Biological: Quadrivalent influenza vaccine;Drug: Ofatumumab

Novartis Pharmaceuticals

NULL

Not yet recruiting

18 Years

55 Years

All

Phase 4

NULL

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

EUCTR2019-003919-53-GB
(EUCTR)

17/12/2020

26/11/2020

FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Primary Progressive multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: fenebrutinib
Product Code: RO7010939
INN or Proposed INN: FENEBRUTINIB
Other descriptive name: GDC-0853 RO7010939
Trade Name: Ocrevus
Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

946

Phase 3

United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

NCT04544436
(ClinicalTrials.gov)

December 15, 2020

4/9/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone

Hoffmann-La Roche

NULL

Recruiting

18 Years

55 Years

All

786

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom

NCT04548999
(ClinicalTrials.gov)

December 3, 2020

9/9/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Multiple Sclerosis

Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone

Hoffmann-La Roche

NULL

Recruiting

18 Years

55 Years

All

699

Phase 3

United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom

NCT04578639
(ClinicalTrials.gov)

November 2, 2020

22/9/2020

Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease

Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing

Relapsing Remitting Multiple Sclerosis

Drug: Rituximab;Drug: Ocrelizumab

Haukeland University Hospital

University Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North Norway

Recruiting

18 Years

60 Years

All

211

Phase 3

Norway

NCT04150549
(ClinicalTrials.gov)

November 2020

11/10/2019

FMT for MS Patients

Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial

Multiple Sclerosis

Biological: Fecal Microbial Transplants

Lawson Health Research Institute

NULL

Not yet recruiting

18 Years

55 Years

All

Phase 2

NULL

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

EUCTR2020-000893-69-PL
(EUCTR)

28/10/2020

09/07/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

786

Phase 3

United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand

NCT04544449
(ClinicalTrials.gov)

October 26, 2020

4/9/2020

A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis

A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.

Multiple Sclerosis, Primary Progressive

Drug: fenebrutinib;Drug: ocrelizumab;Drug: placebo

Hoffmann-La Roche

NULL

Recruiting

18 Years

65 Years

All

946

Phase 3

United States;Canada;France;Argentina;Australia;Austria;Belgium;Brazil;Czechia;Denmark;Germany;Greece;Hungary;Israel;Italy;Mexico;New Zealand;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom

EUCTR2020-000893-69-BE
(EUCTR)

23/10/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

786

Phase 3

United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand

NCT04626921
(ClinicalTrials.gov)

October 22, 2020

30/10/2020

A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: CNM-Au8

Clene Nanomedicine

George Clinical

Enrolling by invitation

18 Years

55 Years

All

150

Phase 2;Phase 3

Australia

EUCTR2019-001829-26-DE
(EUCTR)

19/10/2020

08/01/2020

A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)

A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB
Other descriptive name: h5G1.1-mAb

Alexion Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2;Phase 3

United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of

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

EUCTR2020-000893-69-PT
(EUCTR)

12/10/2020

09/07/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

786

Phase 3

EUCTR2020-000894-26-PT
(EUCTR)

12/10/2020

13/07/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Primary Progressive Multiple Sclerosis (MS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

699

Phase 3

Portugal;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand

EUCTR2020-000893-69-HU
(EUCTR)

09/10/2020

06/08/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

786

Phase 3

United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand

EUCTR2020-000894-26-FR
(EUCTR)

08/10/2020

11/08/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

699

Phase 3

United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand

EUCTR2020-000893-69-GB
(EUCTR)

25/09/2020

29/07/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS - BN42082 Study to evaluate high dose Ocrelizumab in RMS

Relapsing Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

786

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

EUCTR2020-000894-26-GB
(EUCTR)

25/09/2020

30/07/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a HigherDose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

786

Phase 3

United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand

EUCTR2020-000894-26-HU
(EUCTR)

22/09/2020

06/08/2020

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

699

Phase 3

United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand

NCT04561557
(ClinicalTrials.gov)

September 22, 2020

10/9/2020

Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System

An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System

Autoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum Disorder

Biological: CT103A cells;Drug: Cyclophosphamide and fludarabine

Tongji Hospital

NULL

Recruiting

18 Years

65 Years

All

Early Phase 1

China

NCT04528121
(ClinicalTrials.gov)

September 15, 2020

22/8/2020

Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Other: CoDuSe balance training and step square exercises;Other: conventional balance training

Lama Saad El-Din Mahmoud

NULL

Recruiting

20 Years

40 Years

All

N/A

Egypt

EUCTR2019-001341-40-AT
(EUCTR)

10/09/2020

07/07/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;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

EUCTR2019-003625-16-HR
(EUCTR)

26/08/2020

12/11/2020

An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ublituximab
Product Code: TG -1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603, TGTX1101

TG Therapeutics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

United States;Serbia;Belarus;Poland;Ukraine;Romania;Croatia;Russian Federation;Georgia

NCT04510220
(ClinicalTrials.gov)

August 2020

31/7/2020

9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

Open-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: Ofatumumab;Drug: [F-18]PBR06

Brigham and Women's Hospital

Novartis

Not yet recruiting

18 Years

60 Years

All

Phase 3

United States

NCT04377555
(ClinicalTrials.gov)

July 30, 2020

1/5/2020

Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) Before and During Treatment With Ocrelizumab

An Open-Label, Multicenter Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab

Multiple Sclerosis, Relapsing

Drug: Ocrelizumab

Genentech, Inc.

NULL

Recruiting

18 Years

65 Years

All

150

Phase 4

United States;Puerto Rico

NCT04353492
(ClinicalTrials.gov)

July 14, 2020

16/4/2020

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab

A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy

Relapsing Multiple Sclerosis

Biological: Ofatumumab

Novartis Pharmaceuticals

NULL

Recruiting

18 Years

60 Years

All

550

Phase 3

United States;Australia;Belgium;Bulgaria;Czechia;Germany;Greece;Hungary;Portugal;Russian Federation;Slovakia;Spain;Turkey

EUCTR2019-001341-40-PT
(EUCTR)

15/06/2020

31/03/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

Austria;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;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

EUCTR2019-001341-40-BG
(EUCTR)

12/06/2020

07/05/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

EUCTR2019-003352-37-NL
(EUCTR)

11/06/2020

24/02/2020

Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD

Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of

EUCTR2019-001341-40-GR
(EUCTR)

20/05/2020

10/03/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway

EUCTR2019-003352-37-DE
(EUCTR)

11/05/2020

06/01/2020

Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.

Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of

EUCTR2019-001341-40-CZ
(EUCTR)

07/05/2020

11/02/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom

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

EUCTR2019-001341-40-HU
(EUCTR)

29/04/2020

11/03/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway

EUCTR2019-001341-40-BE
(EUCTR)

29/04/2020

17/03/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

EUCTR2019-001341-40-ES
(EUCTR)

24/04/2020

07/05/2020

An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Farmacéutica S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

EUCTR2017-001313-93-DE
(EUCTR)

27/03/2020

12/02/2020

A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis

AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria

EUCTR2019-003352-37-AT
(EUCTR)

27/03/2020

13/02/2020

Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.

Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of

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

EUCTR2018-001511-73-DE
(EUCTR)

17/03/2020

17/06/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

EUCTR2018-001511-73-IE
(EUCTR)

16/03/2020

08/05/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

EUCTR2018-003008-38-DE
(EUCTR)

10/03/2020

06/05/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

An Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension

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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX ®
Product Name: interferon beta -1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta -1a
Other descriptive name: Interferon Beta -1a
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
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
Trade Name: AVONEX ®
Product Name: interferon beta -1a
Product Code: IFN ß-1a
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

United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait

EUCTR2016-002667-34-PL
(EUCTR)

06/03/2020

14/11/2019

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis

AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Relapsing-remitting multiple sclerosis (MS)
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Poland;Italy

EUCTR2018-001511-73-PT
(EUCTR)

02/03/2020

30/04/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Primary progressive multiple sclerosis (PPMS)
MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

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

EUCTR2019-003352-37-ES
(EUCTR)

25/02/2020

14/01/2020

Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.

Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of

NCT04291456
(ClinicalTrials.gov)

January 31, 2020

18/11/2019

Minocycline in MS: Confirmation of Benefit

Open-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment Benefit

Multiple Sclerosis;Clinically Isolated Syndrome

Drug: Minocycline 100mg

University of Calgary

Hotchkiss Brain Institute, University of Calgary

Recruiting

18 Years

60 Years

All

148

Phase 3

Canada

NCT04140305
(ClinicalTrials.gov)

January 16, 2020

24/10/2019

Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

Multiple Sclerosis

Drug: RPC-1063

Celgene

NULL

Recruiting

18 Years

65 Years

All

250

Phase 3

United States;Canada;Puerto Rico

EUCTR2019-003352-37-DK
(EUCTR)

15/01/2020

19/12/2019

Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.

Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of

NCT04155424
(ClinicalTrials.gov)

January 14, 2020

5/11/2019

A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder

A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder

Drug: Eculizumab

Alexion Pharmaceuticals

NULL

Recruiting

2 Years

17 Years

All

Phase 2;Phase 3

United States;Japan;Korea, Republic of;Spain;Canada;Germany;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

NCT04075266
(ClinicalTrials.gov)

January 9, 2020

14/8/2019

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: Ocrelizumab

Hoffmann-La Roche

NULL

Recruiting

10 Years

18 Years

All

Phase 2

United States;Italy;Poland

EUCTR2018-001511-73-GB
(EUCTR)

23/12/2019

09/04/2019

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HAND

Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: no

1000

Phase 3

Portugal;Hungary;Poland;Spain;Ireland;Croatia;Bulgaria;Germany;United Kingdom

NCT03993171
(ClinicalTrials.gov)

December 19, 2019

31/5/2019

31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.

A Phase 2, Open-Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Multiple Sclerosis.

Relapsing Remitting Multiple Sclerosis

Drug: gold nanocrystals

Clene Nanomedicine

University of Texas Southwestern Medical Center

Recruiting

18 Years

55 Years

All

Phase 2

United States

EUCTR2018-001511-73-HU
(EUCTR)

18/12/2019

08/11/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

EUCTR2019-001829-26-ES
(EUCTR)

18/12/2019

06/11/2019

A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)

A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2;Phase 3

United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of

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

EUCTR2018-001511-73-HR
(EUCTR)

16/12/2019

17/01/2020

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

NCT04201262
(ClinicalTrials.gov)

December 13, 2019

11/12/2019

An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder

Biological: Ravulizumab

Alexion Pharmaceuticals

NULL

Recruiting

18 Years

N/A

All

Phase 3

United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain

EUCTR2018-003008-38-HR
(EUCTR)

10/12/2019

17/01/2020

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

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: 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

142

Phase 3

Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany

NCT04130997
(ClinicalTrials.gov)

November 18, 2019

16/10/2019

An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

TG1101-RMS303 is an Open-label, Single-arm Extension Study Designed to Evaluate Long-term Safety and Efficacy of Ublituximab in Subjects With Relapsing Multiple Sclerosis. Subjects Who Complete the 96-week, Double-blind Treatment Period o TG1101-RMS301 or TG1101-RMS302 Are Eligible for Participation in This Open Label Extension (OLE) Study.

Relapsing Multiple Sclerosis (RMS)

Biological: Ublituximab

TG Therapeutics, Inc.

NULL

Enrolling by invitation

18 Years

N/A

All

1000

Phase 3

United States;Belarus;Croatia;Georgia;Poland;Russian Federation;Serbia;Ukraine

NCT04171310
(ClinicalTrials.gov)

November 13, 2019

19/11/2019

Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects

An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male Subjects

Multiple Sclerosis

Drug: SAR442168

Sanofi

NULL

Completed

30 Years

65 Years

Male

Phase 1

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

NCT03958877
(ClinicalTrials.gov)

October 18, 2019

20/5/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

Multiple Sclerosis, Relapsing-Remitting

Drug: BIIB017 (peginterferon beta-1a);Drug: Interferon beta type 1a

Biogen

NULL

Recruiting

10 Years

18 Years

All

142

Phase 3

United States;Argentina;Australia;Belgium;Bulgaria;Croatia;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Kuwait;Portugal;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Tunisia;Turkey

NCT04121403
(ClinicalTrials.gov)

October 16, 2019

23/9/2019

Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)

Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) A Prospective Randomized Open-label Blinded Endpoint (PROBE) Multicenter Non-inferiority Study

Relapsing Multiple Sclerosis;Multiple Sclerosis

Biological: Rituximab;Drug: Cladribine

Oslo University Hospital

University of Oslo;Göteborg University;Sykehuset Ostfold;Sykehuset Telemark;Vestre Viken Hospital Trust;Sorlandet Hospital HF;Helse Stavanger HF;Sykehuset Innlandet HF;Sykehuset i Vestfold HF;Helse Forde;University Hospital of North Norway;St. Olavs Hospital

Recruiting

18 Years

65 Years

All

264

Phase 3

Norway

JPRN-JapicCTI-205119

15/10/2019

20/01/2020

A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients

neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD)

Intervention name : SA237
INN of the intervention : satralizumab
Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Chugai Pharmaceutical Co., Ltd.

F. Hoffmann-La Roche Ltd

complete

BOTH

Japan

EUCTR2018-001511-73-BG
(EUCTR)

02/10/2019

19/06/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

EUCTR2018-001511-73-PL
(EUCTR)

30/09/2019

06/08/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

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

EUCTR2018-003008-38-PT
(EUCTR)

02/09/2019

02/04/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

142

Phase 3

EUCTR2018-001511-73-ES
(EUCTR)

21/08/2019

04/07/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Primary progressive multiple sclerosis (PPMS)
MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

NCT04035005
(ClinicalTrials.gov)

August 12, 2019

17/7/2019

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Multiple Sclerosis, Primary Progressive

Drug: Ocrelizumab;Drug: Placebo

Hoffmann-La Roche

NULL

Recruiting

18 Years

65 Years

All

1000

Phase 3

United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Egypt;France;Georgia;Germany;Hungary;Ireland;Italy;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;Netherlands

NCT03972306
(ClinicalTrials.gov)

August 12, 2019

29/5/2019

A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis

Multiple Sclerosis (MS)

Drug: Ocrelizumab;Drug: rHuPH20

Hoffmann-La Roche

NULL

Recruiting

18 Years

65 Years

All

135

Phase 1

United States

EUCTR2019-001505-24-NO
(EUCTR)

25/07/2019

28/05/2019

A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis

Norwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS

Relapsing Multiple Sclerosis (RMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Phase 3

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

EUCTR2018-003008-38-BE
(EUCTR)

17/07/2019

19/04/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

142

Phase 3

United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait

EUCTR2018-003008-38-BG
(EUCTR)

10/07/2019

05/04/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

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
Trade Name: AVONEX ®
Product Name: interferon beta -1a , 30 µg/0.5 ml
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta -1a
Other descriptive name: Interferon Beta -1a
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
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
Trade Name: AVONEX ®
Product Name: interferon beta -1a , 30 µg/0.5 ml
Product Code: IFN ß-1a
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

EUCTR2018-003008-38-GR
(EUCTR)

27/06/2019

03/05/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

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
Trade Name: AVONEX ®
Product Name: interferon beta -1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta -1a
Other descriptive name: Interferon Beta -1a
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
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
Trade Name: AVONEX ®
Product Name: interferon beta -1a
Product Code: IFN ß-1a
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

EUCTR2018-003008-38-SK
(EUCTR)

24/06/2019

26/04/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

142

Phase 3

EUCTR2017-004703-51-GB
(EUCTR)

18/06/2019

15/10/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;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

EUCTR2017-004703-51-BE
(EUCTR)

17/06/2019

15/01/2019

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden

EUCTR2018-003008-38-HU
(EUCTR)

30/05/2019

08/04/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

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

142

Phase 3

EUCTR2017-004703-51-HR
(EUCTR)

06/05/2019

03/06/2019

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

EUCTR2017-004703-51-GR
(EUCTR)

24/04/2019

27/03/2019

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

EUCTR2018-003008-38-ES
(EUCTR)

02/04/2019

17/05/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

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

142

Phase 3

Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;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

EUCTR2017-004703-51-NL
(EUCTR)

29/03/2019

16/10/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden

EUCTR2017-004703-51-LV
(EUCTR)

28/03/2019

24/01/2019

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden

EUCTR2018-002145-11-GB
(EUCTR)

21/03/2019

11/10/2018

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329

Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom

EUCTR2017-004703-51-PT
(EUCTR)

18/03/2019

24/10/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden

EUCTR2018-002145-11-NL
(EUCTR)

14/03/2019

05/11/2018

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;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

NCT03799718
(ClinicalTrials.gov)

March 13, 2019

7/1/2019

Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS

A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS

Multiple Sclerosis, Chronic Progressive

Biological: NurOwn (MSC-NTF cells)

Brainstorm-Cell Therapeutics

NULL

Active, not recruiting

18 Years

65 Years

All

Phase 2

United States

EUCTR2018-002145-11-FR
(EUCTR)

08/03/2019

31/10/2018

A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - NOVA

Relapsing-remitting multiple sclerosis (RRMS)
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

480

Phase 3

United States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom

EUCTR2017-004703-51-LT
(EUCTR)

19/02/2019

03/12/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden

EUCTR2018-002145-11-DE
(EUCTR)

15/02/2019

17/10/2018

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;New Zealand;Italy

NCT03623243
(ClinicalTrials.gov)

February 14, 2019

7/8/2018

Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.

Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study

Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis

Drug: Siponimod

Novartis Pharmaceuticals

NULL

Recruiting

18 Years

65 Years

All

400

Phase 3

United States;Puerto Rico

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

NCT03825601
(ClinicalTrials.gov)

February 1, 2019

21/1/2019

PET With [18F]Flumazenil as an Index of Neurodegeneration in MS

PET With [18F]Flumazenil as an Index of Neurodegeneration in MS: Sensitivity at an Early Disease Stage and Pathophysiological Meaning

Multiple Sclerosis;Relapsing-Remitting Multiple Sclerosis

Diagnostic Test: PET with [11C]Flumazenil

Institut National de la Santé Et de la Recherche Médicale, France

NULL

Not yet recruiting

18 Years

55 Years

All

N/A

NULL

NCT03784547
(ClinicalTrials.gov)

February 1, 2019

13/12/2018

Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM

Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America

Multiple Sclerosis

Drug: Ocrelizumab

Hospital Italiano de Buenos Aires

NULL

Recruiting

N/A

All

100

Argentina

NCT03696485
(ClinicalTrials.gov)

February 1, 2019

30/9/2018

Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS

A Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

Secondary Progressive Multiple Sclerosis (SPMS)

Biological: SCM -010

Stem Cell Medicine Ltd.

NULL

Not yet recruiting

18 Years

60 Years

All

Phase 1;Phase 2

Israel

EUCTR2017-004703-51-ES
(EUCTR)

31/01/2019

25/10/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Farmacéutica, S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

EUCTR2017-004702-17-PL
(EUCTR)

25/01/2019

17/10/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;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

EUCTR2017-004703-51-DK
(EUCTR)

18/01/2019

11/12/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

EUCTR2017-004703-51-FR
(EUCTR)

18/01/2019

22/10/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

EUCTR2017-004886-29-IE
(EUCTR)

11/01/2019

09/05/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL

Multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden

EUCTR2017-004703-51-DE
(EUCTR)

10/01/2019

27/09/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

100

EUCTR2018-002145-11-ES
(EUCTR)

02/01/2019

05/11/2018

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

France;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;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

101

EUCTR2017-004703-51-FI
(EUCTR)

02/01/2019

11/12/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

102

NCT03650114
(ClinicalTrials.gov)

December 28, 2018

17/8/2018

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Biological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigen

Novartis Pharmaceuticals

NULL

Recruiting

18 Years

N/A

All

2010

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom

103

NCT03689972
(ClinicalTrials.gov)

December 26, 2018

27/9/2018

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

Multiple Sclerosis, Relapsing-Remitting

Drug: Natalizumab

Biogen

NULL

Active, not recruiting

18 Years

60 Years

All

500

Phase 3

United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom

104

EUCTR2017-004703-51-SE
(EUCTR)

17/12/2018

15/11/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

105

EUCTR2017-004702-17-ES
(EUCTR)

12/12/2018

17/09/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Farmacéutica, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;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

106

EUCTR2017-004702-17-BG
(EUCTR)

03/12/2018

23/10/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy

107

NCT03944447
(ClinicalTrials.gov)

December 1, 2018

3/5/2019

Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus

Drug: Cannabis , Medical

OMNI Medical Services, LLC

OMNI Medical Services Inc

Recruiting

7 Years

N/A

All

200000

Phase 2

United States

108

EUCTR2017-004703-51-HU
(EUCTR)

29/11/2018

11/10/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden

109

EUCTR2017-004703-51-AT
(EUCTR)

28/11/2018

17/10/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

Phase 3

110

EUCTR2017-004703-51-SK
(EUCTR)

21/11/2018

28/09/2018

Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2233

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

111

NCT03691077
(ClinicalTrials.gov)

November 11, 2018

28/9/2018

Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714

A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714

Multiple Sclerosis;Relapse;Primary Progressive Multiple Sclerosis

Drug: Ocrelizumab

Assistance Publique - Hôpitaux de Paris

Roche Pharma AG;Institut du Cerveau et de la Moelle épinière

Recruiting

18 Years

60 Years

All

Phase 3

France

112

EUCTR2017-004702-17-IT
(EUCTR)

07/11/2018

04/11/2020

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND

Multiple sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders
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]

Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE
Product Name: Formistin 10 mg
Product Code: [Formistin 10 mg]
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [Tachipirina CPR 500mg]
Other descriptive name: paracetamolo 500 mg
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: Solumedrol IM 125mg/2ml
Product Code: [Metilprednisolone]
Other descriptive name: Metilprednisolone sodio succinato
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: Ofatumumab
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: OFATUMUMAB

NOVARTIS PHARMA AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia

113

NCT03593590
(ClinicalTrials.gov)

November 2, 2018

11/7/2018

Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY

Multiple Sclerosis

Drug: Ocrelizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

N/A

All

1250

Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Portugal;Qatar;Romania;Russian Federation;Saudi Arabia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel

114

EUCTR2017-004702-17-LV
(EUCTR)

02/11/2018

03/09/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy

115

EUCTR2017-004702-17-LT
(EUCTR)

31/10/2018

17/09/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;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

116

EUCTR2017-004702-17-CZ
(EUCTR)

23/10/2018

16/08/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy

117

EUCTR2017-004702-17-EE
(EUCTR)

17/09/2018

28/08/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy

118

NCT03606460
(ClinicalTrials.gov)

September 14, 2018

23/7/2018

A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)

A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3

Genentech, Inc.

NULL

Completed

18 Years

55 Years

All

141

Phase 3

United States

119

NCT03560739
(ClinicalTrials.gov)

September 11, 2018

15/5/2018

A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

Multiple Sclerosis

Combination Product: ofatumumab with PRF;Combination Product: ofatumumab with AI

Novartis Pharmaceuticals

NULL

Completed

18 Years

55 Years

All

284

Phase 2

United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain

120

EUCTR2017-004886-29-NL
(EUCTR)

05/09/2018

27/06/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL

Multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;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

EUCTR2017-004702-17-AT
(EUCTR)

01/09/2018

10/08/2018

A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

284

Phase 2

United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy

122

EUCTR2014-000253-36-NL
(EUCTR)

30/08/2018

16/04/2018

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab

MedImmune LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

252

Phase 2;Phase 3

Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;India;Peru;Australia;South Africa;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;New Zealand;Japan

123

EUCTR2017-004886-29-CZ
(EUCTR)

08/08/2018

10/05/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden

124

NCT03589105
(ClinicalTrials.gov)

August 6, 2018

5/7/2018

A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting

An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mg

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

N/A

All

423

Phase 4

France

125

EUCTR2017-004886-29-SE
(EUCTR)

23/07/2018

05/06/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL

Multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1224

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;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

NCT03567057
(ClinicalTrials.gov)

July 18, 2018

22/5/2018

A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment

A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment

Multiple Sclerosis;Walking Impairment

Drug: ADS-5102

Adamas Pharmaceuticals, Inc.

NULL

Active, not recruiting

18 Years

70 Years

All

540

Phase 3

United States;Canada

127

NCT03599245
(ClinicalTrials.gov)

July 12, 2018

25/6/2018

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

Multiple Sclerosis

Drug: Ocrelizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

65 Years

All

1500

Phase 4

Czechia;Denmark;Estonia;Finland;France;Ireland;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom

128

EUCTR2017-001313-93-CZ
(EUCTR)

09/07/2018

26/03/2018

A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis

AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

Panama;United Arab Emirates;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina

129

EUCTR2017-004886-29-FR
(EUCTR)

05/07/2018

17/05/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden

130

EUCTR2017-004886-29-GB
(EUCTR)

03/07/2018

02/07/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL

Multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1224

Phase 3

France;Czech Republic;Estonia;Finland;Spain;Ireland;Denmark;Netherlands;United Kingdom;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

131

EUCTR2017-004886-29-DK
(EUCTR)

21/06/2018

18/05/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL

Multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1224

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden

132

EUCTR2017-001313-93-HU
(EUCTR)

21/06/2018

25/04/2018

A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis

AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria

133

EUCTR2017-004886-29-FI
(EUCTR)

19/06/2018

15/06/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL

Multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden

134

EUCTR2017-001313-93-PL
(EUCTR)

08/06/2018

15/03/2018

A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis

AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

135

EUCTR2017-004886-29-EE
(EUCTR)

31/05/2018

18/04/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL

Multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;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

136

NCT03552211
(ClinicalTrials.gov)

May 30, 2018

25/4/2018

Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis

Progressive Multiple Sclerosis

Drug: biotin;Other: propensity score

University Hospital, Clermont-Ferrand

OFSEP (Observatoire Français de la Sclérose en Plaques);SFSEP (Société Francophone de la Sclérose en Plaques);MedDay Pharmaceuticals SA

Unknown status

18 Years

80 Years

All

3000

France

137

NCT03523858
(ClinicalTrials.gov)

May 28, 2018

16/4/2018

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

Progressive Multiple Sclerosis (PMS)

Drug: Ocrelizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

65 Years

All

900

Phase 3

United States;Bosnia and Herzegovina;Brazil;Canada;Colombia;Costa Rica;Czechia;Denmark;Egypt;France;Germany;Guatemala;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;Netherlands;Panama;Poland;Russian Federation;Saudi Arabia;Spain;United Arab Emirates;Algeria

138

EUCTR2017-004886-29-ES
(EUCTR)

22/05/2018

09/04/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden

139

EUCTR2017-001313-93-ES
(EUCTR)

11/05/2018

02/03/2018

A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis

AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

140

EUCTR2017-001313-93-IE
(EUCTR)

03/05/2018

06/02/2018

A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis

AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (development)
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (commercial)
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

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

141

NCT03585569
(ClinicalTrials.gov)

May 1, 2018

16/3/2018

Treating MS Patients With Lower Extremity Spasticity Using Dysport

A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport

Multiple Sclerosis;Spasticity, Muscle

Biological: Abobotulinumtoxin A

Neurology Center of New England P.C.

Ipsen

Unknown status

N/A

All

Phase 3

United States

142

EUCTR2017-004101-40-HR
(EUCTR)

27/04/2018

16/05/2019

Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity

An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).

Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen

Osmotica Pharmaceutical US LLC

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina

143

EUCTR2017-001313-93-DK
(EUCTR)

04/04/2018

23/02/2018

A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis

AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

United Arab Emirates;Panama;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina

144

NCT03319732
(ClinicalTrials.gov)

April 3, 2018

13/10/2017

A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS

An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)

Multiple Sclerosis;Spasticity, Muscle

Drug: Arbaclofen

Osmotica Pharmaceutical US LLC

NULL

Active, not recruiting

18 Years

65 Years

All

323

Phase 3

United States

145

EUCTR2017-004101-40-BG
(EUCTR)

23/03/2018

09/01/2018

Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity

An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).

Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen

Osmotica Pharmaceutical US LLC

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina

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

146

EUCTR2017-004101-40-PL
(EUCTR)

21/03/2018

12/02/2018

Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity

An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).

Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen

Osmotica Pharmaceutical US LLC

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina

147

JPRN-JapicCTI-173711

15/3/2018

14/09/2017

Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab

Relapsing Multiple Sclerosis

Intervention name : Ofatumumab
INN of the intervention : -
Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks

Novartis Pharma K.K.

NULL

complete

BOTH

Phase 2

Japan, Russia

148

NCT03249714
(ClinicalTrials.gov)

March 15, 2018

11/8/2017

Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

Relapsing Multiple Sclerosis

Drug: Ofatumumab subcutaneous injection;Drug: Placebo subcutaneous injection matching ofatumumab

Novartis Pharmaceuticals

NULL

Completed

18 Years

55 Years

All

Phase 2

Japan;Russian Federation

149

NCT03551275
(ClinicalTrials.gov)

February 22, 2018

13/2/2018

Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis

A Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis

Biological: BCD-132

Biocad

NULL

Unknown status

18 Years

60 Years

All

Phase 1

Russian Federation

150

EUCTR2017-001224-22-DE
(EUCTR)

23/01/2018

28/07/2017

Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;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

151

EUCTR2017-001224-22-NL
(EUCTR)

11/01/2018

12/09/2017

Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)

Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Opicinumab
Product Code: BIIB033
INN or Proposed INN: Opicinumab
Other descriptive name: BIIB033 (ANTI-LINGO)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden

152

EUCTR2017-001224-22-GB
(EUCTR)

28/12/2017

12/07/2017

Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Spain;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden

153

EUCTR2017-001224-22-CZ
(EUCTR)

19/12/2017

14/08/2017

Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden

154

NCT03362294
(ClinicalTrials.gov)

December 11, 2017

15/11/2017

Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects With PPMS

A Prospective, Multicenter, Single Arm, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)

Primary Progressive Multiple Sclerosis

Drug: GA Depot 40mg once monthly

Mapi Pharma Ltd.

NULL

Recruiting

18 Years

65 Years

All

Phase 2

Israel

155

EUCTR2016-002937-31-HR
(EUCTR)

29/11/2017

13/04/2018

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;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

156

EUCTR2016-003100-30-DE
(EUCTR)

29/11/2017

07/03/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

157

NCT03222973
(ClinicalTrials.gov)

November 14, 2017

17/7/2017

Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)

Multiple Sclerosis

Drug: BIIB033 (opicinumab);Drug: Placebo

Biogen

NULL

Active, not recruiting

18 Years

58 Years

All

263

Phase 2

United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom

158

NCT03350633
(ClinicalTrials.gov)

November 1, 2017

10/11/2017

Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial

Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica

Drug: Tocilizumab Injection;Drug: Azathioprine

Tianjin Medical University General Hospital

NULL

Completed

18 Years

N/A

All

118

Phase 2;Phase 3

China

159

EUCTR2016-003100-30-GR
(EUCTR)

27/10/2017

21/04/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

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]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden

160

NCT03368664
(ClinicalTrials.gov)

October 24, 2017

2/11/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

Multiple Sclerosis

Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist

Genzyme, a Sanofi Company

NULL

Active, not recruiting

10 Years

17 Years

All

Phase 3

Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland

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

161

NCT03283826
(ClinicalTrials.gov)

October 19, 2017

13/9/2017

Phase 1 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis

A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis

Biological: ATA188;Drug: Placebo

Atara Biotherapeutics

NULL

Recruiting

18 Years

55 Years

All

Phase 1

United States;Australia

162

EUCTR2015-005431-41-PL
(EUCTR)

16/10/2017

07/04/2016

A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of

163

EUCTR2016-003100-30-NO
(EUCTR)

12/10/2017

12/04/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

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]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden

164

EUCTR2016-003100-30-NL
(EUCTR)

28/09/2017

11/05/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden

165

NCT03257358
(ClinicalTrials.gov)

September 19, 2017

18/8/2017

A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod

A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]

Relapsing Multiple Sclerosis

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

382

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

166

EUCTR2016-002937-31-NO
(EUCTR)

12/09/2017

18/04/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

167

EUCTR2016-002937-31-DE
(EUCTR)

11/09/2017

02/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden

168

EUCTR2016-002937-31-GB
(EUCTR)

06/09/2017

05/09/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

169

EUCTR2016-003100-30-PT
(EUCTR)

28/08/2017

04/05/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

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]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

170

NCT03183869
(ClinicalTrials.gov)

August 24, 2017

9/5/2017

Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients

Autoimmune Diseases;Relapsing Multiple Sclerosis

Drug: Fecal microbiota

Lawson Health Research Institute

NULL

Terminated

18 Years

N/A

All

Phase 2

Canada

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

171

EUCTR2016-002937-31-NL
(EUCTR)

21/08/2017

15/06/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1228

Phase 3

Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Netherlands;Kuwait;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;Sweden

172

EUCTR2016-003100-30-AT
(EUCTR)

03/08/2017

10/08/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

173

EUCTR2016-002937-31-BG
(EUCTR)

02/08/2017

30/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

174

EUCTR2016-002937-31-ES
(EUCTR)

31/07/2017

29/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

Roche Farma S.A. (Soc.unipersonal)que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden

175

EUCTR2016-002937-31-FR
(EUCTR)

26/07/2017

30/10/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

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

176

EUCTR2016-002937-31-PT
(EUCTR)

24/07/2017

04/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

177

EUCTR2016-003100-30-BE
(EUCTR)

14/07/2017

22/05/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

178

EUCTR2016-002937-31-BE
(EUCTR)

10/07/2017

05/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

179

EUCTR2016-002937-31-HU
(EUCTR)

29/06/2017

08/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Slovakia;Slovenia;Finland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Poland;Belgium;Brazil;Romania;Croatia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden

180

EUCTR2016-002820-10-DE
(EUCTR)

26/06/2017

08/11/2016

Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab

A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN)

Remitting-Relapsing 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]

Trade Name: Zinbryta
Product Name: Daclizumab
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Canada;Germany;Italy;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

181

EUCTR2016-002937-31-PL
(EUCTR)

26/06/2017

10/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

182

EUCTR2016-002937-31-AT
(EUCTR)

19/06/2017

20/04/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

183

EUCTR2016-002937-31-SE
(EUCTR)

19/06/2017

20/04/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

184

EUCTR2016-002937-31-SK
(EUCTR)

16/06/2017

11/05/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

185

EUCTR2016-002937-31-SI
(EUCTR)

16/06/2017

13/06/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1228

Phase 3

Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;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

186

EUCTR2016-002937-31-DK
(EUCTR)

08/06/2017

28/04/2017

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1225

Phase 3

United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden

187

NCT03239860
(ClinicalTrials.gov)

June 6, 2017

12/7/2017

Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: GNbAC1 Monoclonal Antibody

GeNeuro SA

Les Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales Servier

Terminated

18 Years

55 Years

All

220

Phase 2

Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine

188

EUCTR2016-003100-30-GB
(EUCTR)

05/06/2017

27/03/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

189

NCT03381170
(ClinicalTrials.gov)

June 1, 2017

18/12/2017

An Extension of the TG1101-RMS201 Trial

An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis

Biological: Ublituximab

TG Therapeutics, Inc.

NULL

Active, not recruiting

18 Years

55 Years

All

Phase 2

United States

190

EUCTR2015-002500-91-SE
(EUCTR)

01/06/2017

27/06/2016

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2495

Phase 3

Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia

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

191

EUCTR2016-003587-39-SE
(EUCTR)

22/05/2017

23/03/2017

This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.

COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS)

Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA -1B
Other descriptive name: INTERFERON BETA -1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA -1B
Other descriptive name: INTERFERON BETA -1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3700

Phase 4

Sweden

192

EUCTR2011-005249-12-SI
(EUCTR)

15/05/2017

13/03/2017

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 3

Portugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;France;Macedonia, the former Yugoslav Republic of;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland;Bulgaria

193

EUCTR2016-001448-21-PL
(EUCTR)

09/05/2017

13/01/2017

A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.

Relapsing Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: M2951
Product Code: M2951
INN or Proposed INN: M2951
Other descriptive name: M2951
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Czech Republic;Slovakia;Spain;Poland;Ukraine;Turkey;Croatia;Russian Federation;Bulgaria;United Kingdom

194

EUCTR2011-005249-12-PT
(EUCTR)

24/04/2017

01/02/2017

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 3

United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Israel;Russian Federation;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland

195

NCT02881567
(ClinicalTrials.gov)

April 18, 2017

24/8/2016

Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab

A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)

Relapsing-Remitting Multiple Sclerosis (RRMS)

Drug: Daclizumab

Biogen

AbbVie

Terminated

18 Years

55 Years

All

Phase 3

United States;Canada;Germany;Italy;Puerto Rico;France;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

196

EUCTR2016-001448-21-BG
(EUCTR)

11/04/2017

14/02/2017

A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria

197

EUCTR2016-003100-30-IT
(EUCTR)

11/04/2017

14/05/2019

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

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]

GENZYME CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

198

NCT03085810
(ClinicalTrials.gov)

April 4, 2017

16/3/2017

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: Ocrelizumab

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

55 Years

All

1225

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Denmark;France;Germany;Hungary;Italy;Kuwait;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Slovakia;Slovenia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Finland

199

EUCTR2016-003100-30-ES
(EUCTR)

04/04/2017

22/02/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

200

EUCTR2014-000253-36-GR
(EUCTR)

31/03/2017

30/01/2017

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 19.1;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

MedImmune LLC

NULL

Not Recruiting

Female: yes
Male: yes

212

Phase 2;Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;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

201

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

202

EUCTR2011-005249-12-NL
(EUCTR)

15/03/2017

08/11/2016

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

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]

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 3

Portugal;Serbia;United States;Estonia;Morocco;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina

203

EUCTR2016-002820-10-GB
(EUCTR)

13/03/2017

08/11/2016

Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab

Trade Name: Zinbryta
Product Name: Zinbryta
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

France;United States;Canada;Denmark;Germany;Italy;United Kingdom

204

NCT02975349
(ClinicalTrials.gov)

March 7, 2017

23/11/2016

A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.

Relapsing-remitting Multiple Sclerosis

Drug: M2951;Drug: Placebo;Drug: Tecfidera

EMD Serono Research & Development Institute, Inc.

Merck KGaA, Darmstadt, Germany

Active, not recruiting

18 Years

65 Years

All

267

Phase 2

Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States

205

EUCTR2016-001448-21-SK
(EUCTR)

16/02/2017

25/10/2016

A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom

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

206

NCT02949908
(ClinicalTrials.gov)

February 9, 2017

17/10/2016

MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)

A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line Treatment

Multiple Sclerosis

Drug: Rebif

Merck KGaA, Darmstadt, Germany

Merck B.V., Netherlands

Terminated

18 Years

65 Years

All

Phase 4

Germany

207

EUCTR2016-001448-21-CZ
(EUCTR)

06/02/2017

01/11/2016

A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis

Product Name: M2951
Product Code: M2951
Other descriptive name: M2951
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom

208

NCT03062579
(ClinicalTrials.gov)

February 1, 2017

13/2/2017

A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD

Single-center, Open Label Trial of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders (NMOSD)

Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica;Devic's Disease

Drug: Tocilizumab

Fu-Dong Shi

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

China

209

NCT03177083
(ClinicalTrials.gov)

January 30, 2017

26/1/2017

Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy

Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)

Relapsing Remitting Multiple Sclerosis

Drug: peginterferon beta-1a;Drug: interferon beta -1a;Drug: interferon beta -1b

Biogen

NULL

Completed

18 Years

65 Years

All

Phase 4

Portugal

210

EUCTR2014-000253-36-HU
(EUCTR)

24/01/2017

23/11/2016

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab

MedImmune LLC

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2;Phase 3

United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;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

211

NCT04570670
(ClinicalTrials.gov)

January 6, 2017

22/9/2020

Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects

A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions

Relapsing Remitting Multiple Sclerosis

Drug: monomethyl fumarate 190 mg;Drug: dimethyl fumarate 240 mg

Banner Life Sciences LLC

NULL

Completed

18 Years

55 Years

All

Phase 1

NULL

212

EUCTR2016-001448-21-ES
(EUCTR)

05/01/2017

26/10/2016

A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom

213

EUCTR2015-005431-41-HR
(EUCTR)

30/11/2016

15/12/2016

A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of

214

EUCTR2015-004616-37-DE
(EUCTR)

24/11/2016

05/08/2016

A Study to Explore the Mechanism of Action of Ocrelizumab and B-cell Biology in Patients with Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis.

An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis or primary progressive multiple sclerosis.

- Relapsing multiple sclerosis (RMS)/Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

GENENTECH Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Germany;Switzerland;Sweden

215

EUCTR2016-000434-21-PT
(EUCTR)

14/11/2016

14/09/2016

PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)

Relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Plegridy 125 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Rebif 22 micrograms
INN or Proposed INN: Interferon beta -1a
Other descriptive name: INTERFERON BETA -1A
Trade Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta -1a
Other descriptive name: INTERFERON BETA -1A
Trade Name: Betaferon 250 microgram/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Extavia 250 micrograms/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Plegridy 63 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A

Biogen Portugal

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Portugal

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

216

NCT02913157
(ClinicalTrials.gov)

November 2016

20/9/2016

Hydroxychloroquine in Primary Progressive Multiple Sclerosis

Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS)

Multiple Sclerosis, Primary Progressive

Drug: Hydroxychloroquine

University of Calgary

NULL

Active, not recruiting

18 Years

65 Years

All

Phase 2

Canada

217

EUCTR2015-005597-38-CZ
(EUCTR)

07/10/2016

17/06/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

218

NCT02807285
(ClinicalTrials.gov)

October 2016

16/6/2016

Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Multiple Sclerosis

Drug: Ocrelizumab

Genentech, Inc.

NULL

No longer available

18 Years

55 Years

All

N/A

United States

219

JPRN-UMIN000024312

2016/09/20

25/05/2017

Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds.

Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis

Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks

Tsukuba International Clinical Pharmacology Clinic

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not selected

Japan

220

EUCTR2015-005597-38-FI
(EUCTR)

12/09/2016

21/06/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;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

221

NCT02861014
(ClinicalTrials.gov)

September 9, 2016

5/8/2016

A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

Multiple Sclerosis, Relapsing-Remitting

Biological: Ocrelizumab

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

55 Years

All

681

Phase 3

Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong

222

EUCTR2015-005160-41-DE
(EUCTR)

27/07/2016

04/03/2016

an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Bulgaria;Russian Federation;Germany

223

EUCTR2015-005597-38-BE
(EUCTR)

14/07/2016

16/06/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

224

EUCTR2015-005597-38-NL
(EUCTR)

11/07/2016

01/06/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

225

EUCTR2015-005597-38-DE
(EUCTR)

29/06/2016

07/04/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;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

226

EUCTR2015-005160-41-BG
(EUCTR)

27/06/2016

04/05/2016

an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1

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]

Alkermes, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Serbia;United States;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany

227

NCT02797015
(ClinicalTrials.gov)

June 23, 2016

26/5/2016

Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: RPC1063

Celgene

NULL

Completed

18 Years

55 Years

All

Phase 1

United States

228

EUCTR2015-002500-91-HR
(EUCTR)

13/06/2016

06/07/2016

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden

229

EUCTR2016-000464-42-DE
(EUCTR)

13/06/2016

11/04/2016

The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab

A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse

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]

Genzyme GmbH

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

Germany

230

EUCTR2015-005160-41-PL
(EUCTR)

07/06/2016

13/04/2016

an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1

Alkermes, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Serbia;United States;Canada;Belgium;Spain;Poland;Ukraine;Russian Federation;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

231

EUCTR2015-002500-91-PT
(EUCTR)

06/06/2016

13/04/2016

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

232

EUCTR2015-005160-41-ES
(EUCTR)

06/06/2016

20/04/2016

an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis

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]

Alkermes, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Serbia;United States;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany

233

EUCTR2015-005597-38-DK
(EUCTR)

02/06/2016

06/04/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

234

EUCTR2015-002500-91-LT
(EUCTR)

31/05/2016

17/03/2016

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2495

Phase 3

235

EUCTR2015-005597-38-SE
(EUCTR)

25/05/2016

15/03/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;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

236

EUCTR2015-005597-38-EE
(EUCTR)

25/05/2016

06/04/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

237

EUCTR2015-005597-38-FR
(EUCTR)

23/05/2016

15/02/2018

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

238

EUCTR2015-005597-38-GB
(EUCTR)

19/05/2016

09/03/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

239

EUCTR2015-005597-38-IE
(EUCTR)

13/05/2016

10/03/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

240

NCT02720107
(ClinicalTrials.gov)

May 12, 2016

21/3/2016

Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720)

Relapsing-remitting Multiple Sclerosis

Drug: fingolimod

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

133

Phase 4

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

241

NCT02688985
(ClinicalTrials.gov)

April 29, 2016

18/2/2016

Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis

Relapsing Multiple Sclerorsis;Multiple Sclerosis, Primary Progressive

Drug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: Antihistamine

Genentech, Inc.

NULL

Active, not recruiting

18 Years

55 Years

All

127

Phase 3

United States;Canada;Germany;Sweden

242

EUCTR2015-005160-41-BE
(EUCTR)

27/04/2016

07/03/2016

an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700

Alkermes, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Serbia;United States;Canada;Poland;Spain;Belgium;Ukraine;Russian Federation;Bulgaria;Germany

243

EUCTR2015-005597-38-ES
(EUCTR)

26/04/2016

18/03/2016

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis

Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

Roche Farma S.A. que representa en España a F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

244

EUCTR2015-002500-91-LV
(EUCTR)

20/04/2016

19/02/2016

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden

245

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

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

246

EUCTR2015-002500-91-EE
(EUCTR)

04/04/2016

07/03/2016

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2495

Phase 3

247

NCT02782858
(ClinicalTrials.gov)

April 2016

23/5/2016

Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS

An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: GNbAC1;Drug: Placebo

GeNeuro SA

Les Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical Trials

Completed

18 Years

55 Years

All

270

Phase 2

Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine

248

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

249

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

250

EUCTR2015-000922-12-DE
(EUCTR)

12/02/2016

02/10/2015

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE

Relapsing-Remitting Multiple Sclerosis (RRMS)
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: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;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

251

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

252

NCT02637856
(ClinicalTrials.gov)

February 11, 2016

18/12/2015

A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

Multiple Sclerosis, Relapsing-Remitting

Drug: Ocrelizumab

Genentech, Inc.

NULL

Completed

18 Years

55 Years

All

608

Phase 3

United States;Canada

253

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

254

EUCTR2015-000922-12-FR
(EUCTR)

28/01/2016

26/02/2016

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Relapsing-Remitting Multiple Sclerosis (RRMS)
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]

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany

255

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

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

256

EUCTR2015-002500-91-SK
(EUCTR)

22/01/2016

28/10/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain

257

EUCTR2015-002500-91-PL
(EUCTR)

20/01/2016

01/12/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden

258

EUCTR2015-002500-91-BG
(EUCTR)

13/01/2016

20/10/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru

259

EUCTR2015-000922-12-ES
(EUCTR)

12/01/2016

13/01/2016

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Relapsing-Remitting Multiple Sclerosis (RRMS)
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: Copaxone 20 mg/ml
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

820

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany

260

EUCTR2015-000922-12-PL
(EUCTR)

05/01/2016

03/12/2015

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Relapsing-Remitting Multiple Sclerosis (RRMS)
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]

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;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

261

EUCTR2015-000922-12-BE
(EUCTR)

04/01/2016

01/10/2015

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Relapsing-Remitting Multiple Sclerosis (RRMS)
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]

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany

262

NCT02276963
(ClinicalTrials.gov)

January 2016

21/10/2014

Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses

Phase I, Single-Center, Open Label Trial of Ublituximab + Glucocorticoids for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder

Drug: Ublituximab

Johns Hopkins University

NULL

Completed

18 Years

100 Years

All

Phase 1

United States

263

NCT02644044
(ClinicalTrials.gov)

January 2016

23/3/2015

Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study

To Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MS

Drug: Intrathecal methotrexate

Tel-Aviv Sourasky Medical Center

NULL

Not yet recruiting

18 Years

75 Years

Both

Phase 0

NULL

264

EUCTR2015-000922-12-IE
(EUCTR)

22/12/2015

09/10/2015

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Relapsing-Remitting Multiple Sclerosis (RRMS)
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]

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany

265

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

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

266

EUCTR2015-000922-12-FI
(EUCTR)

15/12/2015

07/12/2015

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany

267

EUCTR2015-000922-12-HR
(EUCTR)

11/12/2015

04/02/2016

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Relapsing-Remitting Multiple Sclerosis (RRMS)
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]

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany

268

NCT02634307
(ClinicalTrials.gov)

December 10, 2015

16/12/2015

A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: ALKS 8700

Biogen

Alkermes, Inc.

Active, not recruiting

18 Years

65 Years

All

1057

Phase 3

United States;Belgium;Bulgaria;Canada;Germany;Poland;Russian Federation;Serbia;Spain;Ukraine

269

EUCTR2013-001151-12-HR
(EUCTR)

08/12/2015

01/02/2016

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Relapsing Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

132

Phase 3

United States;Saudi Arabia;Taiwan;Hong Kong;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Romania;Croatia;Germany;Japan;Sweden

270

NCT02583594
(ClinicalTrials.gov)

December 6, 2015

16/10/2015

A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis

A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis

Progressive Multiple Sclerosis

Drug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: Dexchlorpheniramine

Genzyme, a Sanofi Company

NULL

Active, not recruiting

18 Years

N/A

All

Phase 1

Spain

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

271

NCT02893111
(ClinicalTrials.gov)

December 2015

27/8/2016

Efficacy and Safety of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder

Single-center, Open Label Trial of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder

Drug: Bortezomib

Tianjin Medical University General Hospital

NULL

Completed

18 Years

N/A

Female

Phase 2

China

272

EUCTR2015-002500-91-ES
(EUCTR)

24/11/2015

05/10/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Relapsing Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod

Receptos, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2350

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden

273

EUCTR2015-000922-12-AT
(EUCTR)

19/11/2015

01/10/2015

A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

Teva Pharmaceutical Industries, Ltd

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany

274

EUCTR2012-003735-32-GR
(EUCTR)

19/11/2015

06/08/2015

Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.

A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment

Relapsing-remitting multiple sclerosis (RR MS)
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: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: masitinib mesylate
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinb mesylate
Other descriptive name: masitinib mesylate

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany

275

EUCTR2015-002500-91-GR
(EUCTR)

18/11/2015

04/11/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

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

276

EUCTR2015-002500-91-BE
(EUCTR)

10/11/2015

02/09/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

277

EUCTR2015-002500-91-GB
(EUCTR)

10/11/2015

18/09/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

2496

Phase 3

United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden

278

EUCTR2011-005249-12-LT
(EUCTR)

06/11/2015

02/10/2015

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 3

United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria

279

EUCTR2015-000922-12-IT
(EUCTR)

05/11/2015

28/02/2018

A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml daily

A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE

Relapsing-Remitting Multiple Sclerosis (RRMS)
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: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO

TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 4

United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany

280

NCT02686684
(ClinicalTrials.gov)

November 2015

11/2/2016

Tecfidera Diffusion Tensor Imaging

An Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple Sclerosis

Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging

Drug: Dimethyl fumarate

University at Buffalo

NULL

Completed

18 Years

N/A

Both

115

N/A

NULL

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

281

NCT02545868
(ClinicalTrials.gov)

October 27, 2015

8/9/2015

A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Biological: 23-PPV;Biological: 13-PCV Booster;Biological: Influenza Vaccine;Biological: KLH;Drug: OCR;Biological: TT Vaccine

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

55 Years

All

102

Phase 3

United States;Canada

282

NCT02576717
(ClinicalTrials.gov)

October 16, 2015

28/9/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

Multiple Sclerosis

Drug: RPC1063

Celgene

NULL

Active, not recruiting

18 Years

55 Years

All

2495

Phase 3

United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Germany;Greece;Hungary;Italy;Latvia;Lithuania;Moldova, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Ukraine;United Kingdom

283

EUCTR2015-002500-91-HU
(EUCTR)

12/10/2015

26/08/2015

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study

Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2496

Phase 3

Belgium;Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden

284

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

285

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

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

286

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

287

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

288

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

289

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

290

NCT02499900
(ClinicalTrials.gov)

August 10, 2015

1/7/2015

Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®

CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily

Multiple Sclerosis

Drug: Copaxone ®

Teva Pharmaceutical Industries, Ltd.

NULL

Completed

18 Years

N/A

All

861

Phase 4

United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey

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

291

EUCTR2014-000395-26-DE
(EUCTR)

07/08/2015

09/04/2014

Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take Tecfidera

A 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISION

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tecfidera
INN or Proposed INN: Dimethyl fumarate
Other descriptive name: DIMETHYL FUMARATE

Biogen GmbH

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 4

Germany

292

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

293

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

294

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

295

NCT02506751
(ClinicalTrials.gov)

July 2015

12/7/2015

Open-label Study of Liothyronine in MS

A Phase 1b, Open-label Study to Evaluate the Safety and Tolerability of the Putative Remyelinating Agent, Liothyronine, in Individuals With MS

Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive

Drug: liothyronine

Johns Hopkins University

NULL

Completed

18 Years

58 Years

All

Phase 1

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

296

NCT02665221
(ClinicalTrials.gov)

July 2015

22/1/2016

Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY

Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.

Multiple Sclerosis

Other: No Treatment Arm;Drug: Topical Preparation H arm

New York University School of Medicine

NULL

Terminated

18 Years

70 Years

All

Phase 4

United States

297

EUCTR2011-005249-12-PL
(EUCTR)

11/06/2015

07/07/2014

A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis

A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis with Relapsing Forms of Multiple Sclerosis Followed byan Open-Label Extension - TERIKIDS

Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

United States;Estonia;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Poland;Belgium;Australia;China

298

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

299

NCT02090348
(ClinicalTrials.gov)

June 2015

14/3/2014

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate

A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)

Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis

Drug: dimethyl fumarate

Biogen

NULL

Withdrawn

18 Years

N/A

Both

Phase 4

NULL

300

EUCTR2014-001579-30-NL
(EUCTR)

21/05/2015

26/11/2014

A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO

Primary Progressive Multiple Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

United States;Canada;Poland;Spain;Ukraine;Russian Federation;Germany;Netherlands;Italy;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

301

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

302

EUCTR2013-003752-21-ES
(EUCTR)

07/05/2015

11/03/2015

A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Code: SA237
INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
Other descriptive name: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody

Chugai Pharmaceutical Co. Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom

303

EUCTR2013-003752-21-HU
(EUCTR)

04/05/2015

25/02/2015

A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 18.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Code: SA237
INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody

Chugai Pharmaceutical Co. Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France;United States;Taiwan;Hungary;Poland;Spain;Germany;Japan;Italy;United Kingdom

304

NCT02323269
(ClinicalTrials.gov)

May 2015

18/12/2014

Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)

A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)

Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple Sclerosis

Drug: dimethyl fumarate

Biogen

NULL

Terminated

18 Years

N/A

Both

N/A

Canada

305

EUCTR2014-005548-17-FR
(EUCTR)

28/04/2015

03/06/2015

TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY

PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR
MedDRA version: 18.0;Level: PT;Classification code 10029864;Term: Nystagmus;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: NEURONTIN
Product Name: Gabapentine
Product Code: N03AX12
Other descriptive name: GABAPENTIN
Trade Name: EBIXA
Product Name: MEMANTINE
Product Code: N06DX01
INN or Proposed INN: MEMANTINE

HOSPICES CIVILS DE LYON

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France

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

306

EUCTR2013-001151-12-CZ
(EUCTR)

22/04/2015

19/09/2014

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;United Arab Emirates;Saudi Arabia;Thailand;Spain;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden;Taiwan;Hong Kong;Martinique

307

JPRN-UMIN000017217

2015/04/21

21/04/2015

An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica

An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2

Neuromyelitis optica

Rituximab intravenous infusion

Clinical Research Center, Utano National Hospital, National Hospital Organization

Zenyaku Kogyo Co., Ltd.

Complete: follow-up complete

16years-old

80years-old

Male and Female

Phase 2;Phase 3

Japan

308

EUCTR2012-003735-32-SK
(EUCTR)

01/04/2015

09/04/2015

Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.

Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany

309

EUCTR2013-001151-12-DK
(EUCTR)

25/03/2015

11/02/2015

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;Hong Kong;Taiwan;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Singapore;Croatia;Romania;Germany;Japan;Sweden

310

EUCTR2014-001579-30-DE
(EUCTR)

20/03/2015

11/11/2014

Primary Progressive Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2

United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;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

311

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

312

NCT02343159
(ClinicalTrials.gov)

February 28, 2015

9/1/2015

Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.

A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients.

Multiple Sclerosis

Drug: dimethyl fumarate;Device: Medication Event Monitoring System (MEMS);Behavioral: Adherence counseling

Biogen

NULL

Terminated

18 Years

65 Years

All

Phase 4

United States

313

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

314

EUCTR2014-000253-36-DE
(EUCTR)

27/02/2015

30/09/2014

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab

MedImmune LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

231

Phase 2;Phase 3

Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand

315

EUCTR2013-004622-29-DE
(EUCTR)

23/02/2015

11/11/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects

Multiple Sclerosis (MS)
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: Tysabri ®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;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

316

EUCTR2014-000253-36-ES
(EUCTR)

16/02/2015

22/12/2014

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: NA

MedImmune LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

212

United States;Taiwan;Estonia;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Japan;New Zealand

317

EUCTR2014-000253-36-BG
(EUCTR)

04/02/2015

05/11/2014

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

MedImmune LLC

NULL

Not Recruiting

Female: yes
Male: yes

231

Phase 2;Phase 3

Serbia;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand

318

NCT02418351
(ClinicalTrials.gov)

February 2015

8/4/2015

A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

Multiple Sclerosis, Relapsing-Remitting

Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy

Genesis Limited

NULL

Terminated

18 Years

60 Years

Both

Phase 1;Phase 2

India;Trinidad and Tobago

319

NCT02418325
(ClinicalTrials.gov)

February 2015

8/4/2015

A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

An Open-label, Non-randomized, Phase I/II Study of Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and Liberation Therapy (When Associated With Chronic Cerebrovascular Venous Insufficiency) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis, Relapsing-Remitting

Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy

Genesis Limited

NULL

Terminated

18 Years

60 Years

Both

Phase 1;Phase 2

Trinidad and Tobago

320

NCT02587715
(ClinicalTrials.gov)

February 2015

26/10/2015

A Study of Allogeneic Human UC-MSC and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

Multiple Sclerosis, Relapsing-Remitting

Biological: Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells;Other: Liberation therapy

Novo Cellular Medicine Institute LLP

NULL

Recruiting

18 Years

60 Years

Both

Phase 1;Phase 2

Trinidad and Tobago

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

321

NCT02490046
(ClinicalTrials.gov)

February 2015

28/4/2015

D-mannose for the Prevention of UTIs in Multiple Sclerosis

Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis

Multiple Sclerosis;Recurrent Urinary Tract Infections

Dietary Supplement: D Mannose

University College, London

UCLH

Recruiting

18 Years

65 Years

Both

Phase 1

United Kingdom

322

NCT02587806
(ClinicalTrials.gov)

February 2015

26/10/2015

A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

Multiple Sclerosis, Relapsing-Remitting

Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells;Other: Liberation therapy

Novo Cellular Medicine Institute LLP

NULL

Recruiting

18 Years

60 Years

Both

Phase 1;Phase 2

India;Trinidad and Tobago

323

NCT02308137
(ClinicalTrials.gov)

February 2015

2/12/2014

Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)

Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Domperidone 10mg QID for Reducing Progression of Disability in Patients With Secondary Progressive Multiple Sclerosis (SPMS)

Multiple Sclerosis, Secondary Progressive

Drug: Domperidone

University of Calgary

Alberta Innovates Health Solutions

Completed

18 Years

60 Years

All

Phase 2

Canada

324

EUCTR2013-004622-29-DK
(EUCTR)

29/01/2015

04/12/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Multiple Sclerosis (MS)
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]

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden

325

EUCTR2013-005586-39-DE
(EUCTR)

29/01/2015

02/09/2014

Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other Therapies

A Phase 4 Multicenter, Open-Label, Single Arm Study toEvaluate Switching from BRACET/Gilenya® to Natalizumabin Subjects with Relapsing Forms of Multiple Sclerosis (MS)

Multiple Sclerosis (MS)
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri ®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United States;Germany;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

326

NCT02284568
(ClinicalTrials.gov)

January 12, 2015

31/10/2014

A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo

A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS)

Primary Progressive Multiple Sclerosis

Drug: Placebo;Drug: Laquinimod

Teva Branded Pharmaceutical Products R&D, Inc.

NULL

Completed

25 Years

55 Years

All

374

Phase 2

United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom

327

NCT02200770
(ClinicalTrials.gov)

January 6, 2015

16/7/2014

A Double-masked, Placebo-controlled Study With Open Label Period to Evaluate MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Drug: Inebilizumab;Other: Placebo

MedImmune LLC

NULL

Active, not recruiting

18 Years

N/A

All

231

Phase 2;Phase 3

United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine

328

NCT02003144
(ClinicalTrials.gov)

January 2015

18/11/2013

An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)

Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder

Biological: eculizumab

Alexion Pharmaceuticals

NULL

Active, not recruiting

18 Years

N/A

All

119

Phase 3

United States;Argentina;Australia;Canada;Colombia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;France;Singapore

329

EUCTR2013-004622-29-SE
(EUCTR)

30/12/2014

29/09/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

330

EUCTR2014-000253-36-PL
(EUCTR)

30/12/2014

14/11/2014

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

MedImmune LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

231

Phase 2;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

331

EUCTR2014-001579-30-ES
(EUCTR)

22/12/2014

23/10/2014

Primary Progressive Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2

United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom

332

EUCTR2014-000253-36-CZ
(EUCTR)

08/12/2014

14/08/2014

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab

MedImmune LLC

NULL

Not Recruiting

Female: yes
Male: yes

231

Phase 2;Phase 3

United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand

333

EUCTR2014-001579-30-IT
(EUCTR)

04/12/2014

19/09/2014

Primary Progressive Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Teva Pharmaceutical Industries Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy;United States;Canada;Spain

334

EUCTR2013-004622-29-ES
(EUCTR)

03/12/2014

03/10/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Multiple Sclerosis (MS)
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

540

Phase 4

France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

335

NCT02142192
(ClinicalTrials.gov)

December 2014

16/5/2014

Natalizumab Subcutaneous Immunogenicity and Safety Study

A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: natalizumab

Biogen

NULL

Terminated

18 Years

65 Years

Both

Phase 2

Belgium;Denmark;Germany;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

336

NCT02342704
(ClinicalTrials.gov)

November 30, 2014

15/1/2015

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects

Relapsing-Remitting Multiple Sclerosis

Drug: natalizumab;Drug: fingolimod

Biogen

NULL

Terminated

18 Years

60 Years

All

111

Phase 4

United States;Australia;Czechia;France;Germany;Italy;Spain;Sweden;United Kingdom;Czech Republic;Denmark

337

EUCTR2014-001579-30-GB
(EUCTR)

27/11/2014

08/09/2014

Primary Progressive Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2

United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom

338

EUCTR2014-000917-30-DE
(EUCTR)

25/11/2014

03/07/2014

Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis

A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis

Multiple Sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

113

Phase 2

Belgium;Denmark;Germany;Italy

339

EUCTR2013-004622-29-GB
(EUCTR)

20/11/2014

28/08/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

340

EUCTR2013-002378-26-SE
(EUCTR)

13/11/2014

15/08/2013

Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes

Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext

The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial.
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Mabthera ®
Product Name: Mabthera

Västerbottens Läns Landsting

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

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

341

EUCTR2013-004622-29-IT
(EUCTR)

10/11/2014

05/08/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden

342

NCT02253264
(ClinicalTrials.gov)

November 2014

29/9/2014

A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients

A Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal Enhancement

Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis

Drug: Rituximab

Johns Hopkins University

NULL

Completed

18 Years

N/A

All

Phase 1

United States

343

NCT02310048
(ClinicalTrials.gov)

November 2014

14/11/2014

Comparative Oral Bioavailability Study of MT-1303

A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male Subjects

Relapsing-remitting Multiple Sclerosis

Drug: MT-1303-FormA;Drug: MT-1303-FormB

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

18 Years

55 Years

Male

Phase 1

United Kingdom

344

EUCTR2013-004622-29-CZ
(EUCTR)

31/10/2014

13/08/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

345

EUCTR2014-003669-97-BE
(EUCTR)

27/10/2014

02/09/2014

A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.

A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.

Relapsing Forms of Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB

Biogen Idec

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

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

346

EUCTR2014-000253-36-EE
(EUCTR)

24/10/2014

13/10/2014

A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab

MedImmune LLC

NULL

Not Recruiting

Female: yes
Male: yes

231

Phase 2;Phase 3

347

EUCTR2014-000917-30-BE
(EUCTR)

21/10/2014

24/07/2014

Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis

A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis

Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

113

Belgium;Denmark;Italy

348

NCT02212886
(ClinicalTrials.gov)

October 2014

5/8/2014

Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS

A Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis

Drug: GA Depot 80 mg;Drug: GA Depot 40 mg

Mapi Pharma Ltd.

NULL

Active, not recruiting

18 Years

70 Years

All

Phase 1;Phase 2

Israel

349

NCT02296346
(ClinicalTrials.gov)

October 2014

18/11/2014

Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis

A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS)

Secondary Progressive Multiple Sclerosis

Drug: SoluMedrol;Device: Extracorporeal Photopheresis

University of Utah

Mallinckrodt

Terminated

18 Years

75 Years

All

N/A

United States

350

NCT02234869
(ClinicalTrials.gov)

October 2014

5/9/2014

Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy

Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017)

Relapsing Multiple Sclerosis

Drug: Interferon Beta;Drug: BIIB017 (Peginterferon beta-1a)

Biogen Idec

NULL

Withdrawn

18 Years

65 Years

Both

Phase 4

NULL

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

351

NCT02269930
(ClinicalTrials.gov)

October 2014

17/10/2014

Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

Multiple Sclerosis

Drug: peginterferon beta-1a;Drug: Rebif

Biogen Idec

NULL

Completed

18 Years

45 Years

Both

Phase 1

United States

352

NCT02241785
(ClinicalTrials.gov)

September 30, 2014

12/9/2014

Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies

A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS)

Relapsing Multiple Sclerosis

Drug: natalizumab

Biogen

NULL

Terminated

18 Years

60 Years

All

Phase 4

United States;Germany

353

EUCTR2011-005249-12-GB
(EUCTR)

29/09/2014

14/07/2014

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 3

354

NCT02232061
(ClinicalTrials.gov)

September 29, 2014

2/9/2014

Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod

Multiple Sclerosis

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Completed

N/A

All

Phase 4

Belgium;Germany;Italy

355

EUCTR2014-000917-30-DK
(EUCTR)

02/09/2014

10/07/2014

Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis

A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis

Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

113

Belgium;Denmark;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

356

NCT02293967
(ClinicalTrials.gov)

September 2014

14/11/2014

Mass Balance Study of MT-1303

An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.

Relapsing-remitting Multiple Sclerosis

Drug: MT-1303

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

30 Years

65 Years

Male

Phase 1

United Kingdom

357

EUCTR2013-003752-21-PL
(EUCTR)

31/08/2014

04/07/2014

A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Satralizumab (120mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng /SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom

358

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

359

EUCTR2011-005249-12-EE
(EUCTR)

13/08/2014

27/02/2014

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

United States;Estonia;Greece;Canada;Spain;Belgium;Lebanon;Turkey;Australia;Russian Federation;Israel;China

360

NCT02073279
(ClinicalTrials.gov)

August 5, 2014

25/2/2014

Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)

Drug: Satralizumab;Drug: Placebo

Hoffmann-La Roche

Chugai Pharmaceutical

Active, not recruiting

18 Years

74 Years

All

Phase 3

United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Puerto Rico;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Singapore

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

361

EUCTR2014-000917-30-IT
(EUCTR)

25/07/2014

07/07/2014

Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis

A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis

Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

113

Belgium;Denmark;Italy

362

EUCTR2013-001151-12-AT
(EUCTR)

23/07/2014

14/02/2014

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden

363

EUCTR2012-000835-18-PL
(EUCTR)

22/07/2014

06/06/2014

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis

Primary progressive multiple sclerosis.
MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod
Other descriptive name: Fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden

364

NCT02201108
(ClinicalTrials.gov)

July 16, 2014

17/7/2014

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis

A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

Multiple Sclerosis

Drug: Teriflunomide;Drug: Placebo

Genzyme, a Sanofi Company

NULL

Active, not recruiting

10 Years

17 Years

All

166

Phase 3

United States;Belgium;Bulgaria;Canada;China;Estonia;France;Greece;Israel;Lebanon;Lithuania;Morocco;Netherlands;North Macedonia;Portugal;Russian Federation;Serbia;Slovenia;Spain;Tunisia;Turkey;Ukraine;United Kingdom;Australia;Macedonia, The Former Yugoslav Republic of;Poland

365

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

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

366

EUCTR2011-005249-12-BE
(EUCTR)

11/07/2014

17/03/2014

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 3

Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;France;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria

367

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

368

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

369

EUCTR2012-000835-18-DK
(EUCTR)

23/06/2014

09/05/2014

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Primary progressive multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden

370

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

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

371

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

372

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

373

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

374

NCT02117050
(ClinicalTrials.gov)

June 2014

15/4/2014

RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate. A 24-week, Prospective, Open-label, Multicenter Trial Evaluating Treatment Satisfaction in Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment Change From Tecfidera™ to Rebif® 44 mcg Subcutaneously (sc) Three Times Weekly (Tiw)

Multiple Sclerosis

Drug: Rebif ®

EMD Serono

NULL

Terminated

18 Years

65 Years

All

Phase 4

United States

375

NCT02125604
(ClinicalTrials.gov)

June 2014

25/4/2014

Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany

A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)

Relapsing-Remitting Multiple Sclerosis

Drug: dimethyl fumarate

Biogen

NULL

Completed

18 Years

N/A

All

214

Phase 4

Germany

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

376

NCT01941004
(ClinicalTrials.gov)

June 2014

9/9/2013

Safety and Efficacy of Fingolimod in MS Patients in China

A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis (Relapsing Remitting)

Drug: fingolimod;Drug: Placebo (6mos) + open label fingolimod (6 mos)

Novartis Pharmaceuticals

NULL

Withdrawn

18 Years

50 Years

All

Phase 3

NULL

377

NCT02064816
(ClinicalTrials.gov)

May 31, 2014

13/2/2014

A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis

Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: Rebif ®

Merck KGaA, Darmstadt, Germany

NULL

Completed

18 Years

60 Years

All

200

Phase 4

Germany

378

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

379

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

380

EUCTR2013-003752-21-DE
(EUCTR)

22/05/2014

20/12/2013

A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;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

381

EUCTR2013-003752-21-GB
(EUCTR)

19/05/2014

15/10/2013

A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom

382

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

383

EUCTR2013-001151-12-FR
(EUCTR)

13/05/2014

25/09/2015

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Relapsing Neuromyelitis Optica
MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden

384

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

385

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

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

386

NCT02046629
(ClinicalTrials.gov)

May 2014

23/1/2014

A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers

An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects

Multiple Sclerosis

Drug: Teriflunomide HMR1726;Drug: cholestyramine

Sanofi

NULL

Completed

18 Years

45 Years

Both

Phase 1

China

387

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

388

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

389

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

390

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

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

391

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

392

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

393

NCT04256252
(ClinicalTrials.gov)

April 2014

2/2/2020

Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)

Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial

Neuromyelitis Optica Spectrum Disorder

Drug: Rituximab

Tang-Du Hospital

NULL

Completed

16 Years

75 Years

All

108

Phase 4

NULL

394

NCT02865018
(ClinicalTrials.gov)

April 2014

9/8/2016

Neuromyelitis Optica (NMO) & Cetirizine

An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica

Neuromyelitis Optica

Drug: cetirizine

Icahn School of Medicine at Mount Sinai

Guthy Jackson Foundation

Completed

18 Years

85 Years

Both

Phase 1;Phase 2

United States

395

EUCTR2013-003752-21-IT
(EUCTR)

28/03/2014

06/02/2014

A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder

Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 16.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Code: SA237
INN or Proposed INN: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody

Chugai Pharmaceutical Co. Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

France;Hungary;Taiwan;Spain;Poland;Germany;United Kingdom;Japan;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

396

NCT02087813
(ClinicalTrials.gov)

March 2014

11/3/2014

Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses

A Single Center Open Label Pilot Study of Alpha1-Antitrypsin: A Novel Treatment to Mitigate Neuromyelitis Optica Attacks

Neuromyelitis Optica

Drug: Alpha1-antitrypsin;Drug: methylprednisolone

Stanford University

NULL

Withdrawn

18 Years

75 Years

All

Phase 1

United States

397

NCT01973491
(ClinicalTrials.gov)

February 28, 2014

23/10/2013

ATX-MS-1467 in Multiple Sclerosis

An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and Its Effect on Immune Tolerance in Subjects With Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: ATX-MS-1467

Merck KGaA

NULL

Completed

18 Years

65 Years

All

Phase 2

Germany

398

NCT02028884
(ClinicalTrials.gov)

February 20, 2014

6/1/2014

Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)

Drug: Satralizumab;Drug: Placebo;Drug: Baseline Treatment

Hoffmann-La Roche

Chugai Pharmaceutical

Active, not recruiting

12 Years

74 Years

All

Phase 3

United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom

399

JPRN-JapicCTI-132397

20/2/2014

26/12/2013

Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD

A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)

Neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)

Intervention name : SA237
INN of the intervention : satralizumab
Dosage And administration of the intervention : subcutaneous administration of SA237
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Chugai Pharmaceutical Co., Ltd.

F. Hoffmann-La Roche Ltd

complete

BOTH

Phase 3

Japan, Asia except Japan, North America, Europe

400

EUCTR2013-001151-12-GB
(EUCTR)

18/02/2014

25/07/2013

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

132

Phase 3

United States;Taiwan;Hong Kong;Spain;Russian Federation;Colombia;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;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

401

NCT02166346
(ClinicalTrials.gov)

February 2014

16/6/2014

Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)

Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch)

Transverse Myelitis;Neuromyelitis Optica;Idiopathic Transverse Myelitis;Myelitis NOS

Drug: Dalfampridine;Drug: Placebo

Johns Hopkins University

Acorda Therapeutics

Completed

18 Years

70 Years

All

Phase 2

United States

402

EUCTR2013-002082-19-NL
(EUCTR)

09/01/2014

17/10/2013

A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO

Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

403

EUCTR2013-002082-19-ES
(EUCTR)

02/01/2014

31/10/2013

A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon beta-1a (Avonex, authorised drug) administered once weekly.

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon beta-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden

404

NCT01975298
(ClinicalTrials.gov)

January 2014

28/10/2013

A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

Relapsing Remitting Multiple Sclerosis

Drug: Laquinimod;Drug: Avonex ®

Teva Pharmaceutical Industries

NULL

Withdrawn

18 Years

55 Years

Both

Phase 3

Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom

405

EUCTR2013-002916-28-LV
(EUCTR)

12/12/2013

16/10/2013

An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Russian Federation;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

406

EUCTR2013-001151-12-DE
(EUCTR)

12/12/2013

02/07/2013

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3

United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden

407

EUCTR2013-002082-19-FI
(EUCTR)

04/12/2013

15/10/2013

Relapsing remitting multiple sclerosis
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]

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden

408

EUCTR2013-002082-19-DK
(EUCTR)

03/12/2013

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden

409

EUCTR2013-002082-19-BE
(EUCTR)

25/11/2013

13/09/2013

Relapsing remitting multiple sclerosis
MedDRA version: 16.0;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]

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden

410

EUCTR2013-002082-19-SE
(EUCTR)

21/11/2013

13/09/2013

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;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

411

EUCTR2013-002082-19-GB
(EUCTR)

13/11/2013

06/11/2013

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden

412

NCT01939002
(ClinicalTrials.gov)

November 2013

23/8/2013

Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017)

An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017

Relapsing Multiple Sclerosis

Drug: BIIB017;Drug: naproxen

Biogen

NULL

Completed

18 Years

65 Years

All

251

Phase 3

United States

413

NCT02048358
(ClinicalTrials.gov)

November 2013

17/1/2014

Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients

Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201

Healthy Volunteers;Multiple Sclerosis

Drug: 2B3-201;Drug: Placebo;Drug: Methylprednisolone hemisuccinate

BBB-Therapeutics B.V.

NULL

Terminated

18 Years

65 Years

Both

Phase 1

Netherlands

414

NCT01930708
(ClinicalTrials.gov)

October 31, 2013

15/8/2013

A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes

A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting

Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis

Drug: dimethyl fumarate

Biogen

NULL

Completed

18 Years

N/A

All

1114

Phase 4

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

415

EUCTR2012-003176-39-DK
(EUCTR)

30/10/2013

25/10/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND

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: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden;Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada

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

416

EUCTR2013-001151-12-ES
(EUCTR)

17/10/2013

08/08/2013

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Relapsing Neuromyelitis Optica
MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden

417

NCT01863888
(ClinicalTrials.gov)

October 2013

23/5/2013

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Drug: teriflunomide HMR1726;Drug: cholestyramine;Drug: charcoal

Sanofi

NULL

Completed

18 Years

55 Years

Both

Phase 3

Belgium;Germany;Netherlands

418

EUCTR2012-000835-18-CZ
(EUCTR)

27/09/2013

17/06/2013

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Primary progressive multiple sclerosis.
MedDRA version: 16.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden

419

EUCTR2012-005324-16-NL
(EUCTR)

26/09/2013

03/05/2013

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC

multiple sclerosis
MedDRA version: 16.1;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: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Germany;Netherlands

420

EUCTR2013-001151-12-IT
(EUCTR)

17/09/2013

09/07/2013

EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;United Arab Emirates;Taiwan;Saudi Arabia;Hong Kong;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Singapore;Germany;Japan;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

421

EUCTR2012-003647-30-AT
(EUCTR)

27/08/2013

07/02/2013

A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).

A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO

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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2199

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

422

EUCTR2012-005324-16-BE
(EUCTR)

27/08/2013

17/04/2013

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC

multiple sclerosis
MedDRA version: 14.1;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: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Germany;Netherlands

423

EUCTR2012-005324-16-DE
(EUCTR)

05/08/2013

06/06/2013

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC

Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Netherlands;Germany

424

EUCTR2012-003176-39-IE
(EUCTR)

01/08/2013

11/04/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden

425

NCT01903291
(ClinicalTrials.gov)

August 2013

17/7/2013

Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS

A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate

Relapsing Forms of Multiple Sclerosis

Drug: dimethyl fumarate

Biogen

NULL

Completed

18 Years

N/A

Both

333

N/A

United States

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

426

NCT01917019
(ClinicalTrials.gov)

August 2013

2/8/2013

A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension

Multiple Sclerosis, Remittent Progressive;Multiple Sclerosis, Primary Progressive;Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple Sclerosis

Drug: Placebo;Drug: BIIB041 (fampridine)

Biogen

NULL

Completed

18 Years

70 Years

All

101

Phase 3

Japan

427

EUCTR2012-003176-39-GB
(EUCTR)

31/07/2013

12/04/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301

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 Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

428

EUCTR2012-003176-39-GR
(EUCTR)

14/07/2013

22/05/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

Relapsing-remitting Multiple Sclerosis
MedDRA version: 16.0;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: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1841

Phase 3

United States;Serbia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden

429

EUCTR2012-003647-30-CZ
(EUCTR)

08/07/2013

28/11/2012

Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2199

Phase 3

Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany

430

NCT01884935
(ClinicalTrials.gov)

July 2013

20/6/2013

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)

Relapsing-Remitting Multiple Sclerosis

Biological: Natalizumab

Biogen

NULL

Completed

10 Years

17 Years

Both

Phase 1

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

431

NCT01900093
(ClinicalTrials.gov)

July 2013

11/7/2013

Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses

An Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous Methylprednisolone

Multiple Sclerosis

Drug: Acthar Gel

Aaron Miller

Mallinckrodt

Recruiting

18 Years

65 Years

All

N/A

United States

432

EUCTR2012-003176-39-FI
(EUCTR)

11/06/2013

14/05/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

Relapsing-remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1841

433

NCT01874145
(ClinicalTrials.gov)

June 2013

6/6/2013

Safety and Tolerability of Glatiramer Acetate

An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis

Drug: GA 20 mg/mL;Drug: GA 40 mg/mL

Teva Pharmaceutical Industries

NULL

Completed

18 Years

N/A

All

209

Phase 3

United States

434

NCT01621269
(ClinicalTrials.gov)

June 2013

24/4/2012

ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta

Multiple Sclerosis

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Withdrawn

18 Years

65 Years

All

Phase 4

Germany

435

NCT01777412
(ClinicalTrials.gov)

June 2013

21/1/2013

Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations

An Open-label Phase 1b Study of Avastin® (Bevacizumab) for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD).

Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder

Drug: Bevacizumab

Johns Hopkins University

Genentech, Inc.;Guthy Jackson Charitable Foundation

Completed

18 Years

70 Years

All

Phase 1

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

436

EUCTR2012-003176-39-DE
(EUCTR)

31/05/2013

14/12/2012

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

437

EUCTR2012-003056-36-IE
(EUCTR)

31/05/2013

06/09/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND

Secondary progressive multiple sclerosis
MedDRA version: 21.1;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: Siponimod 2 mg tablet
Product Code: BAF312A
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod 1 mg tablet
Product Code: BAF312A
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod 0.5 mg tablet
Product Code: BAF312A
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod 0.25 mg tablet
Product Code: BAF312A
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

438

EUCTR2012-003176-39-FR
(EUCTR)

28/05/2013

20/06/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1841

Phase 3

439

EUCTR2012-003176-39-ES
(EUCTR)

24/05/2013

21/03/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

Relapsing-remitting Multiple Sclerosis
MedDRA version: 15.1;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: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1841

440

EUCTR2012-003647-30-IT
(EUCTR)

24/05/2013

11/01/2013

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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
Other descriptive name: Laquinimod Sodium (USAN)

TEVA PHARMACEUTICALS INDUSTRIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;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

441

NCT01854359
(ClinicalTrials.gov)

May 11, 2013

11/5/2013

Idebenone for Primary Progressive Multiple Sclerosis

Open Label Extension Trial of Idebenone for Primary Progressive Multiple Sclerosis

Multiple Sclerosis;Primary Progressive Multiple Sclerosis

Drug: Idebenone

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Unknown status

18 Years

N/A

All

Phase 1;Phase 2

United States

442

EUCTR2012-003176-39-SE
(EUCTR)

07/05/2013

14/03/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301

Relapsing-remitting Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

443

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

444

EUCTR2012-003176-39-HU
(EUCTR)

23/04/2013

28/02/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

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: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

445

EUCTR2012-003176-39-PL
(EUCTR)

17/04/2013

04/03/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden;Serbia

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

446

EUCTR2012-003176-39-CZ
(EUCTR)

16/04/2013

07/02/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301

Trade Name: Zinbryta
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 3

447

EUCTR2012-000835-18-HU
(EUCTR)

15/04/2013

28/02/2013

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden

448

EUCTR2012-005507-40-IT
(EUCTR)

15/04/2013

25/02/2013

Study to provide access to fingolimod to Multiple Sclerosis patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug

An open-label, single arm study to provide access to fingolimod to MS patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug

Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD HYDROCHLORIDE

NOVARTIS FARMA S.p.A

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3b

Italy

449

EUCTR2012-003647-30-PL
(EUCTR)

11/04/2013

12/02/2013

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2199

Phase 3

Belarus;United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;Estonia

450

EUCTR2012-003056-36-GB
(EUCTR)

08/04/2013

02/10/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;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

451

EUCTR2012-005082-13-IT
(EUCTR)

02/04/2013

18/02/2013

A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

Italy

452

NCT01844232
(ClinicalTrials.gov)

April 2013

24/4/2013

One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity

A One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With Spasticity

Multiple Sclerosis;Spasticity

Drug: arbaclofen

Osmotica Pharmaceutical US LLC

NULL

Completed

18 Years

70 Years

All

150

Phase 3

United States;Russian Federation;Ukraine

453

NCT01808885
(ClinicalTrials.gov)

April 2013

12/2/2013

Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.

A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.

Relapsing Remitting Multiple Sclerosis

Drug: olesoxime (TRO19622);Drug: placebo

Hoffmann-La Roche

Hôpital de la Timone;SGS S.A.;STRAGEN Services

Completed

18 Years

N/A

Both

Phase 1

France

454

EUCTR2012-003056-36-BG
(EUCTR)

20/03/2013

06/02/2013

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

455

EUCTR2012-000835-18-NL
(EUCTR)

19/03/2013

03/01/2013

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Primary progressive multiple sclerosis.
MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;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

456

EUCTR2012-000835-18-GB
(EUCTR)

18/03/2013

09/11/2012

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Primary progressive multiple sclerosis.
MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden

457

EUCTR2012-003056-36-PL
(EUCTR)

18/03/2013

20/12/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

458

EUCTR2012-003176-39-IT
(EUCTR)

14/03/2013

11/01/2013

Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis WhoHave Completed 203MS301.

A Multicenter, Open-Label, Extension Study to Evaluate the Long TermSafety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have CompletedStudy 205MS301. - EXTEND

Product Name: Daclizumab HYP
Product Code: BIIB019
INN or Proposed INN: DACLIZUMAB
Other descriptive name: Daclizumab HYP (DAC HYP

BIOGEN IDEC RESEARCH LTD

NULL

Not Recruiting

Female: yes
Male: yes

1841

Phase 3

United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Georgia;Germany;Sweden

459

EUCTR2010-020338-25-NL
(EUCTR)

02/03/2013

30/09/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand

460

EUCTR2012-000835-18-DE
(EUCTR)

26/02/2013

06/11/2012

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Primary progressive multiple sclerosis.
MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;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

461

NCT01707992
(ClinicalTrials.gov)

February 20, 2013

28/9/2012

The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis

Drug: Laquinimod;Drug: Placebo

Teva Branded Pharmaceutical Products R&D, Inc.

NULL

Completed

18 Years

55 Years

All

2199

Phase 3

United States;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Montenegro;North Macedonia;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom;Czech Republic;Kazakhstan;Macedonia, The Former Yugoslav Republic of;Mexico;Portugal

462

NCT01797965
(ClinicalTrials.gov)

February 15, 2013

15/2/2013

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019

Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis

Drug: BIIB019 (Daclizumab)

Biogen

AbbVie

Terminated

18 Years

N/A

All

1501

Phase 3

United States;Argentina;Australia;Brazil;Canada;Czechia;Denmark;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;China;Czech Republic;Finland

463

EUCTR2012-000411-91-DE
(EUCTR)

13/02/2013

04/12/2012

Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod

Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial - NKZellen-Version1.0

relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya®
Product Name: Gilenya®
Product Code: Gilenya®
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD

Charité - Universitätsmedizin Berlin

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Germany

464

EUCTR2012-004183-21-GB
(EUCTR)

25/01/2013

14/12/2012

Melatonin for Nocturia in patients with Multiple Sclerosis

A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study - Melatonin for Nocturia in MS

Nocturia; Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

North Bristol NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

465

EUCTR2012-000835-18-ES
(EUCTR)

23/01/2013

29/11/2012

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Primary progressive multiple sclerosis.
MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: GYLENIA 0,5 mg
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Farmaceutica S.A.

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;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

466

EUCTR2012-003056-36-BE
(EUCTR)

21/01/2013

19/11/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

467

EUCTR2012-003647-30-BE
(EUCTR)

18/01/2013

08/10/2012

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Belarus;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany

468

EUCTR2012-000835-18-BE
(EUCTR)

18/01/2013

19/11/2012

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Primary progressive multiple sclerosis.
MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Sweden

469

EUCTR2012-004847-61-GB
(EUCTR)

16/01/2013

18/12/2012

INSPIRE: Raltegravir (Isentress) Pilot Study in Relapsing MS

A phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI - INSPIRE (Isentress Pilot Study in Relapsing MS)

Trade Name: ISENTRESS
Product Name: raltegravir
INN or Proposed INN: lactose monohydrate

Queen Mary University of London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

470

EUCTR2012-003056-36-GR
(EUCTR)

15/01/2013

23/10/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;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

471

EUCTR2012-000835-18-IT
(EUCTR)

12/01/2013

19/12/2012

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Sweden

472

NCT01802931
(ClinicalTrials.gov)

January 7, 2013

4/1/2013

GSK239512 DDI Study

An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK239512

Multiple Sclerosis

Drug: GSK239512;Drug: ketoconazole

GlaxoSmithKline

NULL

Completed

18 Years

45 Years

Male

Phase 1

Australia

473

EUCTR2012-003647-30-ES
(EUCTR)

04/01/2013

29/10/2012

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany

474

EUCTR2012-003647-30-HU
(EUCTR)

04/01/2013

25/10/2012

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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2199

Phase 3

Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany

475

EUCTR2012-003647-30-EE
(EUCTR)

03/01/2013

19/11/2012

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2199

Phase 3

Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;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

476

NCT02249676
(ClinicalTrials.gov)

January 2013

15/9/2014

Autologous Mesenchymal Stem Cells for the Treatment of Neuromyelitis Optica Spectrum Disorders

Autologous Mesenchymal Stem Cells for the Treatment of Progressive and Refractory Neuromyelitis Optica Spectrum Disorders: an Open-label Phase 2a Proof-of-concept Study

Devic's Syndrome;Devic's Neuromyelitis Optica;Devic Syndrome;Devic's Disease;Devic Disease

Biological: Autologous mesenchymal stem cells

Tianjin Medical University General Hospital

NULL

Completed

18 Years

80 Years

All

Phase 2

China

477

NCT01779934
(ClinicalTrials.gov)

January 2013

26/10/2012

OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis

Drug: FTY720

Novartis Pharmaceuticals

NULL

Completed

28 Years

N/A

Both

579

Phase 3

United States;Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom

478

EUCTR2012-003056-36-LT
(EUCTR)

21/12/2012

29/10/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

479

NCT01665144
(ClinicalTrials.gov)

December 20, 2012

3/8/2012

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.

Secondary Progressive Multiple Sclerosis

Drug: BAF312;Drug: Placebo

Novartis Pharmaceuticals

NULL

Active, not recruiting

18 Years

60 Years

All

1653

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;China;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Latvia;Lithuania;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Egypt

480

EUCTR2012-003647-30-GB
(EUCTR)

20/12/2012

23/10/2012

A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) consisting of two parts: First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).

Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2199

Phase 3

Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;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

481

EUCTR2012-000835-18-FR
(EUCTR)

20/12/2012

19/06/2013

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden

482

EUCTR2012-003056-36-DE
(EUCTR)

14/12/2012

11/09/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

483

EUCTR2012-003056-36-EE
(EUCTR)

13/12/2012

09/11/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Secondary progressive multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden

484

EUCTR2012-003647-30-LV
(EUCTR)

13/12/2012

25/10/2012

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2199

Phase 3

Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany

485

EUCTR2012-003056-36-SE
(EUCTR)

12/12/2012

08/10/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;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

486

EUCTR2012-003056-36-PT
(EUCTR)

11/12/2012

11/10/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

Secondary progressive multiple sclerosis
MedDRA version: 21.1;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]

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden

487

EUCTR2012-003647-30-GR
(EUCTR)

11/12/2012

14/11/2012

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Belarus;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Albania;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany

488

EUCTR2012-003056-36-SK
(EUCTR)

10/12/2012

13/09/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1530

Phase 3

489

EUCTR2012-003647-30-SK
(EUCTR)

04/12/2012

20/02/2014

Relapsing remitting multiple sclerosis
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]

Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2100

Phase 3

Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany

490

EUCTR2012-003056-36-AT
(EUCTR)

28/11/2012

08/10/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;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

491

EUCTR2012-000835-18-FI
(EUCTR)

28/11/2012

08/11/2012

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden

492

EUCTR2012-003056-36-CZ
(EUCTR)

08/11/2012

12/09/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1530

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden

493

EUCTR2012-000835-18-SE
(EUCTR)

07/11/2012

01/10/2012

A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden

494

NCT02137707
(ClinicalTrials.gov)

November 2012

12/5/2014

Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya

An Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 Years

Multiple Sclerosis-Relapsing-Remitting

Drug: Gilenya

McGill University

Novartis

Completed

18 Years

65 Years

All

135

Phase 4

Canada

495

NCT01767493
(ClinicalTrials.gov)

November 2012

13/12/2012

Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients

An Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: [18F]Florbetapir and PET imaging

Institute for Neurodegenerative Disorders

Biogen Idec

Recruiting

18 Years

60 Years

Both

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

496

EUCTR2012-003418-15-AT
(EUCTR)

23/10/2012

09/11/2012

Methylphenidate modified release as treatment of MS-associated fatigue.

Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial.

Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Ritalin LA 20mg capsules
Product Name: Methylphenidate modified release 20 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 30mg capsules
Product Name: Methylphenidate modified release 30 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 40mg capsules
Product Name: Methylphenidate modified release 40 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE

Medizinische Universität Wien

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

497

EUCTR2010-020315-36-CZ
(EUCTR)

18/10/2012

22/08/2012

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II

Relapsing Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina

498

EUCTR2012-002637-11-DE
(EUCTR)

15/10/2012

09/10/2012

A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis

A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis - STAY

Treatment statisfaction in patients with relapsing remitting Multiple Sclerosis
MedDRA version: 15.0;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: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: Fingolimod Hydrochloride

Novartis Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany

499

NCT01578330
(ClinicalTrials.gov)

October 2012

16/3/2012

A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720

A 12 -Month, Open-label, Multi-center Pilot Study to Explore the Health Outcomes of FTY720 in RRMS Patients Who Have Previously Been Treated With Other Disease Modifying Therapies (DMT)- Fine

Multiple Sclerosis;Relapsing-Remitting

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

Phase 4

Turkey

500

NCT01701856
(ClinicalTrials.gov)

September 2012

18/9/2012

Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis

Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study

Relapsing-remitting Multiple Sclerosis

Drug: Interferon beta -1b

Claudio Gobbi

Bayer

Terminated

18 Years

70 Years

Both

Phase 4

Switzerland

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

501

NCT01639300
(ClinicalTrials.gov)

July 2012

10/7/2012

Safety Study of GNbAC1 in Multiple Sclerosis Patients

Randomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1

Multiple Sclerosis

Biological: GNbAC1;Biological: GNbAC1 placebo

GeNeuro Innovation SAS

NULL

Completed

18 Years

65 Years

All

Phase 2

Switzerland

502

EUCTR2012-000653-32-DE
(EUCTR)

27/06/2012

12/04/2012

A study to explore heart function during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis

A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START) - START

Conduction abnormalities in patients with relapsing-remitting multiple sclerosis
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: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: Fingolimod Hydrochloride

Novartis Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Germany

503

NCT01623596
(ClinicalTrials.gov)

June 8, 2012

18/6/2012

Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS)

Relapsing Remitting Multiple Sclerosis

Drug: Fingolimod;Drug: Disease Modifying therapy

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

881

Phase 4

United States;Puerto Rico

504

NCT01610310
(ClinicalTrials.gov)

June 2012

31/5/2012

Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers

A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) Delivered by Pre-filled Syringe (PFS) or Autoinjector in Healthy Volunteers

Healthy;Multiple Sclerosis

Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS);Device: BIIB017 (peginterferon beta-1a) Autoinjector

Biogen Idec

NULL

Completed

18 Years

45 Years

Both

Phase 1

United States

505

NCT02142205
(ClinicalTrials.gov)

May 2012

16/5/2014

Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).

Relapsing-Remitting Multiple Sclerosis

Biological: BG00002

Biogen Idec

Biogen Idec International GmbH

Completed

18 Years

60 Years

Both

100

Phase 4

Russian Federation

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

506

NCT01585298
(ClinicalTrials.gov)

April 29, 2012

23/4/2012

STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)

A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis

Drug: FTY720

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

6998

Phase 4

Germany

507

EUCTR2010-020337-99-NL
(EUCTR)

13/04/2012

19/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Relapsing 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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand

508

EUCTR2010-020515-37-NO
(EUCTR)

22/03/2012

15/02/2011

A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

509

NCT01404117
(ClinicalTrials.gov)

March 2012

26/7/2011

A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability

Relapsing Multiple Sclerosis

Drug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ Placebo

Teva Pharmaceutical Industries

NULL

Withdrawn

18 Years

55 Years

Both

Phase 2

NULL

510

EUCTR2011-006043-30-NL
(EUCTR)

27/02/2012

16/02/2012

Study to evaluate the effect of oral BAF312 on a monophasic oral contraceptive in healthy female volunteers

An open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on the pharmacokinetices and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers -

healthy volunteers (Multiple sclerosis is the intended indication for BAF312)
;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BAF312 0,25 mg tablet
Product Code: BAF312
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 1 mg tablet
Product Code: BAF312
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 4 mg tablet
Product Code: BAF312
Other descriptive name: BAF312 hemifumarate
Trade Name: Microgynon
Product Name: Microgynon
INN or Proposed INN: ETHINYLESTRADIOL
Other descriptive name: LEVONORGESTREL

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: no

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

511

EUCTR2011-003507-38-IT
(EUCTR)

22/02/2012

02/03/2012

Long-Term Prolonged-Release Fampridine Treatment and Quality of Life

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Dailyon Quality of Life as Reported by Subjects with Multiple Sclerosis

Trade Name: Fampyra
INN or Proposed INN: FAMPRIDINE
Other descriptive name: NA

BIOGEN IDEC RESEARCH LTD

NULL

Not Recruiting

Female: yes
Male: yes

800

Portugal;Denmark;Australia;Netherlands;United Kingdom;Italy

512

NCT01485003
(ClinicalTrials.gov)

February 7, 2012

1/12/2011

Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants

A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

Relapsing-Remitting Multiple Sclerosis

Biological: natalizumab

Biogen

NULL

Completed

18 Years

65 Years

All

231

United States

513

EUCTR2011-003507-38-PT
(EUCTR)

03/02/2012

28/11/2011

Long-Term Prolonged-Release Fampridine Treatment and Quality of Life

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis

Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
INN or Proposed INN: FAMPRIDINE

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

800

France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden

514

NCT01480076
(ClinicalTrials.gov)

February 2012

23/11/2011

Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis

Multiple Sclerosis

Drug: Fampridine

Biogen

NULL

Completed

18 Years

75 Years

All

901

Phase 4

Australia;Belgium;Denmark;France;Germany;Italy;Netherlands;Portugal;United Kingdom;United States

515

NCT01497262
(ClinicalTrials.gov)

February 2012

5/12/2011

Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

162

Phase 3

Argentina;Brazil;Colombia;Jordan;Malaysia;Mexico;Panama;Peru;Costa Rica

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

516

NCT01433250
(ClinicalTrials.gov)

February 2012

26/8/2011

A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis

Drug: AIN457

Novartis Pharmaceuticals

NULL

Completed

18 Years

55 Years

All

Phase 2

Czech Republic;Russian Federation;Ukraine

517

EUCTR2011-000888-27-DE
(EUCTR)

24/01/2012

19/08/2011

A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.

Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE

Synthon BV

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany

518

EUCTR2011-003507-38-BE
(EUCTR)

23/01/2012

04/11/2011

Long-Term Prolonged-Release Fampridine Treatment and Quality of Life

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis

Multiple Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
INN or Proposed INN: FAMPRIDINE

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 4

France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden

519

EUCTR2011-001629-25-CZ
(EUCTR)

10/01/2012

11/10/2011

A clinical extension study to evaluate the safety, tolerability and efficacy of AIN457 in multiple sclerosis patients with relapses

An open label extension study to evaluate the safety, tolerability and efficacy of AIN457 in patients with relapsing-remitting multiple sclerosis

relapsing-remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: rhumAb to IL-17A igG1-k-class

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Ukraine;Russian Federation

520

EUCTR2011-000888-27-GR
(EUCTR)

09/01/2012

13/12/2011

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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Synthon BV

NULL

Not Recruiting

Female: yes
Male: yes

750

Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;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

521

EUCTR2011-003507-38-GB
(EUCTR)

06/01/2012

20/10/2011

Long-Term Prolonged-Release Fampridine Treatment and Quality of Life

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis

Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
INN or Proposed INN: FAMPRIDINE

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 4

United Kingdom;Sweden;France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy

522

EUCTR2011-003507-38-NL
(EUCTR)

05/01/2012

07/11/2011

Long-Term Prolonged-Release Fampridine Treatment and Quality of Life

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis

Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
INN or Proposed INN: FAMPRIDINE

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

800

France;Portugal;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden

523

EUCTR2011-003507-38-DK
(EUCTR)

05/01/2012

05/12/2011

Long-Term Prolonged-Release Fampridine Treatment and Quality of Life

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis

Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
INN or Proposed INN: FAMPRIDINE

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

800

France;Portugal;Belgium;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden

524

EUCTR2010-023023-19-DE
(EUCTR)

04/01/2012

18/11/2011

Studyto compare the efficacy and safety of fingolimod and interferon-beta-1b in patients with mutliple sclerosis

A 18-month, open-label, rater-blinded, randomized, multicenter, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod in comparison to interferon beta 1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy

treating of cognitive symptoms in relapsing-remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
Other descriptive name: INTERFERON BETA -1B
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
Product Name: Extavia
Product Code: NVF233
Other descriptive name: INTERFERON BETA -1B

Novartis Farma S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Italy

525

NCT01534182
(ClinicalTrials.gov)

January 2012

8/2/2012

Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)

Relapsing Remitting Multiple Sclerosis

Drug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA)

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

298

Phase 4

Russian Federation

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

526

NCT01535664
(ClinicalTrials.gov)

January 2012

7/2/2012

An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)

An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS

Multiple Sclerosis

Other: Withdrawal of dalfampridine-ER 10mg

Acorda Therapeutics

Prometrika, LLC;BCS Consulting, Inc.

Completed

18 Years

70 Years

All

United States

527

NCT01498887
(ClinicalTrials.gov)

December 24, 2011

19/12/2011

Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.

Relapsing Remitting Multiple Sclerosis

Drug: Fingolimod (FTY720)

Novartis Pharmaceuticals

NULL

Completed

18 Years

50 Years

All

347

Phase 4

Australia;Spain

528

EUCTR2010-021978-11-PL
(EUCTR)

07/12/2011

28/10/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension

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]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

529

EUCTR2010-021978-11-CZ
(EUCTR)

02/12/2011

22/08/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Secondary Progressive Multiple Sclerosis
MedDRA version: 19.0;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]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

Phase 3

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

530

NCT01470521
(ClinicalTrials.gov)

December 2011

9/11/2011

Worms for Immune Regulation of Multiple Sclerosis

Worms for Immune Regulation of Multiple Sclerosis (WIRMS)

Multiple Sclerosis, Relapsing-Remitting

Biological: Hookworm larvae;Biological: Placebo

University of Nottingham

National Multiple Sclerosis Society

Completed

18 Years

65 Years

Both

Phase 2

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

531

EUCTR2010-020315-36-BG
(EUCTR)

28/11/2011

19/08/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

532

EUCTR2011-000888-27-RO
(EUCTR)

18/11/2011

09/10/2012

Relapsing remitting multiple sclerosis
MedDRA version: 15.0;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]

Synthon BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany

533

EUCTR2010-020315-36-BE
(EUCTR)

14/11/2011

30/06/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Relapsing 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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

534

EUCTR2010-020315-36-IE
(EUCTR)

04/11/2011

08/09/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

535

NCT01436643
(ClinicalTrials.gov)

November 2011

16/9/2011

Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression

A 21-week, Multicenter, Open Label Study to Evaluate the Safety and Tolerability Profile of the Combination of a SSRI or SNRI Antidepressive Therapy With Oral Fingolimod in the Treatment of RRMS Patients With Mild to Moderate Depression

Depression;Relapsing-remitting Multiple Sclerosis

Drug: Venlafaxine;Drug: Fluoxetine;Drug: Citalopram;Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Terminated

18 Years

65 Years

All

Phase 4

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

536

NCT01462318
(ClinicalTrials.gov)

November 2011

14/7/2011

An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis

A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis

Drug: Midazolam;Other: Caffeine;Drug: S-warfarin;Other: Vitamin K;Drug: Omeprazole;Drug: Dextromethorphan;Biological: BIIB019 (Daclizumab)

Biogen

NULL

Completed

18 Years

65 Years

All

133

Phase 3

United States;Czech Republic;Hungary;Poland;Russian Federation

537

EUCTR2011-003484-30-ES
(EUCTR)

26/10/2011

12/04/2012

A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis.

Multiple Sclerosis relapsing-remitting course;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
INN or Proposed INN: Fingolimod

Novartis Farmacéutica S.A.

NULL

Not Recruiting

Female: yes
Male: yes

432

Phase 3

Spain;Australia

538

EUCTR2010-020337-99-PL
(EUCTR)

25/10/2011

13/09/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand

539

EUCTR2011-000888-27-GB
(EUCTR)

24/10/2011

01/08/2011

Synthon BV

NULL

Not Recruiting

Female: yes
Male: yes

750

Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany

540

EUCTR2010-020337-99-GB
(EUCTR)

20/10/2011

05/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

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

541

EUCTR2010-020315-36-GB
(EUCTR)

20/10/2011

16/08/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

542

EUCTR2010-020315-36-SK
(EUCTR)

18/10/2011

28/06/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

543

EUCTR2010-020315-36-ES
(EUCTR)

18/10/2011

21/07/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis
MedDRA version: 14.0;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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Ukraine;Canada;Peru;Belarus;Belgium;Mexico;Argentina;Spain;Bosnia and Herzegovina;United States;Croatia

544

EUCTR2010-023856-97-CZ
(EUCTR)

13/10/2011

09/08/2011

Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe

A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE

Relapsing-remitting Multiple Sclerosis
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]

Product Name: Daclizumab HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

120

United States;Hungary;Czech Republic;Poland

545

EUCTR2011-000888-27-IT
(EUCTR)

13/10/2011

24/01/2012

A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.

Multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE

Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GTR .ace
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: glatiramer acetate

SYNTHON BV

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Estonia;Czech Republic;Greece;Ukraine;Romania;Croatia;Bulgaria;Russian Federation;Germany;United Kingdom;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

546

EUCTR2010-023856-97-PL
(EUCTR)

12/10/2011

26/08/2011

Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe

A Multicenter, Single-Arm, Open-Label, Study to Evaluatethe Immunogenicity and Pharmacokinetics of BIIB019,Daclizumab High Yield Process (DAC HYP), PrefilledSyringe Administered by Subcutaneous Injection inSubjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE

Relapsing-remitting Multiple Sclerosis
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: Daclizumab HYP
Product Code: BIIB019
INN or Proposed INN: -
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Hungary;Czech Republic;Poland;Russian Federation

547

EUCTR2010-020315-36-FR
(EUCTR)

07/10/2011

02/09/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

548

NCT01489254
(ClinicalTrials.gov)

October 2011

8/12/2011

Efficacy and Safety of GTR in Comparison to Copaxone®

Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects

Multiple Sclerosis

Drug: Glatiramer Acetate (GTR);Drug: Glatiramer Acetate (Copaxone®);Drug: Placebo

Synthon BV

NULL

Completed

18 Years

55 Years

All

794

Phase 3

United States;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Ukraine;United Kingdom;Greece;Kazakhstan

549

EUCTR2010-021978-11-FI
(EUCTR)

28/09/2011

15/08/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

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]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

550

EUCTR2010-020315-36-DE
(EUCTR)

22/09/2011

08/07/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

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

551

EUCTR2010-023856-97-HU
(EUCTR)

22/09/2011

15/07/2011

Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe

A Multicenter, Single-Arm, Open-Label, Study to Evaluatethe Immunogenicity and Pharmacokinetics of BIIB019,Daclizumab High Yield Process (DAC HYP), PrefilledSyringe Administered by Subcutaneous Injection inSubjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE

Product Name: Daclizumab HYP
Product Code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

120

United States;Czech Republic;Hungary;Poland;Russian Federation

552

EUCTR2011-000888-27-EE
(EUCTR)

21/09/2011

01/09/2011

Synthon BV

NULL

Not Recruiting

Female: yes
Male: yes

750

Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany

553

EUCTR2011-000888-27-CZ
(EUCTR)

21/09/2011

17/06/2011

Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR .ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE

Synthon BV

NULL

Not Recruiting

Female: yes
Male: yes

750

Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany

554

EUCTR2010-020337-99-ES
(EUCTR)

21/09/2011

20/07/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;Serbia;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain

555

NCT01412333
(ClinicalTrials.gov)

September 20, 2011

8/8/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: Interferon beta -1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta -1a-matching placebo

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

55 Years

All

835

Phase 3

United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco

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

556

EUCTR2010-021978-11-DK
(EUCTR)

19/09/2011

23/08/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

Phase 3

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

557

NCT01416181
(ClinicalTrials.gov)

September 13, 2011

21/7/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis

Drug: natalizumab;Drug: Placebo

Biogen

NULL

Terminated

18 Years

58 Years

All

889

Phase 3

United States;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic

558

EUCTR2010-021219-17-ES
(EUCTR)

12/09/2011

01/07/2011

Evaluación de masitinib en esclerosis múltiple

Estudio prospectivo Fase III, multicéntrico, randomizado, doble ciego, de dos grupos paralelos, controlado con placebo y de 96 semanas de duración, para comparar la eficacia y seguridad de masitinib a la dosis de 6 mg/kg/día con placebo en el tratamiento de pacientes con esclerosis múltiple primaria progresiva o esclerosis múltiple secundaria progresiva sin recidiva

Pacientes con esclerosis múltiple primaria progresiva o secundaria progresiva sin recidiva
MedDRA version: 14.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;United States;Czech Republic;Slovakia;Greece;Poland;Spain;Romania;Bulgaria;Germany

559

EUCTR2010-020337-99-DE
(EUCTR)

05/09/2011

11/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand

560

EUCTR2011-001442-15-ES
(EUCTR)

01/09/2011

07/07/2011

Estudio para evaluar el control de la enfermedad y la seguridad en pacientes con esclerosis múltiple remitente recurrente que que cambian el tratamiento previo con natalizumab por fingolimod.

Estudio multicéntrico, aleatorizado, con enmascaramiento para el paciente y para el evaluador, de grupos paralelos, de 32 semanas de seguimiento, para evaluar el control de la enfermedad y la seguridad en pacientes con esclerosis múltiple remitente recurrente que cambian el tratamiento previo con natalizumab por fingolimod (FTY720)

Escelrosis Múltiple Remitente Recurrente
MedDRA version: 14.0;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: Fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: Hidrocloruro de fingolimod

Novartis Farmacéutica, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;Germany;Switzerland;France;Italy;Austria;Sweden;Israel;Finland;United Kingdom;Czech Republic;Spain;Greece

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

561

NCT01450124
(ClinicalTrials.gov)

September 2011

18/9/2011

Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)

Safety, Tolerability And Mechanism Of Action Of Boswellic Acids In Multiple Sclerosis and Clinically Isolated Syndrome: A MRI-Controlled, Multicenter, Baseline-To-Treatment, 32-Weeks, Open-Label, Phase IIa Trial

Relapsing Remitting Multiple Sclerosis

Drug: Boswellic acids (BOSWELAN)

Universitätsklinikum Hamburg-Eppendorf

NULL

Completed

18 Years

65 Years

All

Phase 2

Germany

562

NCT01360489
(ClinicalTrials.gov)

September 2011

23/5/2011

Arbaclofen Placarbil for the Treatment of Spasticity in Subjects With Multiple Sclerosis (MS)

An Open Label, 26-Week Study Assessing Arbaclofen Placarbil Safety and Efficacy in Subjects With Spasticity Associated With Multiple Sclerosis With an Addendum Open-Label, 36-Week Study Assessing Arbaclofen Placarbil Safety in Subjects With Spasticity Associated With Multiple Sclerosis

Multiple Sclerosis

Drug: arbaclofen placarbil

XenoPort, Inc.

NULL

Completed

18 Years

70 Years

Both

218

Phase 3

United States

563

NCT01247324
(ClinicalTrials.gov)

August 31, 2011

23/11/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: Interferon beta -1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta -1a-matching placebo

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

55 Years

All

821

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;Czech Republic;Morocco;New Zealand

564

EUCTR2010-020315-36-SE
(EUCTR)

31/08/2011

05/07/2011

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

565

EUCTR2010-021978-11-DE
(EUCTR)

19/08/2011

04/04/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Israel;United Kingdom;Iraq;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;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

566

EUCTR2011-000888-27-BG
(EUCTR)

18/08/2011

11/07/2011

Synthon BV

NULL

Not Recruiting

Female: yes
Male: yes

750

Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany

567

NCT01420055
(ClinicalTrials.gov)

August 2011

17/8/2011

Fingolimod -Response According to Coping - Evaluation

A 4-month, Prospective, Open-label, Multi-center Phase IV Study to Assess Response to Fingolimod Initiation According to Coping Profile in Adult Patients With Highly Active Relapsing Remitting Multiple Sclerosis in France

Multiple Sclerosis, Relapsing-Remitting

Drug: fingolimod

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

Both

189

Phase 4

France

568

EUCTR2010-021978-11-GB
(EUCTR)

26/07/2011

04/04/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Secondary Progressive Multiple Sclerosis
MedDRA version: 14.1;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]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

Phase 3

United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

569

EUCTR2010-020337-99-SK
(EUCTR)

23/06/2011

14/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

570

EUCTR2011-001280-49-FR
(EUCTR)

14/06/2011

14/04/2011

« GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude clinique menée dans plusieurs centres français, d'une durée de 4 mois, visant à comparer la réponse à l'initiation du traitement par fingolimod (Gilenya®) selon le profil d'anxiété chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active.

« GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude multicentrique de phase IV, prospective, en ouvert, d'une durée de 4 mois, visant à comparer la réponse à l’initiation du fingolimod (Gilenya®) selon le profil de « coping » chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active en France. - GRACE

Sclérose en plaques rémittente-récurrente active
MedDRA version: 13.1;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: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE

Novartis Pharma S.A.S

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

France

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

571

EUCTR2009-015318-23-DE
(EUCTR)

09/06/2011

08/06/2010

A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION)

A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Product Name: Daclizumab High Yield Process
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 2

Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India

572

EUCTR2010-020338-25-DE
(EUCTR)

08/06/2011

06/10/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10 ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10 ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand

573

EUCTR2010-020338-25-PL
(EUCTR)

04/06/2011

14/05/2011

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Norway;Germany;New Zealand

574

EUCTR2010-020338-25-BE
(EUCTR)

26/05/2011

22/09/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

575

EUCTR2010-020338-25-BG
(EUCTR)

11/05/2011

19/01/2011

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab
Product Code: Ro 496-4913/F03
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Not Recruiting

Female: yes
Male: yes

630

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

576

NCT01333501
(ClinicalTrials.gov)

May 2011

8/4/2011

Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

A 18-month, Open-label, Rater-blinded, Randomized, Multi-center, Active-controlled, Parallel-group Pilot Study to Assess Efficacy and Safety of Fingolimod in Comparison to Interferon Beta 1b in Treating the Cognitive Symptoms Associated to Relapsing-remitting Multiple Sclerosis and to Assess Possible Relationship of These Effects to Regional Brain Atrophy

Multiple Sclerosis

Drug: Fingolimod;Drug: Interferon beta 1b

Novartis Pharmaceuticals

NULL

Completed

18 Years

50 Years

All

151

Phase 4

Germany;Italy

577

NCT01317004
(ClinicalTrials.gov)

May 2011

15/3/2011

Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

Relapsing Remitting Multiple Sclerosis

Drug: Fingolimod;Drug: Standard MS DMT

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

Phase 4

Italy

578

EUCTR2011-000770-60-IT
(EUCTR)

12/04/2011

01/09/2011

An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND

approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
MedDRA version: 14.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: other nervous system drugs

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

600

Italy

579

EUCTR2010-023560-40-SE
(EUCTR)

23/03/2011

21/12/2010

Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.

Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST

Relapsing-remitting multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol

Uppsala l?ns landsting

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

United States;Canada;Brazil;Sweden

580

EUCTR2010-024017-31-IT
(EUCTR)

15/03/2011

08/02/2011

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN

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

Product Name: FINGOLIMOD
Product Code: FTY720D
Trade Name: EXTAVIA
INN or Proposed INN: Interferon beta -1b
Trade Name: AVONEX
INN or Proposed INN: Interferon beta -1a
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

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

581

EUCTR2010-020337-99-BG
(EUCTR)

07/03/2011

17/12/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

582

NCT01194570
(ClinicalTrials.gov)

March 2, 2011

28/8/2010

A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Multiple Sclerosis, Primary Progressive

Drug: Ocrelizumab;Other: Placebo

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

55 Years

All

732

Phase 3

United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czechia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Uruguay;Czech Republic;Denmark;Turkey

583

EUCTR2010-020338-25-DK
(EUCTR)

02/03/2011

07/02/2011

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 3

Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Netherlands;Germany

584

EUCTR2010-020337-99-BE
(EUCTR)

23/02/2011

12/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Relapsing 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]

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

585

EUCTR2010-023021-38-SE
(EUCTR)

23/02/2011

26/11/2010

Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS

Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB

Västerbottens läns landsting

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

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

586

EUCTR2010-020337-99-CZ
(EUCTR)

21/02/2011

11/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

587

EUCTR2010-023172-12-ES
(EUCTR)

14/02/2011

23/12/2010

Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES

Esclerosis múltiple_______Multiple sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide

sanofi-aventis recherche et development

NULL

Not Recruiting

Female: yes
Male: yes

1455

Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

588

EUCTR2010-020515-37-DK
(EUCTR)

14/02/2011

03/01/2011

Relapsing multiple sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Denmark;Estonia;Spain;Greece

589

EUCTR2010-020337-99-PT
(EUCTR)

04/02/2011

29/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913 /F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Serbia;Portugal;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand

590

NCT01310166
(ClinicalTrials.gov)

February 2011

24/2/2011

Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Relapsing-remitting Multiple Sclerosis

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

Both

447

Phase 4

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

591

EUCTR2010-019029-32-SK
(EUCTR)

27/01/2011

12/05/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden

592

EUCTR2010-020338-25-AT
(EUCTR)

26/01/2011

18/10/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

593

EUCTR2010-020338-25-GR
(EUCTR)

21/01/2011

17/01/2011

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

594

EUCTR2010-020338-25-CZ
(EUCTR)

20/01/2011

05/10/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

595

EUCTR2010-020337-99-AT
(EUCTR)

20/01/2011

18/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

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

596

EUCTR2010-022066-28-DE
(EUCTR)

18/01/2011

29/09/2010

A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis

relapsing remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Gilenya
Other descriptive name: Fingolimod

Novartis Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

445

Phase 3

Germany

597

EUCTR2010-020337-99-LT
(EUCTR)

17/01/2011

27/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

598

EUCTR2010-020338-25-PT
(EUCTR)

12/01/2011

14/10/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: OCREVUS
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand

599

EUCTR2010-020515-37-IE
(EUCTR)

04/01/2011

13/10/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.

multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden

600

EUCTR2010-020515-37-CZ
(EUCTR)

03/01/2011

27/07/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Romania;Norway;Germany;Sweden;Poland;Belgium;Brazil

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

601

EUCTR2010-020338-25-GB
(EUCTR)

29/12/2010

05/10/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand

602

EUCTR2010-020337-99-LV
(EUCTR)

29/12/2010

11/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Relapsing 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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

603

EUCTR2010-023023-19-IT
(EUCTR)

28/12/2010

19/11/2010

A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - ND

relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399

Product Name: FINGOLIMOD
Product Code: FTY720D
Trade Name: EXTAVIA
INN or Proposed INN: Interferon beta -1b

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Italy

604

NCT01466322
(ClinicalTrials.gov)

December 22, 2010

3/11/2011

A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers.

An Open-label, Randomised, Crossover Study to Assess the Relative Bioavailability of Different 2mg Formulations of GSK2018682(S1P1 Agonist) in Healthy Volunteers

Multiple Sclerosis, Relapsing-Remitting

Drug: GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state

GlaxoSmithKline

NULL

Completed

18 Years

55 Years

All

Phase 1

Australia

605

EUCTR2010-020338-25-ES
(EUCTR)

20/12/2010

17/09/2010

Estudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio

Esclerosis múltiple progresiva primaria (EMPP)
MedDRA version: 12.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis

Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: -

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria

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

606

EUCTR2010-020515-37-BE
(EUCTR)

17/12/2010

28/10/2010

Long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis

A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis.

Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Greece;Spain;Costa Rica;Ireland;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;Sweden

607

EUCTR2010-020338-25-FI
(EUCTR)

15/12/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

608

EUCTR2010-020337-99-FI
(EUCTR)

15/12/2010

11/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I

Relapsing 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]

F.Hoffmann-La Roche

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand

609

EUCTR2010-020338-25-IT
(EUCTR)

07/12/2010

24/12/2010

A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIO

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063401

Product Name: ocrelizumab

F. Hoffmann - La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

Portugal;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria

610

EUCTR2010-020515-37-NL
(EUCTR)

01/12/2010

12/10/2010

long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis

Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Portugal;Comoros;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria

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

611

NCT01318421
(ClinicalTrials.gov)

December 2010

8/3/2011

A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Drug: ELND002

Elan Pharmaceuticals

NULL

Terminated

18 Years

65 Years

Both

Phase 1

NULL

612

NCT01235221
(ClinicalTrials.gov)

December 2010

4/11/2010

Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.

Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials

Multiple Sclerosis

Drug: BIIB041 (Fampridine-SR)

Biogen Idec

Acorda Therapeutics

Completed

18 Years

70 Years

Both

Phase 3

Canada

613

EUCTR2010-020337-99-EE
(EUCTR)

26/11/2010

27/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

614

EUCTR2009-012989-30-AT
(EUCTR)

25/11/2010

14/12/2009

A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.

A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - -

Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20]

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden

615

EUCTR2010-020515-37-FR
(EUCTR)

19/11/2010

06/09/2010

Relapsing multiple sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;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

616

EUCTR2010-020337-99-HU
(EUCTR)

17/11/2010

11/10/2010

A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis
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]

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Portugal;United States;Serbia;Estonia;Morocco;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand

617

EUCTR2010-020338-25-HU
(EUCTR)

17/11/2010

29/09/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Product Name: ocrelizumab
Product Code: Ro 496-4913/F03
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand

618

EUCTR2010-020338-25-LT
(EUCTR)

02/11/2010

02/09/2010

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab

F.Hoffmann-La Roche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand

619

NCT01440101
(ClinicalTrials.gov)

November 2010

14/4/2011

Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B)

Multiple Sclerosis

Drug: Natalizumab (BG00002);Drug: Placebo

Biogen

NULL

Completed

18 Years

65 Years

All

106

Phase 2;Phase 3

Japan;China

620

EUCTR2010-020515-37-IT
(EUCTR)

25/10/2010

14/09/2010

MS (MULTIPLE SCLEROSIS)
MedDRA version: 9.1;Level: LLT;Classification code 10048393

Product Name: fingolimod
Product Code: FTY720D

NOVARTIS FARMA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5000

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Estonia;Spain;Greece

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

621

EUCTR2010-020515-37-AT
(EUCTR)

21/10/2010

15/09/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden

622

EUCTR2010-018705-11-ES
(EUCTR)

20/10/2010

27/07/2010

ESTUDIO DE EXTENSIÓN DE 26 SEMANAS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A 26-WEEK SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS.

Esclerosis múltiple remitente-recurrente.Relapsing-remitting Multiple Sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Code: ONO-4641
Product Code: ONO-4641
Product Code: ONO-4641

ONO Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

338

Czech Republic;Greece;Belgium;Spain;Germany

623

EUCTR2010-020515-37-ES
(EUCTR)

20/10/2010

02/08/2010

Estudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltiple

Esclerosis Múltiple Remitente Recurrente
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Farmacéutica, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden

624

EUCTR2010-020515-37-SK
(EUCTR)

18/10/2010

03/08/2010

Relapsing multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden

625

EUCTR2010-020515-37-PT
(EUCTR)

11/10/2010

23/07/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;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

626

EUCTR2009-015815-42-LT
(EUCTR)

11/10/2010

09/08/2010

An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease

A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - -

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

714

Phase 3

United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany

627

EUCTR2010-019029-32-BE
(EUCTR)

08/10/2010

03/08/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 2

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden

628

EUCTR2010-020515-37-EE
(EUCTR)

08/10/2010

09/09/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Ireland;Portugal;United States;Estonia;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden

629

EUCTR2010-020515-37-GR
(EUCTR)

05/10/2010

04/10/2010

Relapsing multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden

630

NCT01166178
(ClinicalTrials.gov)

October 2010

19/7/2010

Zoledronic Acid in MS-patients With Osteoporosis

A 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment Phase

Osteoporosis;Multiple Sclerosis

Drug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combination

Novartis

NULL

Terminated

18 Years

75 Years

All

Phase 3

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

631

NCT01416155
(ClinicalTrials.gov)

October 2010

24/3/2011

Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis

A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis

Drug: natalizumab

Biogen

NULL

Completed

18 Years

65 Years

All

Phase 2

Japan;China

632

EUCTR2010-020515-37-HU
(EUCTR)

30/09/2010

11/08/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

633

EUCTR2010-020515-37-GB
(EUCTR)

27/09/2010

17/08/2010

Long-term safety and tolerability of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden

634

EUCTR2010-020515-37-SE
(EUCTR)

27/09/2010

24/08/2010

Long-term safety, tolerability and efficacy study of 0.5 mg fingolimodonce daily in patients with multiple sclerosis.

Multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden

635

EUCTR2010-020515-37-DE
(EUCTR)

13/09/2010

09/07/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;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

636

NCT01201356
(ClinicalTrials.gov)

September 13, 2010

10/9/2010

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis

Drug: Fingolimod

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

4125

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;Egypt;Estonia;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Jordan;Korea, Republic of;Malaysia;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom;Costa Rica;Czech Republic

637

EUCTR2010-019029-32-CZ
(EUCTR)

02/09/2010

08/06/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Hungary;Denmark;Germany;Netherlands;Sweden

638

JPRN-JapicCTI-101335

01/9/2010

08/11/2010

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)

Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain

Intervention name : pregabalin
INN of the intervention : pregabalin
Dosage And administration of the intervention : pregabalin capsules 150mg/day, 300mg/day, 450mg/day or 600mg/day BID
Control intervention name : null

Pfizer Japan Inc.

NULL

BOTH

100

Phase 3

NULL

639

NCT01202227
(ClinicalTrials.gov)

September 2010

31/8/2010

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)

Spinal Cord Diseases;Spinal Cord Injuries;Neuralgia;Pain

Drug: pregabalin

Pfizer

NULL

Completed

18 Years

N/A

All

104

Phase 3

Japan

640

EUCTR2009-015318-23-HU
(EUCTR)

31/08/2010

14/06/2010

A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION)

Product Name: Daclizumab High Yield Process
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 2

Czech Republic;Hungary;Ukraine;Russian Federation;Germany;United Kingdom;India

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

641

EUCTR2010-020515-37-FI
(EUCTR)

06/08/2010

24/06/2010

Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis

multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

5000

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden

642

EUCTR2010-019029-32-NL
(EUCTR)

05/08/2010

07/06/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1350

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

643

EUCTR2010-019029-32-DK
(EUCTR)

02/08/2010

25/06/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

644

NCT01191996
(ClinicalTrials.gov)

August 2010

30/8/2010

Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis

A Phase 2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered MIS416 in Patients With Chronic Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis

Biological: MIS416

Innate Immunotherapeutics

Primorus Clinical Trials;National Multiple Sclerosis Society

Completed

18 Years

N/A

Both

Phase 1;Phase 2

New Zealand

645

NCT01216072
(ClinicalTrials.gov)

August 2010

7/9/2010

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

Relapsing Forms of Multiple Sclerosis

Drug: Fingolimod;Drug: Standard MS DMTs

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

1053

Phase 4

United States;Canada;Puerto Rico

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

646

EUCTR2010-019029-32-AT
(EUCTR)

28/07/2010

08/06/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

647

EUCTR2009-011888-37-DE
(EUCTR)

23/07/2010

26/03/2010

A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT

osteoporosis in patients with multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10049088;Term: Osteopenia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10031282;Term: Osteoporosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Aclasta 5 mg Infusionslösung
Product Name: Aclasta
Product Code: ZOL446H
Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE

Novartis Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase -

Germany

648

EUCTR2010-019029-32-HU
(EUCTR)

21/07/2010

31/03/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1850

Italy;Austria;Hungary;Portugal;Germany;Netherlands;Sweden;Ireland;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

649

EUCTR2009-009503-19-BE
(EUCTR)

20/07/2010

12/05/2009

A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER

Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Tysabri
INN or Proposed INN: Natalizumab

Biogen Idec International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Belgium

650

EUCTR2010-019029-32-IE
(EUCTR)

19/07/2010

18/05/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1850

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

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

651

EUCTR2010-019029-32-GR
(EUCTR)

19/07/2010

14/07/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2400

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

652

EUCTR2010-019029-32-SE
(EUCTR)

12/07/2010

25/05/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

653

EUCTR2009-015815-42-CZ
(EUCTR)

12/07/2010

12/05/2010

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

714

Phase 3

United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany

654

EUCTR2009-015815-42-PL
(EUCTR)

08/07/2010

17/05/2010

An extended clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-302 (BRAVO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease

Laquinimod is developed for the treatment of 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: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

714

Phase 3

United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany

655

EUCTR2010-019029-32-FI
(EUCTR)

07/07/2010

28/05/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

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

656

EUCTR2009-015815-42-SK
(EUCTR)

06/07/2010

17/05/2010

Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1245

Phase 3

Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy

657

NCT01167426
(ClinicalTrials.gov)

July 2010

20/7/2010

Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.

Multiple Sclerosis

Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL

Teva Neuroscience, Inc.

NULL

Completed

18 Years

N/A

All

148

Phase 3

United States

658

EUCTR2009-012500-11-ES
(EUCTR)

24/06/2010

12/04/2010

Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.)

Esclerosis Múltiple recidivante-remitente
MedDRA version: 11;Level: PT;Classification code 10063399;Term: Esclerosis múltiple remitente-recurrente

Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A

Biogen Idec Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Hungary;Germany;France;Ireland;Italy;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Slovenia;Spain;Greece

659

EUCTR2009-015556-15-LV
(EUCTR)

11/06/2010

13/04/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;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: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Sweden

660

EUCTR2009-015556-15-CZ
(EUCTR)

10/06/2010

29/03/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;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

661

EUCTR2009-015556-15-SI
(EUCTR)

07/06/2010

12/04/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

A Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States

662

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

663

EUCTR2010-019029-32-PT
(EUCTR)

31/05/2010

07/05/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

1850

Portugal;Hungary;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

664

NCT01047319
(ClinicalTrials.gov)

May 27, 2010

8/1/2010

A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis

A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: Laquinimod

Teva Pharmaceutical Industries, Ltd.

NULL

Terminated

N/A

All

1047

Phase 3

United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;Macedonia, The Former Yugoslav Republic of;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Puerto Rico

665

EUCTR2009-011470-15-ES
(EUCTR)

18/05/2010

22/03/2010

Estudio de extensión del estudio AC-058B201, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, para evaluar la seguridad, tolerabilidad, y eficacia a largo plazo de 10, 20, y 40 mg/día de ACT-128800, un agonista oral de los receptores S1P1, en pacientes con esclerosis múltiple recurrente-remitente -

Esclerosi Múltiple Recurrente-Remitente
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800

ACTELION Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;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

666

EUCTR2009-015815-42-BG
(EUCTR)

18/05/2010

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

714

Phase 3

United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany

667

EUCTR2010-019029-32-GB
(EUCTR)

07/05/2010

16/04/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

668

EUCTR2009-015556-15-SE
(EUCTR)

06/05/2010

09/03/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack.
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden

669

EUCTR2010-019029-32-DE
(EUCTR)

06/05/2010

02/03/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis.

Relapsing multiple sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: FTY720
Product Code: FTY720D
INN or Proposed INN: fingolimod hydrochloride

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

2400

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Denmark;Germany;Netherlands;Sweden

670

NCT01127750
(ClinicalTrials.gov)

May 2010

19/5/2010

Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis

Relapsing Multiple Sclerosis

Drug: FTY720

Novartis

NULL

Completed

18 Years

65 Years

All

2417

Phase 3

Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;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

671

EUCTR2008-007459-28-BG
(EUCTR)

30/04/2010

29/04/2010

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

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: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

245

France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany

672

EUCTR2010-019029-32-IT
(EUCTR)

27/04/2010

09/04/2010

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND

MS (MULTIPLE SCLEROSIS)
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: fingolimod

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

1200

Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece

673

EUCTR2009-017003-28-IT
(EUCTR)

12/04/2010

08/04/2010

Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome

multiple sclerosis
MedDRA version: 9.1;Level: SOC;Classification code 10029205
MedDRA version: 9.1;Level: HLGT;Classification code 10012303
MedDRA version: 9.1;Level: HLT;Classification code 10052785
MedDRA version: 9.1;Level: LLT;Classification code 10063399

Trade Name: AVONEX
INN or Proposed INN: Interferon beta -1a

BIOGEN-DOMPE` SRL

NULL

Not Recruiting

Female: yes
Male: yes

Italy

674

NCT01181115
(ClinicalTrials.gov)

April 2010

5/8/2010

Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)

An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: Avonex

Biogen Idec

NULL

Completed

18 Years

55 Years

Both

Phase 3

China

675

NCT01051349
(ClinicalTrials.gov)

March 31, 2010

15/1/2010

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis

A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Relapsing-Remitting Multiple Sclerosis

Biological: BIIB019 (Daclizumab);Biological: trivalent seasonal influenza vaccine

Biogen

AbbVie

Completed

18 Years

60 Years

All

410

Phase 2

Czechia;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Czech Republic

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

676

EUCTR2009-012989-30-BG
(EUCTR)

31/03/2010

19/04/2010

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden

677

EUCTR2009-015318-23-GB
(EUCTR)

31/03/2010

17/03/2010

A study designed to determine safety and efficacy of Daclizumab High Yield Process (DAC HYP) in patients with Multiple Sclerosis Who Have Completed Treatment in a previous study, 205MS202 (SELECTION)

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]

Biogen

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 2

Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India

678

EUCTR2008-005167-33-DE
(EUCTR)

29/03/2010

16/03/2010

Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX

Patients with cerebellar ataxia with coordination deficits in walking, upper and lower limb movements and oculomtoor coordination deficits are included in the trial. The cause of their atayia is either a degenerative CNS disease (36 patients) such as autosomal dominant Spinocerebellar Ataxia or sporadic ataxia with late onset or inflammatory CNS disease (Multiple Sclerosis; 36 patients).

Trade Name: Neurontin 300 mg hard capsule
Product Name: gabapentine 300mg
Product Code: GBP
INN or Proposed INN: Gabapentin
Other descriptive name: GABAPENTIN

Charité University Medicine Berlin

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Germany

679

EUCTR2009-014339-19-ES
(EUCTR)

18/03/2010

20/01/2010

ESTUDIO DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Esclerosis múltiple remitente-recurrente.Relapsing-remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Code: ONO-4641
Product Code: ONO-4641
Product Code: ONO-4641

ONO Pharmaceutical Co., Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

376

Germany;Czech Republic;Spain;Greece

680

EUCTR2009-015815-42-IT
(EUCTR)

15/03/2010

01/03/2010

Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399

Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: Laquinimod

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1245

Phase 3

Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;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

681

EUCTR2009-015815-42-EE
(EUCTR)

12/03/2010

12/02/2010

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

714

Phase 3

United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany

682

NCT01097668
(ClinicalTrials.gov)

March 2010

31/3/2010

ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis

SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).

Relapsing Remitting Multiple Sclerosis

Biological: ATX-MS-1467

Apitope Technology (Bristol) Ltd.

Aptiv Solutions;ClinStar, LLC

Completed

18 Years

55 Years

All

Phase 1

Russian Federation;United Kingdom

683

NCT01058005
(ClinicalTrials.gov)

March 2010

26/1/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis

Drug: BG00002 (natalizumab);Drug: interferon beta -1a;Drug: glatiramer acetate

Biogen

Elan Pharmaceuticals

Terminated

18 Years

60 Years

All

Phase 3

United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden

684

EUCTR2009-012989-30-SE
(EUCTR)

23/02/2010

01/02/2010

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden

685

EUCTR2009-015934-30-FR
(EUCTR)

02/02/2010

19/01/2010

étude randomisée en double insu et crossover comparant l’efficacité de la L-carnitine à un placebo dans le traitement de la fatigue dans la sclérose en plaques - FACTSEP

sclérose en plaquefatigue
MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: levocarnil
Product Name: Levocarnil
Product Code: na
INN or Proposed INN: L-carnitine

CHU de Bordeaux

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

France

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

686

EUCTR2009-015318-23-CZ
(EUCTR)

21/01/2010

03/12/2009

A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION)

Product Name: Daclizumab High Yield Process
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 2

Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India

687

EUCTR2009-016140-39-ES
(EUCTR)

19/01/2010

28/10/2009

MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple.

Realce de contraste en resonancia magnética enpacientes con Síndrome Clínico Aislado orecaída de Esclerosis Múltiple con resonanciamagnética anormal anterior después de laadministración de dosis única y acumulada deGADOVIST®High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist®

Trade Name: GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado
INN or Proposed INN: GADOBUTROL
Other descriptive name: GADOBUTROL

Institut Diagnostic per la Imatge

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

688

EUCTR2009-012989-30-FR
(EUCTR)

18/01/2010

22/09/2009

Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden

689

EUCTR2009-012989-30-LT
(EUCTR)

30/12/2009

02/10/2009

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden

690

EUCTR2009-012989-30-GB
(EUCTR)

17/11/2009

13/07/2009

A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.

Laquinimod is developed for the treatment of 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] - Immune System Diseases [C20]

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

542

Phase 3

Serbia;United States;Estonia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Georgia;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

691

EUCTR2009-012989-30-CZ
(EUCTR)

16/11/2009

10/09/2009

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden

692

NCT00988052
(ClinicalTrials.gov)

November 10, 2009

28/9/2009

A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course

A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS

Relapsing Multiple Sclerosis

Drug: Laquinimod

Teva Pharmaceutical Industries, Ltd.

NULL

Terminated

18 Years

55 Years

All

839

Phase 3

United States;Austria;Bulgaria;Canada;Czechia;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;Latvia

693

EUCTR2009-012989-30-ES
(EUCTR)

21/10/2009

05/08/2009

Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - -

Esclerosis Múltiple Remitente Recurrente (RRMS).
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Laquinimod Capsulas 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden

694

EUCTR2008-005021-11-BE
(EUCTR)

14/10/2009

12/12/2008

An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study

Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Belgium;France;Sweden

695

EUCTR2008-007459-28-DE
(EUCTR)

08/10/2009

23/12/2008

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

245

France;Czech Republic;Hungary;Finland;Belgium;Denmark;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

696

EUCTR2009-012989-30-IT
(EUCTR)

06/10/2009

11/09/2009

Relapsing - Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Laquinimod
INN or Proposed INN: Laquinimod

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden

697

EUCTR2009-012989-30-NL
(EUCTR)

02/10/2009

20/07/2009

Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
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] - Immune System Diseases [C20]

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

632

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden

698

EUCTR2008-007459-28-BE
(EUCTR)

21/09/2009

07/01/2009

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

500

France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany

699

EUCTR2009-012989-30-EE
(EUCTR)

11/09/2009

05/08/2009

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden

700

EUCTR2008-006333-27-ES
(EUCTR)

11/09/2009

02/07/2009

Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis. - ADVANCE

Esclerosis múltiple recidivanteRelapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado

Biogen Idec Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1260

United Kingdom;Czech Republic;Germany;Netherlands;Belgium;Bulgaria;Estonia;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

701

EUCTR2009-012989-30-HU
(EUCTR)

09/09/2009

14/08/2009

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

632

Phase 3

United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden

702

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

703

EUCTR2008-005021-11-SE
(EUCTR)

12/08/2009

13/05/2009

Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: atacicept
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Product Name: atacicept
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Product Name: atacicept
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Product Name: atacicept
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5
Product Name: atacicept
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Czech Republic;Belgium;France;Sweden

704

EUCTR2009-013333-24-IT
(EUCTR)

03/08/2009

28/07/2009

Multicenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGE

RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: REBIF
INN or Proposed INN: Interferon beta -1a

MERCK SERONO SPA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Italy

705

NCT00871780
(ClinicalTrials.gov)

August 2009

26/3/2009

A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients

A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER Study

Relapsing Remitting Multiple Sclerosis (RRMS)

Drug: BG00002 (natalizumab)

Biogen

Elan Pharmaceuticals

Completed

18 Years

60 Years

All

224

Phase 4

Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela

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

706

EUCTR2008-007459-28-CZ
(EUCTR)

22/07/2009

05/05/2009

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

245

Hungary;Finland;Germany;Czech Republic;Denmark;Belgium;Bulgaria;France

707

EUCTR2008-005021-11-CZ
(EUCTR)

22/07/2009

08/06/2009

Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

Czech Republic;Belgium;France;Sweden

708

EUCTR2009-013129-41-NL
(EUCTR)

20/07/2009

03/06/2009

A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT

clinical isolated syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10028248;Term: Multiple sclerosis-like syndrome

Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE

Amphia Ziekenhuis

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

709

EUCTR2008-007459-28-DK
(EUCTR)

09/07/2009

29/05/2009

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

245

France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany

710

EUCTR2008-006786-92-ES
(EUCTR)

04/07/2009

06/05/2009

Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente

Esclerosis Múltiple Recurrente-Remitente
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;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

711

EUCTR2008-007459-28-FR
(EUCTR)

01/07/2009

15/05/2009

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Hungary;Finland;Czech Republic;Germany;Denmark;Belgium;Bulgaria;France

712

EUCTR2008-007459-28-HU
(EUCTR)

01/07/2009

27/04/2009

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

500

Finland;Hungary;Czech Republic;Germany;Denmark;Belgium;Bulgaria;France

713

NCT00947752
(ClinicalTrials.gov)

July 2009

25/7/2009

Safety of New Formulation of Glatiramer Acetate

An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection

Relapsing Remitting Multiple Sclerosis

Drug: Glatiramer Acetate;Drug: Experimental Glatiramer Acetate

Teva Pharmaceutical Industries

NULL

Completed

18 Years

N/A

All

147

Phase 3

United States

714

NCT00965497
(ClinicalTrials.gov)

July 2009

7/8/2009

Escitalopram (Lexapro) for Depression MS or ALS

An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis

Major Depression;Multiple Sclerosis;Amyotrophic Lateral Sclerosis

Drug: escitalopram

University of South Carolina

NULL

Completed

18 Years

70 Years

All

Phase 3

United States

715

EUCTR2008-007459-28-FI
(EUCTR)

25/06/2009

18/03/2009

Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

245

France;Czech Republic;Hungary;Finland;Belgium;Denmark;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

716

EUCTR2009-011234-99-DE
(EUCTR)

23/06/2009

21/04/2009

A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administereddaily in subjects with relapsing remitting multiple sclerosis (RRMS)

Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS).This study is planned to assess the tolerability and safety of escalating doses of orallaquinimod administered daily in subjects with RRMS.
MedDRA version: 15.1;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: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Product Name: Laquinimod Capsules 0.3 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 1

Germany

717

NCT00917839
(ClinicalTrials.gov)

June 2009

9/6/2009

The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.

Relapsing-Remitting Multiple Sclerosis

Drug: lamotrigine

Cantonal Hospital of St. Gallen

NULL

Recruiting

18 Years

50 Years

Both

Phase 2

Switzerland

718

NCT00942214
(ClinicalTrials.gov)

June 2009

16/7/2009

Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment

Biomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV Study

Multiple Sclerosis

Drug: Natalizumab

University Hospital, Toulouse

NULL

Completed

18 Years

55 Years

Both

300

Phase 4

France

719

EUCTR2008-005021-11-FR
(EUCTR)

26/05/2009

24/03/2009

Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

Czech Republic;Belgium;France;Sweden

720

EUCTR2008-004954-34-GR
(EUCTR)

19/05/2009

06/03/2009

Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION

Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a

Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt

NULL

Not Recruiting

Female: yes
Male: yes

492

Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;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

721

NCT00799942
(ClinicalTrials.gov)

May 2009

27/11/2008

Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus

Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus

Nystagmus, Congenital;Nystagmus, Acquired;Multiple Sclerosis

Drug: Neramexane mesylate

Merz Pharmaceuticals GmbH

NULL

Terminated

18 Years

81 Years

Both

Phase 2

United Kingdom

722

EUCTR2008-008719-25-ES
(EUCTR)

21/04/2009

06/03/2009

Estudio fase II, a doble ciego, aleatorizado y multicéntrico, con esquema adaptativo de dosis, controlado con placebo y de grupos paralelos, para evaluar la eficacia, tolerabilidad y seguridad en base a parámetros de lesión observados mediante resonancia magnética, así como determinar la curva dosis - respuesta de BAF312 administrado oralmente en dosis única diaria en pacientes con Esclerosis Múltiple remitente recurrente.

Esclerosis Múltiple remitente recurrente
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Code: BAF312
Product Code: BAF312
Product Code: BAF312
Product Code: BAF312

Novartis Farmacéutica, S.A

NULL

Not Recruiting

Female: yes
Male: yes

275

Hungary;Finland;Germany;Spain;Italy

723

NCT00904826
(ClinicalTrials.gov)

April 2009

18/5/2009

An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica

Neuromyelitis Optica;Devic's Disease

Drug: Eculizumab

Mayo Clinic

Alexion Pharmaceuticals

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

724

NCT00914290
(ClinicalTrials.gov)

April 2009

2/6/2009

A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

Spasticity;Multiple Sclerosis

Drug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IR

Impax Laboratories, LLC

NULL

Completed

18 Years

N/A

All

Phase 2

United States

725

NCT00881205
(ClinicalTrials.gov)

April 2009

14/4/2009

Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment Phase

Multiple Sclerosis;Cognitive Impairment

Drug: Rivastigmine transdermal patch;Drug: Placebo

Novartis Pharmaceuticals

NULL

Terminated

18 Years

65 Years

All

Phase 4

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

726

EUCTR2008-004579-22-DE
(EUCTR)

31/03/2009

07/11/2008

A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-cell/Antibody Response Panel to predict the clinical efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis

Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: octagam
Product Name: Octagam 5%

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Austria;Germany

727

EUCTR2008-006226-34-ES
(EUCTR)

25/03/2009

23/01/2009

Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE

Esclerosis Múltiple------------------------Multiple sclerosis

Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: REBIF 44 microgramos solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A

sanofi-aventis recherche et development

NULL

Not Recruiting

Female: yes
Male: yes

300

France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy

728

EUCTR2007-004452-36-GB
(EUCTR)

24/03/2009

01/02/2008

A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator

Multiple sclerosis
MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Teriflunomide
Product Code: HMR 1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1110

Phase 3

Belarus;United States;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Germany;Sweden

729

EUCTR2008-004174-40-FR
(EUCTR)

06/03/2009

25/11/2008

Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP

Groupe I: volontaires sainsGroupe II: patients avec une sclérose en plaques d'évolution rémittente .
MedDRA version: 8.1;Level: PT;Classification code 10012300;Term: Demyelinating disease (excl multiple sclerosis)

Product Name: 11C-PIB
INN or Proposed INN: 11C-PIB

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

730

EUCTR2008-004954-34-ES
(EUCTR)

03/03/2009

19/12/2008

Extensión doble ciega del estudio 27025 (REFLEX) para obtener datos de seguimiento a largo plazo en pacientes con Esclerosis Múltiple clínicamente definida y en pacientes con un primer acontecimiento desmielinizante con alto riesgo de presentar conversión en Esclerosis Múltiple, tratados con Rebif® New Formulation (REFLEXION) - REFLEXION

Pacientes con riesgo alto de conversión en Esclerosis Múltiple o pacientes que ya han convertido a Esclerosis Múltiple.
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: REBIF 44 microgramos solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A

Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

492

Portugal;Germany;France;Bulgaria;Italy;Latvia;Austria;Finland;Czech Republic;Belgium;Estonia;Spain;Greece;Poland

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

731

NCT00853762
(ClinicalTrials.gov)

March 2009

26/2/2009

Atacicept in Multiple Sclerosis Extension Study, Phase II

An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)

Relapsing Multiple Sclerosis

Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg

EMD Serono

Merck KGaA

Terminated

18 Years

60 Years

All

Phase 2

United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom

732

EUCTR2008-005304-93-GB
(EUCTR)

13/02/2009

12/12/2008

A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis

Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease.
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
MedDRA version: 9.1;Classification code 10065687;Term: Bone loss

Trade Name: Aclasta 5mg solution for infusion
Product Name: Aclasta
Product Code: ZOL446H

North Bristol Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

733

EUCTR2008-005906-38-FR
(EUCTR)

09/02/2009

19/03/2009

Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques

sclérose en plaques
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Tysabri
Product Name: Tysabri

CHU de Toulouse

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

France

734

EUCTR2008-001999-67-ES
(EUCTR)

30/01/2009

17/11/2008

Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis

Esclerosis Múltiple______________Multiple Sclerosis
MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term:

Product Name: Nerispirdine hydrochloride
Product Code: HP184
INN or Proposed INN: Nerispirdine hydrochloride

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

368

Finland;Germany;France;Spain

735

EUCTR2008-003098-42-CZ
(EUCTR)

06/01/2009

27/10/2008

A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis

To evaluate the immunogenicity of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: AVONEX
INN or Proposed INN: interferon beta 1a

Biogen Idec Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Czech Republic

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

736

NCT01031199
(ClinicalTrials.gov)

January 2009

11/12/2009

Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers

Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for Its Diagnostic Potential in Either Drug-naïve or Specifically (IFN-beta) Pretreated Patients With Multiple Sclerosis (MS) With Acute Relapse or Patients With Clinically Isolated Syndrome (CIS), Compared to Healthy Volunteers

Positron-Emission Tomography;Multiple Sclerosis

Drug: F-18 FEDAA1106 (BAY85-8101)

Bayer

NULL

Completed

20 Years

55 Years

Both

Phase 1

Australia;Sweden

737

NCT00828204
(ClinicalTrials.gov)

January 2009

20/1/2009

Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects

An Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex® Prefilled Syringe in Multiple Sclerosis Subjects

Multiple Sclerosis

Device: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a)

Biogen

NULL

Completed

18 Years

65 Years

All

Phase 3

United States

738

EUCTR2007-005450-23-DE
(EUCTR)

29/12/2008

28/10/2008

A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
INN or Proposed INN: INTERFERON BETA -1A

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy

739

EUCTR2007-004452-36-ES
(EUCTR)

04/12/2008

23/09/2008

Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER

Esclerosis múltiple_____________Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Teriflunomide
Product Code: HMR 1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1110

France;Estonia;Czech Republic;Slovakia;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Sweden

740

NCT00771043
(ClinicalTrials.gov)

November 2008

7/10/2008

A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a

Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a

Relapsing-Remitting Multiple Sclerosis

Drug: TYSABRI and AVONEX

Biogen Idec

NULL

Withdrawn

18 Years

55 Years

Both

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

741

EUCTR2008-004579-22-AT
(EUCTR)

14/10/2008

15/09/2008

A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)

Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.

Trade Name: Octagam 5%
Product Name: Octagam 5%
INN or Proposed INN: Immunoglobulin

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Austria

742

EUCTR2007-006338-32-FI
(EUCTR)

08/10/2008

30/06/2008

Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis

Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A

Hoffman La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy

743

EUCTR2007-006338-32-BG
(EUCTR)

07/10/2008

31/07/2008

A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI

Multiple sclerosis is a disabling disease of brain and spinal cord thatdisrupts flow of information within brain, characterized by flare-ups withperiods of remission in between (relapsing remitting)
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: oclelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

Hoffman La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany

744

EUCTR2008-000499-25-SE
(EUCTR)

02/10/2008

16/05/2008

Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Rebif New Formulation 44mcg multidose cartridge
INN or Proposed INN: INTERFERON BETA -1A

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3b

Germany;Spain;Italy;Sweden

745

NCT00784836
(ClinicalTrials.gov)

October 2008

29/10/2008

Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients

A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis

Multiple Sclerosis

Drug: BG9418 (interferon beta 1-a)

Biogen

NULL

Terminated

18 Years

60 Years

All

Phase 3

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

746

NCT00780455
(ClinicalTrials.gov)

October 2008

28/5/2008

Rehabilitation Study in MS Patients

Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®

Multiple Sclerosis, Relapsing-Remitting

Drug: Interferon beta -1b , FRP within 15 days after randomization;Drug: Interferon beta -1b , FRP about 6 weeks after randomization

Bayer

NULL

Terminated

18 Years

N/A

All

Phase 4

France

747

EUCTR2007-006338-32-BE
(EUCTR)

15/09/2008

17/04/2008

Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

Hoffman La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

Netherlands;Germany;Serbia;United States;Slovakia;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria

748

EUCTR2007-006338-32-IT
(EUCTR)

11/09/2008

02/10/2008

Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS.

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: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A

F.Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Denmark;Bulgaria;Netherlands;Germany

749

EUCTR2007-005450-23-LT
(EUCTR)

27/08/2008

07/05/2008

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania

750

EUCTR2008-000499-25-ES
(EUCTR)

31/07/2008

10/06/2008

International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS

Relapsing forms of Multiple Sclerosis (RMS) Esclerosis múltiple recidivante (EMR)
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Rebif New Formulation 44mcg multidose cartridge
INN or Proposed INN: INTERFERON BETA -1A

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3b

Germany;Spain;Italy;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

751

EUCTR2007-006338-32-GB
(EUCTR)

28/07/2008

07/03/2008

Relapsing remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

Hoffman La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany

752

NCT00731692
(ClinicalTrials.gov)

July 28, 2008

7/8/2008

This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.

A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis

Drug: FTY720;Drug: Placebo

Novartis Pharmaceuticals

NULL

Terminated

25 Years

65 Years

All

970

Phase 3

United States;Australia;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic

753

EUCTR2008-000499-25-IT
(EUCTR)

24/07/2008

15/02/2010

International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS

Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 9.1;Level: PT;Classification code 10063399

INN or Proposed INN: Interferon beta -1a

MERCK SERONO SA

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3b

Spain;Germany;Italy;Sweden

754

EUCTR2007-002627-32-ES
(EUCTR)

17/07/2008

08/05/2008

Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos, para comparar la eficacia y seguridad de 1,25 mg FTY720 administrado por vía oral una vez al día versus placebo en pacientes con esclerosis múltiple primaria progresiva

Esclerosis múltiple primaria progresiva.
MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis

Product Name: Fingolimod
Product Code: FTY720D
INN or Proposed INN: Fingolimod
Other descriptive name: FTY720

Novartis Farmacéutica S.A

NULL

Not Recruiting

Female: yes
Male: yes

650

France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden

755

EUCTR2007-006338-32-ES
(EUCTR)

16/07/2008

28/03/2008

Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis

Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A

Hoffman La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;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

756

EUCTR2007-006338-32-NL
(EUCTR)

09/07/2008

29/05/2008

Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A

Hoffman La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy

757

EUCTR2007-006338-32-DK
(EUCTR)

09/07/2008

09/04/2008

Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB

Hoffman La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany

758

EUCTR2007-006338-32-DE
(EUCTR)

09/07/2008

17/03/2008

Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Product Name: Ocrrelizumab 300 mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrrelizumab 300 mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

F. Hoffman-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany

759

NCT00735007
(ClinicalTrials.gov)

July 2008

12/8/2008

12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.

International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS)

Multiple Sclerosis

Drug: Rebif ® New Formulation (RNF) using RebiSmartTM

EMD Serono

NULL

Completed

18 Years

65 Years

All

106

Phase 3

United States;Canada;Germany;Italy;Spain;Sweden

760

EUCTR2007-006338-32-SK
(EUCTR)

16/06/2008

09/04/2008

Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB

Hoffman La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;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

761

NCT00716066
(ClinicalTrials.gov)

June 2008

15/7/2008

Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases

High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases

Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis

Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Recruiting

N/A

71 Years

All

Phase 2

United States

762

EUCTR2007-005450-23-BG
(EUCTR)

29/05/2008

27/05/2008

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Germany;Czech Republic;Estonia;Bulgaria;Spain;Italy;Lithuania

763

EUCTR2007-006338-32-CZ
(EUCTR)

28/05/2008

01/04/2008

Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab

Hoffman La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany

764

EUCTR2007-003226-19-BG
(EUCTR)

22/05/2008

22/03/2008

Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1419

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

765

EUCTR2007-000888-15-ES
(EUCTR)

19/05/2008

27/02/2008

ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple

Pacientes afectos de esclerosis múltiple
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: SOLU-MODERIN 1 g
INN or Proposed INN: METHYLPREDNISOLONE
Trade Name: URBASON 40 mg comprimidos
INN or Proposed INN: METHYLPREDNISOLONE

Servicio de Neurología

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

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

766

EUCTR2007-005362-12-FR
(EUCTR)

13/05/2008

07/02/2008

Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de l'IRM multimodale 3 tesla dans l'analyse des lésions de la SEP et leur progression. Etude longitudinale sur 3 ans. - USPIO-Mitox

1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis)
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive
MedDRA version: 9.1;Classification code 10028246;Term: Multiple sclerosis aggravated
MedDRA version: 9.1;Classification code 10028247;Term: Multiple sclerosis like syndrome
MedDRA version: 9.1;Classification code 10028248;Term: Multiple sclerosis-like syndrome
MedDRA version: 9.1;Classification code 10048393;Term: Multiple sclerosis relapse
MedDRA version: 9.1;Classification code 10053395;Term: Progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10063401;Term: Primary progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10064137;Term: Progression of multiple sclerosis
MedDRA version: 9.1;Level: PT;Term: Secondary progressive multiple sclerosis

Product Code: SH U 555 C

C.H.U. de RENNES

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

767

EUCTR2007-005363-10-FR
(EUCTR)

13/05/2008

11/12/2007

Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS

Product Code: SH U 555 C

C.H.U. de RENNES

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

768

EUCTR2007-006338-32-FR
(EUCTR)

06/05/2008

26/02/2008

Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Ocrelizumab
Product Code: RO4964913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A

Hoffman La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy

769

EUCTR2007-005450-23-CZ
(EUCTR)

14/04/2008

12/02/2008

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania

770

EUCTR2007-005450-23-SK
(EUCTR)

10/04/2008

30/04/2008

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Czech Republic;Estonia;Slovakia;Spain;Lithuania;Bulgaria;Germany;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

771

NCT00605215
(ClinicalTrials.gov)

April 2008

8/1/2008

BRAVO Study: Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)

A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With RRMS to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded Design.

Multiple Sclerosis

Drug: laquinimod;Drug: placebo;Drug: Interferon ß-1a (Avonex®)

Teva Pharmaceutical Industries

NULL

Completed

18 Years

55 Years

Both

1331

Phase 3

United States;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Israel;Italy;Lithuania;Macedonia, The Former Yugoslav Republic of;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Latvia;Montenegro;Turkey

772

EUCTR2007-005450-23-EE
(EUCTR)

28/03/2008

11/02/2008

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy

773

EUCTR2007-005450-23-ES
(EUCTR)

17/03/2008

29/01/2008

Estudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVO

Esclerosis Múltiple Remitente Recurrente (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Cápsulas de Laquinimod 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgramos/0.5 ml Solución para inyección

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania

774

EUCTR2007-003936-50-ES
(EUCTR)

10/03/2008

02/01/2008

Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS

Esclerosis múltiple recidivante Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: atacicept
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

332

Phase 2

United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden

775

EUCTR2007-005450-23-IT
(EUCTR)

04/03/2008

13/03/2008

A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon β-1a (Avonex) in a rater-blinded design - Bravo

Multiple sclerosis with relapse
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: laquinimod
Product Code: TV-5600
INN or Proposed INN: laquinimod
Trade Name: AVONEX *IM 4SIR 30MCG/0,5ML+4AG
INN or Proposed INN: Interferon beta -1a

TEVA ITALIA srl

NULL

Not Recruiting

Female: yes
Male: yes

1200

Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania

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

776

EUCTR2007-002179-15-FR
(EUCTR)

04/03/2008

22/11/2007

Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH

Méthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie.
MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

777

NCT00616733
(ClinicalTrials.gov)

March 2008

4/2/2008

12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients

An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis

Multiple Sclerosis

Drug: CS-0777 tablets

Daiichi Sankyo Inc.

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States

778

EUCTR2007-001162-32-ES
(EUCTR)

22/02/2008

14/02/2008

Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II

Esclerosis Múltiple de recaída-remisión
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden

779

EUCTR2007-003226-19-PT
(EUCTR)

01/02/2008

24/10/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

780

NCT00630383
(ClinicalTrials.gov)

February 2008

27/2/2008

Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis.

Multiple Sclerosis

Biological: Live Hookworm Larvae;Other: Histamine

University of Nottingham

NULL

Withdrawn

18 Years

60 Years

Both

Phase 2

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

781

EUCTR2007-003226-19-LT
(EUCTR)

11/01/2008

25/09/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

782

NCT00938366
(ClinicalTrials.gov)

January 2008

9/7/2009

Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects

An Open-label, Cross Over Study, to Assess the Interactions of Pantoprazole (Proton Pump Inhibitor) With Oral Cladribine Administered in Subjects With Multiple Sclerosis

Multiple Sclerosis

Drug: Cladribine;Drug: Pantoprazole

Merck KGaA

Merck Serono S.A., Geneva

Completed

18 Years

65 Years

All

Phase 1

NULL

783

NCT00464958
(ClinicalTrials.gov)

January 2008

22/4/2007

One Year Extension Study To Protocol C2/5/TZ:MS-05

Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension Study

Spasticity;Multiple Sclerosis

Drug: sublingual tizanidine 12 mg

Teva GTC

NULL

Terminated

20 Years

65 Years

Both

Phase 1;Phase 2

Israel

784

NCT00536120
(ClinicalTrials.gov)

January 2008

25/9/2007

The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Biological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td)

Biogen

NULL

Completed

18 Years

60 Years

All

Phase 4

United States

785

EUCTR2007-003226-19-SE
(EUCTR)

27/12/2007

29/10/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Sweden;Lithuania;United Kingdom;Czech Republic;Estonia;Spain

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

786

EUCTR2007-003226-19-IT
(EUCTR)

06/12/2007

10/03/2008

A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro

Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: laquinimod
Product Code: TV-5600
INN or Proposed INN: laquinimod

TEVA ITALIA srl

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

787

EUCTR2007-003226-19-EE
(EUCTR)

04/12/2007

10/10/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

788

NCT00509145
(ClinicalTrials.gov)

December 2007

27/7/2007

Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis

Drug: Laquinimod;Other: Placebo

Teva Pharmaceutical Industries

NULL

Completed

18 Years

55 Years

Both

1106

Phase 3

United States;Austria;Bulgaria;Canada;Czech Republic;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Former Serbia and Montenegro;Spain;Sweden;Turkey;Ukraine;United Kingdom;Portugal

789

NCT00573443
(ClinicalTrials.gov)

December 2007

13/12/2007

Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)

Pseudobulbar Affect (PBA)

Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo

Avanir Pharmaceuticals

INC Research

Completed

18 Years

80 Years

All

326

Phase 3

United States;Argentina;Brazil

790

EUCTR2007-003997-24-ES
(EUCTR)

26/11/2007

15/10/2007

Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias

Multiple Sclerosis.-----------------------Esclerosis Múltiple.

Product Name: Teriflunomide
Product Code: HMR 1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide

Sanofi-Aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

240

United Kingdom;Spain;Italy;Austria

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

791

EUCTR2007-003226-19-ES
(EUCTR)

22/11/2007

04/10/2007

Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - Allegro

Esclerosis Múltiple Remitente Recurrente (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

792

EUCTR2007-003226-19-LV
(EUCTR)

06/11/2007

12/09/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

793

NCT00595920
(ClinicalTrials.gov)

November 2007

3/1/2008

Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis

An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00

Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated Syndrome

Biological: Tovaxin

Opexa Therapeutics, Inc.

NULL

Terminated

N/A

All

116

Phase 2

United States

794

EUCTR2007-003226-19-CZ
(EUCTR)

25/10/2007

10/09/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;Czech Republic;United Kingdom;Estonia;Spain

795

EUCTR2007-003226-19-GB
(EUCTR)

24/10/2007

01/08/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

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

796

EUCTR2007-003226-19-DE
(EUCTR)

23/10/2007

15/07/2008

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden

797

EUCTR2007-003226-19-HU
(EUCTR)

09/10/2007

13/07/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

798

NCT00104143
(ClinicalTrials.gov)

October 2007

23/2/2005

A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.

A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis.

Multiple Sclerosis

Drug: A4I Antagonist

Hoffmann-La Roche

NULL

Withdrawn

18 Years

59 Years

Both

Phase 2

Bulgaria;Canada;Czech Republic;Germany;Poland;Russian Federation;Slovakia;Spain;United Kingdom;Finland;United States

799

NCT00559702
(ClinicalTrials.gov)

October 2007

7/11/2007

Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis

Drug: natalizumab;Other: standard of care

Biogen Idec

Elan Pharmaceuticals

Completed

18 Years

65 Years

Both

Phase 1

United States

800

EUCTR2007-003226-19-AT
(EUCTR)

30/09/2007

19/09/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

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

801

EUCTR2007-003226-19-FR
(EUCTR)

21/09/2007

06/08/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

802

EUCTR2007-001031-63-CZ
(EUCTR)

20/09/2007

10/08/2007

AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.

Spasticity associated with multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028335;Term: Muscle spasticity

Trade Name: Tolposan
Product Code: AV605
INN or Proposed INN: Tolperisone HC1
Other descriptive name: Tolpersan

Avigen Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Czech Republic;Germany

803

EUCTR2007-003226-19-NL
(EUCTR)

05/09/2007

12/07/2007

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1419

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain

804

NCT00532532
(ClinicalTrials.gov)

September 2007

18/9/2007

Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis

AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis

Muscle Spasticity

Drug: tolperisone HCl

Avigen

NULL

Terminated

18 Years

70 Years

Both

150

Phase 2

Czech Republic;Germany;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro

805

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

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

806

EUCTR2007-001031-63-DE
(EUCTR)

15/08/2007

19/01/2009

Spasticity associated with multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028335;Term: Muscle spasticity

Trade Name: Tolposan
Product Code: AV605
INN or Proposed INN: Tolperisone HC1
Other descriptive name: Tolpersan

Avigen Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Germany

807

NCT00649792
(ClinicalTrials.gov)

August 2007

28/3/2008

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

Multiple Sclerosis

Drug: Fampridine -SR

Acorda Therapeutics

NULL

Completed

18 Years

70 Years

All

214

Phase 3

United States;Canada

808

EUCTR2007-000590-37-FR
(EUCTR)

17/07/2007

23/05/2007

Etude randomisée, en double aveugle, comparant l’efficacité et la tolérance de la méthylprednisolone administrée à forte dose par voie orale ou par voie intraveineuse dans le traitement des poussées de sclérose en plaques - COPOUSEP

Traitement des poussées de sclérose en plaques
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Product Name: METHYLPREDNISOLONE
INN or Proposed INN: METHYLPREDNISOLONE
Trade Name: methylprednisolone
Product Name: methylprednisolone
Trade Name: methylprednisolone
Product Name: methylprednisolone

CHU Rennes

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

809

EUCTR2005-004061-41-AT
(EUCTR)

06/07/2007

15/12/2005

An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA

Multiple sclerosis (MS)

Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

900

Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden

810

EUCTR2007-000236-16-LV
(EUCTR)

04/07/2007

02/04/2007

A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis

Established Spasticity Resulting from Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity

Product Code: IPX056-40 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-35 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-30 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-25 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-20 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-10 mg
INN or Proposed INN: BACLOFEN
Trade Name: baclofen
Product Name: baclofen
Product Code: baclofen 20 mg
INN or Proposed INN: BACLOFEN

IMPAX Laboratories, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

180

Estonia;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

811

EUCTR2006-005270-47-GR
(EUCTR)

03/07/2007

18/06/2007

International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Bayer Schering Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

812

EUCTR2004-000463-94-HU
(EUCTR)

03/07/2007

12/07/2004

A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).

Relapsing-remitting multiple sclerosis (R-R MS)
MedDRA version: 5.1;Level: PT;Classification code 10028245

Product Name: Glatiramer acetate 150mg enteric coated tablets
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: COP -1 /Copolymer-1

TEVA Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Italy

813

NCT00619307
(ClinicalTrials.gov)

July 2007

8/2/2008

Transition to Rebif New Formulation

A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis

Relapsing Multiple Sclerosis

Drug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRN

Merck KGaA

NULL

Completed

18 Years

60 Years

All

117

Phase 3

France;Germany

814

NCT01158183
(ClinicalTrials.gov)

July 2007

7/7/2010

Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis

Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon ß-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: BAY86-5046_Interferon-beta-1b

Bayer

NULL

Completed

18 Years

65 Years

Both

226

N/A

United States

815

NCT00469378
(ClinicalTrials.gov)

July 2007

2/5/2007

Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple Sclerosis

An Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With Firategrast

Multiple Sclerosis

Drug: firategrast

GlaxoSmithKline

NULL

Completed

18 Years

65 Years

All

Phase 2

Belgium;Czech Republic;Denmark;Norway;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

816

EUCTR2005-004061-41-SE
(EUCTR)

29/06/2007

15/12/2005

TYSABRI Long Term Re-Dosing Study

Multiple sclerosis (MS)
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]

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

521

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

817

EUCTR2006-005270-47-IT
(EUCTR)

28/06/2007

19/07/2007

International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up

Relapsing multiple sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10028245

Trade Name: BETAFERON 250 mcg
INN or Proposed INN: interferon beta -1b
Product Name: BETAFERON 500 mcg
Product Code: ZK 157046
INN or Proposed INN: interferon beta -1b

SCHERING

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

818

EUCTR2006-007057-42-DK
(EUCTR)

25/06/2007

14/05/2007

An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast

relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis

Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Denmark;Sweden

819

EUCTR2006-005972-42-DE
(EUCTR)

20/06/2007

15/08/2007

A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF

Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA
INN or Proposed INN: Interferon beta -1a
Other descriptive name: recombinant human IFN beta
Trade Name: Ibuprofen Sandoz 400 mg Filmtabletten
Product Name: Ibuprofen
INN or Proposed INN: Ibuprofen

Merck Serono International SA

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 3b

Germany;France

820

EUCTR2006-005972-42-FR
(EUCTR)

12/06/2007

05/04/2007

Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA

Merck Serono International SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 3b

Germany;France

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

821

NCT00488839
(ClinicalTrials.gov)

June 2007

18/6/2007

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

Multiple Sclerosis

Drug: IPX056 20 mg;Drug: IPX056 40 mg;Drug: Encapsulated Baclofen 20 mg;Drug: Placebo Baclofen Tablet;Drug: IPX056 10 mg;Drug: IPX056 30 mg;Drug: IPX056 35 mg;Drug: Placebo IPX056 20 mg;Drug: Placebo IPX056 40 mg

Impax Laboratories, LLC

NULL

Completed

18 Years

N/A

All

173

Phase 3

United States;Canada;Estonia;Latvia;Ukraine

822

NCT00574041
(ClinicalTrials.gov)

June 2007

12/12/2007

How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose

An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)

Relapsing Remitting Multiple Sclerosis

Drug: Interferon beta -1a

Biogen Idec

NULL

Terminated

18 Years

N/A

Both

Phase 4

Australia

823

EUCTR2006-007057-42-BE
(EUCTR)

29/05/2007

14/02/2007

An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast

Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Belgium;Denmark;Sweden

824

EUCTR2004-004519-43-DE
(EUCTR)

29/05/2007

09/02/2007

Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Product Code: RO0506997
Product Code: RO0506997
Product Code: RO0506997

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United Kingdom;Czech Republic;Germany;Spain

825

EUCTR2007-000236-16-EE
(EUCTR)

28/05/2007

16/03/2007

Established Spasticity Resulting from Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity

Product Code: IPX056-40 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-35 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-30 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-20 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-10 mg
INN or Proposed INN: BACLOFEN
Trade Name: baclofen
Product Name: baclofen
Product Code: baclofen 20 mg
INN or Proposed INN: BACLOFEN

IMPAX Laboratories, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

180

Estonia;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

826

EUCTR2006-005270-47-FR
(EUCTR)

22/05/2007

23/01/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Schering AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

827

EUCTR2006-005270-47-SI
(EUCTR)

16/05/2007

04/04/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Bayer Schering Pharma

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

828

EUCTR2006-002204-33-ES
(EUCTR)

04/05/2007

05/03/2007

Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas.

Relapsing forms of multiple slerosisEsclerosis multiple (EM) con recaidas
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse

Product Name: CDP323
Product Code: CDP323

UCB Pharma

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

279

Phase 2

Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden

829

EUCTR2006-007057-42-CZ
(EUCTR)

03/05/2007

16/03/2007

An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast

Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Belgium;Denmark;Sweden

830

EUCTR2006-005270-47-LV
(EUCTR)

02/05/2007

03/04/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Bayer Schering Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

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

831

EUCTR2006-007057-42-SE
(EUCTR)

02/05/2007

15/02/2007

An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast

Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Denmark;Sweden

832

NCT00459667
(ClinicalTrials.gov)

May 2007

11/4/2007

BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose

International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg

Multiple Sclerosis, Relapsing-Remitting

Drug: Interferon beta -1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

18 Years

55 Years

All

1420

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine

833

NCT00461396
(ClinicalTrials.gov)

May 2007

17/4/2007

Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron

Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months

Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting

Drug: Interferon-1beta (Betaseron, BAY86-5046)

Bayer

NULL

Completed

18 Years

50 Years

Both

104

Phase 4

United States

834

EUCTR2006-005270-47-FI
(EUCTR)

23/04/2007

19/12/2006

relapsing multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Schering AG

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3

Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden

835

NCT00548769
(ClinicalTrials.gov)

April 21, 2007

23/10/2007

Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients

An Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple Sclerosis

Multiple Sclerosis

Drug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation D

GlaxoSmithKline

NULL

Completed

18 Years

65 Years

All

Phase 1

Czechia;Germany;Poland;Czech Republic

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

836

EUCTR2006-005270-47-HU
(EUCTR)

16/04/2007

09/03/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Bayer Schering Pharma

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

837

EUCTR2006-005270-47-BE
(EUCTR)

12/04/2007

22/12/2006

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Bayer Schering Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden

838

EUCTR2006-005270-47-ES
(EUCTR)

08/04/2007

05/02/2007

Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up

Esclerosis Múltiple Recidivante

Schering AG

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3

Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden

839

EUCTR2006-005270-47-NL
(EUCTR)

02/04/2007

18/04/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Schering AG

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

840

EUCTR2004-004519-43-SK
(EUCTR)

20/03/2007

13/02/2007

Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Product Code: RO0506997
Product Code: RO0506997
Product Code: RO0506997

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Czech Republic;Slovakia;Spain;Germany;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

841

EUCTR2006-002982-38-EE
(EUCTR)

15/03/2007

31/10/2006

A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)

Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245

Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a

Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece

842

EUCTR2004-004519-43-GB
(EUCTR)

07/03/2007

08/07/2005

Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Product Code: RO0506997
Product Code: RO0506997
Product Code: RO0506997

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Germany;Czech Republic;United Kingdom;Spain

843

EUCTR2006-005270-47-SE
(EUCTR)

28/02/2007

02/02/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Bayer AB, Bayer Health Care, Bayer Schering Pharma

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

844

EUCTR2006-003134-14-ES
(EUCTR)

23/02/2007

26/10/2009

A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”.

Multiple sclerosis.Esclerosis Múltiple.

Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide

Sanofi-aventis U.S. Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Germany;Spain;Italy

845

EUCTR2006-005270-47-AT
(EUCTR)

22/02/2007

31/01/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Schering AG

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;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

846

EUCTR2006-005270-47-IE
(EUCTR)

16/02/2007

10/01/2007

International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up

Relapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Betaferon 250mcg
Product Name: Betaferon 500mcg
Product Code: ZK 157046

Schering AG

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3b

Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden

847

EUCTR2006-003037-32-ES
(EUCTR)

09/02/2007

10/03/2010

Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)

Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399

Trade Name: Rebif
Product Name: Interferon beta -1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable

Merck Serono International SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3b

Germany;Estonia;Spain;Italy;Lithuania

848

NCT00845338
(ClinicalTrials.gov)

February 2007

16/2/2009

Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity

Multiple Sclerosis;Overactive Detrusor

Drug: Darifenacin (BAY79-4998)

Bayer

NULL

Terminated

18 Years

N/A

Both

Phase 2

Germany

849

NCT00870155
(ClinicalTrials.gov)

February 2007

26/3/2009

A Study for Patients With Multiple Sclerosis

An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis

Drug: dirucotide

Eli Lilly and Company

BioMS Technology Corp.

Terminated

18 Years

65 Years

Both

546

Phase 2;Phase 3

Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom

850

EUCTR2006-002982-38-SK
(EUCTR)

12/01/2007

06/10/2006

Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245

Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a

Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

480

Phase 3

Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;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

851

EUCTR2006-002361-39-DE
(EUCTR)

01/12/2006

21/08/2006

A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity

Neurogenic overactive bladder disaese in patients with multiple sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10059617;Term: Overactive bladder

Trade Name: EMSELEX 7,5 mg Retardtabletten
Product Name: Darifenacin
Product Code: BAY 79-4998
INN or Proposed INN: Darifenacin
Trade Name: EMSELEX 15 mg Retardtabletten
Product Name: Darifenacin
Product Code: BAY 79-4998
INN or Proposed INN: Darifenacin

Bayer Vital GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany

852

EUCTR2006-002633-20-ES
(EUCTR)

01/12/2006

13/04/2012

Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente

Esclerosis múltiple remitente-recurrente
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: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)

GlaxoSmithKline S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Germany;Netherlands;France;Norway;Italy;Austria;Australia;Lithuania;Finland;United Kingdom;Russian Federation;Canada;New Zealand;Spain;Poland

853

NCT00428584
(ClinicalTrials.gov)

December 2006

29/1/2007

RNF and Betaseron® Tolerability Study

A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension

Relapsing Remitting Multiple Sclerosis (RRMS)

Drug: New Formulation of rebif - human interferon beta-1a;Drug: Interferon beta -1b

EMD Serono

Pfizer

Completed

18 Years

60 Years

All

129

Phase 3

United States

854

EUCTR2005-004061-41-HU
(EUCTR)

22/11/2006

20/12/2005

TYSABRI Long Term Re-Dosing Study

Multiple sclerosis (MS)
MedDRA version: 16.0;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: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

855

NCT00370071
(ClinicalTrials.gov)

November 2006

29/8/2006

Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis

Open Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple Sclerosis

Multiple Sclerosis

Drug: Interferon beta -1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

16 Years

55 Years

All

Phase 3

China

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

856

EUCTR2005-004061-41-GR
(EUCTR)

31/10/2006

28/07/2006

Multiple sclerosis (MS)
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden

857

EUCTR2005-005265-11-CZ
(EUCTR)

17/10/2006

24/08/2006

A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects.

Relief of central neuropathic pain in subjects with multiple sclerosis (MS)

Product Name: Sativex
Product Code: GW-1000-02
Other descriptive name: delta-9-tetrahydrocannabinol
Other descriptive name: Cannabidiol

GW Pharma Ltd

NULL

Not Recruiting

Female: yes
Male: yes

312

Phase a

United Kingdom;Czech Republic;France

858

NCT00516893
(ClinicalTrials.gov)

October 2006

14/8/2007

Natalizumab High Titer Immunogenicity and Safety

A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Biological: BG00002-E (natalizumab high titer)

Biogen

Elan Pharmaceuticals

Completed

18 Years

55 Years

All

113

Phase 2

United States

859

EUCTR2006-002037-20-ES
(EUCTR)

06/09/2006

07/07/2006

A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE

Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245

Teva Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

980

Phase 3

Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom

860

EUCTR2005-004061-41-BE
(EUCTR)

17/07/2006

29/11/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

521

Phase 3

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;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

861

NCT00638027
(ClinicalTrials.gov)

July 2006

10/3/2008

Memantine for Spasticity in MS Patients

Multiple Sclerosis

Drug: placebo;Drug: memantine

University of Rochester

Forest Laboratories

Completed

18 Years

70 Years

All

Phase 4

United States

862

EUCTR2005-005679-13-IT
(EUCTR)

28/06/2006

23/06/2006

An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - ND

multiple sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10053395

INN or Proposed INN: Naltrexone

OSPEDALE S. RAFFAELE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

863

EUCTR2005-001567-55-DE
(EUCTR)

23/06/2006

29/07/2005

A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis

This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation.

Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody

Protein Design Labs, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

United Kingdom;Germany;Spain

864

EUCTR2005-004061-41-DK
(EUCTR)

19/06/2006

09/01/2006

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;New Zealand;Sweden

865

EUCTR2005-004061-41-GB
(EUCTR)

01/06/2006

25/10/2005

TYSABRI Long Term Re-Dosing Study

Multiple sclerosis (MS)
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]

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Phase 3

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;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

866

NCT00648908
(ClinicalTrials.gov)

June 2006

28/3/2008

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial

Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial

Multiple Sclerosis

Drug: Fampridine -SR

Acorda Therapeutics

NULL

Completed

18 Years

70 Years

All

269

Phase 3

United States;Canada

867

EUCTR2005-004061-41-DE
(EUCTR)

18/05/2006

14/12/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

521

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

868

NCT00324506
(ClinicalTrials.gov)

May 2006

9/5/2006

Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis

A Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: Mycophenolate Mofetil (CellCept)

University of Texas Southwestern Medical Center

Aspreva Pharmaceuticals

Completed

18 Years

55 Years

Both

Phase 2

United States

869

EUCTR2005-005265-11-GB
(EUCTR)

03/04/2006

24/02/2006

A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects

Relief of central neuropathic pain in subjects with multiple sclerosis (MS)

GW Pharma Ltd

NULL

Not Recruiting

Female: yes
Male: yes

312

Phase 3

France;Czech Republic;United Kingdom

870

NCT00297232
(ClinicalTrials.gov)

March 2006

27/2/2006

Natalizumab (Tysabri) Re-Initiation of Dosing

An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation

Relapsing-Remitting Multiple Sclerosis

Drug: Natalizumab

Biogen

NULL

Terminated

18 Years

N/A

All

1094

Phase 3

Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria

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

871

NCT00306592
(ClinicalTrials.gov)

March 2006

31/1/2006

Natalizumab Re-Initiation of Dosing

An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation

Multiple Sclerosis, Relapsing-Remitting

Biological: BG00002 (natalizumab)

Biogen

Elan Pharmaceuticals

Completed

18 Years

N/A

All

404

Phase 3

United States;Canada

872

NCT00317941
(ClinicalTrials.gov)

March 2006

24/4/2006

Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif

The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).

Relapsing-remitting Multiple Sclerosis

Drug: Betaferon /Betaseron;Drug: Rebif

Bayer

NULL

Completed

18 Years

55 Years

All

220

Phase 4

France

873

EUCTR2005-004061-41-IT
(EUCTR)

24/02/2006

21/04/2006

Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatment

sclerosi multipla
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]

Trade Name: Tysabri
INN or Proposed INN: Natalizumab

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

700

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Australia;Germany;New Zealand;Sweden

874

EUCTR2005-004334-41-CZ
(EUCTR)

13/02/2006

12/01/2006

An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.

An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).

Relapsing Remitting Multiple Sclerosis (RRMS)
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: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

105

Phase 2

Hungary;Czech Republic;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom

875

EUCTR2005-004061-41-FI
(EUCTR)

10/02/2006

01/12/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;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

876

EUCTR2005-004334-41-GB
(EUCTR)

10/02/2006

31/10/2005

Relapsing Remitting Multiple Sclerosis (RRMS)
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]

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

105

Phase 2

Hungary;Czech Republic;Poland;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom

877

EUCTR2005-004061-41-CZ
(EUCTR)

26/01/2006

11/01/2006

TYSABRI Long Term Re-Dosing Study

Multiple sclerosis (MS)
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: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

878

EUCTR2005-004061-41-IE
(EUCTR)

20/01/2006

08/12/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

879

EUCTR2005-004334-41-DE
(EUCTR)

11/01/2006

21/11/2005

Relapsing Remitting Multiple Sclerosis (RRMS)
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: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

105

Phase 2

Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom

880

EUCTR2005-004334-41-ES
(EUCTR)

04/01/2006

10/11/2005

An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects

Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245

Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

310

Hungary;Czech Republic;Germany;United Kingdom;Spain;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

881

NCT00280592
(ClinicalTrials.gov)

January 2006

20/1/2006

Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.

Multiple Sclerosis;Urinary Tract Infections;Bladder Dysfunction

Drug: Cranberry;Drug: Placebo

Rennes University Hospital

Pierre Fabre Laboratories;Ministry of Health, France

Completed

18 Years

70 Years

Both

171

Phase 3

France

882

EUCTR2005-004334-41-HU
(EUCTR)

20/12/2005

04/11/2005

Relapsing Remitting Multiple Sclerosis (RRMS)
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]

Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

115

Phase 2

Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom

883

EUCTR2005-001567-55-GB
(EUCTR)

14/12/2005

24/08/2005

A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis

Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody

Protein Design Labs, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

Spain;Austria;Germany;United Kingdom

884

NCT00745615
(ClinicalTrials.gov)

December 7, 2005

2/9/2008

An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease

An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL)

Relapsing Remitting Multiple Sclerosis

Drug: Laquinimod;Drug: Placebo

Teva Pharmaceutical Industries, Ltd.

NULL

Terminated

18 Years

50 Years

All

257

Phase 2

Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic

885

NCT01142466
(ClinicalTrials.gov)

December 2005

10/6/2010

A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone

Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone

Multiple Sclerosis, Relapsing-Remitting

Drug: Interferon beta -1a (Rebif)

Merck KGaA

Gesellschaft für Therapieforschung mbH

Completed

18 Years

60 Years

All

Phase 4

NULL

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

886

NCT00676156
(ClinicalTrials.gov)

December 2005

7/5/2008

A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis

A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis

Multiple Sclerosis

Drug: oral lipoic acid (LA);Drug: lipoic acid (LA) with fish oil and LA without fish oil;Drug: R lipoic acid

Oregon Health and Science University

National Center for Complementary and Integrative Health (NCCIH)

Completed

18 Years

80 Years

Both

Phase 1

United States

887

EUCTR2005-004334-41-IT
(EUCTR)

30/11/2005

01/03/2006

An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).

Product Name: Laquinimod
Product Code: ABR-215062
INN or Proposed INN: LAQUINIMOD

Teva Pharmaceutical Industries Ldt

NULL

Not Recruiting

Female: yes
Male: yes

246

Phase 2

Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy

888

EUCTR2005-003410-15-SE
(EUCTR)

21/11/2005

29/09/2005

A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MS

Multiple sclerosis is a devastating inflammation in the central nervous system and it can often give cognitive dysfunction, affecting memory, mental concentration. Lately it has been shown that the cognitive dysfunction has a big impact on life quality. Immunomodulatory medication can only partially limit the bouts but there is no effective cure at the moment. There is little options to treat the effects on higher functions for the moment.

Trade Name: Aricept 5 mg filmdragerade tabletter
Product Name: Aricept 5 mg
INN or Proposed INN: Donepezil
Trade Name: Aricept 10 mg filmdragerade tabletter
Product Name: Aricept 10 mg
INN or Proposed INN: Donepezil

Neurology Unit

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

889

EUCTR2004-005148-28-DE
(EUCTR)

17/11/2005

16/05/2006

A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS

Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245

Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA

Merck Serono International, a branch of Laboratories Serono S.A.

NULL

Not Recruiting

Female: yes
Male: yes

1290

Phase 3

Finland;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Italy;Latvia;Lithuania

890

NCT00257855
(ClinicalTrials.gov)

November 2005

22/11/2005

A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis

A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis: Single Centre, Phase 2 Trial

Secondary Progressive Multiple Sclerosis

Drug: Lamotrigine

University College London Hospitals

NULL

Completed

18 Years

60 Years

Both

120

Phase 2

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

891

EUCTR2004-005148-28-GB
(EUCTR)

28/10/2005

20/04/2005

Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis

Merck Serono International, a branch of Laboratoires Serono S.A.

NULL

Not Recruiting

Female: yes
Male: yes

1290

Phase 3

Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom

892

EUCTR2005-001567-55-ES
(EUCTR)

18/10/2005

05/09/2005

A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple

Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody

Protein Design Labs, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

290

Phase 2

United Kingdom;Germany;Spain

893

EUCTR2005-001567-55-AT
(EUCTR)

27/09/2005

23/08/2005

A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis

Product Name: Daclizumab
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody

Protein Design Labs, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

Spain;Austria;Germany;United Kingdom

894

EUCTR2005-001949-42-GB
(EUCTR)

08/09/2005

04/07/2005

A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis

Multiple sclerosis

University College London

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United Kingdom

895

NCT00915577
(ClinicalTrials.gov)

August 2005

5/6/2009

Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe

An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects

Multiple Sclerosis

Drug: Interferon beta -1a;Device: Single-use autoinjector

Biogen Idec

NULL

Completed

18 Years

65 Years

Both

Phase 3

NULL

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

896

NCT00239993
(ClinicalTrials.gov)

August 2005

22/9/2005

A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.

Multiple Sclerosis

Drug: glatiramer acetate;Procedure: Warm compress prior to injection of glatiramer acetate

Teva Neuroscience, Inc.

NULL

Completed

18 Years

55 Years

All

Phase 4

United States

897

EUCTR2005-001026-89-DE
(EUCTR)

14/07/2005

13/05/2005

Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study)

Relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) with relapses
MedDRA version: 7.1;Level: LLT;Classification code 10028245

Trade Name: Rebif
Product Name: Rebif 8,8 µg, Rebif 22µg
INN or Proposed INN: Interferon beta -1 a
Trade Name: Rebif
Product Name: Rebif 44 µg
INN or Proposed INN: Interferon beta -1 a

Serono GmbH

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Germany

898

NCT00202423
(ClinicalTrials.gov)

July 2005

12/9/2005

Use of Cannabinoids in Patients With Multiple Sclerosis

fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis

Multiple Sclerosis

Drug: Sativex

S. Andrea Hospital

University of Roma La Sapienza

Recruiting

18 Years

60 Years

Both

Phase 2

Italy

899

EUCTR2005-000171-18-FI
(EUCTR)

12/05/2005

18/04/2005

A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/A

Multiple Sclerosis (Relapsing-remitting MS and Secondary progressive MS with relapses)

Product Name: Temsirolimus Tablets
Product Code: CCI-779
INN or Proposed INN: Temsirolimus
Other descriptive name: WAY-130799

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

180

Finland

900

EUCTR2004-003943-28-DE
(EUCTR)

06/04/2005

14/09/2005

A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects

Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245

Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Hungary;United Kingdom;Czech Republic;Germany;Spain;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

901

EUCTR2004-003943-28-CZ
(EUCTR)

21/03/2005

09/02/2005

Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245

Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy

902

EUCTR2004-003799-13-GB
(EUCTR)

16/03/2005

18/07/2005

A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS

Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245

Serono International SA

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 3

Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden

903

EUCTR2004-003799-13-LT
(EUCTR)

08/03/2005

27/12/2004

Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245

Product Name: Interferon-beta -1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta -1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)

Serono International SA

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 3b

United Kingdom;Spain;Ireland;Sweden;Lithuania

904

NCT00349193
(ClinicalTrials.gov)

March 2005

26/6/2006

A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod

A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects

Relapsing Remitting Multiple Sclerosis

Drug: laquinimod 0.3;Drug: laquinimod 0.6;Other: Placebo

Teva Pharmaceutical Industries

NULL

Completed

18 Years

50 Years

Both

306

Phase 2

Italy

905

EUCTR2004-003799-13-DK
(EUCTR)

24/02/2005

18/01/2005

Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245

Serono International SA

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 3

Spain;Ireland;Lithuania;Denmark;United Kingdom;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

906

EUCTR2004-003943-28-GB
(EUCTR)

18/02/2005

22/02/2005

Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom

907

EUCTR2004-003799-13-ES
(EUCTR)

17/02/2005

04/11/2005

Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245

Trade Name: Rebif
Product Name: Interferon-beta -1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta -1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)

Serono International SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

230

Phase 3b

United Kingdom;Ireland;Spain;Lithuania;Sweden

908

EUCTR2004-003943-28-ES
(EUCTR)

17/02/2005

09/12/2005

Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245

Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy

909

EUCTR2004-003943-28-HU
(EUCTR)

14/02/2005

13/12/2004

Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245

Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt

Teva Pharmaceutical Industries Ltd

NULL

Not Recruiting

Female: yes
Male: yes

265

Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy

910

EUCTR2004-003799-13-SE
(EUCTR)

03/02/2005

23/12/2004

Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245

Serono International SA

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 3b

United Kingdom;Spain;Ireland;Lithuania;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

911

EUCTR2004-003943-28-IT
(EUCTR)

19/01/2005

02/02/2005

A multinational,multicenter,randomized,double-blind,parallel-group,placebo-controlled study,to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R)multiple sclerosis (MS) subjects.

relapsing remitting multiple sclerosis subjects with an active lesion on MRI
MedDRA version: 6.1;Level: PT;Classification code 10048393

Trade Name: CITOCHINE ED IMMUNOMODULATORI
Product Name: LAQUINIMOD
Product Code: ABR-215062
INN or Proposed INN: LAQUINIMOD

TEVA

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy

912

EUCTR2004-004519-43-CZ
(EUCTR)

12/01/2005

04/02/2005

Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

Product Code: RO0506997
Product Code: RO0506997
Product Code: RO0506997

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

Germany;United Kingdom;Czech Republic;Spain

913

NCT00139789
(ClinicalTrials.gov)

January 2005

29/8/2005

A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis

Multiple Sclerosis

Drug: Kemstro

UCB Pharma

NULL

Completed

18 Years

65 Years

Both

Phase 3

United States

914

NCT00110396
(ClinicalTrials.gov)

January 2005

6/5/2005

Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis

A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Biological: Interferon-beta -1a FBS-free/HSA-free

EMD Serono

Pfizer

Completed

18 Years

60 Years

All

260

Phase 3

United States

915

NCT00203099
(ClinicalTrials.gov)

December 2004

13/9/2005

Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine

A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS)

Relapse Remitting Multiple Sclerosis

Drug: Glatiramer Acetate, N-Acetylcysteine

Teva Pharmaceutical Industries

NULL

Completed

18 Years

50 Years

Both

Phase 2

Canada

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

916

NCT00151294
(ClinicalTrials.gov)

November 2004

6/9/2005

The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis

Depression;Multiple Sclerosis

Drug: escitalopram oxalate antidepressant

Weill Medical College of Cornell University

Forest Laboratories

Terminated

18 Years

N/A

Both

Phase 4

United States

917

EUCTR2004-000759-40-IT
(EUCTR)

22/10/2004

15/02/2005

A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.

Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit.
MedDRA version: 6.1;Level: PT;Classification code 10028245

Product Name: glatiramer acetate
Product Code: TV-5010
INN or Proposed INN: Glatiramer acetate

TEVA

NULL

Not Recruiting

Female: yes
Male: yes

Italy

918

EUCTR2004-000463-94-IT
(EUCTR)

11/10/2004

16/02/2005

Subject with relapsing remitting multiple sclerosis. Subject must have at least one documented relapse within one year prior to screening visit
MedDRA version: 6.1;Level: PT;Classification code 10028245

Product Name: glatiramer acetate
Product Code: GA
INN or Proposed INN: Glatiramer acetate

TEVA

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Italy

919

EUCTR2004-000762-13-IT
(EUCTR)

31/08/2004

31/08/2012

A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.

Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit.
MedDRA version: 15.0;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: Glatiramer acetate
Product Code: TV-5010
INN or Proposed INN: Glatiramer acetate

TEVA ITALIA srl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

920

NCT00220922
(ClinicalTrials.gov)

August 2004

20/9/2005

A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®

Multiple Sclerosis

Procedure: Alcohol Wipes vs. No Alcohol Wipes

Teva Neuroscience, Inc.

NULL

Completed

18 Years

N/A

Both

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

921

EUCTR2004-000462-13-IT
(EUCTR)

30/07/2004

17/09/2004

A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).

Subjects with Relapsing-Remitting Multiple Sclerosis.Subjects must have had at least one documented relapse within one year prior to screening visit
MedDRA version: 6.1;Level: PT;Classification code 10028245

Product Name: glatiramer acetate
Product Code: GA
INN or Proposed INN: Glatiramer acetate

TEVA

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Italy

922

EUCTR2004-000047-18-SE
(EUCTR)

27/07/2004

28/06/2004

An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803.

Male and female subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803

Product Name: natalizumab
Product Code: AN100226
INN or Proposed INN: natalizumab

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1900

Sweden

923

EUCTR2004-000337-12-HU
(EUCTR)

23/07/2004

29/09/2004

A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study

MS with 2 or more relapses within the last 2 years
MedDRA version: 7.0;Level: PT;Classification code 10028245

Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta -1a
Other descriptive name: Recombinant human interferon beta
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta -1a
Other descriptive name: Recombinant human interferon beta

Serono International SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 4

Hungary

924

EUCTR2004-000462-13-HU
(EUCTR)

12/07/2004

Relapsing-remitting multiple sclerosis (R-R MS)
MedDRA version: 5.1;Level: PT;Classification code 10028245

Product Name: Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: COP -1 /Copolymer-1

TEVA Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Italy

925

NCT00493077
(ClinicalTrials.gov)

May 2004

25/6/2007

Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy

A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy

Multiple Sclerosis

Drug: low immunogenic interferon-beta-1a

Biogen Idec

NULL

Completed

18 Years

55 Years

Both

Phase 4

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

926

NCT00300716
(ClinicalTrials.gov)

April 2004

8/3/2006

Trial of Memantine for Cognitive Impairment in Multiple Sclerosis

Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis

Multiple Sclerosis;Cognition Disorders

Drug: Memantine

Oregon Health and Science University

Forest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub Seattle

Completed

18 Years

65 Years

All

Phase 2;Phase 3

United States

927

NCT00078338
(ClinicalTrials.gov)

March 2004

23/2/2004

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis

Relapsing-remitting Multiple Sclerosis

Drug: Human interferon beta -1a and glatiramer acetate

EMD Serono

Pfizer

Completed

18 Years

60 Years

Both

764

Phase 4

United States;Argentina;Austria;Brazil;France;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;United Kingdom

928

NCT00501748
(ClinicalTrials.gov)

January 2004

12/7/2007

Safety and Tolerability of Rituximab in Neuromyelitis Optica

Open Label Study of Safety and Tolerability of Rituximab in Neuromyelitis Optica, Recurrent Transverse Myelitis and Recurrent Bilateral Simultaneous Optic Neuritis

Neuromyelitis Optica

Drug: Rituximab

University of California, San Francisco

Genentech, Inc.

Completed

12 Years

86 Years

Both

Phase 1

United States

929

NCT00276172
(ClinicalTrials.gov)

December 2003

11/1/2006

Open-Label Natalizumab Safety Extension Study

An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803

Multiple Sclerosis

Drug: Natalizumab

Biogen Idec

NULL

Completed

18 Years

N/A

Both

1615

Phase 3

United States

930

NCT00246324
(ClinicalTrials.gov)

December 2003

27/10/2005

Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis

An Open Label Trial of Safety and Efficacy of Combination Therapy With Interferon-B-1a and Oral Doxycycline in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis

Drug: Interferon beta 1a , oral doxycycline

Louisiana State University Health Sciences Center Shreveport

Biogen

Completed

18 Years

55 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

931

NCT00654927
(ClinicalTrials.gov)

November 2003

4/4/2008

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis

Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis

Multiple Sclerosis

Drug: Fampridine -SR b.i.d. (Twice Daily)

Acorda Therapeutics

NULL

Completed

18 Years

70 Years

All

177

Phase 3

United States;Canada

932

NCT00493116
(ClinicalTrials.gov)

October 2003

25/6/2007

Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta

A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability

Relapsing-Remitting Multiple Sclerosis

Drug: Interferon-beta -1a;Drug: methylprednisolone

Biogen Idec

NULL

Completed

18 Years

55 Years

Both

Phase 4

Australia;New Zealand

933

NCT00203073
(ClinicalTrials.gov)

June 2003

13/9/2005

A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.

Relapsing Remitting Multiple Sclerosis

Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg , with mitoxantrone

Teva Pharmaceutical Industries

NULL

Completed

18 Years

55 Years

Both

Phase 2

United States;Canada

934

NCT00235989
(ClinicalTrials.gov)

June 2003

10/10/2005

Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis, Relapsing-Remitting

Drug: Interferon beta 1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

18 Years

55 Years

All

Phase 2

United States

935

NCT00095329
(ClinicalTrials.gov)

May 2003

2/11/2004

Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor

A Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple Sclerosis

Multiple Sclerosis (MS) - Relapsing-remitting

Biological: sirolimus

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Terminated

18 Years

58 Years

Both

Phase 1;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

936

NCT00492466
(ClinicalTrials.gov)

March 2003

25/6/2007

Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies

A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies

Relapsing-Remitting Multiple Sclerosis

Drug: Interferon-beta -1a;Drug: methylprednisolone

Biogen Idec

NULL

Completed

18 Years

55 Years

Both

Phase 4

Finland

937

NCT00298662
(ClinicalTrials.gov)

February 2003

2/3/2006

Combination Therapy of Betaseron-Prograf in Multiple Sclerosis

A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents

Multiple Sclerosis

Drug: Interferon beta -1b and Tacrolimus

Clinique de sclérose en plaques et neuromusculaire de l'Outaouais

NULL

Active, not recruiting

18 Years

55 Years

Both

Phase 2

Canada

938

NCT00912860
(ClinicalTrials.gov)

January 2003

2/6/2009

Immunogenicity and Safety Study of Serum-Free Avonex

A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: Interferon beta -1a

Biogen Idec

NULL

Completed

18 Years

60 Years

Both

155

Phase 2

NULL

939

NCT00050778
(ClinicalTrials.gov)

December 2002

19/12/2002

A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Biological: Interferon beta -1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg

Genzyme, a Sanofi Company

Bayer

Completed

18 Years

50 Years

All

334

Phase 2

United States;Croatia;Poland;Russian Federation;United Kingdom

940

NCT00913666
(ClinicalTrials.gov)

November 2002

2/6/2009

Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers

A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects

Multiple Sclerosis

Drug: Interferon beta -1a (Avonex)

Biogen Idec

NULL

Completed

18 Years

65 Years

Both

121

Phase 4

NULL

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

941

NCT00185211
(ClinicalTrials.gov)

August 2002

9/9/2005

BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study

Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.

Multiple Sclerosis

Drug: Interferon beta -1b (Betaseron, BAY86-5046)

Bayer

NULL

Completed

18 Years

48 Years

All

468

Phase 3

Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom

942

NCT00587691
(ClinicalTrials.gov)

July 2002

21/12/2007

Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive

Biological: Tovaxin Autologous T Cell Vaccine

Opexa Therapeutics, Inc.

NULL

Completed

18 Years

65 Years

All

Phase 1;Phase 2

United States

943

NCT00047580
(ClinicalTrials.gov)

June 2002

8/10/2002

Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.

A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe Spasticity

Multiple Sclerosis;Muscle Spasticity;Spinal Cord Injury;Stroke

Drug: tizanidine hydrochloride capsule

Elan Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

120

Phase 3

United States

944

NCT00037115
(ClinicalTrials.gov)

May 2002

15/5/2002

Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event.

An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results.

Demyelinating Disorders;Multiple Sclerosis;Optic Neuritis;Myelitis;Neuritis

Drug: interferon beta 1a;Drug: methotrexate;Drug: methylprednisolone

MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute

Consultants in Neurology

Withdrawn

18 Years

50 Years

All

Phase 4

United States

945

NCT01606137
(ClinicalTrials.gov)

February 2002

21/5/2012

A Study of the Long-term Safety of Sativex Use

A Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine.

Multiple Sclerosis;Spasticity;Pain

Drug: GW-1000-02

GW Pharmaceuticals Ltd.

NULL

Completed

18 Years

N/A

All

507

Phase 3

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

946

NCT00037102
(ClinicalTrials.gov)

July 2001

15/5/2002

Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis

An Open Label Study of the Safety and Efficacy of Combination Therapy With AVONEX and Bi-Monthly High Dose Intravenous Methotrexate With Leucovorin Rescue in the Treatment of Multiple Sclerosis

Multiple Sclerosis

Drug: interferon beta 1a;Drug: methotrexate

MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute

Consultants in Neurology;Biogen

Completed

18 Years

60 Years

All

Phase 4

United States

947

NCT01610687
(ClinicalTrials.gov)

July 2001

31/5/2012

A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

A Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension

Multiple Sclerosis;Spasticity

Drug: GW-1000-02

GW Pharmaceuticals Ltd.

NULL

Completed

18 Years

N/A

All

137

Phase 3

United Kingdom

948

NCT01610700
(ClinicalTrials.gov)

May 2001

31/5/2012

An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients

Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension

Multiple Sclerosis

Drug: GW-1000-02;Drug: Placebo

GW Pharmaceuticals Ltd.

NULL

Completed

18 Years

N/A

All

160

Phase 3

United Kingdom

949

NCT01610713
(ClinicalTrials.gov)

May 2001

31/5/2012

An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension

Multiple Sclerosis

Drug: GW-1000-02

GW Pharmaceuticals Ltd.

NULL

Completed

18 Years

N/A

All

154

Phase 3

United Kingdom

950

NCT00011375
(ClinicalTrials.gov)

February 2001

16/2/2001

Rolipram to Treat Multiple Sclerosis

Safety, Tolerability & Effects of Rolipram on Inflammatory Activity in the Central Nervous System in Multiple Sclerosis. A Phase II, Open Label Crossover Trial Using MRI as an Outcome Measure

Multiple Sclerosis

Drug: Rolipram

National Institute of Neurological Disorders and Stroke (NINDS)

NULL

Completed

N/A

Both

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

951

NCT00292266
(ClinicalTrials.gov)

November 1999

13/2/2006

A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)

An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: Rebif ®;Drug: Avonex ®

EMD Serono

Merck Serono International SA

Completed

18 Years

55 Years

Both

677

Phase 3

NULL

952

NCT00915460
(ClinicalTrials.gov)

September 1999

5/6/2009

Open-Label Safety Extension Study of Avonex

An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830

Multiple Sclerosis

Drug: Interferon beta -1a (Avonex)

Biogen Idec

NULL

Completed

N/A

Both

408

Phase 4

NULL

953

NCT00001781
(ClinicalTrials.gov)

February 1998

3/11/1999

Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS)

Open-Label Baseline vs. Treatment Trial Evaluating the Safety, Tolerability and Effect on MRI Lesion and Immunology Parameters of CGP 77116 in Patients With Multiple Sclerosis Mark

Multiple Sclerosis

Drug: CGP 77116

National Institute of Neurological Disorders and Stroke (NINDS)

NULL

Completed

N/A

Both

Phase 2

United States

954

NCT00203021
(ClinicalTrials.gov)

March 26, 1994

12/9/2005

Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone

Relapsing-Remitting Multiple Sclerosis

Drug: Glatiramer acetate

Teva Branded Pharmaceutical Products R&D, Inc.

NULL

Completed

18 Years

N/A

All

208

Phase 4

United States

955

EUCTR2009-014724-32-DE
(EUCTR)

26/10/2010

Boswellic Acids in Multiple Sclerosis

SAFETY, TOLERABILITY AND MECHANISM OF ACTION OF BOSWELLIC ACIDS (BA) IN MULTIPLE SCLEROSIS (MS) AND CLINICALLY ISOLATED SYNDROME (CIS): A MRI-CONTROLLED, MULTICENTER, BASELINE-TO-TREATMENT, 32-WEEKS, OPEN-LABEL, PHASE IIA TRIAL IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS OR CLINICALLY ISOLATED SYNDROME - SABA

Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

University Medical Center Eppendorf

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

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

956

EUCTR2018-003008-38-FR
(EUCTR)

29/03/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

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

Female: yes
Male: yes

142

Phase 3

957

EUCTR2008-007015-32-DE
(EUCTR)

03/03/2009

A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase

cognitive impairment in Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
INN or Proposed INN: Rivastigmin
Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
INN or Proposed INN: Rivastigmin
Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
INN or Proposed INN: Rivastigmin
Trade Name: Exelon transdermales Pflaster
Product Name: Exelon
Product Code: ENA713
INN or Proposed INN: Rivastigmin

Novartis Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase A

Germany

958

EUCTR2008-000499-25-DE
(EUCTR)

13/05/2008

Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Product Name: Rebif New Formulation 44mcg multidose cartridge
INN or Proposed INN: INTERFERON BETA -1A

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3b

Germany;Spain;Italy;Sweden

959

EUCTR2011-005249-12-Outside-EU/EEA
(EUCTR)

10/05/2016

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Genzyme Corporation

NULL

Female: yes
Male: yes

165

Phase 3

Tunisia;Turkey;United States;Australia;Bosnia and Herzegovina;Canada;China;Israel;Lebanon;Morocco;Russian Federation

960

EUCTR2018-003008-38-CZ
(EUCTR)

06/03/2019

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

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

Female: yes
Male: yes

142

Phase 3

Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;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

961

EUCTR2016-003100-30-PL
(EUCTR)

21/07/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

962

EUCTR2015-000137-78-AT
(EUCTR)

17/09/2015

Mesenchymal stem cells therapy for patients with multiple sclerosis

Randomised, double-blind, cross-over phase II study with intravenous autologous mesenchymal stem cells vs. placebo for multiple sclerosis patients in Austria (MESEMS Austria)

multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Human autologous mesenchymal stem cells
INN or Proposed INN: MSC2015
Other descriptive name: UNDIFFERENTIATED AUTOLOGOUS MESENCHYMAL STEM CELLS

SALK - Gemeinnützige Salzburger Landeskliniken Betriebsges. m.b.H., Christian-Doppler-Klinik, UK für Neurologie der PMU

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Austria

963

EUCTR2017-005129-18-IT
(EUCTR)

26/03/2018

Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis.

Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis.

Relapsing-remitting multiple sclerosis with paediatric onset
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]

Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: AVONEX 30 µg/0,5 ml solution for injection
INN or Proposed INN: Interferon beta -1a
Other descriptive name: INTERFERON BETA -1A

Università degli Studi Aldo Moro

NULL

Female: yes
Male: yes

142

Phase 3

Italy

964

EUCTR2016-003100-30-FR
(EUCTR)

17/07/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

965

EUCTR2014-004613-93-Outside-EU/EEA
(EUCTR)

12/01/2015

Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosis

Open label study to evaluate the effect, safety and tolerability of 250µg (8 MIU) interferon beta 1b (Betaferon) given subcutaneously every other day (for 24 weeks) in patients of Chinese origin with multiple sclerosis

Multiple sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Betaseron
Product Code: BAY86-5046
INN or Proposed INN: INTERFERON BETA -1B

Bayer HealthCare AG

NULL

Female: yes
Male: yes

China

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

966

EUCTR2009-016442-74-ES
(EUCTR)

22/12/2009

Trasplante autólogo de células madre mesenquimales en esclerosis múltiple: ensayo clínico fase II aleatorizado, enmascarado y cruzado con placebo.

Esclerosis Múltiple
MedDRA version: 9;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive

Product Name: Células madre mesenquimales
INN or Proposed INN: Células madre mesenquimales

Fundació Clínic per a la Recerca Biomèdica

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

967

EUCTR2011-005249-12-BG
(EUCTR)

13/01/2017

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

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]

Genzyme Corporation

NULL

Female: yes
Male: yes

165

Phase 3

968

EUCTR2011-001692-39-DE
(EUCTR)

08/06/2011

A study to evaluate the safety and tolerability of the combination of an antidepressive therapy with oral fingolimod in the treatment of relapsing remitting multiple sclerosis patients with mild to moderate depression

A 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depression

Multiple SclerosisDepression
MedDRA version: 14.1;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1;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: Gilenya
Product Name: Gilenya
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
Trade Name: Gilenya
Product Name: Gilenya
Other descriptive name: FINGOLIMOD HYDROCHLORIDE

Novartis Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany

969

EUCTR2006-005270-47-DE
(EUCTR)

09/02/2007

relapsing multiple sclerosis

Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta -1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta -1b

Bayer Schering Pharma

NULL

Not Recruiting

Female: yes
Male: yes

1880

Phase 3b

Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

970

EUCTR2012-003056-36-NL
(EUCTR)

21/09/2012

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Novartis Pharma Services AG

NULL

Female: yes
Male: yes

1530

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Latvia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;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

971

EUCTR2004-003799-13-IE
(EUCTR)

13/01/2005

Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245

Serono International SA

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 3

Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden

972

EUCTR2016-003100-30-Outside-EU/EEA
(EUCTR)

16/06/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Female: yes
Male: yes

Phase 3

Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Greece;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation

973

EUCTR2011-005249-12-IE
(EUCTR)

21/06/2016

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 3

Portugal;United States;Estonia;Slovenia;Morocco;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Tunisia;China;Bosnia and Herzegovina

974

EUCTR2016-003100-30-BG
(EUCTR)

02/06/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway